2020 Annual Report
Dear Stockholders,
This is my first of hopefully many letters to come. As the President and CEO of CareDx, I am honored to be leading this
remarkable company. CareDx has invested in building a strong foundation over the last two decades by being a leading
innovator and partner in the transplant ecosystem. We plan to continue driving this incredible mission to improve
outcomes for transplant patients.
In 2020, the entire world was stopped in its tracks by the COVID-19 pandemic. As the world’s largest publicly traded
company dedicated to transplantation, we at CareDx recognized our obligation to our patients during this time of
change and chaos. By focusing on patients, we provided new ways to monitor transplant health despite the
unprecedented challenges of the pandemic and built a sustainable path to provide best-in-class services to every
patient.
I would like to share three new ways in which CareDx further accelerated its strategy to be the leading partner in the
transplant patient journey during 2020.
The first is with our support of the patient. Within a week of the onset of the March 2020 shutdowns due to COVID, we
were able to build and launch an offering called RemoTraC, a mobile phlebotomy solution for transplant patients, which
today is used by patients associated with more than 150 transplant centers. This implementation excellence was only
possible because of the long-standing relationship and trust we had already established with centers given our singular
focus on all things transplant. We have since furthered our relationship with the patient by offering a transplant-specific
smartphone app called AlloCare. By adding RemoTraC and AlloCare to the existing patient-centric approach of our
patients care managers, we can now assist more patients through their transplant journey from access to testing
without safety or transportation concerns, day-to-day medication compliance tracking and appointment reminders.
The second is continuing to lead with innovation as we received the first multi-modality approval through MolDx, with
the recent approval of HeartCare. This continues our tradition of being a leader in transplant. We were the first in
transplant to have gene-expression profiling technology approved for use, and the first to bring donor-derived cell free
DNA to the clinic. Now, we are the first to bring multi-modality as a unified offering, to increase clinical utility. We are
proud to have helped bring innovation and continue to elevate the focus around the field of transplant.
The third is with the rapid progression of our rich program pipeline into new areas. In 2020, we continued to broaden
our portfolio across the transplant continuum. We submitted AlloSure Lung to MolDx for reimbursement approval. We
also started our new cell therapy and stem cell business with AlloCell and AlloSeq HCT. With our strong pipeline, we
expect to deliver new clinical solutions for solid organ, stem cell and cell therapy transplant patients for years to come.
I am proud of the entire CareDx team. Despite the pandemic, this team delivered outstanding results in 2020, expanded
the portfolio, improved our connection with patients, and acted as a leader should by putting patients first with our
decision-making.
We have both a tremendous opportunity and responsibility at CareDx to continue to improve transplant patient
outcomes. I am energized by our mission every day and look forward to this challenge in the years to come as we
continue on this gratifying journey.
Warm regards,
Dr. Reg Seeto
President and 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 001-36536
________________________________________________________________________________________________________
CAREDX, INC.
(Exact Name of Registrant as Specified in its Charter)
________________________________________________________________________________________________________
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
94-3316839
(I.R.S. Employer
Identification Number)
1 Tower Place
South San Francisco, California 94080
(Address of Principal Executive Offices, Including Zip Code)
(415) 287-2300
(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, par value $0.001 per share
CDNA
The Nasdaq Stock Market LLC
Securities Registered Pursuant to Section 12(g) of the Act: None
________________________________________________________________________________________________________
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an
emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer
Non-accelerated filer
☒
☐
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 the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of a share
of the registrant’s common stock on June 30, 2020, the last business day of the registrant's most recently completed second fiscal quarter, as reported
by the Nasdaq Global Market on such date was approximately $1.7 billion. Shares of the registrant’s common stock held by each executive officer,
director and holder of 10% or more of the outstanding common stock have been excluded in that such persons may be deemed to be affiliates. This
calculation does not reflect a determination that certain persons are affiliates of the registrant for any other purpose.
The number of shares of the registrant’s Common Stock outstanding as of February 22, 2021 was 51,822,662.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s Proxy Statement relating to the 2021 Annual Meeting of Stockholders, are incorporated by reference into Part III of this
Annual Report on Form 10-K where indicated. Such Proxy Statement, or an amendment to this Annual Report on Form 10-K, will be filed with the
Securities and Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2020.
TABLE OF CONTENTS
Item No.
PART I
Item 1. Business
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Mine Safety Disclosures
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6. Selected Financial Data
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A. Controls and Procedures
Item 9B. Other Information
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14. Principal Accountant Fees and Services
PART IV
Item 15. Exhibits, Financial Statement Schedules
Item 16. Form 10-K Summary
Signatures
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2 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this
Annual Report on Form 10-K other than statements of historical fact, including statements regarding our future results of
operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking
statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,”
“would,” “project,” “plan,” “target,” “contemplate,” “predict,” “expect” and the negative and plural forms of these words and
similar expressions are intended to identify forward-looking statements.
These forward-looking statements may include, but are not limited to, statements concerning the following:
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the potential impact to our business, revenue, financial condition and employees, including
disruptions to our testing services, laboratories, clinical trials, supply chain and operations, due to the
COVID-19 global pandemic;
our ability to take advantage of opportunities under the Coronavirus Aid, Relief, and Economic
Security Act, or the CARES Act, and the potential impact of the CARES Act on our business, results
of operations, financial condition or liquidity.
our ability to generate revenue and increase the commercial success of our current and future testing
services, products and digital solutions;
our ability to obtain, maintain and expand reimbursement coverage from payers for our current and
other future testing services, if any;
our plans and ability to continue updating our testing services, products and digital solutions to
maintain our leading position in transplantations;
the outcome or success of our clinical trial collaborations and registry studies, including Kidney
Allograft Outcomes AlloSure Registry, or K-OAR, the Outcomes of KidneyCare™ on Renal
Allografts registry study, or OKRA, and the Surveillance HeartCare Outcomes Registry, or SHORE;
the favorable review of our testing services and product offerings, and our future solutions, if any, in
peer-reviewed publications;
our ability to obtain additional financing on terms favorable to us, or at all;
our anticipated cash needs and our anticipated uses of our funds, including our estimates regarding
operating expenses and capital requirements;
anticipated trends and challenges in our business and the markets in which we operate;
our dependence on certain of our suppliers, service providers and other distribution partners;
disruptions to our business, including disruptions at our laboratories and manufacturing facilities;
our ability to retain key members of our management team;
our ability to make successful acquisitions or investments and to manage the integration of such
acquisitions or investments;
our ability to expand internationally;
our compliance with federal, state and foreign regulatory requirements;
our ability to protect and enforce our intellectual property rights, our strategies regarding filing
additional patent applications to strengthen our intellectual property rights, and our ability to defend
against intellectual property claims that may be brought against us;
our ability to successfully assert, defend against or settle any litigation brought by or against us or
other legal matters or disputes; and
our ability to comply with the requirements of being a public company.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in
the section entitled “Risk Factors” included in Part I, Item 1A and elsewhere in this Annual Report on Form 10-K. Moreover,
we operate in a very competitive and rapidly changing environment, and 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 and adversely from those contained in any
forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this report may not occur and actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements.
3 You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover,
neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements.
Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after
the date of this report to conform these statements to actual results or to changes in our expectations.
You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K
and have filed with the Securities and Exchange Commission, or the SEC, as exhibits to this Annual Report on Form 10-K with
the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially
different from what we expect. We qualify all forward-looking statements by these cautionary statements.
4 ITEM 1. BUSINESS
Company Overview
PART I
CareDx, Inc., or “CareDx” or the “Company” or “we” or “us” and “our”, together with our subsidiaries, is a leading precision
medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value
diagnostic solutions for transplant patients and caregivers. We offer testing services, products, and digital solutions along the
pre- and post-transplant patient journey, and are a leading provider of genomics-based information for transplant patients. Our
headquarters are in South San Francisco, California. Our primary operations are in Brisbane, California; Omaha, Nebraska;
Fremantle, Australia and Stockholm, Sweden.
Our commercially available testing services consist of AlloSure® Kidney, which is a donor-derived cell-free DNA, or dd-
cfDNA solution for kidney transplant patients, AlloMap® Heart, which is a gene expression solution for heart transplant
patients, and AlloSure® Heart, which is a dd-cfDNA test that can identify underlying cell injury leading to organ rejection. We
have initiated several clinical studies to generate data on our existing and planned future testing services. In April 2020, we
announced our first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of engraftment
and persistence of allogeneic cells for patients who have received cell therapy transplants. We also offer high quality products
that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and
organs. In 2019, we began providing digital solutions to transplant centers following the acquisitions of Ottr Complete
Transplant Management, or Ottr, Inc. and XynManagement, Inc., or XynManagement. During the year 2020, we performed
more than 79,000 commercial AlloSure Kidney, AlloMap Heart and AlloSure Heart tests from our Brisbane, California,
laboratory. According to the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation
Network, there are approximately 346 and 216 centers performing kidney and heart transplants, respectively, in the United
States.
Testing Services
We develop and provide a diagnostic surveillance testing service for kidney and heart transplant recipients.
Kidney
AlloSure Kidney, our transplant surveillance solution, was commercially launched in October 2017 and is our dd-cfDNA
offering built on a Next Generation Sequencing, or NGS, platform. In transplantation, 109 papers from 55 studies globally have
shown the value of dd-cfDNA in the management of solid organ transplantation. AlloSure Kidney is able to discriminate dd-
cfDNA from recipient-cell-free DNA, targeting polymorphisms between donor and recipient. This single-nucleotide
polymorphism, or SNPs, approach across all the somatic chromosomes is specifically designed for transplantation, allowing a
scalable, high-quality test to differentiate dd-cfDNA.
AlloSure Kidney has received positive coverage decisions for reimbursement from Medicare. The Medicare reimbursement rate
for AlloSure Kidney is currently $2,841. AlloSure Kidney has received positive coverage decisions from Blue Cross Blue
Shield, or BCBS of South Carolina, BCBS of Kansas City and Capital Health, and is reimbursed by other private payers on a
case-by-case basis.
Multiple studies have demonstrated that significant allograft injury can occur in the absence of changes in serum creatinine.
Thus, clinicians have limited ability to detect injury early and intervene to prevent long term damage using this marker. While
histologic analysis of the allograft biopsy specimen remains the standard method used to assess injury and differentiate rejection
from other injury in kidney transplants, as an invasive test with complications, repetitive biopsies are not well tolerated.
AlloSure Kidney provides a non-invasive test, assessing allograft injury that enables more frequent, quantitative and safer
assessment of allograft rejection and injury status. Beyond allograft rejection, the assessment of molecular inflammation has
shown further utility in the assessment of proteinuria, the formation of De Novo donor specific antibodies, or DSAs, and as a
surrogate predictive measure of estimated glomerular filtration rate, or eGFR, decline. Monitoring of graft injury through
AlloSure Kidney allows clinicians to optimize allograft biopsies, identify allograft injury and guide immunosuppression
management more accurately.
Since the analytical validation paper in the Journal of Molecular Diagnostics in 2016, before the commercial launch of AlloSure
Kidney, there has been an increasing body of evidence supports the use of AlloSure Kidney dd-cfDNA in the assessment and
surveillance of kidney transplants. Bloom et al, the lead authors on the cfDNA and Active Rejection in Kidney Allografts paper,
evaluated 102 kidney recipients and demonstrated that dd-cfDNA levels could discriminate accurately and non-invasively
distinguish rejection from other types of graft injury. In contrast, serum creatinine has area under the curve, or AUC, of 50%,
showing no significant difference between patients with and without rejection.
5 Multiple publications and abstracts have shown AlloSure Kidney’s value in the management of BK viremia, as well as
numerous pathologies that cause molecular inflammation and injury such as DSAs and eGFR decline. Most recently its utility
in the assessment of T-cell mediated rejection (TCMR) 1A and borderline rejection has also been published in the American
Journal of Transplant, or the AJT.
The prospective multicenter trial, the Kidney Allograft Outcomes AlloSure Kidney Registry study, or K-OAR, has enrolled
over 1,700 patients, with plans to survey patients with AlloSure Kidney for 3 years and provide further clinical utility of
AlloSure Kidney in the surveillance of kidney transplant recipients.
KidneyCare
KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap
Kidney and the predictive artificial intelligence technology of KidneyCare iBox in one surveillance solution. We have not yet
made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare iBox.
In September 2019, we announced the enrollment of the first patient in the Outcomes of KidneyCare on Renal Allografts, or
OKRA, study, which is an extension of the K-OAR study. OKRA is a prospective, multi-center, observational registry of
patients receiving KidneyCare for surveillance. Combined with K-OAR, 4,000 patients will be enrolled into the study.
Heart
AlloMap Heart is a gene expression test that helps clinicians monitor and identify heart transplant recipients with stable graft
function who have a low probability of moderate-to-severe acute cellular rejection. Since 2008, we have sought to expand the
adoption and utilization of our AlloMap Heart solution through ongoing studies to substantiate the clinical utility and
actionability of AlloMap Heart, secure positive reimbursement decisions from large private and public payers, develop and
enhance our relationships with key members of the transplant community, including opinion leaders at major transplant centers,
and explore opportunities and technologies for the development of additional solutions for post-transplant surveillance.
We believe the use of AlloMap Heart, in conjunction with other clinical indicators, can help healthcare providers and their
patients better manage long-term care following a heart transplant, can improve patient care by helping healthcare providers
avoid the use of unnecessary, invasive surveillance biopsies and may help to determine the appropriate dosage levels of
immunosuppressants. In 2008, AlloMap Heart received 510(k) clearance from the U.S. Food and Drug Administration, or the
FDA, for marketing and sale as a test to aid in the identification of heart transplant recipients, who have a low probability of
moderate/severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment. The 510(k)
clearance from the FDA is also for an In Vitro Diagnostic Multivariate Index Assay, or IVDMIA. AlloMap Heart Score
Variability, or AMV, is an additional service we offer providing complementary information to help personalize long-term care
of heart transplant recipients. It is available only upon request by clinicians. A patient’s AMV is based on the variability of a
patient’s AlloMap Heart scores over time and may be used as a risk stratification tool in estimating the probability that one or
more of the clinical events in heart transplant recipients may occur in the future. AMV may be computed from four AlloMap
Heart test results within a 24-month period. In addition, the clinical utility of AlloMap Heart is supported by numerous clinical
trials that we have sponsored, the results of which have been published in leading peer-reviewed medical journals
AlloMap Heart has been a covered service for Medicare beneficiaries since January 1, 2006. The Medicare reimbursement rate
for AlloMap Heart is currently $3,240. AlloMap Heart has also received positive coverage decisions for reimbursement from
many of the largest U.S. private payers, including Aetna, Cigna, Health Care Services Corporation, or HCSC, Humana, Kaiser
Foundation Health Plan, Inc., or Kaiser, several BCBS plans and UnitedHealthcare.
In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, our Medicare Administrative contractor, issued a parallel coverage policy
granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare
reimbursement rate for AlloSure Heart is currently $2,753.
We have also successfully completed several landmark clinical trials in the transplant field demonstrating the clinical utility of
AlloMap Heart for surveillance of heart transplant recipients. We initially established the analytical and clinical validity of
AlloMap Heart based on our Cardiac Allograft Rejection Gene Expression Observational (Deng, M. et al., Am J
Transplantation 2006), or CARGO, study, which was published in the AJT. A subsequent clinical utility trial, Invasive
Monitoring Attenuation through Gene Expression (Pham MX et al., N. Eng. J. Med., 2010), or IMAGE, published in The New
England Journal of Medicine, demonstrated that clinical outcomes in recipients managed with AlloMap Heart surveillance were
equivalent (non-inferior) to outcomes in recipients managed with biopsies.
The results of our clinical trials have also been presented at major medical society congresses. AlloMap Heart is now
recommended as part of the International Society for Heart and Lung Transplantation, or ISHLT, guidelines.
6 HeartCare
HeartCare includes the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure Heart
in one surveillance solution. An approach to surveillance using HeartCare provides information from two complementary
measures: (i) AlloMap Heart – a measure of immune activation, and (ii) AlloSure Heart – a measure of graft injury.
Clinical validation data from the Donor-Derived Cell-Free DNA-Outcomes AlloMap Registry (NCT02178943), or D-OAR,
was published in AJT in 2019. D-OAR was an observational, prospective, multicenter study to characterize the AlloSure Heart
dd-cfDNA in a routine, clinical surveillance setting with heart transplant recipients. The D-OAR study was designed to validate
that plasma levels of AlloSure Heart dd-cfDNA can discriminate acute rejection from no rejection, as determined by
endomyocardial biopsy criteria.
HeartCare provides robust information about distinct biological processes, such as immune quiescence, active injury, Acute
Cellular Rejection, or ACR, and Antibody Mediated Rejection, or AMR. In September 2018, we initiated the Surveillance
HeartCare™ Outcomes Registry, or SHORE study. SHORE is a prospective, multi-center, observational, registry of patients
receiving HeartCare for surveillance. Patients enrolled in SHORE will be followed for 5 years with collection of clinical data
and assessment of 5-year outcomes.
Lung
In February 2019, AlloSure® Lung became available for lung transplant patients through a compassionate use program while
the test is undergoing further studies. One of these studies, launched in April 2020, is the ALARM study, or AlloSure Lung
Allograft Remote Monitoring, with Johns Hopkins University, where the impact of AlloSure Lung combined with RemoTraC
will be measured. AlloSure Lung applies proprietary NGS technology to measure dd-cfDNA from the donor lung in the
recipient bloodstream to monitor graft injury. In June 2020, we submitted an application to the Palmetto MolDx Technology
Assessment program seeking coverage and reimbursement for AlloSure Lung.
Cellular Therapy
In April 2020, we initiated a research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and
persistence of allogeneic cells for patients who have received cell therapy transplants. AlloCell will initially be commercialized
through collaborative research agreements with biopharma companies developing cell therapies.
Products
We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better
match between a solid organ or stem cell donor and a recipient, and help to provide post-transplant surveillance of these
recipients.
QTYPE® enables Human Leukocyte Antigen, or HLA, typing at a low to intermediate resolution for samples that require a fast
turn-around-time and uses real-time polymerase chain reaction, or PCR, methodology. Olerup SSP® is used to type HLA alleles
based on the sequence specific primer, or SSP, technology. Olerup SBT is a complete product range for sequence-based typing
of HLA alleles.
On May 4, 2018, we entered into a license agreement with Illumina, Inc., or Illumina, which provides us with worldwide
distribution, development and commercialization rights to Illumina’s NGS products and technologies for use in transplantation
diagnostic testing, or the Illumina Agreement.
On June 1, 2018, we became the exclusive worldwide distributor of Illumina’s TruSight HLA product line. TruSight HLA is a
high-resolution solution that uses NGS methodology. In addition, we were granted the exclusive right to develop and
commercialize other NGS product lines in the field of bone marrow and solid organ transplantation on diagnostic testing. These
NGS products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeq cfDNA, our surveillance solution designed
to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, a NGS solution for
chimerism testing for stem cell transplant recipients.
In September 2019, we commercially launched AlloSeq cfDNA during the European Society for Organ Transplantation, or
ESOT, Congress. AlloSeq cfDNA is our surveillance solution designed to measure dd-cfDNA in blood to detect active rejection
in transplant recipients, and we received CE mark authorization on January 10, 2020. AlloSeq cfDNA is now commercially
available for transplant patients outside of the U.S. Our ability to increase the clinical uptake for AlloSeq cfDNA will be a result
of multiple factors, including local clinical education, customer lab technical proficiency and levels of country-specific
reimbursement.
7 Also in September 2019, we commercially launched AlloSeq Tx during the American Society for Histocompatibility and
Immunogenetics, or ASHI, and Banff Foundation for Allograft Pathology’s Joint meeting in Pittsburgh, PA. AlloSeq Tx is the
first of its kind NGS high-resolution HLA typing solution utilizing hybrid capture technology. This technology enables the most
comprehensive sequencing, covering more of the HLA genes than current solutions and adding coverage of non-HLA genes
that may impact transplant patient matching and management. AlloSeq Tx has simple NGS workflow, with a single tube for
processing and steps to reduce errors. AlloSeq Tx 17 received CE mark authorization on May 15, 2020.
In June 2020, we commercially launched AlloSeq HCT, a NGS solution for chimerism testing for stem cell transplant
recipients. This technology has the potential to provide better sensitivity and data analysis compared to current solutions on the
market.
Digital and Other
In 2019, we began providing digital solutions to transplant centers following the acquisition of Ottr Complete Transplant
Management, or Ottr, Inc., and the acquisition of XynManagement, Inc., or XynManagement.
On May 7, 2019, we acquired 100% of the outstanding common stock of Ottr, Inc. Ottr, Inc. was formed in 1993 and is a
leading provider of transplant patient tracking software, or the Ottr software, which provides comprehensive solutions for
transplant patient management. The Ottr software enables integration with electronic medical records, or EMR, systems,
including Cerner Corporation, or Cerner, and Epic Systems Corporation, or Epic, providing patient surveillance management
tools and outcomes data to transplant centers.
On August 26, 2019, we acquired 100% of the outstanding common stock of XynManagement. XynManagement provides two
unique solutions, XynQAPI software, or XynQAPI, and XynCare. XynQAPI simplifies transplant quality tracking and
Scientific Registry of Transplant Recipients, or SRTR, reporting. XynCare includes a team of transplant assistants who
maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility. Refer to Note 6
of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for further detail regarding
these acquisitions.
In September 2020 we launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to
manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics.
COVID-19 Pandemic
On January 30, 2020, the World Health Organization, or the WHO, announced a global health emergency because of a new
strain of coronavirus, or COVID-19, originating in Wuhan, China and the risks to the international community as the virus
spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based
on the rapid increase in exposure globally. The full impact of the COVID-19 pandemic, including the impact associated with
preventative and precautionary measures that we, other businesses and governments are taking, continues to evolve as of the
date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on us, but the pandemic may
materially affect our financial condition, liquidity and future results of operations.
In the final weeks of March and during April 2020, with hospitals increasingly caring for COVID-19 patients, hospital
administrators chose to limit or even defer, non-emergency procedures. Immunosuppressed transplant patients either self-
prescribed or were asked to avoid transplant centers and caregiver visits to reduce the risk of contracting COVID-19. As a
result, with transplant surveillance visits down, we experienced a slowdown in testing services volumes in the final weeks of
March and during April 2020. As a response to the COVID-19 pandemic, and to enable immune-compromised transplant
patients to continue to have their blood drawn, in late March 2020, we launched RemoTraC, a remote home-based blood draw
solution using mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other standard monitoring tests.
To date, more than 150 transplant centers can offer RemoTraC to their patients and over 6,000 kidney, heart and lung transplant
patients have enrolled. Based on existing and new relationships with partners we have established a nationwide network of
more than 10,000 mobile phlebotomists. Following the introduction of RemoTraC and with the easing of stay-at-home
restrictions and the opening up of many hospitals to non-COVID-19 patients, our testing services volumes returned to levels
consistent with those experienced immediately prior to the COVID-19 pandemic, and through December 31, 2020, volumes
continued to be at or above those levels since May 2020.
In spite of the resurgence of COVID-19 infection rates, which resulted in increased stay-at-home and renewed travel
restrictions, our testing services did not experience a decrease in testing services volumes. Our product business experienced a
reduction in forecasted sales volume throughout the second and third quarters of 2020, as we were unable to undertake onsite
discussions and demonstrations of our recently launched NGS products, including AlloSeq Tx 17, which was awarded CE mark
authorization in May 2020. Our product business maintained normal sales volumes during the fourth quarter of 2020.
8 We are maintaining our testing, manufacturing, and distribution facilities while implementing specific protocols to reduce
contact among our employees. In areas where COVID-19 impacts healthcare operations, our field-based sales and clinical
support teams are supporting providers through telephone and online platforms. In August 2020, the state of California released
revised criteria for loosening and tightening restrictions on certain activities on generally a county-by-county basis. Under the
updated executive orders, San Mateo County, where our laboratory and headquarters are located, continues to be subject to
certain restrictions. These orders and others may be further modified, amended and adopted depending upon the COVID-19
transmission rates in our county and state, as well as other factors. In addition, we have created a COVID-19 task force that is
responsible for crisis decision making, employee communications, enforcing pre-arrival temperature checking, daily health
check-ins and enhanced safety training/protocols in our offices for employees that do not work from home.
Due to COVID-19, quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns
or other restrictions on the conduct of business operations could occur or could impact personnel at third-party suppliers in the
United States and other countries, or the availability or cost of materials, there may be disruptions in our supply chain. Any
manufacturing supply interruption of materials could adversely affect our ability to conduct ongoing and future research and
testing activities.
In addition, our clinical studies may be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment may
be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients may not be able to
comply with clinical study protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the
ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
exposure to COVID-19, may adversely impact our clinical trial operations.
Our History
We were originally incorporated in Delaware in December 1998 under the name Hippocratic Engineering, Inc. In April 1999,
we changed our name to BioCardia, Inc., and in June 2002, we changed our name to Expression Diagnostics, Inc. In July 2007,
we changed our name to XDx, Inc. and in March 2014, we changed our name to CareDx, Inc. Our principal executive offices
are located at 1 Tower Place, South San Francisco, California and our telephone number is (415) 287-2300.
For a further timeline of our history, please refer to our Annual Report on Form 10-K for the fiscal year ended December 31,
2019, filed with the SEC on February 28, 2020.
Our software solutions are currently used in over 90 transplant centers in the U.S.
As of December 31, 2020, substantially all of our revenues came from the United States and Europe, and substantially all of our
assets and operations were located in the United States, Sweden and Australia.
We are organized and operate as a single reportable segment. Refer to Note 16 of the consolidated financial statements included
elsewhere in this Annual Report on Form 10-K.
Limitations of Existing Approaches for Surveillance of Transplant Recipients
The care of organ transplant recipients is an intense and costly effort and requires life-long surveillance and management by
highly specialized clinicians and other healthcare providers. The estimated U.S. average 2020 charges for a heart transplant are
$1.66 million and for a kidney transplant are $0.44 million for the period 30 days before the transplant and 180 days after the
transplant. The lifetime cost for transplant recipients varies significantly depending on each individual patient's circumstances.
Unsuccessful treatment of rejection can result in an additional transplant. In the case of a kidney transplant, the median annual
Medicare cost of care for a recipient whose kidney fails and is on dialysis is 500% more than the median annual cost of care for
a recipient with a functioning transplant.
The historical standard for heart transplant surveillance has been the microscopic examination of heart tissue obtained through
an invasive endomyocardial biopsy. In the biopsy procedure, a catheter is inserted into the right internal jugular vein in the
recipient’s neck and threaded into the right ventricle of the heart. Four pieces of tissue are cut from the wall of the heart and
sent to the laboratory for examination by a pathologist who uses a microscope to look for evidence of cellular
rejection. Limitations of biopsies include: (i) the pathologist evaluations, which are subjective and dependent upon visual
assessment and qualitative interpretation, (ii) tissue sampling errors, and (iii) the potential for procedure related complications
such as damage to the valve structures in the heart. The typical schedule of biopsy surveillance may involve eight to ten
biopsies within the first six months after transplant and up to fifteen biopsies within the first year post-transplant.
Because repeated biopsies can cause cumulative risk and trauma to the heart, the frequency of biopsy surveillance after one year
is low, despite the fact that recipients would benefit from continued monitoring for rejection and management of their
immunosuppressive drugs for the rest of their lives. With less biopsy data collected after the first year post-transplant, clinicians
have less information upon which to tailor immunosuppression treatment for their recipients.
9 The use of renal biopsies for surveillance of kidney transplants is similarly limited due to the costs and risks associated with the
invasive procedure. Therefore, the main clinical test of transplanted kidney surveillance is serum creatinine levels. An increase
in serum creatinine levels is an indicator of diminished kidney function, and although this test is widely used, changes in serum
creatinine are nonspecific as to cause and not sensitive, as serum creatinine may only be detected after significant and
irreversible renal function loss has occurred.
The prevention and treatment of rejection in heart and kidney transplant recipients is managed primarily through the use of
immunosuppressive drugs. Surveillance biopsies are infrequent after the first year because of procedural risks, discomfort,
inconvenience, expense and the low rate of finding silent rejection. As a result, clinicians have limited and infrequent
information about an individual recipient’s risk of rejection over the months and years following transplant. In the average
recipient, the immune system gradually adapts to the organ graft, and the need for immunosuppression declines over
time. However, there is meaningful variation in the level of rejection activity and need for immunosuppression among
transplant recipients. Limited insight into the immune status of the individual recipient often causes clinicians to adopt a “one-
size-fits all” approach to immunosuppression to help protect against the severe consequences of rejection. Although typical
doses of immunosuppressants result in a low rate of rejection in the transplant population as a whole, many individuals may
receive more intense immunosuppressants than they actually need.
The Need for a Better Surveillance Solution
Improved post-transplant diagnostics are necessary to achieve further gains in the long-term care and health outcomes of heart,
kidney and other organ transplant recipients. More effective solutions for the surveillance and risk assessment of recipients
would improve the clinician’s ability to individualize immunosuppression therapy and to reduce the use of invasive biopsies.
We believe that core elements of effective surveillance solutions include:
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highly accurate and quantitative results differentiating rejection from non-rejection status;
non-invasive procedure that do not create risks to the recipient;
ease of implementation;
earlier detection of rejection; and
the ability to provide results with timing and at a frequency that allows for informed and effective
treatment decisions.
Clinical Studies for our Testing Services
Kidney
In March 2017, the Journal of the American Society of Nephrology published the article Cell-Free DNA and Active Rejection
in Kidney Allografts. The article reports that increased levels of dd-cfDNA detected using AlloSure Kidney are associated with
active rejection of the kidney allograft. The Diagnosing Acute Rejection in Kidney Transplant Recipients, or DART, study
evidence suggests that AlloSure Kidney, a non-invasive blood test, may enable more frequent, quantitative, and safer
assessment of allograft rejection and injury. As part of a surveillance strategy, AlloSure Kidney could help identify patients
with new or ongoing organ injury. In the DART study, to investigate the use of AlloSure Kidney as a surveillance tool, the
investigators prospectively collected blood specimens from renal transplant patients at scheduled intervals and at the time of
clinically indicated biopsies. Key findings of the study were as follows:
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AlloSure Kidney provides clear stratification of patients for probability of rejection;
Active rejection patients showed median AlloSure Kidney levels at 1.6%;
Antibody- mediated rejection, or ABMR, patients showed median AlloSure Kidney levels at 2.9%;
Non-rejection patients showed median AlloSure Kidney levels of 0.21%; and
AlloSure Kidney was superior to serum creatinine in identifying which patients had active rejection.
This was the first report to establish clinical performance characteristics for dd-cfDNA in renal transplant patients with an
analytically validated assay of dd-cfDNA in the largest (N =398 patients) prospective, multicenter observational study of dd-
cfDNA. Elevations in AlloSure Kidney were found to be strongly correlated with active rejection, especially ABMR. ABMR is
increasingly recognized as the form of immune-mediated injury causing long-term graft loss. This progress was made possible
by collaboration with 14 major renal transplant centers and their patients who volunteered to participate in the study.
A publication in the Journal of Applied Laboratory Medicine in March 2017 described the biological variation and clinical
reference intervals of dd-cfDNA in stable healthy renal transplant recipients.
10 The AlloSure Kidney test has been approved for Medicare coverage for clinical use when a physician determines there is a need
to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that AlloSure Kidney
can be used to discriminate the probability of active rejection from absence of rejection in a renal transplant recipient. Use of
the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection.
Publications based on the analyses of the accumulated DART database results were used as a guide to design K-OAR. K-OAR
is a multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,700 renal transplant
recipients who will receive AlloSure Kidney as part of long-term surveillance. The clinical outcomes of these patients will be
entered into a registry database as the patients will be surveilled for three years.
The study cohort will include a minimum of 300 patients from centers that use renal surveillance biopsies showing the value of
AlloSure Kidney in subclinical rejection. The remaining patients will be from centers that do not perform protocol surveillance
biopsies, but for cause biopsies, which is the more common practice. Outcomes in these cohorts will be compared, showing the
performance of AlloSure Kidney in all variations of clinical practice. A prospective propensity matched control cohort of 1,000
patients will be retrospectively analyzed from the subset of centers showing the value of AlloSure Kidney compared to its non-
use.
The primary safety endpoint of this study is the amount of kidney tissue scarring and atrophy at one-year post-transplant,
quantified by biopsy-based histopathology grade(s). The primary efficacy endpoint is the change in eGFR with the number of
renal allograft biopsies performed during the first year being a secondary outcome. Other endpoints include patient survival,
graft survival, change and serum creatinine, evaluated at years 1, 2 and 3 post-transplantation.
In January 2018, we initiated the “K-OAR” study to develop additional data on the clinical utility of AlloSure Kidney for
surveillance of kidney transplant recipients. K-OAR is a multicenter, non-blinded, prospective observational cohort study which
has enrolled more than 1,700 renal transplant patients who will receive AlloSure Kidney long-term surveillance.
In September 2019, we announced the commencement of the “OKRA” study, which is an extension of K-OAR. OKRA is a
prospective, multi-center, observational, registry of patients receiving KidneyCare for surveillance. KidneyCare combines the
dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap Kidney and the predictive
artificial intelligence technology of KidneyCare iBox developing a multimodality surveillance solution. We have not yet made
any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare iBox. Enrollment for OKRA
was negatively affected by the COVID-19 restrictions during the year 2020 and the study has been delayed by six months;
however, the collection of samples is currently at normal levels as a result of the introduction of RemoTraC.
Heart
The clinical validation and utility of AlloMap Heart is supported by a number of major clinical trials involving more than 2,000
heart transplant recipients and published in leading peer-reviewed medical journals. Our trials are designed to evaluate the
clinical utility of our solutions and are an integral part of our business strategy, clinical development and marketing programs.
In heart transplantation, two major observational trials, CARGO and CARGO II, enabled the initial development, validation
and further validation of AlloMap Heart to detect and monitor acute cellular rejection in heart transplant recipients. In addition
to preserving blood samples and clinical data from these two trials, we have sponsored a multi-year, 34 multicenter-registry
named OAR, which focuses on long-term outcomes of patients. We expect these samples and data to enable further discovery
and product development of new biomarkers of organ rejection activity, and new diagnostic solutions. These repositories
contain over 37,000 samples obtained from individual recipients who were typically followed for 10 serial visits and over one
year or more, and who in many cases have associated biopsy-based rejection grades and other clinical outcome endpoints. We
believe this extensive biorepository and database will be useful for new product development derived from analyses, correlative
studies and validation efforts.
Additional clinical utility trials, including IMAGE and the Early Invasive Monitoring Attenuation through Gene Expression, or
EIMAGE, have demonstrated that clinical outcomes in recipients managed with AlloMap Heart surveillance were equivalent to
outcomes in recipients managed with biopsies. We have also published two reports of retrospective analyses from IMAGE and
CARGO II trials that demonstrate that the variability in AlloMap Heart scores over time in an individual patient may be useful
in predicting the risk for the patient of a future event of rejection and graft dysfunction.
In September 2018, we initiated the SHORE study. SHORE is a prospective, multi-center, observational registry of patients
receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap Heart with the
dd-cfDNA analysis of AlloSure® Heart in one surveillance solution.
11 Products
Our suite of AlloSeq products are commercial “NGS”-based kitted solutions that we have developed as a result of the Illumina
Agreement. These products include: AlloSeq™ Tx, a high-resolution “HLA” typing solution, AlloSeq™ cfDNA, a surveillance
solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq™ HCT, a
solution for chimerism testing for stem cell transplant recipients.
Our other HLA typing products include: TruSight HLA, a NGS-based high resolution typing solution; Olerup SSP, based on the
“SSP” technology; and QTYPE, which uses real-time “PCR” methodology, to perform HLA typing at a low to intermediate
resolution for samples that require a fast turnaround time.
QTYPE was commercially launched at the end of September 2016. QTYPE enables HLA typing at a low to intermediate
resolution for samples that require a fast turn-around-time and uses real-time PCR methodology. QTYPE primarily focuses on
low to intermediate resolution typing where high-resolution typing is not a requirement but even more rapid typing results are
required, such as for deceased donor typing. When transplanting organs from deceased donors it is of great importance to be
able to expediently carry out HLA typing to find an appropriate recipient. Typing with QTYPE requires approximately one
hour compared to the up to 2-3 hours that it takes to do traditional SSP typing and the 5-7 hours that it takes with sequence-
specific oligonucleotides, or SSO. QTYPE comes with custom software, SCORE6.
Olerup SSP is used to type HLA alleles based on the SSP technology. The Olerup SSP product line comprises products for low
to high-resolution HLA typing. The product line includes close to 400 different typing products, covering the approximately
17,331 different HLA alleles (gene variants) that have been identified to date. New HLA alleles are identified frequently and
the typing kits are routinely updated for new alleles. SCORE6, our custom developed software simplifies interpretation and
documentation of laboratory results. We offer one of the most up-to-date and comprehensive libraries of HLA typing kits based
on SSP technology.
Olerup SBT is a sequence-based typing product for HLA alleles that uses specifically designed software, Assign SBT, a
sequence analysis software program that provides high-resolution HLA typing.
TruSight HLA is high-resolution solution that uses NGS methodology. TruSight HLA is a NGS-based high-resolution typing
solution that provides NGS-level resolution to HLA typing. We licensed the exclusive world-wide distribution rights to this
product from Illumina in May 2018. In addition, we were granted the exclusive right to develop and commercialize other NGS
product lines. These products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeq cfDNA, our surveillance
solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, a NGS
solution for chimerism testing for stem cell transplant recipients. Our AlloSeq products are designed to run on Illumina’s NGS
instrumentation.
Research and Development
Our research and development activities focus on developing cutting edge organ transplant surveillance solutions, further
expanding on our pre-transplant matching solutions and seeking to continuously explore and develop new clinically-relevant
approaches to our products. Clinical operations dedicated to the design and implementation of high quality studies and registries
for data collection to develop evidence to address unmet clinical needs of transplant recipients are included in research and
development.
One area of focus for research and development activities has been to integrate acquired technology from the acquisitions of
Ottr, Inc. and XynManagement and our Cibiltech Agreement. Integration of such technology with our current service offerings
aligns a rich data set with augmented intelligence tools to better assess risk and help physicians better manage their daily patient
care.
Research and development expenses of $48.9 million, $30.7 million and $14.5 million were incurred during the years ended
December 31, 2020, 2019 and 2018, respectively.
Our ongoing efforts include:
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increasing understanding of biological processes of transplant rejection through analysis of genes/
metagenes of ongoing clinical trials such as K-OAR and OKRA, and commercial laboratory testing
to further improve clinical utility of AlloSure Kidney and KidneyCare;
validation and clinical utility studies of AlloSure Kidney for other organs such as lung, pancreas and
liver;
increasing understanding of biological processes of transplant rejection through analysis of genes/
metagenes of archived clinical trials, OAR registry, SHORE registry and commercial laboratory
testing to further improve clinical utility of AlloMap Heart and AlloSure Heart;
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technology platform and procedure optimization as well as further advances of laboratory
information management to increase efficiency and lower costs in our testing and laboratory
operations;
validation and clinical utility studies of dd-cfDNA reagents and software distributed outside the
United States;
developing solutions for monitoring the success of hematopoietic stem cell transplantation;
developing HistoMap to identify allograft rejection in transplant biopsy tissue;
developing an NGS transplant genetic matching system that includes critical genes in addition to
HLA;
further development of QTYPE to expand its addressable market by including additional genetic
content;
further development of NGS product lines such as AlloSeq Tx, AlloSeq cfDNA and AlloSeq HCT;
merging and analyzing internal and public clinical data sets to better understand factors that impact
short and long term outcomes;
designing a multi-stakeholder transplant innovation ecosystem to accelerate improved patient
management;
integrating real world data to confirm and extend results from other clinical data sets; and
developing and deploying smart analytics and machine learning artificial intelligence that provide
clinical utility with respect to patient health such as AiTraC.
Testing Services Advancement and Development
Our research and development efforts are not limited to specific technology platforms, biomarkers or methodologies. Instead,
we aim to leverage current and future innovations in biomarker identification and measurement, study design and data
integration in developing future solutions.
dd-cfDNA for Kidney Transplants
Our published DART clinical study has established the clinical validity of a dd-cfDNA-based solution for kidney transplant
patients, AlloSure Kidney. This was the first report to establish clinical performance characteristics for this molecular
biomarker in renal transplant patients with an analytically validated assay of dd-cfDNA in the largest (N =398 patients)
prospective, multicenter observational study of dd-cfDNA. The study population is representative of the spectrum renal
transplant recipients in the United States. Elevations in AlloSure Kidney were found to be strongly correlated with active
rejection, especially with ABMR. ABMR is increasingly recognized as the form of immune-mediated injury causing long-term
graft loss.
K-OAR is the next step in the further development of data to support the clinical utility of AlloSure Kidney. The Centers for
Medicare & Medicaid Services, or CMS, Medicare Administrative Contractor, or MAC, Palmetto GBA, or Palmetto, in
October 2017, recommended Medicare coverage for AlloSure Kidney. The K-OAR study commenced in January 2018. K-OAR
is a 1, 2 and 3 year post-transplant clinical outcomes study in approximately 1,500 patients managed with AlloSure Kidney
surveillance compared to another 300 patients who will serve as a comparative control group managed without AlloSure
Kidney.
OKRA is a multicenter, prospective, observational registry, designed to measure outcomes of kidney transplant recipients
managed with KidneyCare. KidneyCare complements AlloSure Kidney to include multimodality testing with the addition of
AlloMap Kidney Gene Expression Profiling and prognostic graft assessment using KidneyCare iBox. The patient transplant
registry is statistically powered to determine the utility of KidneyCare and provide real world data on the use of KidneyCare
and AlloSure Kidney. OKRA targets more than 50 transplant centers and will enroll approximately 1,500 newly transplanted
patients, complementing the K-OAR with 1,500 patients, matching both arms with a total of 1,000 control patients.
dd-cfDNA for Heart Transplants
We believe that the AlloSure Kidney dd-cfDNA-based solution could provide additional value to AlloMap Heart testing for
clinicians caring for heart transplant patients, particularly in situations where a recipient’s AlloMap Heart score suggests a
probability of acute rejection.
13 Studies have reported that a higher percentage of dd-cfDNA in the blood stream of patients is found with moderate or severe
heart rejection compared to patients without rejection. We believe a dd-cfDNA solution such as AlloSure Kidney for the heart
could help clinicians identify recipients with a higher probability of rejection and help determine which patients warrant a
subsequent biopsy, because the likelihood of detecting rejection in the biopsy specimen would be enhanced.
Accordingly, we offer HeartCare. HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-
cfDNA analysis of AlloSure Heart in one surveillance solution. An approach to surveillance using HeartCare provides
information from the two complementary measures: (i) AlloMap Heart – a measure of immune activation, and (ii) AlloSure
Heart – measures graft injury. HeartCare provides complementary information about distinct biological processes, such as
immune quiescence, active injury, ACR and AMR in heart transplant recipients.
We have established our proprietary strategy for quantification of donor specific dd-cfDNA and published a validation study of
AlloSure Heart in 2019. We now offer AlloSure Heart as a laboratory developed test as part of our SHORE study of dd-cfDNA
in association with gene-expression profiling (AlloMap Heart) in heart transplant recipients.
HistoMap
We have established a strategic research partnership with NanoString Technologies, Inc., or NanoString, to develop HistoMap,
a gene expression profiling, or GEP, solution to identify allograft rejection in transplant biopsy tissue. NanoString is a leading
provider of life science tools for translational research and molecular diagnostic products. The partnership will combine our
clinical expertise and extensive transplant registries with NanoString’s technological capabilities and development expertise to
provide solutions that bring precision medicine to histopathology. We will utilize NanoString’s nCounter® technology in
conjunction with the newly introduced Human Organ Transplant panel, a 770-gene panel designed to evaluate the human
immune response in biopsy tissue from a transplanted organ. In May 2020, we established a partnership with Veracyte, Inc.,
pursuant to which we have certain exclusive worldwide field rights to develop and commercialize products, such as HistoMap
using the nCounter technology.
Product Advancement and Development
Our ongoing research and development for products is divided between kitted products for pre-transplant and post-transplant. In
the last decade of next generation, the ubiquity of sequencing has unveiled significant additional sequence diversity in the HLA
region on chromosome 6 of the human genome. While the clinical impact of some of the sequence diversity is unclear, many
newly identified HLA alleles need to be integrated into ongoing updates of the QTYPE and AlloSeq Tx kits. We have been
updating, and intend to continue to update, our HLA typing kits with newly identified alleles. QTYPE and AlloSeq Tx use
technology platforms that can readily accommodate this increase in HLA allele assays.
The advent of NGS technology has enabled significant improvement in HLA sequencing data. We are developing further
improved versions of NGS HLA testing that will provide full gene coverage while streamlining the laboratory workflow.
AlloSeq Tx is the first of its kind next-generation sequencing HLA typing solution, utilizing hybrid capture technology. This
technology enables the most comprehensive sequencing available, covering more of the HLA genes than current solutions and
adding coverage of non-HLA genes that may impact transplant patient matching and patient management. Our HLA typing
products are used in labs throughout the world to help determine which organs or bone marrow are a transplantation match
between the donor and the recipient.
We expanded our market-leading portfolio of NGS transplantation offerings with the global launch of AlloSeq cfDNA and
AlloSeq HCT. These post-transplant surveillance products enable access to our dd-cfDNA technology to laboratories and
patients outside the United States. We also introduced AlloSeq Tx at the 2019 ASHI Annual Meeting and continue to improve
the product.
Finally, our research and development staff are collaborating to advance the synergies of products across the pre- and post-
transplant continuum.
Digital Solutions Business Development
We acquired Ottr, Inc. and XynManagement in 2019. These acquisitions have strengthened our growing portfolio of transplant
software solutions such as Ottr and XynQAPI. We are committed to continue upgrading these software programs and further
integrating them into our current testing service offerings.
We plan to develop, deploy and promote a rational set of analytical tools that provide clinical utility with respect to patient
health. Our vision is to add smart analytics and machine learning to artificial intelligence in transplant, which we call AiTraC.
Going forward, we will strive to bring our multi-modality testing solutions and machine learning algorithms to the transplant
clinic under our AiTraC umbrella. AiTraC will utilize the large clinical data that are collected through our registry studies to
provide caregivers with point of care decision-making support tools that allow them to stratify the patient population.
14 We are actively working on partnerships in order to help our in house software resources continue to execute on a vision of
including smart analytics in the user experience.
Reimbursement
We have been successful in achieving reimbursement for our testing services. Reimbursement for AlloSure Kidney comes
primarily from Medicare. Reimbursement for AlloMap Heart comes primarily from Medicare and private third party payers
such as insurance companies and managed care organizations.
Medicare
We are reimbursed by Medicare for AlloSure Kidney, AlloMap Heart and AlloSure Heart tests performed on patients covered
by Medicare. Tests performed on patients covered by Medicare represented 48%, 49% and 46% of all tests in 2020, 2019 and
2018, respectively. Approximately 67%, 66% and 62% of all testing services revenue was derived from Medicare for the years
ended December 31, 2020, 2019 and 2018, respectively.
AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017. The Medicare reimbursement rate
for AlloSure Kidney is currently $2,841. AlloSure Kidney has received positive coverage decisions from BCBS of South
Carolina, BCBS of Kansas City and Capital Health, and is reimbursed by other private payers including Kaiser on a contract or
case-by-case basis.
Following the assignment of a Category 1 Current Procedural Terminology, or CPT code, for AlloMap Heart in September
2015, CMS issued a proposed Clinical Laboratory Fee Schedule, or CLFS, Preliminary Determinations for calendar year 2016.
In October 2016, CMS reversed its preliminary gapfill determination for the 2017 CLFS and restored the final pricing
determinations for AlloMap Heart in the 2017 CLFS to $2,821. The Protecting Access to Medicare Act of 2014, or PAMA,
includes a substantial new payment system for clinical laboratory tests under the CLFS. Under PAMA, laboratories that receive
the majority of their Medicare revenues from payments made under the CLFS would report initially and then on a subsequent
three-year basis thereafter (or annually for advanced diagnostic laboratory tests, or ADLTs), private payer payment rates and
volumes for their tests. CMS will use the rates and volumes reported by laboratories to develop Medicare payment rates for the
tests equal to the volume-weighted median of the private payer payment rates for the tests. The CARES Act freezes current
(2020) CMS CLFS rates through 2021. Further, the CARES Act delays the reporting cycle under PAMA to January 1 and
March 31, 2025, and the preceding data collection period will become January 1 through June 30, 2024.
AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for
AlloMap Heart is currently $3,240. AlloMap Heart has also received positive coverage decisions for reimbursement from many
of the largest U.S. private payers, including Aetna, Cigna, HCSC, Humana, Kaiser and UnitedHealthcare.
In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, our Medicare Administrative contractor, issued a parallel coverage policy
granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare
reimbursement rate for AlloSure Heart is currently $2,753.
Private Payers and Medicaid Payers
Due to End Stage Renal Disease, or ESRD, regulations by Medicare, most ESRD patients are covered by Medicare and
Medicare Advantage plans and have access to AlloSure Kidney. Private payers that have adopted a positive coverage policy for
AlloSure Kidney include BCBS of South Carolina, BCBS of Kansas City, Kaiser and Capital Blue. However, other private
payers and Medicaid payers have not yet adopted positive coverage policies for AlloSure Kidney.
We are reimbursed for a substantial portion of the AlloMap Heart tests we perform on patients covered by private payers.
Coverage policies approving AlloMap Heart have approached nearly 90% of all covered lives and are published by many of the
largest private payers, including Aetna, Anthem, Cigna, HCSC, Humana, Kaiser, and UnitedHealthcare. Many other payers
have positive coverage policies for AlloMap Heart.
AlloSure Heart is covered by Geisinger Health Plan and Kaiser. AlloSure Kidney is covered by BCBS of South Carolina,
BCBS of Kansas City and Kaiser. For all tests performed outside the scope of the payer’s policy, and for tests performed where
the payer has not adopted a coverage policy, we pursue reimbursement on a case-by-case basis. If a reimbursement claim is
denied, we generally pursue payment through the particular payer’s appeal process.
International
Our products have a broad international presence. We sell directly to customers in many regions and also sell through third-
party distributors and sub-distributors throughout Europe and the rest of the world.
15 Testing and Laboratory Operations
AlloSure Kidney, AlloMap Heart and AlloSure Heart testing is performed in our clinical laboratory, which is located in our
Brisbane, California location. Our laboratory holds a certificate of accreditation under the Clinical Laboratory Improvement
Amendments of 1988, or CLIA, and is accredited by the College of American Pathologists, or CAP. We believe that our
laboratory capacity will be adequate to meet demand for AlloSure Kidney, AlloMap Heart, AlloSure Heart and other tests in the
development pipeline for the next few years.
When a clinician orders AlloMap Heart, a blood sample is drawn and processed to isolate the white blood cells, which are
subsequently broken down, frozen and sent via overnight courier to our laboratory. Each of the 20 genes comprising AlloMap
Heart is tested in triplicate, and the 11 informative genes are combined to produce the AlloMap Heart score. The remaining 9
genes are used as part of the rigorous quality control testing performed to assess every phase of the test process. The test results
are reported to the ordering clinician by fax or electronically via WebPortal within two business days of receipt of the sample.
Test samples that fail to meet quality control criteria are immediately re-tested and the ordering clinician is notified of the need
to re-test if turnaround time will be affected.
When AlloSure Kidney is ordered by a clinician, a blood sample is drawn and sent overnight at ambient temperature to our
laboratory. Cell-free DNA is purified from the plasma and the fraction of the total cell-free DNA derived from the transplanted
organ, the dd-cfDNA, is quantified and reported as a percentage. Tests that fail to meet quality control criteria are immediately
re-tested and the ordering clinician is notified of the need to re-test if turnaround time will be affected. Results are reported to
the ordering clinician by fax or electronically via WebPortal within two business days of receipt of the sample.
We rely solely on certain suppliers to provide some of the laboratory instruments and key reagents that we use to perform
AlloSure Kidney, AlloMap Heart, and AlloSure Heart testing. These sole source suppliers include Thermo Fisher Scientific,
which supplies us with instruments, laboratory reagents, a master mix formula and consumables; Roche Molecular Systems,
which supplies us with laboratory reagents and consumables; Hamilton Robotics, which supplies equipment and consumables;
Illumina, which supplies us with instruments, laboratory reagents and consumables; Avantor, which supplies us with kitting
services, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supply us with cell
preparation tubes; Beckman Coulter, which provides laboratory equipment, reagents and consumables; and Qiagen N.V., which
supplies us with a proprietary buffer reagent.
Manufacturing
We have historically purchased many of the components and raw materials used in our product kits from numerous suppliers
worldwide. For reasons of quality assurance, sole source availability or cost effectiveness, certain components and critical raw
materials used in the manufacture of our products are available only from one supplier. We have worked closely with our
suppliers to develop alternate backup plans to assure continuity of supply while maintaining high quality and reliability, and in
some cases, we have established long-term supply contracts with our suppliers. Due to the high standards and FDA
requirements applicable to the manufacturing of our products, we may not be able to quickly establish additional or replacement
sources for certain components or materials.
In the event that we are unable to obtain sufficient quantities of raw materials or components on commercially reasonable terms
or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised,
which may have a material adverse effect on our business, financial condition and results of operations.
Our manufacturing facility in Stockholm, Sweden is used to support the production, packaging and labeling of our proprietary
test kits: Olerup SSP, XM-One, and QTYPE. The facility has a certified Quality Management System, or QMS, to standards
ISO 9001:2008 and ISO 13485: 2016. These standards include a special set of requirements specifically related to the supply of
medical devices and related services. ISO is an internationally recognized standard for QMS. Recertification is required every
three years and we have been successfully recertified since obtaining our original ISO certification. The facility maintains a
valid EC certificate for compliance to Directive 98/79/EC Annex IV, excluding Sections 4 and 6, Full Quality Assurance
System In Vitro Diagnostic Medical Devices. Annual surveillance audits are also conducted by the site’s notified body to
ensure ongoing compliance.
Additionally, we seek to manufacture to current Good Manufacturing Practice requirements and our QMS is implemented in
accordance with FDA Quality System Regulations.
Our manufacturing facility in Fremantle, Australia, is used to support the production, packaging and labeling of our proprietary
Olerup SBT and AlloSeq brand kits. The facility maintains a valid EC certificate for compliance to Directive 98/79/EC Annex
IV, excluding Sections 4 and 6, Full Quality Assurance System In Vitro Diagnostic Medical Devices, and is certified to
standards ISO 13485: 2016 and the Canadian Medical Devices Conformity Assessment System, or CMDCAS, for Medical
Devices, undergoing the same certification and surveillance audit requirements.
16 Sales and Marketing
Testing Services Sales and Marketing Team
We have a direct field team in the United States that interacts with all aspects of the testing services channel, including sales,
marketing, medical science liaison, managed care, and patient care management representatives.
Our marketing strategy focuses on the clinical benefits of AlloSure Kidney and AlloMap Heart, and the scientific validation that
supports our tests. Our strategy includes education to clinicians and the care team at transplant centers, assistance with
scheduling ordered tests for patients, and working with centers to adopt formal protocols.
Product Sales and Marketing Team
The product business has sales offices in Vienna, Austria; Stockholm, Sweden; West Chester Pennsylvania, United States; and
Fremantle, Australia, which manage direct sales to customers and sales through third-party distributors.
Digital Solutions Sales and Marketing Team
Our sales teams are located in the United States. They manage customer sales for Ottr software and XynQAPI software. Our
strategy includes educating clinicians and care teams at transplant centers through software demos. Our marketing team
supporting the product marketing for Ottr, XynQAPI, AlloCare and other digital offerings is based in South San Francisco.
Competition
With our comprehensive portfolio of surveillance testing services, diagnostic products and digital business offerings, we face
many different types of competition.
Testing Services
Our competition principally includes clinical reference labs and hospital labs using existing and routine clinical chemistry tests.
Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic
tests. In the field of post-transplant surveillance, Natera Inc., or Natera, and Eurofins Viracor, Inc., or Eurofins, have
commercially available molecular diagnostics tests.
We expect the competition for post-transplant surveillance to increase as there are several established and early-stage
companies in the process of developing products and services for the transplant market that may directly or indirectly compete
with AlloSure Kidney, AlloMap Heart or our development pipeline. In addition, companies that have not historically focused
on transplantation, but have knowledge of dd-cfDNA technology, have indicated they are considering this market.
We believe the principal competitive factors in our target markets include:
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quality and strength of clinical and analytical validation data;
confidence in diagnostic results;
technical performance and innovation to deliver new products that provide clinically actionable
results;
reputation among customers as a provider of high value transplant diagnostic tests and diagnostic
test services;
the extent of reimbursement;
inclusion in practice guidelines;
cost-effectiveness; and
ease of use.
We believe we compete favorably on the factors described above.
Existing diagnostic methods for kidney transplant rejection include general, non-specific clinical chemistry tests, although
biopsies are also a surveillance diagnostic tool. Existing diagnostic methods for heart transplant rejection generally involve
evaluating biopsy samples to determine the presence or absence of rejection.
These practices have been the standard of care in the United States for many years, and we will need to continue to educate
clinicians, transplant recipients and payers about the various benefits of our tests in order to change clinical practice. Also,
many transplant centers are located within hospitals that have their own laboratory facilities and have capacity to conduct
various tests, and some hospitals may choose to rely on internally developed and/or internally performed surveillance and
diagnostic tests.
17 Products
Our competitors within the HLA tissue typing markets comprise a diverse range of manufacturers servicing hospital and
commercial reference testing laboratories. The market leader in HLA typing and third party distributors is Thermo Fisher
through its acquisition of transplant-focused companies One Lambda and Linkage Biosciences. In certain HLA tissue typing
markets that incorporate a wide variety of technology test platforms, such as SSP, SBT, SSO and NGS, competitors include
Thermo Fisher, Omixon, GenDx, BAG, Qiagen, and Immucor. We also face competition from hospital and commercial
reference labs that develop their own in-house testing solutions known in the diagnostics industry as “home brews”. We believe
that our product line competes favorably with Thermo Fisher as a leading supplier of HLA test kits based on performance,
reputation and service.
We expect future competition for post-transplant surveillance kitted solutions for AlloSeq cfDNA and AlloSeq HCT. There are
several established and early-stage companies in the process of developing products and services for the transplant market that
may directly or indirectly compete with our development pipeline. In addition, companies that have not historically focused on
transplantation, but have knowledge of dd-cfDNA technology, have indicated they are considering the transplantation market.
Digital Solutions
Competition for our digital solutions include various companies that develop application software and operate in the healthcare
field. Our primary competitor in this field is Epic. In addition, other established and emerging healthcare, information
technology and service companies may commercialize competitive products including informatics, analysis, integrated genetic
tools and services for health and wellness.
Intellectual Property
Patents and Proprietary Technology
In order to remain competitive, we seek to develop and maintain protection on the proprietary aspects of our technologies. We
rely on a combination of patents, copyrights, trademarks, material data transfer agreements and licenses to protect our
intellectual property rights. We also rely upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to develop and maintain our competitive position. We generally protect this information
with confidentiality agreements and reasonable security measures.
As of December 31, 2020, we had 25 issued U.S. patents related to transplant rejection and autoimmunity. We have five issued
U.S. patents covering methods of diagnosing transplant rejection that use all 11 informative genes measured in AlloMap Heart.
The expiration dates of these patents range from 2021 to 2024. We have six additional patents covering additional genes or
gene variants for diagnosing transplant rejection. In connection with our June 2014 acquisition of ImmuMetrix, Inc., we
obtained an exclusive license from the Board of Trustees of the Leland Stanford Junior University, or Stanford, to a patent
relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. This patent has an expiration date of
November 5, 2030. A second patent included in the license from Stanford was issued in December 2017 and further covers the
use of dd-cfDNA to diagnose and predict transplant status or outcome. A third and fourth patent were issued from this Stanford
set in June 2019 and December 2019, respectively, covering the use of dd-cfDNA to diagnose and predict transplant status or
outcome. Both patents have the same 2030 expiration date as the original Stanford patent.
We have developed trade secrets and know-how since our inception. These trade secrets and know-how are found particularly
in technical areas such as optimized systems for making precise and reproducible q-PCR, measurements, and in the analysis of
genomic data and algorithm development.
AlloMap, AlloSure, Olerup SSP, Olerup XM-ONE, QTYPE, Ottr and CareDx are registered trademarks of ours in the United
States.
License Agreements
We currently rely on license agreements to obtain rights under certain patents that we believe may be necessary to make, use
and sell our AlloSure tests and future solutions. We may in the future rely, at least in part, upon licensing agreements with third
parties to obtain patent rights and transfers of technology, information and know-how that enable us to further our development
of additional solutions for post-transplant surveillance. Of the 25 existing U.S. patents related to transplant rejection and
autoimmunity, nine are the product of exclusive licensing agreements.
In June 2014, we entered into an amended and restated license agreement with Stanford, which granted us an exclusive license
to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA and a non-exclusive license to
related technology provided by Stanford. Subject to various rights of extension, we are required to achieve certain development
and commercialization milestones set forth in the license agreement. Under the terms of the Stanford license, we are required to
report and pay royalties in the low single digits on net sales of products incorporating the licensed technology.
18 In May 2018, we entered into the License Agreement with Illumina, which provides us with worldwide distribution,
development and commercialization rights to Illumina’s next generation sequencing product line for use in transplantation
diagnostic testing. Two issued patents for HLA genotyping are exclusively licensed as part of this agreement.
On April 30, 2019, we entered into a license and collaboration agreement with Cibiltech SAS, or Cibiltech, pursuant to which
we were granted an irrevocable, non-transferable right to commercialize Cibiltech’s proprietary software, KidneyCare iBox, for
the predictive analysis of post-transplantation kidney allograft loss in the field of transplantation in the U.S. for a period of ten
years.
In April 2020, we entered into a license agreement with Cornell University pursuant to which we were granted exclusive rights
to three patents and two patent applications covering methods and technology for measurement of gene expression in urine to
diagnose kidney transplant rejection.
Regulation
Our business is subject to and impacted by frequently changing laws and regulations in the United States and internationally.
These laws and regulations include regulations particular to our business and laws and regulations relating to conducting
business generally (e.g., U.S. Foreign Corrupt Practices Act, Sarbanes Oxley Act, and similar laws of other jurisdictions). We
also are subject to inspections and audits by governmental agencies. Below are certain key regulations applicable to our
business.
Clinical Laboratory Improvement Amendments of 1988
Having a clinical laboratory in California, we are required to hold certain federal, state and local licenses, certifications and
permits to conduct our business. Under the CLIA, administered by CMS, we are required to hold a certificate applicable to the
type of work we perform and to comply with standards covering personnel, facilities administration, quality systems,
proficiency testing and performance. Most clinical laboratories are subject to regulation under the CLIA, which is designed to
ensure that laboratory testing services performed on materials derived from the human body are accurate and reliable.
We have a certificate of accreditation under the CLIA to perform “high complexity” testing. Laboratories performing high
complexity testing are required to meet more stringent personnel and quality system requirements than laboratories performing
less complex tests. To renew our CLIA certificate, we are subject to survey and inspection every two years to assess compliance
with program standards. We were inspected as part of the customary College of American Pathologists audit in 2020 and
recertified under the CLIA as a result of passing that inspection.
California Laboratory Licensing
In addition to federal certification requirements of laboratories under the CLIA, licensure is required and maintained for our
laboratory under California law. Such laws establish standards for the day-to-day operation of a clinical laboratory, including
the training and skills required of personnel and quality control. In addition, California laws mandate proficiency testing, which
involves testing of specimens that have been specifically prepared for the laboratory. We are required to maintain compliance
with California standards as a condition to continued operation of our laboratory in California.
Other States’ Laboratory Testing
Other states require out-of-state laboratories that accept specimens for testing from those states to be licensed. We have
obtained licenses in California, Florida, New York, Maryland, Pennsylvania and Rhode Island, and believe we are in
compliance with applicable licensing laws.
Food and Drug Administration
The FDA regulates the design, testing, development, manufacture, safety, labeling, marketing, promotion, storage, sale and
distribution of medical devices pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or FFDCA. The
FFDCA and its implementing regulations govern, among other things, the following activities relating to our medical devices:
preclinical and clinical testing, design, manufacture, safety, efficacy, labeling, storage, record keeping, sales and distribution,
post-market adverse event reporting, import/export, and advertising and promotion. These regulations apply to all of our
products sold in the United States, as well as our facilities in Stockholm, Sweden used to produce some of our products. The
FDA has also asserted that it has the authority to regulate laboratory developed tests, or LDTs, as medical devices under the
FFDCA. An LDT is a test developed by a single laboratory for use only in that laboratory, such as AlloMap Heart or AlloSure
Kidney.
19 The FDA has traditionally chosen not to exercise its authority to regulate LDTs because it regulates the primary components in
most laboratory-developed tests and because it believes that laboratories certified as high complexity under the CLIA, such as
ours, have demonstrated expertise and ability in test procedures and analysis. In the event the FDA changes their policy in
regards to “Enforcement discretion” for LDTs, it could require us to modify our business model and incur higher costs in order
to maintain compliance with this new policy. A similar situation may occur if Congress decides to enable newly proposed
regulations, such as the Verifying Accurate Leading-edge IVCT Development Act of 2018. For AlloSure Kidney and other
similar testing solutions, we may be required to conduct additional clinical trials to demonstrate clinical validity and utility of
our test, and submit to the FDA a premarket approval application, or PMA, or 510(k) premarket notification application and
obtain approval or clearance for the test subsequent to commercialization. There can be no assurance that any of our tests or
additional uses of our tests for which we seek clearance or approval in the future will be cleared or approved on a timely basis,
or at all, and there can be no assurance that labeling claims will be consistent with our current claims or adequate to support
continued adoption of and reimbursement for our current and future tests. Moreover, any new FDA or regulatory requirements
could complicate our compliance efforts.
Health Insurance Portability and Accountability Act
Under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, the U.S. Department of Health and
Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information and
standardize data content, codes and formats used in healthcare transactions and the standardized identifiers used by healthcare
providers, such as us, and health plans.
We have developed policies and procedures to comply with these regulations. The requirements under these regulations may
change periodically and could have an effect on our business operations if compliance becomes substantially more costly than
under current requirements or a significant breach to protected health information, or PHI, may occur.
In addition to federal privacy regulations, there are a number of state laws governing confidentiality of health information that
are applicable to our operations. New laws governing privacy may be adopted in the future as well. We have taken steps to
comply with health information privacy requirements to which we are aware that we are subject.
Federal and State Self-Referral Prohibitions
We are subject to the federal self-referral prohibitions, commonly known as the Stark Law, and to similar state restrictions such
as California’s Physician Ownership and Referral Act, or PORA. Where applicable, these restrictions generally prohibit us from
billing patients or certain governmental or private payers for clinical laboratory testing services when the physician ordering the
test, or any member of such physician’s immediate family, has an investment interest in, or compensation arrangement with, us,
unless the arrangement meets an exception to the prohibition.
Both the Stark Law and PORA contain exceptions for compensation paid to a physician for personal services rendered by the
physician, provided that certain conditions are satisfied. We have compensation arrangements with a number of physicians for
personal services, such as speaking engagements and clinical advisory boards. We have structured these arrangements with
terms intended to comply with the requirements of the applicable exceptions to the Stark Law, PORA and other similar state
laws. However, we cannot be certain that regulators would find these arrangements to be in compliance with the Stark Law,
PORA or similar state laws.
Sanctions for a violation of the Stark Law include the following:
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denial of Medicare 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 of up to $25,820 per service for submitting or causing to be submitted a claim in
violation of the Stark Law and an assessment of up to three times the amount claimed;
exclusion from federal health care programs, including the Medicare and Medicaid programs; and
a civil penalty of up to $172,137 against parties that enter into a scheme to circumvent the Stark
Law’s prohibitions.
Further, a violation of PORA is a misdemeanor and could result in civil penalties and criminal fines. Finally, other states have
self-referral restrictions with which we have to comply that differ from those imposed by federal and California law.
Federal and State Fraud and Abuse Laws
Because of the significant federal funding involved in Medicare and Medicaid, Congress and the states have enacted, and
actively enforce, a number of laws to eliminate fraud and abuse in federal health care programs and across the healthcare
system. Our business is subject to compliance with these laws.
20 In March 2010, the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Affordability
Reconciliation Act, or collectively, the Affordable Care Act, was enacted in the United States. The Affordable Care Act
expands the government’s investigative and enforcement authority and increases the penalties for fraud and abuse, including
amendments to both the Anti-Kickback Statute and the False Claims Act, to make it easier to bring suit under these statutes.
The Affordable Care Act also allocates additional resources and tools for the government to police healthcare fraud, with
expanded subpoena power for HHS, additional funding to investigate fraud and abuse across the healthcare system and
expanded use of recovery audit contractors for enforcement.
There have previously been public announcements by members of the U.S. Congress regarding their plans to repeal and replace
the Affordable Care Act, and the Biden administration has announced plans to expand the Affordable Care Act. We cannot
predict whether future healthcare initiatives, including at the federal level, will be initiated or the effect such initiatives could
have on our business.
The Eliminating Kickbacks in Recovery Act of 2018
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 payer” statute). For purposes of EKRA, the term “laboratory” is defined broadly and without reference to any
connection to substance use disorder treatment. EKRA is a criminal statute and violations can result in fines of up to $200,000,
up to 10 years in prison, or both, per violation. The law includes a limited number of exceptions, some of which closely align
with corresponding Anti-Kickback Statute exceptions and safe harbors and others that materially differ.
Information Blocking Prohibition
On May 1, 2020, the Office of the National Coordinator for Health Information Technology promulgated final regulations
under the authority of the 21st Century Cures Act to impose new conditions to obtain and maintain certification of certified
health information technology and prohibit certain covered actors—developers of certified health information technology,
health information networks / health information exchanges, and health care providers (including laboratories)—from engaging
in activities that are likely to interfere with the access, exchange or use of electronic health information (information blocking).
The final regulations further defined exceptions for activities that are permissible, even though they may have the effect of
interfering with the access, exchange or use of electronic health information. Originally, the Office of the National Coordinator
for Health Information Technology established an information blocking effective date of November 2, 2020; however, the
agency subsequently issued an interim final rule to extend the effective date to April 5, 2021. Under the 21st Century Cures
Act, health care providers that violate the information blocking prohibition will be subject to appropriate disincentives, which
the U.S. Department of Health and Human services has yet to establish through required rulemaking. Developers of certified
information technology and health information networks / health information exchanges, however, may be subject to civil
monetary penalties of up to $1 million per violation. The U.S. Department of Health and Human Services Office of Inspector
General has the authority to impose such penalties and on April 24, 2020 published a proposed rule to codify new authority in
regulation, which the agency proposed would be effective 60 days after it issues a final rule, but in no event before November
2, 2020. The U.S. Department of Health and Human Services Office of Inspector General has not yet issued a final rule.
Anti-Kickback Statutes
The federal health care programs’ Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering,
receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind in return for referring an
individual for the furnishing of or arranging for the furnishing of any good or service, for which payment may be made under a
federal health care program, such as Medicare or Medicaid, or the purchasing, leasing, ordering or arranging for or
recommending purchasing, leasing, or order any good, facility, services, or item payable under such programs.
The definition of “remuneration” has been broadly interpreted to include anything of value, including, for example, gifts,
certain discounts, the furnishing of free supplies, equipment or services, credit arrangements, payment of cash and waivers of
payments. Several courts have interpreted the statute to mean that if any one purpose of remuneration is to induce or reward
referrals of federal health care program payable business, the statute has been violated. The statute contains a number of
statutory exceptions and the U.S. Department of Health and Human Services has created several regulatory "safe harbors."
Arrangements that meet all of the conditions of an applicable exception or safe harbor are protected from liability under the
Anti-Kickback Statute. However, the failure to fit an arrangement within an exception or a safe harbor does not necessarily
mean that the statute has been violated or that the arrangement will be prosecuted. Penalties for violations include criminal
penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal
health care programs. Violations of the Anti-Kickback Statute also are actionable under the federal False Claims Act.
Many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to items or services
reimbursed by any third-party payer, including commercial insurers.
21 Federal False Claims Act
The federal False Claims Act, which includes “whistleblower” or “qui tam” provisions imposes liability on any person or entity
that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by the federal
government. The qui tam provisions of the federal False Claims Act allow a private individual to bring actions on behalf of the
federal government alleging that the defendant has violated the federal False Claims Act and to share in any monetary recovery.
In recent years, the number of suits brought against healthcare providers by private individuals has increased dramatically. In
addition, various states have enacted false claims laws analogous to the federal False Claims Act, and many of these state laws
apply where a claim is submitted to any third-party payer and not merely the federal government.
When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual
damages sustained by the government, plus civil penalties of between $11,665 and $23,331 for each false claim for penalties
assessed after June 19, 2020. There are many potential bases for liability under the False Claims Act. Liability arises, primarily,
when an entity knowingly submits or causes another to submit, a false claim for reimbursement to the federal government. The
federal government has used the False Claims Act to assert liability on the basis of, among other things, causing physicians to
order excessive or unnecessary services, providing false documentation in support of claims, kickbacks, off-label promotion of
products, and Stark Law violations and other improper referrals, in addition to the more predictable allegations as to
misrepresentations with respect to the services rendered. Our future activities relating to billing, compliance with certain
regulations and Medicare reimbursement requirements, physician and other healthcare provider financial relationships and the
sale and marketing of our products may be subject to scrutiny under these laws.
CCPA
The California Consumer Privacy Act, or the CCPA, was enacted in 2018 and took effect on January 1, 2020. This piece of
legislation secures new privacy rights for California consumers. The CCPA grants consumers the right to:
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know the types of personal information that are collected, used, shared or sold, both as to the categories and specific
pieces of personal information;
have personal information held by businesses and, by extension, a business’s service provider deleted;
opt-out of the sale of personal information. Consumers are able to direct a business that sells personal information to
stop selling that information. Children under the age of 16 must provide opt in consent, with a parent or guardian
consenting for children under 13; and
non-discrimination in terms of price or service when a consumer exercises a privacy right under the CCPA.
The CCPA applies to certain businesses and such businesses must create procedures to respond to requests from consumers to
opt-out, know and delete.
For requests to opt-out, businesses must provide a “Do Not Sell My Info” link on their website or mobile app. Under the CCPA,
we are required to:
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respond to requests from consumers to know, delete and opt-out within specific time frames;
verify the identity of consumers who make requests to know and to delete, whether or not the consumer maintains a
password-protected account with us;
• maintain records of requests and how we responded for 24 months in order to demonstrate our compliance;
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treat user-enabled privacy settings that signal a consumer’s choice to opt-out as a validly submitted opt-out request;
disclose financial incentives offered in exchange for the retention or sale of a consumer’s personal information and
explain how we calculate the value of the personal information; and
explain how these incentives are permitted under the CCPA.
Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs
of ensuring and maintaining compliance. In addition, we cannot predict how future regulatory conditions will affect our
business and may also have an adverse impact on our results of operations or financial condition.
22 Foreign Jurisdictions
Laws and regulations outside of the United States also apply to our products. The number and scope of these requirements
continues to grow, and there can be no assurance that we will be able to maintain any approvals that may be required to market
our pre-transplant line of products outside the United States. Further, there may be significant expense and effort required to
comply with these approvals for new products as they become ready for the commercial marketplace or for our existing
products that we wish to sell abroad.
We currently produce products, which are CE labeled and subject to the In Vitro Diagnostic Medical Devices Directive (98/79/
EC), or IVDD, a European Union, or EU, Directive. Some of our products are currently labeled by self-declaration based on
their intended use or certified by a Notified Body for Compliance to the IVDD requirements. A product that is not CE marked
is automatically considered to be non-compliant. Appointed national enforcement agencies monitor the market for violations
and imported products are checked for compliance at customs offices.
No in vitro device or accessory may be placed on the market or put into service unless it satisfies the essential requirements set
forth in the IVDD. Devices considered to meet the essential requirements must bear the CE marking of conformity, placed by
the manufacturer, when introduced on the market. A manufacturer placing devices on the market in its name must notify its
national competent authorities.
Our products also comply with the CMDCAS, which is a system designed to implement Canadian regulations requiring some
medical devices be designed and manufactured under a registered QMS. The SCC and Health Canada's Therapeutic Products
Directorate developed this system. CMDCAS came into effect January 1, 2003.
GDPR
The General Data Protection Regulation (EU) 2016/679, or the GDPR, is a regulation on data protection and privacy in the EU,
and the European Economic Area, or the EEA, that went into effect in May 2018. It also addresses the transfer of personal data
outside the EU and EEA. The GDPR aims primarily to give control to individuals over their personal data and to simplify the
regulatory environment for international business by unifying the regulation within the EU. The regulation contains provisions
and requirements related to the processing of personal data of individuals, or data subjects, who reside in the EEA, and applies
to any enterprise—regardless of its location and the data subjects' citizenship or residence—that is processing the personal
information of data subjects inside the EEA.
Controllers and processors of personal data must put in place appropriate technical and organizational measures to implement
the data protection principles. Business processes that handle personal data must be designed and built with consideration of the
principles and provide safeguards to protect data (for example, using pseudonymization or full anonymization where
appropriate). Data controllers and processors must design information systems with privacy in mind; for instance using the
highest-possible privacy settings by default, so that the datasets are not publicly available, and cannot be used to identify a
subject. No personal data may be processed unless it is done under one of six lawful bases specified by the regulation (consent,
contract, public interest, vital interest, legitimate interest or legal requirement). When the processing is based on consent the
data subject has the right to revoke it at any time.
Data controllers and processors must clearly disclose any data collection, declare the lawful basis and purpose for data
processing, and state how long data is being retained and if it is being shared with any third parties or outside of the EEA. Data
subjects have the right to request a portable copy of the data collected by a data controller or processor in a common format,
and, under certain circumstances, the right to have their data erased. Public authorities, and businesses whose core activities
consist of regular or systematic processing of personal data, are required to employ a data protection officer, who is responsible
for managing compliance with the GDPR. Businesses must report data breaches to national supervisory authorities within 72
hours if they have an adverse effect on user privacy. In some cases, violators of the GDPR may be fined up to €20 million or up
to 4% of the annual worldwide turnover of the preceding financial year in case of an enterprise, whichever is greater.
Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs
of ensuring and maintaining compliance.
23 Employees and Human Capital Resources
At December 31, 2020, we had 475 employees, of which 456 were full-time employees. We had 127 employees in
manufacturing operations and support, 116 in research and development; 147 in sales and marketing and 85 in general and
administrative positions. As of December 31, 2020, 399 employees were located in the United States and 76 were located
outside of the United States.
The diagnostics industry is characterized by rapid product development and technological advances, which require an adept and
skilled workforce. We believe that it is critical to attract, develop and retain employees with the experience, knowledge,
expertise and vision capable of not only operating, but also excelling, in this complex and competitive business environment,
including competing against larger competitors and developing and commercializing new products, new and improved
technologies and new applications for our existing technologies.
We consider our employees to be our greatest asset and therefore focus on attracting, developing, retaining and motivating our
employees. Our recruitment and retention strategies include partnerships with external agencies to help hire top talent,
onboarding processes, a leadership development program and a professional work environment that promotes innovation and
rewards performance.
Our total compensation for employees includes a variety of components that support sustainable employment and the ability to
build a strong financial future, including competitive market-based pay and comprehensive benefits. In addition to earning a
base salary, eligible employees are compensated for their contributions to our goals with both short-term cash incentives and
long-term equity-based incentives. Through our global pay philosophy, principles and consistent implementation, we are
committed to providing fair and equitable pay for employees. Eligible full-time employees in the United States also have access
to medical, dental, and vision plans; savings and retirement plans; an employee stock purchase plan; and other resources.
Programs and benefits differ internationally for a variety of reasons, such as local legal requirements, market practices, and
negotiations with works councils and other employee representative bodies.
In addition, the success of our business is fundamentally connected to the well-being, health and safety of our employees. We
are maintaining our testing, manufacturing, and distribution facilities while implementing specific protocols to reduce contact
among our employees. In areas where COVID-19 impacts healthcare operations, our field-based sales and clinical support
teams are supporting providers through telephone and online platforms.
In addition, we have created a COVID-19 task force that is responsible for crisis decision making, employee communications,
enforcing pre-arrival temperature checking, daily health check-ins and enhanced safety training/protocols in our offices for
employees that do not work from home.
From time to time, we also employ independent contractors, consultants and temporary employees to support our operations.
Currently, the CareDx SSP production group in Sweden is represented by an IF Metall collective bargaining agreement. None
of our other employees are represented by a union or are subject to collective bargaining agreements. We have never
experienced a work stoppage and believe that our relations with our employees are good.
Environmental Matters
Our operations require the use of hazardous materials (including biological materials), which subjects us to a variety of federal,
state and local environmental and safety laws and regulations. Some of these regulations provide for strict liability, or holding a
party potentially liable without regard to fault or negligence. We could be held liable for damages and fines as a result of our, or
others, business operations should contamination of the environment or individual exposure to hazardous substances occur. In
addition, we could be subject to significant fines for failure to comply with applicable environmental, health and safety
requirements. We cannot predict how changes in laws or new regulations will affect our business, operations or the cost of
compliance.
Available Information
Our website is www.caredx.com. Information contained on, or that can be accessed through, our website is not part of this
Annual Report on Form 10-K, and you should not consider information on our website to be part of this report unless
specifically incorporated herein by reference. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities
Exchange Act of 1934, as amended, are available free of charge on our investor relations website as soon as reasonably
practicable after we electronically file such material with, or furnish it to the SEC. The SEC also maintains a website that
contains our SEC filings. The address of the website is www.sec.gov.
24 ITEM 1A. RISK FACTORS
Summary of Risk Factors
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary
does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and
other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together
with other information in this Annual Report on Form 10-K, or this Form 10-K, and our other filings with the SEC before
making an investment decision regarding our common stock.
• Our business may be adversely affected by the effects of health epidemics, including the recent coronavirus outbreak.
• We have a history of losses, and we expect to incur net losses for the next several years.
• We may require additional financing.
• We receive a substantial portion of our revenues from Medicare, and the loss of, or a significant reduction in,
reimbursement from Medicare would severely and adversely affect our financial performance.
• Our financial results currently are largely dependent on sales of AlloSure Kidney and AlloMap Heart tests and
products, and we will need to generate sufficient revenues from these and other solutions and tests we develop to grow
our business.
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The development and commercialization of additional diagnostic solutions are key to our growth strategy. New test or
product development involves a lengthy and complex process, and we may not be successful in our efforts to develop
and commercialize additional diagnostic solutions.
The field of diagnostic testing in transplantation is evolving and is subject to rapid technological change. If we are
unable to develop solutions to keep pace with rapid medical and scientific change, our operating results could be
harmed.
If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will
not achieve future sales growth.
• Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities
analysts, each of which may cause our stock price to fluctuate or decline.
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Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, or our other solutions due to
historical practices or due to more favorable reimbursement policies associated with other means of monitoring
transplants.
If we are unable to successfully compete with larger and more established players in the clinical surveillance of the
transplantation field, we may be unable to increase or sustain our revenues or achieve profitability.
If we are unable to successfully manage our growth and support demand for our tests, our business may suffer.
• Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may
decline.
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If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap
Heart, AlloSure Heart, and future testing solutions, if any, and our business will be harmed.
Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our
business and harm our reputation and ability to provide our services on a timely basis.
If we are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and
commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations.
The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists,
clinicians and laboratory and field personnel could adversely affect our business.
25 •
Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating
results, dilute your ownership of us and increase our debt or cause us to incur significant expense.
• We rely extensively on third party service providers. Failure of these parties to perform as expected, or interruptions in
our relationship with these providers or their provision of services to us, could interfere with our ability to provide test
results for our testing services business and kits for our products business.
• We face four primary risks relative to protecting critical information: loss of access risk, inappropriate disclosure risk,
inappropriate modification risk and the risk of our being unable to identify and audit our controls over the first three
risks.
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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.
• Our operating results may be adversely affected by unfavorable economic and market conditions.
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Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may
negatively affect our revenue, cash flows and profitability.
• Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart and
AlloSure Heart.
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In order to operate our laboratory, we have to comply with the CLIA and federal and state laws and regulations
governing clinical laboratories and laboratory developed tests, including FDA regulations.
• We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of
any one of which could harm our business.
• Our competitive position depends on maintaining intellectual property protection.
• Our business is dependent on licenses from third parties.
• Our operating results may fluctuate, which could cause our stock price to decrease.
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The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part
of your investment.
26 Risk Factors
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties
described below, together with all of the other information in this Annual Report on Form 10-K, including the section titled
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial
statements and related notes, before investing in our common stock. If any of the follows risks occur, our business, financial
condition, results of operations and prospects could be materially harmed. In that event, the market price of our common stock
could decline, and you could lose part or all of your investment.
Risks Related to Our Business
Our business may be adversely affected by the effects of health epidemics, including the recent coronavirus outbreak.
On January 30, 2020, the World Health Organization, or the WHO, announced a global health emergency because of a new
strain of coronavirus, or COVID-19, originating in Wuhan, China and the risks to the international community as the virus
spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based
on the rapid increase in exposure globally. The full impact of the COVID-19 pandemic, including the impact associated with
preventative and precautionary measures that we, other businesses and governments are taking, continues to evolve as of the
date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on us, but the pandemic may
materially affect our financial condition, liquidity and future results of operations.
Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions
on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at
third-party suppliers in the United States and other countries, or the availability or cost of materials, which would disrupt our
supply chain. Any interruption in manufacturing or our supply of materials could adversely affect our ability to conduct
ongoing and future research and testing activities.
In addition, our clinical studies may be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment may
be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients may not be able to
comply with clinical study protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the
ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
exposure to COVID-19, may adversely impact our clinical trial operations. Additionally, collaborators at research hospitals may
be subject to limitations with respect to accessing their laboratories and sample banks which could impact timelines for research
and product development dependent on external collaborations. Limits on the ability of individuals to move freely during a
pandemic may also negatively impact recruiting new staff necessary to expand our operations.
The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the
potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread
pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could in
the future negatively affect our liquidity. In addition, a recession or market correction resulting from the spread of COVID-19
could materially affect our business and the value of our common stock.
Management is actively monitoring the effect of the global situation on our financial condition, liquidity, operations, suppliers,
industry and workforce. Given the daily evolution of the COVID-19 pandemic and the global responses to curb its spread, we
are not able to estimate the effects of the COVID-19 pandemic on our results of operations, financial condition or liquidity for
fiscal year 2021.
We have a history of losses, and we expect to incur net losses for the next several years.
We have incurred substantial net losses since our inception, and we may continue to incur additional losses for the next several
years. For the year ended December 31, 2020, our net loss was $18.7 million. As of December 31, 2020, we had an
accumulated deficit of $352.5 million. We expect to continue to incur significant operating expenses and anticipate that our
expenses will increase due to costs relating to, among other things:
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researching, developing, validating and commercializing potential new testing services, products and
digital solutions, including additional expenses in connection with our continuing development and
commercialization of KidneyCare, HeartCare, AlloSeq, AiTraC and other future solutions;
developing, presenting and publishing additional clinical and economic utility data intended to
increase payer coverage and clinician adoption of our current and future solutions;
expansion of our operating capabilities;
maintenance, expansion and protection of our intellectual property portfolio and trade secrets;
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the process of fully integrating acquired companies and operations and the associated potential
disruptions to our business;
future clinical trials;
expansion of the size and geographic reach of our sales force and our marketing capabilities to
commercialize our existing and future solutions;
employment of additional clinical, quality control, scientific, customer service, laboratory, billing
and reimbursement and management personnel;
compliance with existing and changing laws, regulations and standards, including those relating to
corporate governance and public disclosure and regulations implemented by the Securities and
Exchange Commission, or the SEC, and The Nasdaq Stock Market LLC;
employment of operational, financial, accounting and information systems personnel, consistent with
expanding our operations and our status as a public company; and
failure to achieve expected operating results may cause a future impairment of goodwill or other
assets.
Even if we achieve significant revenues, we may not become profitable, and even if we achieve profitability, we may not be
able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain consistently profitable
could adversely affect the market price of our common stock and could significantly impair our ability to raise capital, expand
our business or continue to pursue our growth strategy or even continue to operate. For a detailed discussion of our financial
condition and results of operations, see “Management’s Discussion and Analysis of Financial Condition and Results of
Operations.”
We may require additional financing.
As of December 31, 2020, we had cash, cash equivalents and marketable securities of $224.7 million and an accumulated
deficit of $352.5 million. On January 25, 2021, we completed an underwritten public offering of common stock, and on
February 11, 2021, we sold additional shares of common stock pursuant to the underwriters' full exercise of an overallotment
option granted to the underwriters in connection with the offering. The aggregate net proceeds to us, including the shares sold
pursuant to the underwriters' full exercise of the overallotment option, were approximately $188.7 million, after deducting
underwriting discounts and commissions and estimated offering expenses. We may require additional financing in the future to
fund working capital, pay our obligations as they come due and fund our acquisitions of complementary businesses and assets.
Additional financing might include issuance of equity securities, debt, cash from collaboration agreements, or a combination of
these. However, there can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund
our operations or on terms favorable to us.
We receive a substantial portion of our revenues from Medicare, and the loss of, or a significant reduction in,
reimbursement from Medicare would severely and adversely affect our financial performance.
For the year ended December 31, 2020, revenue from Medicare for AlloMap Heart, AlloSure Kidney and AlloSure Heart
represented 67% of testing services revenue. However, we may not be able to maintain or increase our tests reimbursed by
Medicare for a variety of reasons, including changes in reimbursement practices, general policy shifts, or reductions in
reimbursement amounts. We cannot predict whether Medicare reimbursements will continue at the same payment amount or
with the same breadth of coverage in the future, if at all.
The Protecting Access to Medicare Act of 2014, or PAMA, included a substantial new payment system for clinical laboratory
tests under the Clinical Laboratory Fee Schedule, or CLFS. Under PAMA, laboratories that receive the majority of their
Medicare revenues from payments made under the CLFS report initially and then on a subsequent three-year basis thereafter (or
annually for advanced diagnostic laboratory tests, or ADLTs), private payer payment rates and volumes for their tests. The final
PAMA ruling was issued June 17, 2016 and the new market based rates took effect January 1, 2018. The Centers for Medicare
& Medicaid Services, or CMS, uses the rates and volumes reported by laboratories to develop Medicare payment rates for the
tests equal to the volume-weighted median of the private payer payment rates for the tests. Under PAMA, the reimbursement
rate for AlloMap Heart is currently $3,240 for Medicare beneficiaries.
On September 26, 2017, we announced that the Molecular Diagnostic Services, or MolDX, Program developed by Palmetto
GBA, or Palmetto, has set AlloSure Kidney reimbursement at $2,841. AlloSure Kidney began to be reimbursed for kidney
transplants covered by Medicare across the United States on October 9, 2017, the effective date of the Palmetto local coverage
determination, or LCD.
28 In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, our Medicare Administrative contractor, issued a parallel coverage policy
granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare
reimbursement rate for AlloSure Heart is currently $2,753.
If an AlloMap Heart, AlloSure Kidney or AlloSure Heart reimbursement rate that is significantly lower than the current rate is
set by CMS or MolDx in the future, it could cause us to discontinue AlloMap Heart, AlloSure Kidney or AlloSure Heart testing
for Medicare patients because providing tests at a substantially lowered reimbursement rate may not be economically viable.
Given the significant portion of payments represented by Medicare, our remaining test revenue may be insufficient to sustain
our operations.
If future reimbursement levels are less than the current price, our revenues and our ability to achieve profitability could be
impaired, and the market price of our common stock could decline. We may also not be able to maintain or increase the portion
of our tests reimbursed by Medicare for a variety of other reasons, including changes in reimbursement practices and general
policy shifts.
On a five-year rotational basis, Medicare requests bids for its regional Medicare Administrative Contractors, or MAC, services.
The MAC for California is currently Noridian Healthcare Solutions. Our current Medicare coverage through Noridian provides
for reimbursement for tests performed for qualifying Medicare patients throughout the U.S. so long as the tests are performed in
our California laboratory. We cannot predict whether Noridian or any future MAC will continue to provide reimbursement for
AlloMap Heart, AlloSure Kidney or AlloSure Heart at the same payment amount or with the same breadth of coverage in the
future, if at all. Additional changes in the MAC processing Medicare claims for AlloSure Kidney, AlloMap Heart or AlloSure
Heart could impact the coverage or payment amount for our tests and our ability to obtain Medicare coverage for any products
we may launch in the future.
Any decision by CMS or its local contractors to reduce or deny coverage for our tests would have a significant adverse effect on
our revenue and results of operations and ability to operate and raise capital. Any such decision could also cause affected
clinicians treating Medicare covered patients to reduce or discontinue the use of our tests.
Our financial results currently are largely dependent on sales of AlloSure Kidney and AlloMap Heart tests and products,
and we will need to generate sufficient revenues from these and other solutions and tests we develop to grow our business.
We expect that sales of testing services and products will account for a substantial portion of our revenue for at least the next
two years. If we are unable to increase sales of our testing services or products or successfully develop and commercialize other
solutions, tests or enhancements, our revenues and ability to achieve profitability would be impaired, and the market price of
our common stock could decline.
We could become subject to legal proceedings that could be time consuming, result in costly litigation and settlements/
judgments, require significant amounts of management attention and result in the diversion of significant operational
resources, which could adversely affect our business, financial condition and results of operations.
We have in the past been, and from time to time in the future may become, involved in lawsuits, claims and proceedings
incident to the ordinary course of, or otherwise in connection with, our business. For example, in response to our false
advertising suit filed against Natera Inc., or Natera, on April 10, 2019, Natera filed a counterclaim against us on February 18,
2020 in the U.S. District Court for the District of Delaware, or the Court, alleging we made false and misleading claims about
the performance capabilities of AlloSure. The suit seeks injunctive relief and unspecified monetary relief. On September 30,
2020, Natera requested leave of the Court to amend its counterclaims to include additional allegations regarding purportedly
false claims we made with respect to AlloSure, and the Court granted Natera’s request. Trial is currently scheduled to begin on
July 26, 2021.
In addition, in response to our patent infringement suit filed against Natera on March 26, 2019, Natera filed suit against us on
January 13, 2020 in the Court alleging, among other things, that AlloSure infringes Natera’s U.S. Patent 10,526,658. On March
25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also infringes Natera’s U.S. Patent
10,597,724. The suit seeks a judgment that we have infringed Natera’s patents, an order preliminarily and permanently
enjoining us from any further infringement of such patents and unspecified damages. We intend to defend both of these matters
vigorously, and believe that we have good and substantial defenses to the claims alleged in the suits, but there is no guarantee
that we will prevail.
Litigation is inherently unpredictable. It is possible that an adverse result in one or more of these possible future events could
have a material adverse effect on us including increased expenses to defend, settle or resolve such litigation.
29 The development and commercialization of additional diagnostic solutions are key to our growth strategy. New test or
product development involves a lengthy and complex process, and we may not be successful in our efforts to develop and
commercialize additional diagnostic solutions.
Key elements of our strategy are to discover, develop, validate and commercialize a portfolio of new diagnostic solutions. We
cannot be sure that we will be able to successfully complete development of or commercialize any of our planned future
solutions, or that they will prove to be capable of reliably being used for organ surveillance in the heart or in other types of
organs. Before we can successfully develop and commercialize any of our currently planned or other new diagnostic solutions,
we will need to:
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conduct substantial research and development;
obtain the necessary testing samples and related data;
conduct clinical validation studies;
expend significant funds;
expand and scale-up our laboratory processes;
expand and train our sales force;
gain acceptance from ordering clinicians at a larger number of transplant centers;
gain acceptance from ordering laboratories associated with transplant centers; and
seek and obtain regulatory clearance or approvals of our new solutions, as required by applicable
regulations.
This process involves a high degree of risk and may take up to several years or more. Our test development and
commercialization efforts may be delayed or fail for many reasons, including:
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failure of the test at the research or development stage;
difficulty in accessing suitable testing samples, especially testing samples with known clinical
results;
lack of clinical validation data to support the effectiveness of the test;
delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a
timely and cost-effective manner;
failure to obtain or maintain necessary clearances or approvals to market the test; or
lack of commercial acceptance by patients, clinicians or third-party payers.
Few research and development projects result in commercial products, and success in early clinical studies often is not
replicated in later studies. At any point, we may abandon development of new diagnostic solutions, or we may be required to
expend considerable resources repeating clinical trials, which would adversely impact the timing for generating potential
revenues from those new diagnostic solutions. In addition, as we develop diagnostic solutions, we will have to make additional
investments in our sales and marketing operations, which may be prematurely or unnecessarily incurred if the commercial
launch of a test is abandoned or delayed. If a clinical validation study fails to demonstrate the prospectively defined endpoints
of the study, we would likely abandon the development of the test or test feature that was the subject of the clinical trial, which
could harm our business.
If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of
additional diagnostic solutions by us may be delayed and, as a result, our business will suffer and our stock price may
decline.
From time to time, we expect to estimate and publicly announce the anticipated timing of the accomplishment of various
clinical and other product development goals. In addition, we have included a discussion of a number of anticipated targets in
this Form 10-K. The actual timing of accomplishment of these targets could vary dramatically compared to our estimates, in
some cases for reasons beyond our control, including the impact of the COVID-19 pandemic. We cannot be certain that we will
meet our projected targets and if we do not meet these targets as publicly announced, the commercialization of our diagnostic
solutions may be delayed or may not occur at all and, as a result, our business will suffer and our stock price may decline.
30 The field of diagnostic testing in transplantation is evolving and is subject to rapid technological change. If we are unable to
develop solutions to keep pace with rapid medical and scientific change, our operating results could be harmed.
The field of diagnostic testing in transplantation is evolving. Although there have been few advances in technology relating to
organ rejection in transplant recipients, the market for medical diagnostic companies is marked by rapid and substantial
technological development and innovations that could make AlloSure Kidney, AlloMap Heart, AlloSure Heart and our other
products and digital solutions, including those in development, outdated. We must continually innovate, expand and update our
test offerings to address unmet needs in monitoring transplant related conditions. AlloSure Kidney, AlloMap Heart, AlloSure
Heart, and our other products and digital solutions, including those in development, could become obsolete unless we
continually innovate, enhance and expand our product offerings to include new clinical applications. If we are unable to
demonstrate the effectiveness of AlloSure Kidney, AlloMap Heart, AlloSure Heart, our other products and digital solutions and
future diagnostic solutions and tests, if any, compared to new methodologies and technologies, then sales of our tests, products,
and digital solutions could decline, which would harm our business and financial results.
If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will not
achieve future sales growth.
Clinicians and healthcare administrators are traditionally slow to adopt new products, testing practices and clinical treatments,
partly because of perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of our
sales efforts that we continue to educate clinicians, administrators and laboratory directors about our testing services, products
and digital solutions, and demonstrate the clinical and diagnostic benefits of these services, products and digital solutions. We
believe that clinicians, transplant centers and laboratories may not use our services, products and digital solutions unless they
determine, based on published peer-reviewed journal articles, the experience of other clinicians or laboratory verification, that
our services, products and digital solutions provide accurate, reliable and cost-effective information that is useful in pre-
transplant matching and monitoring their post-transplant recipients.
Our product kits are sold to hundreds of laboratories, mainly in Europe and the U.S. Laboratories order our products based on
the accuracy, speed and cost of the test together with the cost and availability of equipment on which to run the test. Switching
to or adopting our products may require the purchase of new and costly testing equipment. To attract new laboratory customers,
the performance of our products must provide a performance or cost advantages over similar products sold by our competitors.
If clinicians, hospital administrators and laboratories do not adopt and continue to use our tests and products or our future
solutions and tests, our business and financial results will suffer.
Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities
analysts, each of which may cause our stock price to fluctuate or decline.
Historically, our financial results have been, and we expect that our operating results will continue to be, subject to quarterly
fluctuations. Our net income (loss) and other operating results will be affected by numerous factors, including:
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our ability to successfully market and sell our testing services and products;
our ability to successfully commercialize new diagnostic solutions;
the amount of our research and development expenditures;
the timing of cash collections from third-party payers;
the extent to which our current and future solutions, if any, are eligible for coverage and
reimbursement from third-party payers;
the process of integrating new acquisitions, and the associated potential disruption to our business;
changes in coverage and reimbursement or in reimbursement-related laws directly affecting our
business;
any intellectual property infringement lawsuit or opposition, interference or cancellation proceeding
in which we may become involved or that otherwise may affect our intellectual property position;
announcements by our competitors of new or competitive products;
regulatory or legal developments affecting our test or competing products;
total operating expenses; and
changes in expectation as to our future financial performance, including financial estimates,
publications or research reports by securities analysts.
31 If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock
could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our
stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful
and should not be relied upon as an indication of our future performance.
If the use of AlloSure Kidney, AlloMap Heart, AlloSure Heart or any of our other solutions is not supported by studies
published in peer-reviewed scientific and medical publications, and then periodically supplemented with additional support
in peer-reviewed journals, the rate of adoption of our current and future solutions by clinicians and treatment centers and
the rate of reimbursement of our current and future solutions by payers may be negatively affected.
Transplant, like all specialties, is based on evidence-based medicine. As a result, laying a strong foundation of evidence and
improved clinical utility is essential in the adoption of the tools offered by us. The results of our studies involving AlloSure
Kidney, AlloMap Heart and AlloSure Heart have been presented at major medical society congresses and published in peer-
reviewed publications in leading medical journals. This continued presence in peer-reviewed publications is necessary to
promote clinician adoption and favorable reimbursement decisions. We believe that peer-reviewed journal articles that provide
evidence of the utility of our solutions or the technology underlying AlloSure Kidney, AlloMap Heart, AlloSure Heart and our
other products and digital solutions are very important to the commercial success of our solutions. Clinicians typically take a
significant amount of time to adopt new products, testing practices and clinical treatments, partly because of perceived liability
risks and the uncertainty of third-party reimbursement. It is critical to the success of our sales efforts that we educate a
sufficient number of clinicians and administrators about AlloSure Kidney, AlloMap Heart, AlloSure Heart and our future
solutions, and demonstrate the clinical benefits of these solutions. Clinicians may not adopt, and third-party payers may not
cover or adequately reimburse for, our current and future products and digital solutions unless they determine, based on
published peer-reviewed journal articles and the experience of other clinicians, that our diagnostic current and future products
and digital solutions provide accurate, reliable and cost-effective information that is useful in monitoring transplant recipients
and making informed and timely treatment decisions.
The administration of clinical and economic utility studies is expensive and demands significant attention from our
management team. Data collected from these studies may not be positive or consistent with our existing data, or may not be
statistically significant or compelling to the medical community. If the results obtained from our ongoing or future studies are
inconsistent with certain results obtained from our previous studies, adoption of our current and future products and digital
solutions would suffer and our business would be harmed.
While we have had success in generating peer-reviewed publications regarding AlloSure Kidney, AlloMap Heart, and AlloSure
Heart, additional peer-reviewed publications regarding AlloSure Kidney, AlloMap Heart, AlloSure Heart and our future
products and digital solutions may be limited by many factors, including delays in the completion of, poor design of, or lack of
compelling data from clinical studies that would be the subject of the article. If our current and future products and digital
solutions or the technology underlying AlloSure Kidney, AlloMap Heart, AlloSure Heart, or our future products and digital
solutions do not receive sufficient favorable exposure in peer-reviewed publications, the rate of clinician adoption and positive
reimbursement coverage decisions could be negatively affected. The publication of clinical data in peer-reviewed journals is a
crucial step in commercializing and obtaining reimbursement for diagnostic solutions such as ours, and our inability to control
when, if ever, results are published may delay or limit our ability to derive sufficient revenue from any product that is the
subject of a study.
To ensure the success of AlloSure Kidney and future tests based on donor-derived cell-free DNA, or dd-cfDNA, we will need
to continue our efforts to complete and publicize research and trials, especially the Kidney Allograft Outcomes AlloSure
Registry, or K-OAR, registry study, that provides evidence of the utility of dd-cfDNA and validate AlloSure Kidney as a
solution.
Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, or our other solutions due to historical
practices or due to more favorable reimbursement policies associated with other means of monitoring transplants.
Due to the historically limited monitoring options and the well-established coverage and reimbursement for biopsies, clinicians
are accustomed to monitoring for acute rejection in kidney and heart transplant recipients by utilizing biopsies. Many clinicians
use AlloSure Kidney, AlloMap Heart and AlloSure Heart in parallel with biopsies rather than as an alternative to biopsies.
While we do not market AlloSure Kidney, AlloMap Heart or AlloSure Heart as biopsy alternatives, per se, if treatment center
administrators view our test as an alternative to a biopsy but believe they would derive more revenue from the performance of
biopsies, such administrators may be motivated to reduce or avoid the use of our test. While biopsies are less common for
monitoring kidney transplant patients, there are transplant centers that manage patients with protocol biopsies, which could
impact AlloSure Kidney revenue. We cannot provide assurance that our efforts will increase the use of our test by new or
existing customers. Our failure to increase the frequency of use of our test by new and existing customers would adversely
affect our growth and revenues.
32 If we are unable to successfully compete with larger and more established players in the clinical surveillance of the
transplantation field, we may be unable to increase or sustain our revenues or achieve profitability.
Our AlloSure Kidney solution for kidney transplant recipients competes against existing diagnostic tests utilized by
pathologists, which involves evaluating biopsy samples to determine the presence or absence of rejection. However, because of
the risks and discomforts of the invasive kidney biopsy procedure, as well as the expense and relatively low rate of finding
moderate to severe grade rejection, biopsy is not a standard practice for surveillance of transplanted kidneys. Additional
competition for kidney surveillance diagnostics currently comes from general, non-specific clinical chemistry tests such as
serum creatinine, urine protein, donor specific antibodies, complete blood count, lipid profile and others that are widely ordered
by physician offices and routinely performed in clinical reference labs and hospital labs. Our competitors also include
companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-
transplant surveillance, Natera and Eurofins, have commercially available molecular diagnostics tests.
Competition for our AlloMap Heart solution for heart transplant recipients also comes from biopsies, which generally involve
evaluating biopsy samples to determine the presence or absence of rejection. This practice has been the standard of care in the
United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the
various benefits of our test in order to change clinical practice.
We expect the competition for pre-transplant typing and post-transplant surveillance to increase as there are numerous
established and startup companies in the process of developing products and services for the transplant market which may
directly or indirectly compete with our existing pre- and post-transplant solutions, or our development pipeline. Competition
from other companies, especially those with an eye toward transitioning to more automated typing processes, could impact our
ability to maintain market share and its current margins. For example, we launched QTYPE in September 2016 and QTYPE
competes with other quantitative polymerase chain reaction, or PCR, products including products offered by Thermo Fisher
Scientific, Inc., or Thermo Fisher, as well as alternatives to PCR such as next generation sequencing, or NGS, typing products.
In addition to businesses focused on pre-transplantation such as Thermo Fisher’s One Lambda and Immucor, Inc.’s
LIFECODES, companies that have not historically focused on transplantation, but that possesses existing knowledge of dd-
cfDNA technology have indicated they are considering this market.
Competition for our digital solutions include various companies that develop application software and operate in the healthcare
field. Our primary competitor in this field is Epic Systems Corporation, or Epic. In addition, other established and emerging
healthcare, information technology and service companies may commercialize competitive products including informatics,
analysis, integrated genetic tools and services for health and wellness.
The field of clinical surveillance of transplantation is evolving. New and well-established companies are devoting substantial
resources to the application of molecular diagnostics to the treatment of medical conditions. Some of these companies may elect
to develop and market diagnostic solutions in the post-transplant surveillance market.
Many of our potential competitors may have greater brand recognition or substantially greater financial and technical resources
and development, production and marketing capabilities than we do. Others may develop lower-priced, less complex tests that
could be viewed by clinicians and payers as functionally equivalent to our AlloSure Kidney, AlloMap Heart and AlloSure Heart
tests, which could force us to lower the current list price of our test and impact our operating margins and our ability to achieve
profitability. If we are unable to compete successfully against current or future competitors, we may be unable to increase
market acceptance for and sales of AlloSure Kidney, AlloMap Heart, AlloSure Heart and our products and digital solutions,
which could prevent us from increasing or sustaining our revenues or achieving profitability and could cause the market price
of our common stock to decline.
If we are unable to successfully and continually update our products on a timely basis, our ability to attract and retain
customers could be impaired and our competitive position could be harmed.
We operate in an environment characterized by rapid development and continuing innovation. We will need to continue to
maintain the value of our product offering. To compete successfully, we must continually update our product range and produce
continually updated test kits and software. The failure to maintain the quality of our products or inability to keep pace with this
innovation could render our existing or future solutions obsolete or less attractive to lab directors and clinicians. Any failure to
anticipate or develop new or enhanced solutions in a timely manner could result in decreased revenue and harm to our business
and prospects. If we fail to introduce new or enhanced solutions that meet the needs of our customers, we will lose market share
and our business, operating results and prospects will be adversely affected.
33 Our research and development efforts will be hindered if we are not able to acquire or contract with third parties for access
to additional tissue and blood samples.
Our clinical development relies on our ability to secure access to tissue and blood samples, as well as recipient information
including biopsy results and clinical outcomes from the same patient. Furthermore, the studies through which our future
solutions are developed may rely on access to multiple samples from the same recipient over a period of time as opposed to
samples at a single point in time or archived samples. We will require additional samples and recipient data for future research,
development and validation. Access to recipients and samples on a real-time, or non-archived, basis is limited and often on an
exclusive basis, and there is no guarantee that future initiatives will be successful in obtaining and validating additional
samples. Additionally, the process of negotiating access to new and archived donor and recipient data and samples is lengthy
since it typically involves numerous parties and approval levels to resolve complex issues, such as usage rights, institutional
review board approval, recipient consent, privacy rights and informed consent of recipients, publication rights, intellectual
property ownership and research parameters. If we are not able to acquire or negotiate access to new and archived donor and
recipient data and tissue and blood samples with source institutions, or if other laboratories or our competitors secure access to
these samples before us, our ability to research, develop and commercialize future solutions such as AlloSure Kidney will be
limited or delayed.
If we cannot maintain existing clinical collaborations and enter into new ones, our efforts to commercialize and develop
products could be delayed.
In the past, we have entered into clinical collaborations with highly regarded academic institutions and leading treatment
centers in the transplant field. Our success in the future may depend in part on our ability to enter into agreements with other
leading institutions in the transplant field. Securing these agreements can be difficult due to internal and external constraints
placed on these organizations. Some organizations may limit the number of collaborations they have with any one company so
as to not be perceived as biased or conflicted. Organizations may also have insufficient administrative and related infrastructure
to enable collaborations with many companies at once, which can extend the time it takes to develop, negotiate and implement a
collaboration.
In addition to completing clinical collaborations, publication of clinical data in peer-reviewed journals is a crucial step in
commercializing and obtaining coverage and reimbursement for solutions such as ours. Our inability to control when, if ever,
results of such studies are published may delay or limit our ability to derive sufficient revenues from any test that may result
from a collaboration.
From time to time, we expect to engage in discussions with potential clinical collaborators, which may or may not lead to
collaborations. We cannot guarantee that any discussions will result in clinical collaborations or that any clinical studies that
may result will be enrolled or completed in a reasonable time frame or with successful outcomes. Once news of discussions
regarding possible collaborations becomes known in the medical community, regardless of whether the news is accurate, failure
to announce a collaborative agreement or the other entity’s announcement of a collaboration with an entity other than us may
result in adverse speculation about us, our current and future solutions or our technology, resulting in harm to our reputation
and our business.
If we are unable to successfully manage our growth and support demand for our tests, our business may suffer.
As the volume of the tests that we perform grows, we will need to continue to ramp up our testing capacity, implement
increases in scale and related processing, customer service, billing and systems process improvements and expand our internal
quality assurance program to support testing on a larger scale. We will also need additional certified laboratory scientists and
other scientific and technical personnel to process our tests. We cannot be certain that any increases in scale, related
improvements and quality assurance will be successfully implemented or that appropriate personnel will be available. As
additional products are developed, we may need to bring new equipment on-line, implement new systems, technology, controls
and procedures and hire personnel with different qualifications. We plan to expand our sales force to support additional
products. There is significant competition for qualified, productive sales personnel with advanced sales skills and technical
knowledge in our field. Our ability to achieve significant growth in revenue in the future will depend, in large part, on our
success in recruiting, training and retaining sufficient qualified sales personnel.
The value of AlloSure Kidney, AlloMap Heart and AlloSure Heart depends, in large part, on our ability to perform AlloSure
Kidney, AlloMap Heart and AlloSure Heart tests on a timely basis and at a high quality standard, and on our reputation for such
timeliness and quality. Failure to implement necessary procedures, transition to new equipment or processes or hire new
personnel could result in higher costs of processing or an inability to meet market demand in a timely manner.
34 There can be no assurance that we will be able to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, or our future
solutions, if any, on a timely basis at a level consistent with demand, that our efforts to scale our commercial operations will not
negatively affect the quality of test results or that we will be successful in responding to the growing complexity of our testing
operations. If we encounter difficulty meeting market demand for our current and future solutions, our reputation could be
harmed and our future prospects and our business could suffer.
In addition, our growth may place a significant strain on our management, operating and financial systems and our sales,
marketing and administrative resources. As a result of our growth, our operating costs may escalate even faster than planned,
and some of our internal systems may need to be enhanced or replaced. If we cannot effectively manage our expanding
operations and our costs, we may not be able to grow effectively or we may grow at a slower pace, and our business could be
adversely affected.
Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may decline.
From 2019 to 2020, our revenue grew from $127.1 million to 192.2 million, which represents annual growth of 51%. In the
future, our revenue may not grow at all and it may decline. We believe that our future revenue will depend on, among other
factors:
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the continued usage and acceptance of our current and future solutions;
demand for our testing services, products and digital solutions;
the introduction and acceptance of new or enhanced products or services by us or by competitors;
our ability to maintain reimbursement for AlloSure Kidney, AlloMap Heart and AlloSure Heart and
secure reimbursement for our future solutions;
our ability to anticipate and effectively adapt to developing markets and to rapidly changing
technologies;
our ability to attract, retain and motivate qualified personnel;
the initiation, renewal or expiration of significant contracts with our commercial partners;
pricing changes by us, our suppliers or our competitors; and
general economic conditions and other factors.
We may not be successful in our efforts to manage any of the foregoing, and any failure to be successful in these efforts could
materially and adversely affect revenue growth. You should not consider our past revenue growth to be indicative of future
growth.
If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart,
AlloSure Heart, and future testing solutions, if any, and our business will be harmed.
We perform all of our testing services for the U.S. in our laboratory located in Brisbane, California. We do not have redundant
laboratory facilities. Brisbane, California is situated on or near earthquake fault lines. Our facility and the equipment we use to
perform testing services would be costly to replace and could require substantial lead time to repair or replace if damaged or
destroyed. Our facilities may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes,
wildfires, flooding and power outages, which may render it difficult or impossible for us to perform our tests for some period of
time. The inability to perform our tests may result in the loss of customers or harm our reputation, and we may be unable to
regain those customers in the future. Although we possess insurance for damage to our property and the disruption of our
business, we do not have earthquake insurance and thus coverage may not be sufficient to cover all of our potential losses and
may not continue to be available to us on acceptable terms, if at all.
In order to establish a redundant laboratory facility, we would have to spend considerable time and money securing adequate
space, constructing the facility, recruiting and training employees and establishing the additional operational and administrative
infrastructure necessary to support a second facility. Additionally, any new clinical laboratory facility opened by us in the U.S.
would be required to be certified under the Clinical Laboratory Improvement Amendments of 1988, or 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. We would also be required to secure and maintain state licenses required
by several states, including California, Florida, Maryland, New York, Rhode Island and Pennsylvania, which can take a
significant amount of time and result in delays in our ability to begin operations at that facility.
35 If we failed to secure any such licenses, we would not be able to process samples from recipients in such states. We also expect
that it would be difficult, time-consuming and costly to train, equip and use a third-party to perform tests on our behalf. We
could only use another facility with the established state licensures and CLIA certification necessary to perform AlloSure
Kidney, AlloMap Heart, AlloSure Heart or future solutions following validation and other required procedures. We cannot be
certain that we would be able to find another CLIA-certified facility willing or able to adopt AlloSure Kidney, AlloMap Heart,
AlloSure Heart or future solutions or able to comply with the required quality and regulatory standards, or that this laboratory
would be willing or able to perform the tests for us on commercially reasonable terms.
In mid-March 2020, in response to the COVID-19 pandemic, the Governor of California and the State Public Health Officer
and Director of the California Department of Public Health ordered all individuals living in the State of California, where our
laboratory is located, to stay at their place of residence for an indefinite period of time (subject to certain exceptions to facilitate
authorized necessary and other permitted activities) to mitigate the impact of the COVID-19 pandemic. The executive order
exempts certain individuals needed to maintain continuity of operations of essential critical infrastructure sectors and additional
sectors as the State Public Health Officer may designate as critical to protect health and well-being of all Californians. In May
2020, the Governor of California issued an executive order that informed local health jurisdictions and industry sectors that they
may gradually reopen under new modifications and guidance provided by the state of California. In August 2020, the state of
California released revised criteria for loosening and tightening restrictions on certain activities on generally a county-by-
county basis. San Mateo County, where our laboratory and headquarters are located, is currently subject to certain restrictions
on non-essentials business operations. These orders and others may be further modified, amended and adopted depending upon
the COVID-19 transmission rates in our county and state, as well as other factors. If the operations in our laboratory are deemed
non-essential, or if sufficient numbers of our laboratory staff are infected with COVID-19 and are unable to perform their roles,
we may not be able to perform our tests for the duration of any shelter-in-place order or while we have insufficient numbers of
laboratory staff, either of which could negatively impact our business, operating results and financial condition.
Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and
harm our reputation and ability to provide our services on a timely basis.
Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable and
secure point-to-point transport of recipient samples to our laboratory and enhanced tracking of these recipient samples. Should a
carrier encounter delivery performance issues such as loss, damage or destruction of a sample, it may be difficult to replace our
patient samples in a timely manner and such occurrences may damage our reputation and lead to decreased demand for our
services and increased cost and expense to our business. In addition, any significant increase in shipping rates could adversely
affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters or other service
interruptions, such as the COVID-19 pandemic, affecting delivery services we use would adversely affect our ability to receive
and process recipient samples on a timely basis.
Our ability to commercialize our testing solutions that we develop is dependent on our relationships with laboratory services
providers and their willingness to support our current and future solutions.
We rely on third-party laboratory services providers to draw and partially process the patient blood samples that are analyzed in
our Brisbane, California laboratory. Our business will suffer if these service providers do not support AlloSure Kidney,
AlloMap Heart, AlloSure Heart or the other solutions that we may develop. For example, these laboratories may determine that
processing the samples for our solutions requires too much additional effort. Additionally, if transplant facilities have
relationships with large reference laboratories that will not process and send out our specimens, the clinicians at these facilities
may deem ordering our tests outside of these relationships too inconvenient for their patients. A lack of acceptance of our
current and future solutions by these service providers could result in lower test volume.
If we are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and
commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations.
We expect capital outlays and operating expenditures to increase over the next several years as we expand our infrastructure,
commercial operations and research and development activities. Specifically, we may need to raise additional capital to, among
other things:
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develop other solutions for clinical surveillance in transplantation;
increase our selling and marketing efforts to drive market adoption and address competitive
developments;
expand our clinical laboratory operations;
fund our clinical validation study activities;
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expand our research and development activities;
sustain or achieve broader commercialization of AlloSure Kidney, KidneyCare, AlloMap Heart,
AlloSure Heart, HeartCare, our products, and digital solutions or enhancements to those tests,
products and digital solutions;
acquire or license products or technologies including through acquisitions; and
finance our capital expenditures and general and administrative expenses.
Our present and future funding requirements will depend on many factors, including:
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the level of research and development investment required to develop our new solutions;
costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property
rights;
our need or decision to acquire or license complementary technologies or acquire complementary
businesses;
changes in test development plans needed to address any difficulties in commercialization;
competing technological and market developments;
whether our diagnostic solutions become subject to additional FDA or other regulation; and
changes in regulatory policies or laws that affect our operations.
Additional capital, if needed, may not be available on satisfactory terms, or at all. Furthermore, if we raise additional funds by
issuing equity securities, dilution to our existing stockholders could result. Any equity securities issued also may provide for
rights, preferences or privileges senior to those of holders of our common stock and would result in dilution to our stockholders.
For example, we have the ability to sell up to $50.0 million of additional shares of our common stock to the public through an
“at the market” offering pursuant to the Sales Agreement we entered into with Jefferies, LLC, on August 31, 2018. Any shares
of common stock issued in the at-the-market offering will result in dilution to the existing stockholders. If we raise additional
funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of
our common stock, and the terms of the debt securities issued could impose significant restrictions on our operations. If we
raise additional funds through collaborations and licensing arrangements, we might be required to relinquish significant rights
to our technologies or our solutions under development, or grant licenses on terms that are not favorable to us, which could
lower the economic value of those programs to us. If adequate funds are not available, we may have to scale back our
operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our
business could be adversely affected.
The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists,
clinicians and laboratory and field personnel could adversely affect our business.
Our success depends largely on the skills, experience and performance of key members of our executive management team. The
efforts of each of these persons will be critical to us as we continue to develop our technologies and testing processes. If we
were to lose one or more of these key employees, including due to disease (such as COVID-19), disability or death, we may
experience difficulties in competing effectively, developing our technologies and implementing our business strategies. We do
not currently maintain “key person” insurance on any of our employees.
Our research and development programs and commercial laboratory operations depend on our ability to attract and retain highly
skilled scientists and technicians, including geneticists, biostatisticians, engineers, licensed laboratory technicians and chemists.
We may not be able to attract or retain qualified scientists and technicians in the future due to the intense competition for
qualified personnel among life science businesses, particularly in the San Francisco Bay Area. We also face competition from
universities, public and private research institutions and other organizations in recruiting and retaining highly qualified
scientific personnel.
In addition, our success depends on our ability to attract and retain laboratory and field personnel with extensive experience in
transplant recipient care and surveillance and close relationships with clinicians, pathologists and other hospital personnel. We
may have difficulties locating, recruiting or retaining qualified salespeople, which could cause a delay or decline in the rate of
adoption of AlloSure Kidney, AlloMap Heart, AlloSure Heart or our future solutions, if any. If we are not able to attract and
retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect
our ability to support our discovery, development, verification and commercialization programs.
37 Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating
results, dilute your ownership of us and increase our debt or cause us to incur significant expense.
As part of our business strategy, we may pursue acquisitions of complementary businesses and assets, as well as technology
licensing arrangements to expand our existing know-how, expertise and intellectual property in other fields, including for the
development of other commercial tests. We also may pursue strategic alliances that leverage our core technology and industry
experience to expand our test offerings or distribution. The identification of suitable acquisition candidates can be difficult,
time-consuming and costly, and we may not successfully complete acquisitions that we target in the future. Risks we may face
in connection with acquisitions include:
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diversion of management time and focus from operating our business to addressing acquisition
integration challenges;
reduction of available cash reserves, assumption of debt or dilutive issuances of equity securities due
to payment of consideration;
coordination of research and development and sales and marketing functions;
integration of product and service offerings;
expectations for acquired technology or research and development may prove unsuccessful;
inability to retain key personnel from the acquired company;
financial reporting, revenue recognition or other financial control deficiencies of or arising from the
acquired company that we do not adequately address and that cause our reported results to be
incorrect or delayed;
liability for activities of the acquired company before the acquisition, including intellectual property
infringement claims, violations of laws, commercial disputes, tax liabilities and other known and
unknown liabilities;
litigation or other claims in connection with the acquired company, including claims from terminated
employees, customers, former stockholders or other third parties;
integrating a global workforce of the acquired company into our business;
obtaining the approval of minority shareholders to complete an acquisition; and
commercialization of new products being developed by the acquired company.
Our failure to address these risks or other problems encountered in connection with our past or future acquisitions and
investments could cause us to fail to realize the anticipated benefits of these acquisitions or investments, cause us to incur
unanticipated liabilities, and harm our business generally.
There is also a risk that future acquisitions will result in the incurrence of debt, contingent liabilities, amortization expenses,
incremental operating expenses or the write-off of goodwill and other intangible assets, any of which could harm our business
and results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at
all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.
To finance any acquisitions, we may choose to issue shares of our common stock as consideration, which would dilute your
interest in us. If the price of our common stock is low or volatile, we may not be able to acquire other companies using our
stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or
private financings. Additional funds may not be available on terms that are favorable to us, or at all.
Undetected errors or defects in our products could result in voluntary corrective actions or agency enforcement actions,
including recall of our products, as well as harm our reputation, decrease market acceptance of our products and expose us
to product liability or professional liability claims, which could exceed our resources.
Our products may contain undetected errors or defects that are not identified until after the products are first introduced.
Disruptions or other performance problems with our products, or the perception of disruption or performance problems with our
products, may require us to initiate a product recall, such as the recall that occurred in April 2016 with respect to one of the
Olerup products, and may damage our customers’ businesses and harm our reputation. We may also be subject to warranty and
liability claims for damages related to errors or defects in our products. A material liability claim, product recall or similar
occurrence may cause us to incur significant expense, decrease market acceptance of our products and adversely impact our
business and operating results.
38 In addition, the marketing, sale and use of AlloSure Kidney, AlloMap Heart, AlloSure Heart and our other products and
solutions, or activities related to our research and clinical studies could lead to the filing of product liability claims if someone
were to allege that one of our products contained a design or manufacturing defect which resulted in the failure to adequately
perform the analysis for which it was designed. For example, a defect in one of our diagnostic solutions could lead to a false
positive or false negative result, affecting the eventual diagnosis. Any incomplete or inaccurate analysis on the part of our
technicians could also affect the reliability of the test results. A product liability or professional liability claim could result in
substantial damages and be costly and time consuming to defend, either of which could materially harm our business or
financial condition. We cannot provide assurance that our product liability insurance would adequately protect our assets from
the financial impact of defending product liability or professional liability claims or any judgments, fines or settlement costs
arising out of any such claims. In addition, any product liability claim brought against us, with or without merit, could increase
our product liability insurance rates and prevent us from securing insurance coverage in the future at reasonable coverage
levels, or at all. Additionally, any product liability lawsuit could cause injury to our reputation, result in the suspension of our
testing pending an investigation into the cause of the alleged failure, or cause current collaborators to terminate existing
agreements and potential collaborators to seek other partners, any of which could negatively impact our results of operations.
We rely extensively on third party service providers. Failure of these parties to perform as expected, or interruptions in our
relationship with these providers or their provision of services to us, could interfere with our ability to provide test results for
our testing services business and kits for our products business.
Our relationship with any of our third party service providers may impair our ability to perform our services. The failure of any
of our third party service providers to adequately perform their service obligations may reduce our revenues and increase our
expenses or prevent us from providing our products and services in a timely manner if at all. In addition, our reputation,
business and financial performance could be materially harmed if we are unable to, or are perceived as unable to provide test
kits and perform reliable services.
We rely solely on certain suppliers to supply some of the laboratory instruments and key reagents that we use in the production
of our products and/or in the performance of our tests. These sole source suppliers include Thermo Fisher, which supplies us
with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents
and consumables; Illumina, which supplies us with instruments, laboratory reagents, and consumables; Avantor, which supplies
us with kitting services, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supplies us
with cell preparation tubes; Beckman Coulter, which provides laboratory reagents and consumables; and Qiagen N.V., which
supplies us with a proprietary buffer reagent and reagent kits. We do not have guaranteed supply agreements with Thermo
Fisher, Becton, Dickinson and Company, Avantor or Qiagen N.V., which exposes us to the risk that these suppliers may choose
to discontinue doing business with us at any time. We periodically forecast our needs to these sole source suppliers and enter
into standard purchase orders based on these forecasts.
In addition, our ABI 7900 Thermocycler, a real time PCR instrument used in AlloMap Heart, is no longer in production.
Thermo Fisher has committed to provide service and support of this instrument through 2021. We believe that there are
relatively few suppliers other than Thermo Fisher, Roche, Illumina, Becton, Dickinson and Company and Qiagen N.V. that are
currently capable of supplying the instruments, reagents and other supplies necessary for our current products and services.
Even if we were to identify secondary suppliers, there can be no assurance that we will be able to enter into agreements with
such suppliers on a timely basis on acceptable terms, if at all. If we should encounter delays or difficulties in securing from
Thermo Fisher, Becton, Dickinson and Company or Avantor, or Avantor encounters delays or difficulties in securing from
Qiagen N.V., the quality and quantity of reagents, supplies or instruments that we require for our current products and services
or other solutions we develop, we may need to reconfigure our test processes, which would result in delays in
commercialization or an interruption in sales. Clinicians and customers who order our current products and services rely on the
continued and timely availability of our products and services. If we are unable to provide results within a timely manner,
clinicians may elect not to use our products or services in the future and our business and operating results could be harmed.
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or
prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our
reputation.
We store sensitive intellectual property and other proprietary business information, including that of our customers, payers and
collaboration partners. We manage and maintain our applications and data utilizing a combination of on-site systems, managed
data center systems and cloud-based data center systems. These applications and data encompass a wide variety of business
critical information, including research and development information, commercial information and business and financial
information. We work with a third-party billing software to collect and store sensitive data, including legally-obtained-protected
health information, credit card information and personally identifiable information about our customers, payers, recipients and
collaboration partners. A data breach or loss of data could have a material adverse effect on our operations, including the
potential for material fines and business interruption.
39 We face four primary risks relative to protecting critical information: loss of access risk, inappropriate disclosure risk,
inappropriate modification risk and the risk of our being unable to identify and audit our controls over the first three risks.
We are highly dependent on information technology networks and systems, including the Internet, to securely process, transmit
and store our critical information. Security breaches of this infrastructure, including physical or electronic break-ins, computer
viruses, attacks by hackers and similar breaches, can create system disruptions, shutdowns or unauthorized disclosure or
modification of confidential information. The secure processing, storage, maintenance and transmission of this critical
information are vital to our operations and business strategy, and we devote significant resources to protecting such
information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our
information technology and infrastructure, and that of our third-party billing and collections provider, may be vulnerable to
attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions. In addition, as a result of the
COVID-19 pandemic, we may face increased cybersecurity risks due to our or our third-party billing agent’s reliance on
internet technology and the number of our and our third-party billing agent’s employees who are working remotely, which may
create additional opportunities for cybercriminals to exploit vulnerabilities.
A security breach or privacy violation that leads to disclosure or modification of or prevents access to consumer information
(including personally identifiable information or protected health information) could harm our reputation, compel us to comply
with disparate state breach notification laws, require us to verify the correctness of database contents and otherwise subject us
to liability under laws that protect personal data, resulting in increased costs or loss of revenue. If we are unable to prevent such
security breaches or privacy violations or implement satisfactory remedial measures, our operations could be disrupted, and we
may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information,
including sensitive consumer data. In addition, these breaches and other inappropriate access can be difficult to detect, and any
delay in identifying them may lead to increased harm of the type described above.
Any such breach or interruption could compromise our networks or those of our third-party billing agent, and the information
stored there could be inaccessible or could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such
interruption in access, improper access, disclosure or other loss of information could result in legal claims or proceedings,
liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability
Act of 1996, or HIPAA, and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations,
including our ability to perform tests, provide test results, bill our payers or patients, process claims and appeals, provide
customer assistance services, conduct research and development activities, collect, process and prepare company financial
information, provide information about our current and future products and solutions and other patient and clinician education
and outreach efforts through our website, and manage the administrative aspects of our business, any of which could damage
our reputation and adversely affect our business. Any such breach could also result in the compromise of our trade secrets and
other proprietary information, which could adversely affect our competitive position.
In addition, the interpretation and application of consumer, health-related, privacy and data protection laws in the U.S., Europe
and elsewhere are often uncertain, contradictory and in flux. It is possible that these laws may be interpreted and applied in a
manner that is inconsistent with our practices. If so, this could result in government-imposed fines or orders requiring that we
change our practices, which could adversely affect our business. Complying with these various laws could cause us to incur
substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business.
For example, the California Consumer Privacy Act, or the CCPA, took effect on January 1, 2020. The CCPA, among other
things, requires covered companies to provide disclosures to California consumers concerning the collection and sale of
personal information, and will give such consumers the right to opt-out of certain sales of personal information. The CCPA may
increase our compliance costs and potential liability, and we cannot yet predict the impact of the CCPA on our business.
Internationally, the General Data Protection Regulation, or the GDPR, took effect in May 2018 within the European Economic
Area, or the EEA, and many EEA jurisdictions have also adopted their own data privacy and protection laws in addition to the
GDPR. Furthermore, other international jurisdictions, including Singapore, South Korea, China, Brazil, Mexico and Australia,
have also implemented laws relating to data privacy and protection. Although we believe that we are complying with the GDPR
and similar laws, these laws are still relatively new.
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.
As part of our longer-term growth strategy, we intend to target select international markets to grow our presence outside of the
U.S. We currently have a commercial agreement for the promotion of AlloMap Heart in Europe with Eurobio Scientific, or
Eurobio (formerly known as Diaxonhit SA). We also currently distribute products directly in Germany, UK, New Zealand,
Sweden, Austria, Belgium, Netherlands and Australia and sell products via sub-distributors, in Canada and in significant
markets in Europe such as France, Italy, UK and Turkey, and to certain countries in Asia, the Middle East, and Central and
South America. To promote the growth of our business internationally, we will need to attract additional partners to expand into
new markets.
40 Relying on partners for our sales and marketing subjects us to various risks, including:
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our partners may fail to commit the necessary resources to develop a market for our products, may
spend the majority of their time selling products unrelated to ours, or may be unsuccessful in
marketing our products for other reasons;
under certain agreements, our partners’ obligations, including their required level of promotional
activities, may be conditioned upon our ability to achieve or maintain a specified level of
reimbursement coverage;
agreements with our partners may terminate prematurely due to disagreements or may result in
disputes or litigation with our partners;
we may not be able to renew existing partner agreements, or enter into new agreements, on
acceptable terms;
our existing relationships with partners may preclude us from entering into additional future
arrangements;
our partners may violate local laws or regulations, potentially causing reputational or monetary
damage to our business;
our partners may engage in sales practices that are locally acceptable but do not comply with
standards required under U.S. laws that apply to us; and
our partners may be negatively affected by the financial instability of, and austerity measures
implemented by, the countries in which they operate.
If our present or future partners do not perform adequately, or we are unable to enter into agreements in new markets, we may
be unable to achieve revenue growth or market acceptance in jurisdictions in which we depend on partners.
In addition, conducting international operations subjects us to risks that, generally, we have not faced in the U.S., including:
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uncertain or changing regulatory registration and approval processes;
failure by us to obtain regulatory approvals or adequate reimbursement for the use of our current and
future solutions in various countries;
competition from companies located in the countries in which we offer our products that may put us
at a competitive disadvantage;
financial risks, such as longer accounts receivable payment cycles and difficulties in collecting
accounts receivable;
logistics and regulations associated with shipping recipient samples, including infrastructure
conditions and transportation delays;
limits in our ability to penetrate international markets if we are not able to process solutions locally;
difficulties in managing and staffing international operations and assuring compliance with foreign
corrupt practices laws;
potentially adverse tax consequences, including the complexities of foreign value added tax systems,
tax inefficiencies related to our corporate structure and restrictions on the repatriation of earnings;
increased financial accounting and reporting burdens and complexities;
multiple, conflicting and changing laws and regulations such as healthcare regulatory requirements
and other governmental approvals, permits and licenses;
the imposition of trade barriers such as tariffs, quotas, trade wars, preferential bidding or import or
export licensing requirements;
political and economic instability, including interruptions in international relations, wars, terrorism
and political unrest, general security concerns, outbreak of disease, boycotts, curtailment of trade and
other business restrictions;
fluctuations in currency exchange rates;
regulatory and compliance risks that relate to maintaining accurate information and control over
activities that may fall within the purview of the Foreign Corrupt Practices Act of 1977, its books
and records provisions or its anti-bribery provisions, as well as risks associated with other anti-
bribery and anti-corruption laws; and
reduced or varied protection for intellectual property rights in some countries.
41 The occurrence of any one of the above could harm our business and, consequently, our revenues and results of operations. Our
expanding international operations could be affected by changes in laws, trade regulations, labor and employment regulations,
and procedures and actions affecting approval, production, pricing, reimbursement and marketing of our current and future
products and solutions, as well as by inter-governmental disputes. Any of these changes could adversely affect our business.
Additionally, operating internationally requires significant management attention and financial resources. We cannot be certain
that the investment and additional resources required in establishing operations in other countries will produce desired levels of
revenue or profitability.
In addition, any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways that
include, but are not limited to, significant criminal, civil and administrative penalties, including imprisonment of individuals,
fines and penalties, denial of export privileges, seizure of shipments, and restrictions on certain business activities. Also, the
failure to comply with applicable legal and regulatory obligations could result in the disruption of our distribution and sales
activities.
We are also unable to predict how changing global economic conditions or potential global health concerns such as the
COVID-19 pandemic will affect our partners, suppliers and distributors. Any negative impact of such matters on our partners,
suppliers or distributors may also have an adverse impact on our results of operations or financial condition.
Our success expanding internationally will depend, in part, on our ability to develop and implement policies and strategies that
are effective in anticipating and managing these and other risks in the countries in which we do business. Failure to manage
these and other risks may have a material adverse effect on our operations in any particular country and on our business as a
whole.
Our operating results may be adversely affected by unfavorable economic and market conditions.
Many of the countries in which we operate, including the U.S. and several of the members of the European Union, or EU, have
experienced and continue to experience uncertain economic conditions resulting from global as well as local factors. On June
23, 2016, the United Kingdom, or the UK, held a referendum pursuant to which voters elected to leave the EU, commonly
referred to as Brexit. The UK formally left the EU on January 31, 2020 and began a transition period that ended on December
31, 2020. Although the effects of Brexit have yet to be seen, and the UK is in the process of negotiating trade deals with other
countries, Brexit has created additional uncertainties that may ultimately result in new regulatory costs and challenges for
companies and increased restrictions on imports and exports throughout Europe, which could adversely affect our ability to
conduct and expand our operations in Europe and which may have an adverse effect on our business, financial condition and
results of operations. Additionally, Brexit may increase the possibility that other countries may decide to leave the EU in the
future.
Our business or financial results may be adversely impacted by these uncertain economic conditions, including: adverse
changes in interest rates, foreign currency exchange rates, tax laws or tax rates; inflation; contraction in the availability of credit
in the marketplace due to legislation or other economic conditions, which may potentially impair our ability to access the
capital markets on terms acceptable to us or at all; and the effects of government initiatives to manage economic conditions. In
addition, we cannot predict how future economic conditions will affect our critical customers, suppliers and distributors and any
negative impact on our critical customers, suppliers or distributors may also have an adverse impact on our results of operations
or financial condition.
On December 22, 2017, the Tax Cuts and Jobs Act of 2017, the Tax Act, was signed into law, making significant changes to the
Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax
years beginning after December 31, 2017. We calculated the impact of the Tax Act in our year end income tax provision in
accordance with our understanding of the Tax Act and guidance available as of the date of the filing of our Annual Report on
Form 10-K for the year ended December 31, 2017, which did not result in any additional income tax expense in the fourth
quarter of 2017. The enactment of the Tax Act also requires companies to recognize the effects of changes in tax laws and rates
on deferred tax assets and liabilities and the retroactive effects of changes in tax laws in the period in which the new legislation
is enacted. Consequently, we accounted for a provisional estimated reduction of the U.S. deferred tax assets from $72.5 million
to approximately $45.9 million with a corresponding decrease of $27.0 million to our valuation allowance in 2018. We
completed our analysis of the impacts of the 2017 Tax Act in the fourth quarter of 2018 with no change to our provisional
estimates.
42 The Tax Cuts and Jobs Act of 2017 also implemented global intangible low tax income, or GILTI, which is a tax on foreign
income in excess of a deemed return on tangible assets of foreign corporations as well as the new base erosion anti-abuse tax, or
BEAT, under the Tax Act. GILTI will be effectively taxed at a tax rate of 10.5%. Due to the complexity of the GILTI tax rules,
companies are allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable
income related to GILTI as a current-period expense when incurred or (2) factoring such amounts into a company’s
measurement of its deferred taxes. We have not made an election with respect to GILTI and do not believe that GILTI will have
a material impact on our 2020 taxes. We will continue to review the GILTI and BEAT rules to determine their applicability to
us and the impact that the rules may have on our results of operations of financial condition.
Our effective tax rate may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been
accrued.
We are subject to income taxes in the United States and various foreign jurisdictions. Our effective tax rate may be lower or
higher than experienced in the past due to numerous factors, including a change in the mix of our profitability from country to
country, the establishment or release of valuation allowances against our deferred tax assets, and changes in tax laws. In
addition, we have recorded gross unrecognized tax benefits in our financial statements that, if recognized, would impact our
effective tax rate. We are subject to tax audits in various jurisdictions, including the United States, and tax authorities may
disagree with certain positions we have taken and assess additional taxes. There can be no assurance that we will accurately
predict the outcomes of these audits, and the actual outcomes could have a material impact on our net income or financial
condition. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or
our current expectations, which could have an adverse effect on our business and results of operations. The recognition of
deferred tax assets is reduced by a valuation allowance if it is more likely than not that the tax benefits will not be realized. We
regularly review our deferred tax assets for recoverability and establish a valuation allowance based on historical income,
projected future income, the expected timing of the reversals of existing temporary differences, and the implementation of tax-
planning strategies.
Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to
significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. For example, we do not carry earthquake
insurance. In the event of a major earthquake in our region, our business could suffer significant and uninsured damage and
loss. Some of the policies we currently maintain include general liability, foreign liability, employee benefits liability, property,
automobile, umbrella, workers’ compensation, products liability and directors’ and officers’ insurance. We do not know,
however, if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability
may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.
If we use hazardous materials in a manner that causes injury, we could be liable for damages.
Our activities currently require the use of hazardous chemicals. We cannot eliminate the risk of accidental contamination or
injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination
or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable
insurance coverage we may have. Additionally, we are subject on an ongoing basis to federal, state and local laws and
regulations governing the use, storage, handling and disposal of these materials and specified waste products.
We may use third party collaborators to help us develop, validate or commercialize any new diagnostic solutions, and our
ability to commercialize such solutions could be impaired or delayed if these collaborations are unsuccessful.
We may in the future selectively pursue strategic collaborations for the development, validation and commercialization of any
new diagnostic solutions we may develop. In any future third party collaboration, we may be dependent upon the success of the
collaborators in performing their responsibilities and their continued cooperation. Our collaborators may not cooperate with us
or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’
resources that will be devoted to performing their responsibilities under our agreements with them. Our collaborators may
choose to pursue alternative technologies in preference to those being developed in collaboration with us. The development,
validation and commercialization of our potential solutions may be delayed if collaborators fail to fulfill their responsibilities in
a timely manner or in accordance with applicable regulatory requirements or if they breach or terminate their collaboration
agreements with us. Any issues arising from these arrangements will affect our ability to serve the entire region, and our
reputation may suffer even if we subsequently locate new partners, which may permanently affect our business. Disputes with
our collaborators could also impair our reputation or result in development delays, decreased revenues and litigation expenses.
43 Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting changes or
require us to change our compensation policies.
Accounting methods and policies for diagnostic companies, including policies governing revenue recognition, research and
development and related expenses and accounting for stock-based compensation, are subject to further review, interpretation
and guidance from relevant accounting authorities, including the SEC. Changes to, or interpretations of, accounting methods or
policies may require us to reclassify, restate or otherwise change or revise our consolidated financial statements, including those
contained in this Annual Report on Form 10-K. In addition, the preparation of our consolidated financial statements requires us
to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent
assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue generated and expenses
incurred during the reporting periods. Any changes or modifications to the methodology used for determining our estimates,
assumptions and forecasts could have a material adverse effect on our business, financial condition and results of operations.
Risks Related to Acquisitions, Partnerships and Investments
Intangibles, including goodwill, acquired in connection with acquisitions may subsequently be impaired and, if so, could
increase our net accumulated deficit.
Under United States Generally Accepted Accounting Principles, or U.S. GAAP, we are required to evaluate our goodwill and
indefinite-lived intangibles for impairment when events or changes in circumstances indicate the carrying value may not be
recoverable; specifically, we are required to evaluate whether the intangible assets and goodwill as a result of an acquisition
continue to have a fair value that meets or exceeds the amounts recorded on our balance sheet. We test goodwill and indefinite-
lived intangibles for impairment at least annually and more frequently if impairment indicators are present. If the fair values of
such assets decline below their carrying value on the balance sheet, we may be required to recognize an impairment charge
related to such decline.
Under U.S. GAAP, we are also required to evaluate finite-lived intangible assets, which are long-lived assets, for indicators of
possible impairment when events or changes in circumstances indicate the carrying amount of the intangible asset may not be
recoverable. Finite-lived intangible assets are intangible assets that we are amortizing over their estimated useful lives. If
recoverability is in question, we would then compare the carrying amounts of the intangible assets with the future net
undiscounted cash flows expected to be generated by such asset. Should an impairment exist, the impairment loss would be
measured based on the excess carrying value of the intangible asset over the asset’s fair value determined using discounted
estimates of future cash flows.
Lower than expected revenue growth, a trend of weaker than anticipated financial performance, a decline in our market
capitalization for a sustained period of time, unfavorable changes in market or economic and industry conditions all could
significantly impact our impairment analysis. If we determine an impairment exists, we may be required to recognize further
impairment charges that, if incurred, could have a material adverse effect on our financial condition and results of operations.
We may not be able to achieve the anticipated strategic benefits from our acquisition of Ottr Complete Transplant
Management, or Ottr, Inc. or XynManagement, Inc., or XynManagement, or any other businesses or assets that we may
acquire.
The integration of any businesses or assets we may acquire will be a time-consuming process. The integration process will
require substantial management time and attention, which may divert attention and resources from other important areas,
including our existing business. In addition, we may not be able to fully realize the anticipated strategic benefits of any such
combination or integration and any other businesses or assets we have or may acquire, which includes, with respect to Ottr,
Inc., the complementary Ottr software, and, with respect to XynManagement, XynQAPI, and in each case the benefits of any
significant cross-selling opportunities. If we are not able to achieve the anticipated strategic benefits of any such combination, it
could adversely affect our business, financial condition and results of operations, and could adversely affect the market price of
our common stock if the anticipated financial and strategic benefits of the acquisition are not realized as rapidly as, or to the
extent anticipated by investors and analysts. Failure to achieve these anticipated benefits could result in increased costs and
decreases in future revenue and/or net income following the acquisition.
Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.
Under the License and Commercialization Agreement, or the License Agreement, with Illumina, Inc., or Illumina, we are
obligated to complete timely development and commercialization of future products, including meeting certain
commercialization milestones. The failure to meet any such milestones could result in the loss of exclusivity for the affected
licensed products. Additionally, we agreed to minimum purchase commitments of finished products and raw materials from
Illumina through 2023 and we are required to pay royalties in the mid-single to low-double digits on sales of future
commercialized products.
44 We cannot make any assurances that our efforts under the License Agreement will be successful. As a result, we may not be
able to fully realize the anticipated strategic benefits of the License Agreement. If we fail to successfully execute on the License
Agreement, we may not realize the benefits expected from the transaction and our business may be harmed.
Our License and Commercialization Agreement, or the Cibiltech Agreement, with Cibiltech SAS, or Cibiltech, may not
result in material benefits to our business.
The Cibiltech Agreement provides us an exclusive right to commercialize its proprietary software KidneyCare iBox. We have
not yet made any applications to payers for reimbursement coverage of KidneyCare iBox. The failure to obtain reimbursement
coverage from payers for KidneyCare iBox could result in material amounts of revenue not being recognized, and failure to
successfully integrate predictive artificial intelligence technology with our existing tests.
Our portfolio of marketable securities is significant and subject to market, interest and credit risk that may reduce its value.
At December 31, 2020, we had $90.0 million in marketable securities invested through a professional investment management
firm. These investments are primarily in corporate debt securities, but our investments also include money market funds that
meet the criteria of our investment policy, which is focused on the preservation of our capital, maintaining liquidity and
providing diversification. Changes in the value of this portfolio could adversely affect our earnings, and these investments are
subject to general credit, liquidity and market and interest rate risks. In particular, the value of our investments may decline due
to increases or decreases in interest rates, downgrades of debt securities included in our portfolio, instability in the global
financial markets that reduces the liquidity of securities included in our portfolio and other factors, including unexpected or
unprecedented events such as the COVID-19 pandemic. Each of these events may cause us to record charges to reduce the
carrying value of our investment portfolio or sell investments for less than our acquisition cost, and could have a material
adverse impact on our financial condition and operating results.
Risks Related to Billing and Reimbursement
Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may
negatively affect our revenue, cash flows and profitability.
Billing for clinical laboratory testing services is complex. In cases where we do not have a contract in place requiring the
payment of a fixed fee per test, we perform tests in advance of payment and without certainty as to the outcome of the billing
process. In cases where we do receive a fixed fee per test, we may still have disputes over pricing and billing. We receive
payment from individual recipients and from a variety of payers, such as commercial insurance carriers and governmental
programs, primarily Medicare. Each payer typically has different billing requirements.
Among the factors complicating our billing of third-party payers are:
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disputes among payers regarding which party is responsible for payment;
disparity in coverage among various payers;
different process, information and billing requirements among payers; and
incorrect or missing billing information, which is required to be provided by the prescribing
clinician.
Additionally, from time to time, payers change processes that may affect timely payment. For example, some commercial
payers have instituted prior authorization requirements before our testing is performed. These changes may result in uneven
cash flow or impact the timing of revenue recognized with these payers. With respect to payments received from governmental
programs, factors such as a prolonged government shutdown could cause significant regulatory delays or could result in
attempts to reduce payments made to us by federal government healthcare programs. In addition, payers may refuse to
ultimately make payment if their processes and requirements have not been met on a timely basis. These billing complexities,
and the resulting uncertainty in obtaining payment for AlloSure Kidney, AlloMap Heart, AlloSure Heart and future solutions,
could negatively affect our revenue, cash flows and profitability.
Health insurers and other third-party payers may decide to revoke coverage of our existing test, decide not to cover our
future solutions or may provide inadequate reimbursement, which could jeopardize our commercial prospects.
Successful commercialization of AlloSure Kidney, AlloMap Heart and AlloSure Heart depends, in large part, on the availability
of coverage and adequate reimbursement from government and private payers. Favorable third-party payer coverage and
reimbursement are essential to meeting our immediate objectives and long-term commercial goals.
45 For new diagnostic testing services, each private and government payer decides whether to cover the test, the amount it will
reimburse for a covered test and the specific conditions for reimbursement. Clinicians and recipients may be likely not to order
a diagnostic test unless third-party payers pay a substantial portion of the test price. Therefore, coverage determinations and
reimbursement levels and conditions are critical to the commercial success of a diagnostic testing service, and if we are not able
to secure positive coverage determinations and reimbursement levels, our business will be materially adversely affected.
Coverage and reimbursement by a commercial payer may depend on a number of factors, including a payer’s determination that
our current and future testing services are:
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not experimental or investigational;
medically necessary;
lead to improved patient outcomes;
appropriate for the specific recipient;
cost-saving or cost-effective; and
supported by peer-reviewed publications.
In addition, several payers and other entities conduct technology assessments of new medical tests and devices and provide and/
or sell the results of their assessments to other parties. These assessments may be used by third-party payers and healthcare
providers as grounds to deny coverage for or refuse to use a test or procedure. We believe we have received a negative
technology assessment from at least one of these entities and could receive more.
If third-party payers decide not to cover our diagnostic testing services or if they offer inadequate payment amounts, our ability
to generate revenue from AlloSure Kidney, AlloMap Heart, AlloSure Heart and future solutions could be limited. Payment for
diagnostic tests furnished to Medicare beneficiaries is typically made based on a fee schedule set by CMS. In recent years,
payments under these fee schedules have decreased and may decrease further.
Any third-party payer may stop or lower payment at any time, which could substantially reduce our revenue. See the risk factor
above titled “We receive a substantial portion of our revenues from Medicare, and the loss of, or a significant reduction in,
reimbursement from Medicare would severely and adversely affect our financial performance”.
Since each payer makes its own decision as to whether to establish a policy to reimburse for a test, seeking payer coverage and
other approvals is a time-consuming and costly process. We cannot be certain that adequate coverage and reimbursement for
AlloSure Kidney, AlloMap Heart, AlloSure Heart, or future solutions will be provided in the future by any third-party payer.
Reimbursement for AlloSure Kidney, AlloMap Heart and AlloSure Heart comes primarily from Medicare and private third
party payers such as insurance companies and managed care organizations. The reimbursement process can take six months or
more to complete depending on the payer. Coverage policies approving AlloMap Heart have been adopted by many of the
largest private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation, Humana, Kaiser Foundation Health
Plan, Inc., and UnitedHealthcare. Many of the payers with positive coverage policies have also entered into contracts with us to
formalize pricing and payment terms. We continue to work with third-party payers to expand and seek such coverage and to
appeal denial decisions based on existing and ongoing studies, peer reviewed publications, support from physician and patient
groups and the growing number of AlloMap Heart tests that have been reimbursed by public and private payers. There are no
assurances that the current policies will not be modified in the future. If our test is considered on a policy-wide level by major
third-party payers, whether at our request or on their own initiative, and our test is determined to be ineligible for coverage and
reimbursement by such payers, our collection efforts and potential for revenue growth could be adversely impacted.
Our Medicare Part B coverage for AlloSure Kidney and AlloMap Heart is included in a formal local coverage decision for
molecular diagnostics. However, any change in this coverage decision or other future adverse coverage decisions by the CMS,
including with respect to coding, could substantially reduce our revenue.
Medicare reimbursements currently comprise a significant portion of our revenue. Our current Medicare Part B reimbursement
was not set pursuant to a national coverage determination by CMS. Although we believe that coverage is available under
Medicare Part B even without such a determination, we currently lack the national coverage certainty afforded by a formal
coverage determination by CMS. This means that Medicare contractors, including our California Medicare contractor, currently
may continue to develop their own coverage and reimbursement policies with respect to our technology.
Until 2016, AlloMap Heart was billed using an unlisted Current Procedural Terminology, or CPT, code, but in 2016 a new CPT
Category 1 Multianalyte Assays with Algorithmic Analyses, or MAAA, code was added that specifically describes the test.
Further, pursuant to MolDX billing requirements, the AlloMap Heart test also has been assigned a McKesson Diagnostics Z
code™, which is included on all Medicare claims.
46 If in the future CMS makes a determination not to pay for this code, or for any MAAA codes, this could be harmful to our
business, and could have negative spillover implications that prevent or limit coverage by other third-party payers that might
mirror aspects of Medicare payment criteria.
Since the launch of AlloSure Kidney in October 2016, and at the instruction of the MolDX Program of Palmetto, the test has
been billed utilizing an unlisted CPT code. If in the future CMS makes a determination to no longer provide coverage for
services billed with an unlisted CPT code, our ability to bill and obtain reimbursement from public and private payers could be
negatively impacted.
Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart and
AlloSure Heart.
The pricing and reimbursement environment may change in the future and become more challenging as a result of any of
several possible regulatory developments, including policies advanced by the U.S. government, new healthcare legislation or
fiscal challenges faced by government health administration authorities. Specifically, there have been a number of legislative
and regulatory proposals and initiatives to change the healthcare system in ways that could affect our ability to profitably sell
any diagnostic products we may develop and commercialize. Some of these proposed and implemented reforms could result in
reduced reimbursement rates for our diagnostic products from governmental agencies or other third-party payers, which would
adversely affect our business strategy, operations and financial results. For example, as a result of the Patient Protection and
Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), or collectively, the
Affordable Care Act, substantial changes have been made and may continue to be made to the current system for paying for
healthcare in the U.S., including changes made in order to extend medical benefits to those who currently lack insurance
coverage. The Affordable Care Act also provided that payments under the Medicare CLFS were to receive a negative 1.75%
annual adjustment through 2015. Although we have not been subject to such adjustment in the past, we cannot be certain that
the claims administrators will not attempt to apply this adjustment in the future.
Among other things, the Affordable Care Act includes payment reductions to Medicare Advantage plans. These cuts have been
mitigated in part by a CMS demonstration program that expired in 2015. We cannot be assured that future cuts would be
mitigated by CMS. Any reductions in payment to Medicare Advantage plans could materially impact coverage and
reimbursement for AlloMap Heart.
In addition to the Affordable Care Act, various healthcare reform proposals have also emerged from federal and state
governments. For example, in February 2012, Congress passed the “Middle Class Tax Relief and Job Creation Act of 2012”,
which in part reduced the potential future cost-based increases to the Medicare CLFS by 2%. The Protecting Access to
Medicare Act of 2014 introduced a multi-year phase in of a new payment system for services paid under the CLFS. Under this
new system, beginning in 2017 laboratories began reporting to CMS the payment rates paid to the laboratories by commercial
third-party payers including Medicare and Medicaid managed care plans, for each test and the volume of each test performed.
CMS began using the reported data to set new payment rates under the CLFS in 2018. For most tests, rates will only be adjusted
every three years. For newly developed tests that are considered to be “advanced diagnostic lab tests,” the Medicare payment
rate will be the actual list price offered to third-party payers for the first three quarters that the tests are offered, subject to later
adjustment. CMS will establish subsequent payment rates using the commercial third-party payer data reported for those tests.
PAMA includes a substantial new payment system for clinical laboratory tests under the CLFS. Under PAMA, laboratories that
receive the majority of their Medicare revenues from payments made under the CLFS report initially and then on a subsequent
three-year basis thereafter (or annually for ADLTs), private payer payment rates and volumes for their tests. The new PAMA
rules took effect January 1, 2018 and used the rates and volumes reported by laboratories to develop Medicare payment rates
for the tests equal to the volume-weighted median of the private payer payment rates for the tests.
There have been public announcements by members of the U.S. Congress regarding plans to repeal and replace the Affordable
Care Act, and the Biden administration has announced plans to expand the Affordable Care Act. We cannot predict the ultimate
form or timing of any repeal, replacement or expansion of the Affordable Care Act or the effect such repeal, replacement or
expansion would have on our business. Regardless of the impact of any or repeal, replacement or expansion of the Affordable
Care Act on us, the government has shown significant interest in pursuing healthcare reform and reducing healthcare costs. Any
government-adopted reform measures could decrease the amount of reimbursement available from governmental and other
third-party payers. On April 1, 2013, cuts to the federal budget resulting from sequestration were implemented, requiring a 2%
cut in Medicare payment for all services, including AlloSure Kidney and AlloMap Heart, and is expected to remain in effect
through at least 2025. Federal budgetary limitations and changes in healthcare policy, such as the creation of broad limits for
diagnostic products or requirements that Medicare patients pay for portions of clinical laboratory tests or services received,
could substantially diminish the sale, or inhibit the utilization, of AlloSure Kidney, AlloMap Heart, AlloSure Heart and our
future diagnostic solutions, increase costs, divert management’s attention and adversely affect our ability to generate revenue
and achieve profitability.
47 In addition to the Affordable Care Act, there will continue to be proposals by legislators at both the federal and state levels,
regulators and third-party payers to reduce costs while expanding individual healthcare benefits. Certain of these changes could
impose additional limitations on the prices we will be able to charge for our current and future solutions or the amounts of
reimbursement available for our current and future solutions from governmental agencies or third-party payers.
While in general it is difficult to predict specifically what effects the Affordable Care Act or any future healthcare reform
legislation or policies will have on our business, current and future healthcare reform legislation and policies could have a
material adverse effect on our business and financial condition.
In December 2020, U.S. Congress passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant
Patients Act of 2019, or the Immuno Bill. The Immuno Bill extends Medicare’s Part B coverage of immunosuppressive drugs
for kidney transplant recipients beyond the current three-year limit, allowing patients to more easily maintain access to their
treatment and prevent graft failure, costly dialysis treatments and retransplantation. While the Immuno Bill will help improve
the long term outcomes of transplant patients, future policies advanced by the U.S. government, new healthcare legislation or
fiscal challenges faced by government health administration authorities could result in changes to the Immuno Bill and
Medicare’s coverage of immunosuppressive drugs for kidney transplant recipients in the future.
Risks Related to the Healthcare Regulatory Environment
In order to operate our laboratory, we have to comply with the CLIA and federal state laws and regulations governing
clinical laboratories and laboratory developed tests, including FDA regulations.
We are subject to the CLIA, a federal law that regulates clinical laboratories that perform testing on specimens taken from
humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. If our laboratory is out of
compliance with the CLIA requirements, we may be subject to sanctions such as suspension, limitation or revocation of our
CLIA certificate, as well as a direct plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit or
criminal penalties. We must maintain the CLIA compliance and certification to be eligible to bill for services provided to
Medicare beneficiaries. If we were to be found to be out of compliance with the CLIA program requirements and subjected to
sanction, our business could be materially harmed.
Licensure is also required for our laboratory under California law in order to conduct testing. California laws establish
standards for day-to-day operation of our clinical laboratory, including the training and skills required of personnel and quality
control. Moreover, several states, including New York, require that we hold licenses to test specimens from patients residing in
those states. Other states have similar requirements or may adopt similar requirements in the future. In addition to our
California certifications, we currently hold licenses in Florida, Maryland, New York, Pennsylvania and Rhode Island. The loss
of any of these state certifications would impact our ability to provide services in those states, which could negatively affect our
business.
Finally, we may be subject to regulation in foreign jurisdictions where we offer our test. Failure to maintain certification in
those states or countries where it is required could prevent us from testing samples from those states or countries, could lead to
the suspension or loss of licenses, certificates or authorizations, and could have an adverse effect on our business.
We were inspected as part of the customary College of American Pathologists audit and recertified in September 2020 as a
result of passing that inspection. We expect the next regular inspection under the CLIA to occur in 2022. If we were to lose our
CLIA accreditation or California license, whether as a result of a revocation, suspension or limitation, we would no longer be
able to perform AlloMap Heart, AlloSure Kidney or AlloSure Heart, which would limit our revenues and materially harm our
business. If we were to lose our license in other states where we are required to hold licenses, we would not be able to test
specimens from those states, which could also have a material adverse effect on our business.
The FDA has traditionally chosen not to exercise its authority to regulate laboratory developed tests, or LDTs, because it
believes that laboratories certified as high complexity under the CLIA, such as ours, have demonstrated expertise and ability in
test procedures and analysis. However, beginning in September 2006, the FDA issued draft guidance on a subset of LDTs
known as “in vitro diagnostic multivariate index assays,” or IVDMIAs. According to the draft guidance, IVDMIAs do not fall
within the scope of LDTs over which the FDA has exercised enforcement discretion because such tests incorporate complex
and unique interpretation functions, which require clinical validation. We believed that AlloMap Heart met the definition of
IVDMIA set forth in the draft guidance document. As a result, we applied for, and obtained in August 2008, 510(k) clearance
for AlloMap Heart for marketing and sale as a test to aid in the identification of recipients with a low probability of moderate or
severe rejection. A 510(k) submission is a premarketing submission made to the FDA. Clearance may be granted by the FDA if
it finds the device or test provides satisfactory evidence pertaining to the claimed intended uses and indications for the device or
test.
48 While we believe that we are currently in material compliance with applicable laws and regulations relating to our LDTs, we
cannot be certain that the FDA or other regulatory agencies would agree with our determination. A determination that we have
violated these laws, or a public announcement that we are being investigated for possible violation of these laws, could hurt our
business and our reputation.
If we were required to conduct additional clinical trials prior to marketing our solutions under development, those trials
could lead to delays or a failure to obtain necessary regulatory approvals and harm our ability to be profitable.
If the FDA or Congress decide to regulate AlloSure Kidney and other future solutions under development as medical devices,
we could be required to conduct additional premarket clinical testing subsequent to commercialization in the case of AlloSure
Kidney and/or conduct premarket clinical testing prior to submitting a regulatory application for commercial sales for future
products not yet developed. If we are required to conduct premarket clinical trials, whether using prospectively acquired
samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase our
development costs and delay test commercialization and also ultimately lead to delay or denial of regulatory clearance or
approval. The commencement of clinical trials may be delayed due to insufficient blood or tissue samples or insufficient data
regarding the associated clinical outcomes. We may find it necessary to engage contract research organizations to perform data
collection and analysis and other aspects of our clinical trials, which might increase the cost and complexity of our trials and
reduce our control over such activities. If these parties do not successfully carry out their contractual duties or obligations or
meet expected deadlines, or if the quality, completeness or accuracy of the clinical data they obtain is compromised due to the
failure to adhere to our clinical protocols, applicable regulatory requirements, or for other reasons, our clinical trials may have
to be extended, delayed or terminated. We may not be able to enter into replacement arrangements without undue delays or
considerable expenditures. In addition, we may not be able to establish or maintain relationships with these parties on favorable
terms, if at all. Each of these outcomes would harm our ability to market our solutions under development and our ability to be
profitable.
Any test for which we obtain regulatory clearance will be subject to extensive ongoing regulatory requirements, and we may be
subject to penalties if we or our contractors or commercial partners fail to comply with regulatory requirements or if we
experience unanticipated problems with our products.
AlloSure Kidney, AlloMap Heart, AlloSure Heart, and our other products and solutions, along with the manufacturing
processes, packaging, labeling, distribution, import, export, and advertising and promotional activities for such products and
solutions, are or will be subject to continual requirements of, and review by, CMS, state licensing agencies, the FDA and
comparable regulatory authorities. These requirements include submissions of safety and other post-marketing information and
reports, registration and listing requirements, requirements relating to quality control, quality assurance and corresponding
maintenance of records and documents, requirements relating to product labeling, advertising, promotion, recordkeeping and
adverse event reporting. Regulatory clearance of a test or device may be subject to limitations by the regulatory body as to the
indicated uses for which the product may be marketed or to other conditions of approval. For example, we are exploring
utilization of AlloMap Heart in areas that could be considered outside the scope of our current labeling. Broader uses would
require FDA clearance as well as changes to the labeling.
In addition, clearance may contain requirements for costly post-marketing testing and surveillance to monitor the safety or
efficacy of the test or device. Discovery of previously-unknown problems with our current or future solutions, or failure to
comply with regulatory requirements, may result in actions such as:
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restrictions on operations of our laboratory;
restrictions on manufacturing processes;
restrictions on marketing of a test;
warning or untitled letters;
withdrawal of the test from the market;
refusal to approve applications or supplements to approved applications that we may submit;
fines, restitution or disgorgement of profits or revenue;
suspension, limitation or withdrawal of regulatory clearances;
exclusion from participation in U.S. federal or state healthcare programs, such as Medicare and
Medicaid;
refusal to permit the import or export of our products;
product seizure;
injunctions; and
imposition of civil or criminal penalties.
49 We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of any
one of which could harm our business.
The clinical laboratory testing industry is highly regulated, and there can be no assurance that the regulatory environment in
which we operate will not change significantly and adversely in the future. Our arrangements with customers may expose us to
broadly applicable fraud and abuse and other laws and regulations that may restrict the financial arrangements and relationships
through which we market, sell and distribute our products. Our employees, consultants, principal investigators and commercial
partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and
requirements. In addition to the CLIA regulation, other federal and state healthcare laws and regulations that may affect our
ability to conduct business, include, without limitation:
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federal and state laws and regulations regarding billing and claims payment applicable to clinical
laboratories and/or regulatory agencies enforcing those laws and regulations;
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among
other things, individuals or entities from knowingly presenting, or causing to be presented to the
government, claims for payment from Medicare, Medicaid or other third-party payers that are false
or fraudulent, or making a false statement material to a false or fraudulent claim;
the federal Anti-Kickback Statute, which constrains our marketing practices, educational programs,
pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among
other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly
or indirectly, to induce or reward, or in return for, either the referral of an individual or the purchase
or recommendation of an item or service reimbursable under a federal health care program, such as
the Medicare and Medicaid programs;
the federal physician self-referral law, commonly known as the Stark Law, which prohibits a
physician from making a referral to an entity for certain designated health services, including clinical
laboratory services, reimbursed by Medicare if the physician (or a member of the physician’s family)
has a financial relationship with the entity, and which also prohibits the submission of any claims for
reimbursement for designated health services furnished pursuant to a prohibited referral;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of
2009, or HITECH, and its implementing regulations, which imposes certain requirements relating to
the privacy, security and transmission of individually identifiable health information; HIPAA also
created criminal liability for knowingly and willfully falsifying or concealing a material fact or
making a materially false statement in connection with the delivery of or payment for healthcare
benefits, items or services;
state laws regarding prohibitions on fee-splitting;
the federal health care program exclusion statute; and
state and foreign law equivalents of each of the above federal laws and regulations, such as anti-
kickback, false claims, and self-referral laws, which may apply to items or services reimbursed by
any third-party payer, including commercial insurers, and state and foreign laws governing the
privacy and security of health information in certain circumstances, many of which differ from each
other in significant ways and often are not preempted by HIPAA, thus complicating compliance
efforts.
Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that
some of our business activities could be subject to challenge under one or more of such laws. Any action brought against us for
violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal
expenses and divert our management’s attention from the operation of our business. We may be subject to private “qui tam”
actions brought by individual whistleblowers on behalf of the federal or state governments, with potential liability under the
federal False Claims Act, including mandatory treble damages and significant per-claim penalties. If our operations are found to
be in violation of any of the federal, state and foreign laws described above or any other current or future fraud and abuse or
other healthcare laws and regulations that apply to us, we may be subject to penalties, including significant criminal, civil, and
administrative penalties, damages, fines, imprisonment for individuals, exclusion from participation in government programs,
such as Medicare and Medicaid, injunctions, recall or seizure of products, total or partial suspension of production, denial or
withdrawal of pre-marketing product approvals, 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. Any of the foregoing consequences could
seriously harm our business and our financial results.
50 Foreign governments may impose reimbursement standards, which may adversely affect our future profitability.
When we market our products and our solutions under development in foreign jurisdictions, we are subject to rules and
regulations in those jurisdictions. In some foreign countries, including countries in the EU, the reimbursement of our current
and future solutions is subject to governmental control. In these countries, reimbursement negotiations with governmental
authorities can take considerable time after the receipt of marketing approval for a test candidate. If reimbursement of our future
solutions in any jurisdiction is unavailable or limited in scope or amount, or if reimbursement rates are set at unsatisfactory
levels, we may be unable to, or decide not to, market our test in that jurisdiction.
Risks Related to Our Intellectual Property
Our competitive position depends on maintaining intellectual property protection.
Our ability to compete and to achieve and maintain profitability depends on our ability to protect our proprietary discoveries
and technologies. We currently rely on a combination of patents, copyrights, trademarks, trade secrets, confidentiality
agreements and license agreements to protect our intellectual property rights.
Our patent position for AlloMap Heart is based on issued patents and patent applications disclosing identification of genes
differentially expressed between activated and resting leukocytes and demonstration of correlation between gene expression
patterns and specific clinical states and outcomes. As of December 31, 2020, we had 25 issued U.S. patents related to transplant
rejection and autoimmunity. We have five issued U.S. patents covering methods of diagnosing transplant rejection using all
11 informative genes measured in AlloMap Heart. The expiration dates of these patents range from 2021 to 2024. We have five
additional patents covering additional genes or gene variants for diagnosing transplant rejection.
In connection with our June 2014 acquisition of ImmuMetrix, Inc., we obtained an exclusive license from Stanford to a U.S.
patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. This patent has an expiration date of
November 5, 2030. A second patent included in the license from Stanford was issued in December 2017 and further covers the
use of dd-cfDNA to diagnose and predict transplant status or outcome. A third and fourth patent were issued from this Stanford
set in June 2019 and December 2019, respectively, covering the use of dd-cfDNA to diagnose and predict transplant status or
outcome. Both patents have the same 2030 expiration date as the original Stanford patent.
Our patents and the patents we exclusively license from others may be successfully challenged by third parties as being invalid
or unenforceable. Third parties may independently develop similar or competing technology that avoids the patents we own or
exclusively license. We cannot be certain that the steps we have taken will prevent the misappropriation and use of our
intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the
United States.
The extent to which the patent rights of life sciences companies effectively protect their products and technologies is often
highly uncertain and involves complex legal and factual questions for which important legal principles remain unresolved. No
consistent policy regarding the proper scope of allowable claims of patents held by such companies has emerged to date in the
United States. Various courts, including the United States Supreme Court, have rendered decisions that impact the scope of
patentability of certain inventions or discoveries relating to diagnostic solutions or genomic diagnostics. In the Ariosa
Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015) case, a federal court recently determined that a dd-cfDNA product for fetal
testing was not eligible for patent protection. These decisions generally stand for the proposition that inventions that recite laws
of nature are not themselves patentable unless they have sufficient additional features that provide practical assurance that the
processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize a law of
nature itself. What constitutes a “sufficient” additional feature for this purpose is uncertain. This evolving case law in the
United States may adversely impact our ability to obtain new patents and may facilitate third-party challenges to our existing
owned and exclusively licensed patents.
Changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the
value of our intellectual property rights. In particular, in September 2011, the United States Congress passed the Leahy-Smith
America Invents Act, or the AIA, which became effective in March 2013. The AIA reforms United States patent law in part by
changing the standard for patent approval for certain patents from a “first to invent” standard to a “first to file” standard and
developing a post-grant review system. This has not yet had a material impact on the operation of our business and the
protection and enforcement of our intellectual property, but it may in the future. The AIA and its implementation could still
increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of
our issued patents, all of which could have a material adverse effect on our business and financial condition. Patent applications
in the United States and many foreign jurisdictions are not published until at least eighteen months after filing, and it is possible
for a patent application filed in the United States to be maintained in secrecy until a patent is issued on the application. In
addition, publications in the scientific literature often lag behind actual discoveries.
51 We therefore cannot be certain that others have not filed patent applications that cover inventions that are the subject of pending
applications that we own or exclusively license or that we or our licensors, as applicable, were the first to invent the technology
(pre-AIA) or first to file (post-AIA). Our competitors may have filed, and may in the future file, patent applications covering
technology that is similar to or the same as our technology. Any such patent application may have priority over patent
applications that we own or exclusively license and, if a patent issues on such patent application, we could be required to obtain
a license to such patent in order to carry on our business. If another party has filed a United States patent application covering
an invention that is similar to, or the same as, an invention that we own or license, we or our licensors may have to participate
in an interference or other proceeding in the PTO or a court to determine priority of invention in the United States for pre-AIA
applications and patents. For post-AIA applications and patents, we or our licensors may have to participate in a derivation
proceeding to resolve disputes relating to inventorship. The costs of these proceedings could be substantial, and it is possible
that such efforts would be unsuccessful, resulting in our inability to obtain or retain any United States patent rights with respect
to such invention.
We may face intellectual property infringement claims that could be time-consuming and costly to defend and could result in
our loss of significant rights and the assessment of treble damages.
We may in the future receive offers to license patents or notices of claims of infringement, misappropriation or misuse of other
parties’ proprietary rights. We may also initiate claims to defend our intellectual property. Intellectual property litigation,
regardless of outcome, is unpredictable, expensive and time-consuming, could divert management’s attention from our business
and have a material negative effect on our business, operating results or financial condition. If there is a successful claim of
infringement against us, we may be required to pay substantial damages (including treble damages if we were to be found to
have willfully infringed a third party’s patent) to the party claiming infringement, develop non-infringing technology, stop
selling our test or using technology that contains the allegedly infringing intellectual property or enter into royalty or license
agreements that may not be available on acceptable or commercially practical terms, if at all. Our failure to develop non-
infringing technologies or license the proprietary rights on a timely basis could harm our business.
In addition, revising our current or future solutions to exclude any infringing technologies would require us to re-validate the
test, which would be costly and time consuming. Also, we may be unaware of pending patent applications that relate to our
current or future solutions. Parties making infringement claims on future issued patents may be able to obtain an injunction that
would prevent us from selling our current or future solutions or using technology that contains the allegedly infringing
intellectual property, which could harm our business. For example, see the risk factor above titled: “We could become subject
to legal proceedings that could be time consuming, result in costly litigation and settlements/judgments, require significant
amounts of management attention and result in the diversion of significant operational resources, which could adversely affect
our business, financial condition and results of operations” for a discussion of our ongoing litigation with Natera.
We may be required to take further action to maintain and protect our intellectual property rights against third parties.
In the event we determine that a party is infringing our intellectual property rights, we may try to negotiate a license
arrangement with such party or we may determine to initiate a lawsuit against such party. The process of negotiating a license
with a third party can be lengthy, and may take months or even years in some circumstances. In addition, it is possible that third
parties who we believe are infringing our intellectual property rights are unwilling to license our intellectual property from us
on terms we can accept, or at all. For example, see the risk factor above titled: “We could become subject to legal proceedings
that could be time consuming, result in costly litigation and settlements/judgments, require significant amounts of management
attention and result in the diversion of significant operational resources, which could adversely affect our business, financial
condition and results of operations” for a discussion of our ongoing litigation with Natera.
The decision to commence litigation over infringement of a patent is complex and may lead to several risks to us, including the
following, among others:
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the time, significant expense and distraction to management of managing such litigation;
the uncertainty of litigation and its potential outcomes;
the possibility that in the course of such litigation, the defendant may challenge the validity of our
patents, which could result in a re-examination or post grant review of our patents and the possibility
that the claims in our patents may be limited in scope or invalidated altogether;
the potential that the defendant may successfully persuade a court that their technology or products
do not infringe our intellectual property rights;
the impact of such litigation on other licensing relationships we have or seek to establish, including
the timing of renewing or entering into such relationships, as applicable, as well as the terms of such
relationships;
the potential that a defendant may assert counterclaims against us; and
adverse publicity to us or harm to relationships we have with customers or others.
52 If we are unable to protect or enforce our intellectual property rights effectively in all major markets, our business would be
harmed.
Filing, prosecuting, defending and enforcing patents on all of our technologies and solutions throughout the world would be
prohibitively expensive. As a result, we seek to protect our proprietary position by filing patent applications in the U.S. and in
select foreign jurisdictions and cannot guarantee that we will obtain the patent protection necessary to protect our competitive
position in all major markets. Competitors may use our technologies or solutions in jurisdictions where we have not obtained
patent protection to develop their own products and, further, may export infringing products to territories where we have patent
protection but where enforcement is not as strong as that in the U.S. These products may compete with our current and future
products in jurisdictions where we do not have any issued patents, and our patent claims or other intellectual property rights
may not be effective or sufficient to prevent them from so competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign
jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of
patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or
the marketing of competing products in violation of our proprietary rights generally. Further, the legal systems of certain
countries make it difficult or impossible to obtain patent protection for diagnostic solutions. Proceedings to enforce our patent
rights in foreign jurisdictions could result in substantial costs and could divert our efforts and attention from other aspects of our
business.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technologies and solutions, we also rely on trade secrets, including unpatented
know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade
secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as
our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other
third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and
consultants that obligate them to assign to us any inventions developed in the course of their work for us. However, we cannot
be certain that we have executed these agreements with each party that may have or have had access to our trade secrets or that
the agreements we have executed will provide adequate protection. Despite these efforts, any of these parties may breach the
agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate
remedies for such breaches. Monitoring unauthorized disclosure is difficult and we do not know whether the procedures we
have followed to prevent such disclosure are, or will be adequate.
For example, we recently became aware that in October 2020, prior to terminating employment and joining a competitor of ours
with which we are in current litigation, a former employee of ours downloaded certain of our confidential and privileged
information without permission. After our claims against this former employee were filed, the former employee subsequently
brought various claims against us. We are in the process of reviewing and, with the assistance of counsel, have conducted
certain interviews and gathered information. We intend to vigorously pursue and defend against these matters. Although we
believe we have strong claims against, and good and substantial defenses to the claims made by, the former employee, there is
no guarantee that we will prevail in these matters. Enforcing a claim that a party illegally disclosed or misappropriated a trade
secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside
the U.S. may be less willing or unwilling to protect trade secrets. If any of the technology or information that we protect as
trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them
from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to, or
independently developed by, a competitor, our competitive position would be harmed.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our
markets of interest, and our business may be adversely affected.
AlloMap, AlloSure, Olerup SSP, Olerup XM-ONE, QTYPE, Ottr and CareDx are registered trademarks of our company in the
United States. Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared
generic or determined to be infringing on other marks. As a means to enforce our trademark rights and prevent infringement, we
may be required to file trademark claims against third parties or initiate trademark opposition proceedings. This process can be
expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may
decide that a trademark of ours is not valid or is unenforceable, or may refuse to stop the other party from using the trademark
at issue. We may not be able to protect our rights to these and other trademarks and trade names which we need to build name
recognition by potential partners or customers in our markets of interest. Over the long-term, if we are unable to establish name
recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be
adversely affected.
53 We may be subject to claims by third parties that we or our employees have wrongfully used or disclosed alleged trade
secrets or misappropriated intellectual property, or claiming ownership of what we view as our own intellectual property.
As is commonplace in our industry, we employ individuals who were previously employed at other diagnostics, medical device,
life sciences or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that
our employees do not use the proprietary information of others in the course of their work for us and no claims against us are
currently pending, we may be subject to claims that these employees have inadvertently or otherwise used or disclosed trade
secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims.
We may also be forced to bring claims against third parties or defend against third-party claims in order to determine the
ownership of our intellectual property. An adverse result in the prosecution or defense of any such claims could require us to
pay substantial monetary damages and could result in the loss of valuable intellectual property rights or personnel. Even if we
are successful in prosecuting or defending against these claims, litigation could result in substantial costs and be a distraction to
management.
Our business is dependent on licenses from third parties.
We license technology from third parties necessary to develop and commercialize our products. In connection with our
acquisition of ImmuMetrix, Inc., we obtained an exclusive license from Stanford to a patent relating to the diagnosis of
rejection in organ transplant recipients using dd-cfDNA. This technology is critical to AlloSure Kidney under the terms of the
Stanford license, we are required to report and pay an annual license maintenance fee, six milestone payments and royalties in
the low single digits on net sales of products incorporating the licensed technology. This patent has an expiration date of
November 5, 2030. A second patent included in the license from Stanford was issued in December 2017 and further covers the
use of dd-cfDNA to diagnose and predict transplant status or outcome. A third and fourth patent was issued from this Stanford
set in June 2019 and December 2019, respectively, covering the use of dd-cfDNA to diagnose and predict transplant status or
outcome. Both patents have the same 2030 expiration date as the original Stanford patent.
On May 4, 2018, we entered into the License Agreement with Illumina, which provides us with worldwide distribution,
development and commercialization rights to Illumina’s NGS product line for use in transplantation diagnostic testing. As a
result, on June 1, 2018, we became the exclusive worldwide distributor of Illumina’s TruSight HLA product line.
On April 30, 2019, we entered into the Cibiltech Agreement, pursuant to which we were granted an irrevocable, non-
transferable right to commercialize Cibiltech’s proprietary software, KidneyCare iBox, for the predictive analysis of post-
transplantation kidney allograft loss in the field of transplantation in the U.S. for a period of ten years.
In April 2020, we entered into a license agreement with Cornell University pursuant to which we were granted exclusive rights
to three patents and two patent applications covering methods and technology for measurement of gene expression in urine to
diagnose kidney transplant rejection.
Our rights to use this and other licensed technologies, data and materials and to employ the inventions claimed in licensed
patents are subject to the continuation of and our compliance with the terms of the applicable licenses.
Termination of the license could prevent us from producing or selling some or all of our products. Failure of a licensor to abide
by the terms of a license or to prevent infringement by third parties could also harm our business and negatively impact our
market position.
Risks Related to Our Common Stock
Our operating results may fluctuate, which could cause our stock price to decrease.
Fluctuations in our operating results may lead to fluctuations, including declines, in the share price for our common stock. In
2020, our closing stock price ranged from $13.94 to $77.09 per share. Our operating results and our share price may fluctuate
from period to period due to a variety of factors, including:
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demand by clinicians and recipients for our current and future solutions, if any;
coverage and reimbursement decisions by third-party payers and announcements of those decisions;
clinical trial results and publication of results in peer-reviewed journals or the presentation at
medical conferences;
the inclusion or exclusion of our current and future solutions in large clinical trials conducted by
others;
new or less expensive tests and services or new technology introduced or offered by our competitors
or us;
54 •
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the level of our development activity conducted for new solutions, and our success in
commercializing these developments;
our ability to efficiently integrate the business of new acquisitions;
the level of our spending on test commercialization efforts, licensing and acquisition initiatives,
clinical trials, and internal research and development;
changes in the regulatory environment, including any announcement from the U.S. Food and Drug
Administration regarding its decisions in regulating our activities;
changes in recommendations of securities analysts or lack of analyst coverage;
failure to meet analyst expectations regarding our operating results;
additions or departures of key personnel;
public health emergencies such as the COVID-19 pandemic; and
general market conditions.
Variations in the timing of our future revenues and expenses could also cause significant fluctuations in our operating results
from period to period and may result in unanticipated earning shortfalls or losses. In addition, national stock exchanges, and in
particular the market for life science companies, have experienced significant price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of those companies. Moreover, we may be subject to additional
securities class action litigation as a result of volatility in the price of our common stock, which could result in substantial costs
and diversion of management’s attention and resources and could harm our stock price, business, prospects, results of
operations and financial condition.
The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of your
investment.
Our common stock is currently traded on the Nasdaq Global Market, but we can provide no assurances that there will be active
trading on that market or on any other market in the future. If there is no active market or if the volume of trading is limited,
holders of our common stock may have difficulty selling their shares. The market price of our common stock has been and may
continue to be subject to wide fluctuations in response to various factors, some of which are beyond our control. In addition to
the factors discussed in this "Risk Factors" section and elsewhere in this Annual Report on Form 10-K, factors that could cause
fluctuations in the market price of our common stock include the following:
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price and volume fluctuations in the overall stock market from time to time;
volatility in the market prices and trading volumes of life sciences stocks;
changes in operating performance and stock market valuations of other life sciences companies
generally, or those in our industry in particular;
sales of shares of our common stock by us or our stockholders;
entering into financing or other arrangements with rights or terms senior to the interests of common
stockholders;
failure of securities analysts to maintain coverage of us, changes in financial estimates by securities
analysts who follow our company, or our failure to meet these estimates or the expectations of
investors;
the financial projections we may provide to the public, any changes in those projections or failure to
meet those projections;
announcements by us or our competitors of new products or services;
the public’s reaction to our press releases, other public announcements and filings with the SEC;
rumors and market speculation involving us or other companies in our industry;
actual or anticipated changes in our operating results or fluctuations in our operating results;
actual or anticipated developments in our business, our competitors’ businesses or the competitive
landscape generally;
litigation involving us, our industry or both, or investigations by regulators into our operations or
those of our competitors;
developments or disputes concerning our intellectual property or other proprietary rights;
announced or completed acquisitions of businesses or technologies by us or our competitors;
new laws or regulations or new interpretations of existing laws or regulations applicable to our
business;
changes in accounting standards, policies, guidelines, interpretations or principles;
55 •
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any significant change in our management;
public health emergencies, including the COVID-19 pandemic; and
general economic conditions and slow or negative growth of our markets.
If our principal stockholders, executive officers and directors choose to act together, they may be able to control our
management and operations, which may prevent us from taking actions that may be favorable to you.
Our executive officers, directors and holders of 5% or more of our outstanding common stock (based on the most recent public
filings), and entities affiliated with them, beneficially own in the aggregate approximately 41.4% of our common stock as of
February 22, 2021. These stockholders, acting together, will have the ability to exert substantial influence over all matters
requiring approval by our stockholders, including the election and removal of directors and any proposed merger, consolidation
or sale of all or substantially all of our assets. In addition, they could dictate the management of our business and affairs. This
concentration of ownership could have the effect of delaying, deferring or preventing a change in control of us or impeding a
merger or consolidation, takeover or other business combination that could be favorable to you.
Sales of substantial amounts of our common stock in the public markets, or sales of our common stock by our executive
officers and directors under Rule 10b5-1 plans, could adversely affect the market price of our common stock.
We currently have effective registration statements registering shares of our common stock for resale, and such shares are
currently freely tradable in the public market. Sales of a substantial number of shares of our common stock in the public market,
or the perception that such sales could occur, could adversely affect the market price of our common stock and may make it
more difficult for you to sell your common stock at a time and price that you deem appropriate.
In addition, our executive officers and directors may adopt written plans, known as “Rule 10b5-1 Plans,” under which they will
contract with a broker to sell shares of our common stock on a periodic basis to diversify their assets and investments. Sales
made by our executive officers and directors pursuant to Rule 10b5-1, regardless of the amount of such sales, could adversely
affect the market price of our common stock.
We do not expect to pay dividends in the foreseeable future. As a result, you must rely on stock appreciation for any return
on your investment.
We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any payment of cash dividends will
also depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion
of our board of directors. Accordingly, you will have to rely on capital appreciation, if any, to earn a return on your investment
in our common stock.
If we are unable to substantially utilize our net operating loss carryforwards, our financial results could be harmed.
Section 382 of the U.S. Internal Revenue Code of 1986, as amended, generally limits the ability of a corporation that undergoes
an “ownership change” to utilize its net operating loss carry-forwards, or NOLs, and certain other tax attributes against any
taxable income in taxable periods after the ownership change. The amount of taxable income in each taxable year after the
ownership change that may be offset by pre-change NOLs and certain other pre-change tax attributes is generally equal to the
product of (a) the fair market value of the corporation’s outstanding shares (or, in the case of a foreign corporation, the fair
market value of items treated as connected with the conduct of a trade or business in the United States) immediately prior to the
ownership change and (b) the long-term tax exempt rate (i.e., a rate of interest established by the U.S. Internal Revenue Service,
or IRS, that fluctuates from month to month). In general, an “ownership change” occurs whenever the percentage of the shares
of a corporation owned, directly or indirectly, by “5-percent shareholders” (within the meaning of Section 382 of the Internal
Revenue Code of 1986, as amended) increases by more than 50 percentage points over the lowest percentage of the shares of
such corporation owned, directly or indirectly, by such “5-percent shareholders” at any time over the preceding three years.
Based on a preliminary review of our equity transactions since inception, we believe a portion of our NOLs may be limited due
to the equity financings that we have completed. Utilization of our NOLs may be subject to a substantial annual limitation due
to the ownership change limitations provided by the Internal Revenue Code of 1986, as amended, and similar state provisions.
Limitations imposed on our ability to utilize NOLs could cause U.S. federal and state income taxes to be paid earlier than would
be paid if such limitations were not in effect and could cause such NOLs to expire unused, in each case reducing or eliminating
the benefit of such NOLs. Furthermore, we may not be able to generate sufficient taxable income to utilize our NOLs before
they expire. If any of these events occur, we may not derive some or all of the expected benefits from our NOLs.
56 Our organizational documents and Delaware law make a takeover of our company more difficult, which may prevent certain
changes in control and limit the market price of our common stock.
Our certificate of incorporation and bylaws and Section 203 of the General Corporation Law of the State of Delaware, or
Section 203, contain provisions that may have the effect of deterring or delaying attempts by our stockholders to remove or
replace management, engage in proxy contests and effect changes in control. These provisions include:
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our board of directors is authorized, without prior stockholder approval, to create and issue preferred
stock which could be used to implement anti-takeover devices;
advance notice is required for director nominations or for proposals that can be acted upon at
stockholder meetings;
our board of directors is classified such that not all members of our board are elected at one time,
which may make it more difficult for a person who acquires control of a majority of our outstanding
voting stock to replace all or a majority of our directors;
stockholder action by written consent is prohibited;
special meetings of the stockholders may be called only by the chairman of our board of directors, a
majority of our board of directors or by our chief executive officer or president (if at such time we
have no chief executive officer);
stockholders are not permitted to cumulate their votes for the election of directors; and
stockholders may amend our bylaws and certain provisions of our certificate of incorporation only
upon receiving at least 66 2/3% of the votes entitled to be cast by holders of all outstanding shares
then entitled to vote generally in the election of directors, voting together as a single class.
In addition, as a Delaware corporation, we are subject to Delaware law, including Section 203. In general, Section 203 prohibits
a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years
following the date that the stockholder became an interested stockholder unless certain specific requirements are met as set
forth in Section 203. These provisions, alone or together, could have the effect of deterring or delaying changes in incumbent
management, proxy contests or changes in control.
These provisions also could discourage proxy contests and make it more difficult for you and other stockholders to elect
directors and take other corporate actions. The existence of these provisions could limit the price that investors might be willing
to pay in the future for shares of our common stock. Some provisions in our certificate of incorporation and bylaws may deter
third parties from acquiring us, which may limit the market price of our common stock.
General Risk Factors
We incur costs and demands upon management as a result of complying with the laws and regulations affecting public
companies in the U.S., which may adversely affect our operating results.
As a public company listed in the U.S., we incur significant additional legal, accounting and other expenses. In addition,
changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations
implemented by the SEC and The Nasdaq Stock Market LLC, may increase legal and financial compliance costs and make
some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, and as a
result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. We
invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general
and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to
compliance activities. If, notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply,
regulatory authorities may initiate legal proceedings against us, and our business may be harmed.
Further, if we fail to comply with these laws, regulations and standards, it might also be more difficult for us to obtain certain
types of insurance, including director and officer liability insurance, and we might 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 persons to serve on our board of directors, on committees of our board of
directors or as members of senior management.
57 If equity research analysts do not publish research or reports about our business, or if they issue unfavorable commentary
or downgrade our common stock, the price of our common stock could decline.
The trading market for our common stock relies in part on the research and reports that equity research analysts publish about
us and our business. We do not control these analysts or the content and opinions included in their reports. Securities analysts
may elect not to provide research coverage of our common stock and a lack of research coverage may adversely affect the
market price of our common stock. The price of our stock could decline if one or more equity research analysts downgrade our
stock or if those analysts issue other unfavorable commentary or cease publishing reports about us or our business. If one or
more equity research analysts cease coverage of our company, we could lose visibility in the market, which in turn could cause
our stock price to decline.
Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information,
which could materially harm our stock price, exchange listing and our ability to finance our operations.
We are required to comply with the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the SEC, including
expanded disclosures and accelerated reporting requirements and more complex accounting rules. Compliance with Section 404
of the Sarbanes-Oxley Act, or Section 404, and other requirements will increase our costs and require additional management
resources. Pursuant to Section 404, we are required to, among other things, file a report by our management on our internal
control over financial reporting, including an attestation report on internal control over financial reporting issued by our
independent registered public accounting firm. We are continuing to implement and update new finance and accounting systems
as we grow our business and organization and to satisfy internal control and reporting requirements.
Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude
that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction
in the financial markets due to a loss of confidence in the reliability of our consolidated financial statements.
The effectiveness of our controls and procedures may in the future be limited by a variety of factors, including:
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faulty human judgment and simple errors, omissions or mistakes;
fraudulent action of an individual or collusion of two or more people;
inappropriate management override of procedures; and
the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and
accurate financial information.
If we are unable to complete the required Section 404 assessment as to the adequacy of our internal control over financial
reporting or otherwise fail to maintain or implement effective controls and procedures for financial reporting, we could be
unable to accurately and timely report our financial position, results of operations, and cash flows or key operating metrics,
which could result in late filings of our annual and quarterly reports under the Securities Exchange Act of 1934, as amended,
restatements of our consolidated financial statements or other corrective disclosures, a decline in our stock price, suspension or
delisting of our common stock from the Nasdaq Global Market, SEC investigations, civil or criminal sanctions, an inability to
access the capital and commercial lending markets, defaults under our debt and other agreements or other material adverse
effects on our business, reputation, results of operations, financial condition or liquidity.
Techniques employed by short sellers may drive down the market price of our common stock.
Short selling is the practice of selling securities that the seller does not own, but rather has borrowed from a third-party with the
intention of buying identical securities back at a later date to return to the lender. The short seller hopes to profit from a decline
in the value of the securities between the sale of the borrowed securities and the purchase of the replacement shares, as the short
seller expects to pay less in that purchase than it received in the sale. As it is in the short seller’s best interests for the price of
the stock to decline, many short sellers publish, or arrange for the publication of, negative opinions regarding the relevant issuer
and its business prospects in order to create negative market momentum and generate profits for themselves after selling a stock
short. These short attacks have, in the past, led to selling of shares in the market. We believe that our securities have in the past
been, and may continue to be, the subject of short selling. Reports and information have been published about us that we
believe are mischaracterized or incorrect, and which have in the past been followed by a decline in our stock price.
It is not clear what additional effects the negative publicity will have on us, if any, other than potentially affecting the market
price of our common stock. If we continue to be the subject of unfavorable allegations, we may have to expend a significant
amount of resources to investigate such allegations and/or defend ourselves. While we would strongly defend against any such
short seller attacks, we may be constrained in the manner in which we can proceed against the relevant short seller by
applicable state law or issues of commercial confidentiality. Such a situation could be costly and time-consuming, and could be
distracting for our management team. Additionally, such allegations against us could negatively impact our business operations
and stockholders' equity, and the value of any investment in our stock could be reduced.
58 ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Our headquarters are located in South San Francisco, California. We lease facilities in North America, Europe, and Australia.
The following is a summary of the locations, functions and approximate square footage of those facilities as of December 31,
2020:
Location
United States
South San Francisco, California
Brisbane, California
West Chester, Pennsylvania
Omaha, Nebraska
Europe
Stockholm, Sweden
Vienna, Austria
Australia
Fremantle
Function
Square Footage
Corporate headquarters
Research & development and clinical laboratory
Sales office and distribution
Digital solutions office
Research & development and product manufacturing
Sales office and distribution
Research & development and product manufacturing
28,968
46,000
6,336
13,132
24,746
1,744
10,265
We do not own any real property. We believe that our leased facilities are adequate to meet our current needs and that
additional facilities are available for lease to meet future needs.
ITEM 3. LEGAL PROCEEDINGS
The information set forth in Note 9, Commitments and Contingencies, to the consolidated financial statements included
elsewhere in this Annual Report on Form 10-K under the caption “Litigation and Indemnification Obligations” is incorporated
herein by reference.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
59 PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock has been trading on the Nasdaq Global Market under the symbol “CDNA” since July 22, 2014. The daily
market activity and closing prices of our common stock can be found at www.nasdaq.com.
Holders of Record
As of February 22, 2021, there were approximately 79 holders of record of our common stock. Because many of our shares of
common stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number
of stockholders represented by these record holders.
Dividend Policy
We have never declared or paid cash dividends on our common stock, and currently do not have any plans to do so in the
foreseeable future. We expect to retain our future earnings, if any, for use in the operation and expansion of our business.
Any payment of cash dividends will also depend on our financial condition, results of operations, capital requirements and other
factors deemed relevant by our board of directors and will be at the discretion of our board of directors.
Stock Performance Graph
The following stock performance graph and related information shall not be deemed “soliciting material” or to be “filed” with
the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act of 1934, as
amended, or the Exchange Act, except to the extent that we specifically incorporate it by reference into such filing.
The following stock performance graph compares total stockholder returns for CareDx, Inc. from December 31, 2015 through
December 31, 2020 against the Nasdaq Market Composite Index and Nasdaq Biotech Index, assuming a $100 investment made
on December 31, 2015. Each of the two comparative measures of cumulative total return assumes reinvestment of dividends.
The stock performance shown on the graph below is not necessarily indicative of future price performance.
60 Sales of Unregistered Securities
There were no sales of unregistered securities by us during the fourth quarter of 2020.
Securities Authorized for Issuance Under Equity Compensation Plans
See Item 12 of Part III of this Annual Report on Form 10-K regarding information about securities authorized for issuance
under our equity compensation plans.
Issuer Purchases of Equity Securities
We satisfy certain U.S. federal and state tax withholding obligations due upon the vesting of restricted stock unit awards by
automatically withholding from the shares being issued in connection with such award a number of shares of our common stock
with an aggregate fair market value on the date of vesting equal to the minimum tax withholding obligations. The following
table sets forth information with respect to shares of our common stock repurchased by us to satisfy certain tax withholding
obligations during the three months ended December 31, 2020:
(a) Total Number of Shares (or Units)
Purchased
(b) Average Price Paid per Share (or Unit)
October 1, 2020 - October 31, 2020
November 1, 2020 - November 30, 2020
December 1, 2020 - December 31, 2020
Total
2,382 (1) $
6,096 (1) $
1,479 (1) $
9,957
17.18
23.80
20.29
—
(1) Represents shares of our common stock withheld from employees for the payment of taxes.
ITEM 6. SELECTED FINANCIAL DATA
Not required.
61 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with our
consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion
contains certain forward-looking statements that involve risk and uncertainties. Our actual results may differ materially from
those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified
below and those set forth under the Section entitled “Risk Factors” in Item 1A, and other documents we file with the Securities
and Exchange Commission. Historical results are not necessarily indicative of future results.
Overview and Recent Highlights
We are a leading precision medicine company focused on the discovery, development and commercialization of clinically
differentiated, high-value diagnostic solutions for transplant patients and caregivers. We offer testing services, products, and
digital healthcare solutions along the pre- and post-transplant patient journey, and we are a leading provider of genomics-based
information for transplant patients.
Testing Services
Kidney
AlloSure Kidney, our transplant surveillance solution, was commercially launched in October 2017 and is our dd-cfDNA
offering built on a NGS platform. In transplantation, 109 papers from 55 studies globally have shown the value of dd-cfDNA in
the management of solid organ transplantation. AlloSure Kidney is able to discriminate dd-cfDNA from recipient-cell-free
DNA, targeting polymorphisms between donor and recipient. This SNP approach across all the somatic chromosomes is
specifically designed for transplantation, allowing a scalable, high-quality test to differentiate dd-cfDNA.
AlloSure Kidney has received positive coverage decisions for reimbursement from Medicare. The Medicare reimbursement rate
for AlloSure Kidney is $2,841. AlloSure Kidney has received positive coverage decisions from BCBS of South Carolina, BCBS
of Kansas City and Capital Health, and is reimbursed by other private payers on a case-by-case basis.
Multiple studies have demonstrated that significant allograft injury can occur in the absence of changes in serum creatinine.
Thus, clinicians have limited ability to detect injury early and intervene to prevent long-term damage using this marker. While
histologic analysis of the allograft biopsy specimen remains the standard method used to assess injury and differentiate rejection
from other injury in kidney transplants, as an invasive test with complications, repetitive biopsies are not well tolerated.
AlloSure Kidney provides a non-invasive test, assessing allograft injury that enables more frequent, quantitative and safer
assessment of allograft rejection and injury status. Beyond allograft rejection, the assessment of molecular inflammation has
shown further utility in the assessment of proteinuria, the formation of DSAs, and as a surrogate predictive measure of eGFR
decline. Monitoring of graft injury through AlloSure Kidney allows clinicians to optimize allograft biopsies, identify allograft
injury and guide immunosuppression management more accurately.
Since the analytical validation paper in the Journal of Molecular Diagnostics in 2016 before the commercial launch of AlloSure
Kidney, there has been an increasing body of evidence supports the use of AlloSure Kidney dd-cfDNA in the assessment and
surveillance of kidney transplants. Bloom et al evaluated 102 kidney recipients and demonstrated that dd-cfDNA levels could
discriminate accurately and non-invasively distinguish rejection from other types of graft injury. In contrast, serum creatinine
has AUC of 50%, showing no significant difference between patients with and without rejection. Multiple publications and
abstracts have shown AlloSure Kidney’s value in the management of BK viremia, as well as numerous pathologies that cause
molecular inflammation and injury such as DSAs and eGFR decline. Most recently its utility in the assessment of T-cell
mediated rejection (TCMR) 1A and borderline rejection has also been published in the AJT.
The prospective multicenter trial, the K-OAR study, has enrolled over 1,700 patients, with plans to survey patients with
AlloSure Kidney for 3 years and provide further clinical utility of AlloSure Kidney in the surveillance of kidney transplant
recipients.
KidneyCare
KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap
Kidney and the predictive artificial intelligence technology of KidneyCare iBox in one surveillance solution. We have not yet
made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare iBox.
In September 2019, we announced the enrollment of the first patient in the OKRA study, which is an extension of the K-OAR
study. OKRA is a prospective, multi-center, observational registry of patients receiving KidneyCare for surveillance. Combined
with K-OAR, 4,000 patients will be enrolled into the study.
62 Heart
AlloMap Heart is a gene expression test that helps clinicians monitor and identify heart transplant recipients with stable graft
function who have a low probability of moderate-to-severe acute cellular rejection. Since 2008, we have sought to expand the
adoption and utilization of our AlloMap Heart solution through ongoing studies to substantiate the clinical utility and
actionability of AlloMap Heart, secure positive reimbursement decisions from large private and public payers, develop and
enhance our relationships with key members of the transplant community, including opinion leaders at major transplant centers,
and explore opportunities and technologies for the development of additional solutions for post-transplant surveillance.
We believe the use of AlloMap Heart, in conjunction with other clinical indicators, can help healthcare providers and their
patients better manage long-term care following a heart transplant, can improve patient care by helping healthcare providers
avoid the use of unnecessary, invasive surveillance biopsies and may help to determine the appropriate dosage levels of
immunosuppressants. In 2008, AlloMap Heart received 510(k) clearance from the FDA for marketing and sale as a test to aid in
the identification of heart transplant recipients, who have a low probability of moderate/severe acute cellular rejection at the
time of testing, in conjunction with standard clinical assessment.
AlloMap Heart has been a covered service for Medicare beneficiaries since January 1, 2006. The Medicare reimbursement rate
for AlloMap Heart is currently $3,240. AlloMap Heart has also received positive coverage decisions for reimbursement from
many of the largest U.S. private payers, including Aetna, Anthem, Cigna, HCSC, Humana, Kaiser, several BCBS plans and
UnitedHealthcare.
In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, our Medicare Administrative contractor, issued a parallel coverage policy
granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare
reimbursement rate for AlloSure Heart is currently $2,753.
We have also successfully completed several landmark clinical trials in the transplant field demonstrating the clinical utility of
AlloMap Heart for surveillance of heart transplant recipients. We initially established the analytical and clinical validity of
AlloMap Heart based on our CARGO study, which was published in the AJT. A subsequent clinical utility trial, IMAGE,
published in The New England Journal of Medicine, demonstrated that clinical outcomes in recipients managed with AlloMap
Heart surveillance were equivalent (non-inferior) to outcomes in recipients managed with biopsies. The results of our clinical
trials have also been presented at major medical society congresses. AlloMap Heart is now recommended as part of the ISHLT
guidelines.
HeartCare
HeartCare includes the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure Heart
in one surveillance solution. An approach to surveillance using HeartCare provides information from two complementary
measures: (i) AlloMap Heart – a measure of immune activation, and (ii) AlloSure Heart – a measure of graft injury.
Clinical validation data from the D-OAR was published in AJT in 2019. D-OAR was an observational, prospective, multicenter
study to characterize the AlloSure Heart dd-cfDNA in a routine, clinical surveillance setting with heart transplant recipients.
The D-OAR study was designed to validate that plasma levels of AlloSure Heart dd-cfDNA can discriminate acute rejection
from no rejection, as determined by endomyocardial biopsy criteria.
HeartCare provides robust information about distinct biological processes, such as immune quiescence, active injury, ACR and
AMR. In September 2018, we initiated the SHORE study. SHORE is a prospective, multi-center, observational, registry of
patients receiving HeartCare for surveillance. Patients enrolled in SHORE will be followed for 5 years with collection of
clinical data and assessment of 5-year outcomes.
Lung
In February 2019, AlloSure Lung became available for lung transplant patients through a compassionate use program while the
test is undergoing further studies. One of these studies, launched in April 2020, is the ALARM study, or AlloSure Lung
Allograft Remote Monitoring, with Johns Hopkins University, where the impact of AlloSure Lung combined with RemoTraC
will be measured. AlloSure Lung applies proprietary NGS technology to measure dd-cfDNA from the donor lung in the
recipient bloodstream to monitor graft injury. In June 2020, we submitted an application to the Palmetto MolDx Technology
Assessment program seeking coverage and reimbursement for AlloSure Lung.
Cellular Therapy
In April 2020, we initiated a research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and
persistence of allogeneic cells for patients who have received cell therapy transplants. AlloCell will initially be commercialized
through collaborative research agreements with biopharma companies developing cell therapies.
63 Products
We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better
match between a solid organ or stem cell donor and a recipient, and help to provide post-transplant surveillance of these
recipients.
QTYPE enables HLA typing at a low to intermediate resolution for samples that require a fast turn-around-time and uses real-
time PCR methodology. Olerup SSP is used to type HLA alleles based on the SSP technology. Olerup SBT is a complete
product range for sequence-based typing of HLA alleles.
On May 4, 2018, we entered into the Illumina Agreement, which provides us with worldwide distribution, development and
commercialization rights to Illumina’s NGS products and technologies for use in transplantation diagnostic testing.
On June 1, 2018, we became the exclusive worldwide distributor of Illumina’s TruSight HLA product line. TruSight HLA is a
high-resolution solution that uses NGS methodology. In addition, we were granted the exclusive right to develop and
commercialize other NGS product lines in the field of bone marrow and solid organ transplantation on diagnostic testing. These
NGS products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeq cfDNA, our surveillance solution designed
to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, a NGS solution for
chimerism testing for stem cell transplant recipients.
In September 2019, we commercially launched AlloSeq cfDNA, our surveillance solution designed to measure dd-cfDNA in
blood to detect active rejection in transplant recipients, and we received CE mark authorization on January 10, 2020. Our ability
to increase the clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including local clinical education,
customer lab technical proficiency and levels of country-specific reimbursement.
Also in September 2019, we commercially launched AlloSeq Tx, the first of its kind NGS high-resolution HLA typing solution
utilizing hybrid capture technology. This technology enables the most comprehensive sequencing, covering more of the HLA
genes than other solutions on the market and adding coverage of non-HLA genes that may impact transplant patient matching
and management. AlloSeq Tx has simple NGS workflow, with a single tube for processing and steps to reduce errors. AlloSeq
Tx 17 received CE mark authorization on May 15, 2020.
In June 2020, we commercially launched AlloSeq HCT, a NGS solution for chimerism testing for stem cell transplant
recipients. This technology has the potential to provide better sensitivity and data analysis compared to current solutions on the
market.
Digital
In 2019, we began providing digital solutions to transplant centers following the acquisitions of Ottr, Inc. and XynManagement.
On May 7, 2019, we acquired 100% of the outstanding common stock of Ottr, Inc. Ottr, Inc. was formed in 1993 and is a
leading provider of the Ottr software, which provides comprehensive solutions for transplant patient management. The Ottr
software enables integration with EMR systems, including Cerner and Epic, providing patient surveillance management tools
and outcomes data to transplant centers.
On August 26, 2019, we acquired 100% of the outstanding common stock of XynManagement. XynManagement provides two
unique solutions, XynQAPI and XynCare. XynQAPI simplifies transplant quality tracking and SRTR reporting. XynCare
includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their
transplant and maintain eligibility.
In September 2020 we launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to
manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics.
In January 2021, we acquired TransChart for cash. TransChart provides EMR software to hospitals throughout the United
States to care for patients who have or may need an organ transplant. TransChart builds on our digital offerings, which include
Ottr transplant electronic medical record software and XynQAPI transplant quality management solutions.
64 COVID-19 Impact
In the final weeks of March and during April 2020, with hospitals increasingly caring for COVID-19 patients, hospital
administrators chose to limit or even defer, non-emergency procedures. Immunosuppressed transplant patients either self-
prescribed or were asked to avoid transplant centers and caregiver visits to reduce the risk of contracting COVID-19. As a
result, with transplant surveillance visits down, we experienced a slowdown in testing services volumes in the final weeks of
March and during April 2020. As a response to the COVID-19 pandemic, and to enable immune-compromised transplant
patients to continue to have their blood drawn, in late March 2020, we launched RemoTraC, a remote home-based blood draw
solution using mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other standard monitoring tests.
To date, more than 150 transplant centers can offer RemoTraC to their patients and over 6,000 kidney, heart and lung transplant
patients have enrolled. Based on existing and new relationships with partners, we have established a nationwide network of
more than 10,000 mobile phlebotomists. Following the introduction of RemoTraC and with the easing of stay-at-home
restrictions and the opening up of many hospitals to non-COVID-19 patients, our testing services volumes returned to levels
consistent with those experienced immediately prior to the COVID-19 pandemic, and volumes continued to be at or above
those levels since May 2020. In spite of the resurgence of COVID-19 infection rates, which resulted in increased stay-at-home
and renewed travel restrictions, we did not experience a decrease in testing services volumes. Our product business experienced
a reduction in forecasted sales volume throughout the second and third quarters of 2020, as we were unable to undertake onsite
discussions and demonstrations of our recently launched NGS products, including AlloSeq Tx 17, which was awarded CE mark
authorization in May 2020. Our product business maintained normal sales volumes during the fourth quarter of 2020.
We are maintaining our testing, manufacturing, and distribution facilities while implementing specific protocols to reduce
contact among our employees. In areas where COVID-19 impacts healthcare operations, our field-based sales and clinical
support teams are supporting providers through telephone and online platforms. In August 2020, the state of California released
revised criteria for loosening and tightening restrictions on certain activities on generally a county-by-county basis. Under the
updated executive orders, San Mateo County, where our laboratory and headquarters are located, continues to be subject to
certain restrictions. These orders and others may be further modified, amended and adopted depending upon the COVID-19
transmission rates in our county and state, as well as other factors. In addition, we have created a COVID-19 task force that is
responsible for crisis decision making, employee communications, enforcing pre-arrival temperature checking, daily health
check-ins and enhanced safety training/protocols in our offices for employees that do not work from home.
Due to COVID-19, quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns
or other restrictions on the conduct of business operations could occur or could impact personnel at third-party suppliers in the
United States and other countries, or the availability or cost of materials, there may be disruptions in our supply chain. Any
manufacturing supply interruption of materials could adversely affect our ability to conduct ongoing and future research and
testing activities.
In addition, our clinical studies may be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment may
be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients may not be able to
comply with clinical study protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the
ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
exposure to COVID-19, may adversely impact our clinical trial operations.
Financial Operations Overview
Revenue
We derive our revenue from testing services, products sales and digital and other revenues. Revenue is recorded considering a
five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance
obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and
recognizing revenue when, or as, an entity satisfies a performance obligation.
Testing Services Revenue
Our testing services revenue is derived from AlloSure Kidney, AlloMap Heart and AlloSure Heart tests, which represented
85%, 82% and 79% of our total revenues for the years ended December 31, 2020, 2019 and 2018, respectively. Our testing
services revenue depends on a number of factors, including (i) the number of tests performed; (ii) establishment of coverage
policies by third-party insurers and government payers; (iii) our ability to collect from payers with whom we do not have
positive coverage determination, which often requires that we pursue a case-by-case appeals process; (iv) our ability to
recognize revenues on tests billed prior to the establishment of reimbursement policies, contracts or payment histories; and
(v) how quickly we can successfully commercialize new product offerings.
65 We currently market testing services to healthcare providers through our direct sales force that targets transplant centers and
their physicians, coordinators and nurse practitioners. The healthcare providers that order the tests and on whose behalf we
provide our testing services are generally not responsible for the payment of these services. Amounts received by us vary from
payer to payer based on each payer’s internal coverage practices and policies. We generally bill third-party payers upon
delivery of a test result report to the ordering physician. As such, we take the assignment of benefits and the risk of collection
from the third-party payer and individual patients.
Product Revenue
Our product revenue is derived primarily from sales of AlloSeq Tx, Olerup SSP, QTYPE and TruSight products. Product
revenue represented 10%, 15% and 20% of total revenue for the years ended December 31, 2020, 2019 and 2018, respectively.
We recognize product revenue from the sale of products to end-users, distributors and strategic partners when all revenue
recognition criteria are satisfied. We generally have a contract or a purchase order from a customer with the specified required
terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and
risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement. There are no further
performance obligations related to a contract and revenue is recognized at the point of delivery consistent with the terms of the
contract or purchase order.
Digital and Other Revenue
Our digital and other revenue is mainly derived from sales of our Ottr software and XynQAPI licenses and services and other
licensing agreements. Digital and other revenue represented 5%, 3% and 1% of total revenue for the years ended December 31,
2020, 2019 and 2018, respectively.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated
financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the
disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue
generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on
various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may
differ from these estimates under different assumptions or conditions.
Our significant accounting policies are described in Note 2 of the consolidated financial statements included elsewhere in this
Annual Report on Form 10-K for additional information. Some of these accounting policies require us to make difficult and
subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. We believe that
the following critical accounting policies reflect the more significant estimates and assumptions used in the preparation of our
consolidated financial statements.
Revenue Recognition
We recognize revenue from testing services, product sales and digital and other revenue in the amount that reflects the
consideration which it expects to be entitled in exchange for goods or services as it transfers control to its customers. Revenue
is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying
the performance obligations in the contract, determining the transaction price, allocating the transaction price to the
performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
Testing Services Revenue
AlloSure Kidney, AlloMap Heart, and AlloSure Heart patient tests are ordered by healthcare providers. We receive a test
requisition form with payer information along with a collected patient blood sample. We consider the patient to be our customer
and the test requisition form to be the contract. Testing services are performed in our laboratory. Testing services represent one
performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a
point in time.
The healthcare providers that order the tests and on whose behalf we provide testing services are generally not responsible for
the payment of these services. The first and second revenue recognition criteria are satisfied when we receive a test requisition
form with payer information from the healthcare provider. Generally, we bill third-party payers upon delivery of an AlloSure
Kidney, AlloMap Heart or AlloSure Heart test result to the healthcare provider. Amounts received may vary amongst payers
based on coverage practices and policies of the payer.
66 We have used the portfolio approach, a practical expedient under Accounting Standards Codification, or ASC, Topic 606,
Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other
contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where
applicable. We estimate revenue for non-contracted payers and self-payers using transaction prices determined for each
financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a
percentage of tests reimbursed. This estimate requires significant judgment.
We monitor revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to
the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes
made to contracted rates.
Product Revenue
Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue
recognition criteria are satisfied. We generally have a contract or a purchase order from a customer with the specified required
terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and
risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement.
Digital and Other Revenue
Digital revenue is mainly derived from perpetual software license agreements entered into with various transplant centers
(customers). The main performance obligations in connection with our perpetual software license agreement are the following:
(i) implementation services and delivery of the perpetual software license are considered a single performance obligation, (ii)
post contract support ("PCS"). We allocate the transaction price to each performance obligation based on relative stand-alone
selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements
is recognized over time based on our satisfaction of each distinct performance obligation in each agreement.
Perpetual software license agreements typically require advance payments from customers upon the achievement of certain
milestones. We record deferred revenue in relation to these agreements when cash payments are received, or invoices are issued
in advance of our performance, and generally recognize revenue over the contractual term, as performance obligations are
fulfilled.
In addition, we derive digital revenue from software subscriptions. We generally bill software subscription fees in advance.
Revenue from software subscriptions is deferred and recognized ratably over the subscription term.
Business Combinations
We determine and allocate the purchase price of an acquired business to the assets acquired and liabilities assumed based on
their estimated fair values as of the business combination date, including separately identifiable intangible assets, which are
separable from goodwill. We base the estimated fair value of identifiable intangible assets acquired in a business combination
on independent valuations that use information and assumptions provided by management, which consider management’s best
estimates of inputs and assumptions that a market participant would use. We allocate any excess purchase price over the
estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill.
The use of alternative valuation assumptions, including estimated revenue projections, growth rates, royalty rates, cash flows,
discount rates, estimated useful lives and probabilities surrounding the achievement of contingent milestones, could result in
different purchase price allocations and amortization expense in current and future periods.
In those circumstances where an acquisition involves a contingent consideration arrangement that meets the definition of a
liability under ASC Topic 480, Distinguishing Liabilities from Equity, we recognize a liability equal to the fair value of the
contingent payments that we expect to make as of the acquisition date. We remeasure this liability each reporting period and
record changes in the fair value as a component of operating expenses. In circumstances where the contingent consideration is
classified as equity, we recognize it at fair value at the acquisition date. Contingent consideration classified as equity is not
subsequently remeasured.
Transaction costs associated with acquisitions are expensed as incurred in general and administrative expenses. Results of
operations and cash flows of acquired companies are included in our operating results from the date of acquisition.
67 Acquired Intangible Assets
Amortizable intangible assets include customer relationships, developed technology, trademarks, contracts and acquired in-
process technology assets acquired as part of a business combination. Intangible assets subject to amortization are amortized
over their estimated useful lives. Acquired in-process technology assets are considered to be indefinite-lived until the
completion or abandonment of the associated research and development efforts. If and when development is complete, which
generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-
lived and would then be amortized based on their respective estimated useful lives at that point in time.
Impairment of Goodwill, Intangible Assets and Long-lived Assets
Goodwill
Goodwill recorded in a business combination is not subject to amortization. Instead, it is tested for impairment on an annual
basis and whenever events or changes in circumstances indicate its carrying amount may not be recoverable.
Our annual impairment test date is December 1st. A qualitative assessment is initially made to determine whether it is necessary
to perform a quantitative assessment. A qualitative assessment includes, among others, consideration of: (i) past, current and
projected future earnings; (ii) recent trends and market conditions; and (iii) valuation metrics involving similar companies that
are publicly-traded and acquisitions of similar companies, if available. If this qualitative assessment indicates that it is more
likely than not that an impairment exists, or if we decide to bypass this option, we proceed to perform the quantitative
assessment. The quantitative assessment consists of a comparison between the estimated fair value of our reporting unit and its
respective carrying amount including goodwill. Where the carrying value of the reporting unit exceeds its estimated fair value,
we will record an impairment charge based on that difference. The impairment charge will be limited to the amount of goodwill
allocated to that reporting unit.
When necessary, to determine the reporting unit’s fair value under the quantitative approach, we use a combination of income
and market approaches, such as estimated discounted future cash flows of that reporting unit, multiples of earnings or revenues,
and analysis of recent sales or offerings of comparable entities. We also consider our market capitalization on the date of the
analysis to ensure the reasonableness of the reporting unit’s fair value.
In connection with our annual goodwill assessment on December 1, 2020, we performed a qualitative assessment taking into
consideration past, current and projected future earnings, recent trends and market conditions; and its market capitalization.
Based on this analysis, we concluded that it was more likely than not that the fair value of the reporting unit exceeded its
carrying amount. As such, it was not necessary to perform the quantitative goodwill impairment assessment at that time. As of
December 31, 2020, no impairment of goodwill has been identified.
Intangible assets not subject to amortization
We evaluate the carrying value of intangible assets not subject to amortization, related to acquired in-process technology assets,
which are considered to be indefinite-lived until the completion or abandonment of the associated research and development
efforts. Accordingly, amortization of the acquired in-process technology assets will not occur until the products reach
commercialization.
During the period the assets are considered indefinite-lived, they are tested for impairment on an annual basis, as well as
between annual tests if we become aware of any events occurring or changes in circumstances that would indicate that the fair
values of the acquired in-process technology assets are less than their carrying amounts. An impairment loss would be recorded
when the fair value of an acquired in-process technology asset is less than its carrying value. If and when development is
complete, which generally occurs when the products are made commercially available, the associated acquired in-process
technology asset will be deemed finite-lived and will then be amortized based on its estimated useful life. As of December 31,
2020, no impairment of acquired in-process technology assets has been identified.
Intangible assets and long-lived assets subject to amortization
We evaluate our finite-lived intangible assets and our long-lived assets for indicators of possible impairment when events or
changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We then compare the carrying
amounts of the assets with the future net undiscounted cash flows expected to be generated by such asset. If an impairment
exists, we measure the impairment based on the excess carrying value of the asset over the asset’s fair value determined using
discounted estimates of future cash flows. We have not identified any such impairment losses to date.
68 Common Stock Warrants
Common stock warrants issued with debt, equity or as standalone financing instruments are recorded as either liabilities or
equity in accordance with the respective accounting guidance. Warrants recorded as equity are recorded at their relative fair
value determined at the issuance date and are not remeasured after that. Warrants recorded as liabilities are recorded at their fair
value and remeasured on each reporting date with changes recorded in change in estimated fair value of common stock warrant
liability and derivative liability in the consolidated statements of operations.
We utilize a binomial-lattice pricing model, or the Monte Carlo Simulation Model, that involves a market condition simulation
to estimate the fair value of the warrants. The application of the Monte Carlo Simulation Model requires the use of a number of
complex assumptions including our stock price, expected life of the warrants, stock price volatility determined from our
historical stock prices and stock prices of peer companies in the diagnostics industry, and risk-free rates based on the implied
yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected life of the
warrants. Increases (decreases) in these assumptions result in a directionally similar impact to the fair value of the common
stock warrant liability.
Recently Issued Accounting Standards
Refer to Note 2, Summary of Significant Accounting Policies - Recent Accounting Pronouncements, to the consolidated
financial statements included elsewhere in this Annual Report on Form 10-K for a description of recently issued accounting
pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial position
and cash flows.
Factors Affecting Our Performance
COVID-19 Pandemic
COVID-19 may impact personnel at third-party suppliers in the United States and other countries, or the availability or cost of
materials, which would disrupt our supply chain. Any manufacturing supply interruption of materials could adversely affect our
ability to conduct ongoing and future research and testing activities. Clinical trials, clinical site initiation and patient enrollment
may be delayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some patients may not be able to
comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. Similarly, the
ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened
exposure to COVID-19, may adversely impact our clinical trial operations.
The Number of AlloMap Heart, AlloSure Kidney and AlloSure Heart Tests We Receive and Report
The growth of our testing services business is tied to the number of AlloSure Kidney, AlloMap Heart and AlloSure Heart
patient samples we receive and patient results we report. We incur costs in connection with collecting and shipping all samples
and a portion of the costs when we cannot ultimately issue a report. As a result, the number of patient samples received largely
correlates directly to the number of patient results reported.
Reimbursement for AlloMap Heart
AlloMap Heart test volume and the corresponding reimbursement revenue has generally increased over time since the launch of
AlloMap Heart, as the ISHLT included AlloMap in guidelines, payers adopted coverage policies and many payers no longer
consider AlloMap Heart to be experimental and investigational. The rate at which our tests are covered and reimbursed has, and
is expected to continue to vary by payer. Revenue growth depends on our ability to maintain Medicare and third party payer
reimbursement, and to expand utilization by healthcare providers.
PAMA included a substantial new payment system for clinical laboratory tests under the CLFS. Under PAMA, laboratories that
receive the majority of their Medicare revenues from payments made under the CLFS would report initially and then on a
subsequent three-year basis thereafter (or annually for ADLTs), private payer payment rates and volumes for their tests. The
final PAMA ruling was issued June 17, 2016 indicating that data for reporting for the new PAMA process would begin in 2017
and the new market based rates took effect on January 1, 2018. Effective January 1, 2018, Medicare reimburses us $3,240 for
AlloMap Heart testing of Medicare beneficiaries, an increase from the 2017 reimbursement rate of $2,841. The CARES Act
freezes current (2020) CMS CLFS rates through 2021. Further, the CARES Act delays the reporting cycle under PAMA to
January 1 and March 31, 2025, and the preceding data collection period will become January 1 through June 30, 2024.
AlloMap Heart has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers,
including Aetna, Anthem, Cigna, HCSC, Humana, Kaiser Foundation Health Plan, Inc., several BCBS plans and
UnitedHealthcare.
69 Reimbursement for AlloSure Kidney
On September 26, 2017, we received notice that the MolDX Program developed by Palmetto GBA had set AlloSure Kidney
reimbursement at $2,841. Effective October 9, 2017, AlloSure Kidney was made available for commercial testing with
Medicare coverage and reimbursement. We believe the use of AlloSure Kidney, in conjunction with other clinical indicators,
can help healthcare providers and their patients better manage long-term care following a kidney transplant. In particular, we
believe AlloSure Kidney can improve patient care by helping healthcare providers to reduce the use of invasive biopsies and
determine the appropriate dosage levels of immunosuppressants.
Reimbursement for AlloSure Heart
In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, our Medicare Administrative contractor, issued a parallel coverage policy
granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare
reimbursement rate for AlloSure Heart is currently $2,753.
Continued Growth of Product Sales
We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better
match between a donor and a recipient of stem cells and solid organs.
QTYPE enables speed and precision in HLA typing at a low to intermediate resolution for samples that require a fast turn-
around-time and uses real-time polymerase chain reaction, or PCR, methodology. QTYPE received CE mark certification on
April 10, 2018. Olerup SSP is used to type HLA alleles based on the SSP technology. Olerup SBT is a complete product range
for sequence-based typing of HLA alleles.
On May 4, 2018, we entered into the Illumina Agreement, which provides us with worldwide distribution, development and
commercialization rights to Illumina’s NGS product line for use in transplantation diagnostic testing. As a result, on June 1,
2018, we became the exclusive worldwide distributor of Illumina’s TruSight HLA product line. TruSight HLA is a high-
resolution solution that uses NGS methodology. In addition, we were granted the exclusive right to develop and commercialize
other NGS product lines for use in the field of bone marrow and solid organ transplantation diagnostic testing. These NGS
products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeq cfDNA, our surveillance solution designed to
measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, a NGS solution for chimerism
testing for stem cell transplant recipients.
In September 2019, we commercially launched AlloSeq cfDNA, our surveillance solution designed to measure dd-cfDNA in
blood to detect active rejection in transplant recipients, and we received CE mark authorization on January 20, 2020. Our ability
to increase the clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including local clinical education,
customer lab technical proficiency and levels of country-specific reimbursement.
Also in September 2019, we commercially launched AlloSeq Tx, the first of its kind NGS high-resolution HLA typing solution
utilizing hybrid capture technology. This technology enables the most comprehensive sequencing, covering more of the HLA
genes than current solutions and adding coverage of non-HLA genes that may impact transplant patient matching and
management. AlloSeq Tx has a simple NGS workflow that reduces complexity and can reduce errors. AlloSeq Tx 17 received
CE mark authorization on May 15, 2020.
In June 2020, we commercially launched AlloSeq HCT, a NGS solution for chimerism testing for stem cell transplant
recipients. This technology can provide better sensitivity and data analysis compared to current solutions on the market.
Continued Growth of Digital Sales
The growth of our digital revenues is tied to the continued successful implementation of our Ottr and XynQAPI software
businesses, as well as continued support and maintenance of existing Ottr, Inc. and XynManagement customers. The Ottr
software and XynQAPI are currently implemented in multiple locations in the U.S. The Ottr software implementation and
XynQAPI implementation and support teams are based in Omaha, Nebraska.
Development of Additional Services and Products
Our development pipeline includes other transplant diagnostic solutions to help clinicians and transplant centers make
personalized treatment decisions throughout a transplant patient’s lifetime. We expect to invest in research and development in
order to develop additional products. Our success in developing new products and services will be important in our efforts to
grow our business by expanding the potential market for our services and products and diversifying our sources of revenue.
70 Timing of Research and Development Expenses
Our spending on research and development may vary substantially from quarter to quarter. We conduct clinical studies to
validate our new products, as well as on-going clinical and outcome studies to further the published evidence to support our
commercialized tests. Spending on research and development for both experiments and studies may vary significantly by
quarter depending on the timing of these various expenses.
Results of Operations
Comparison of the Years Ended December 31, 2020 and 2019
(In thousands)
Revenue:
Testing services revenue
Product revenue
Digital and other revenue
Total revenue
Operating expenses:
Cost of testing services
Cost of product
Cost of digital and other
Research and development
Sales and marketing
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Interest income (expense), net
Change in estimated fair value of common stock
warrant liabilities
CARES Act Provider Relief Fund
Other expense, net
Total other income
Loss before income taxes
Income tax benefit
Net loss
Testing Services Revenue
Year Ended December 31,
2020
2019
Change
$
163,610 $
19,302
9,282
192,194
104,550 $
18,279
4,239
127,068
43,932
13,847
5,338
48,941
53,858
48,806
214,722
(22,528)
29,622
12,919
2,914
30,711
38,894
36,540
151,600
(24,532)
59,060
1,023
5,043
65,126
14,310
928
2,424
18,230
14,964
12,266
63,122
2,004
271
985
(714)
(1,495)
4,813
(811)
2,778
(19,750)
1,036
(18,714) $
319
—
(719)
585
(23,947)
1,979
(21,968) $
(1,814)
4,813
(92)
2,193
4,197
(943)
3,254
$
Testing services revenue increased by $59.1 million, or 56%, for the year ended December 31, 2020, compared to the same
period in 2019. This increase is primarily due to an increase of more than 29,000 AlloSure Kidney, AlloMap Heart and
AlloSure Heart patient results provided during the year ended December 31, 2020, compared to the year ended December 31,
2019.
Product Revenue
Product revenue increased by $1.0 million, or 6%, for the year ended December 31, 2020, compared to the same period in 2019.
Our product business was impacted by a reduction in forecasted sales volume throughout the second and third quarters of 2020
due to COVID-19, as there were delays in onsite discussions and demonstrations of recently launched NGS products, including
AlloSeq Tx 17, which was awarded CE mark authorization in May 2020. Sales volumes began to recover in the fourth quarter
of 2020.
71 Digital and Other Revenue
Digital and other revenue increased by $5.0 million, or 119%, during the year ended December 31, 2020, compared to the year
ended December 31, 2019, primarily due to the new Ottr software implementations and our acquisitions of Ottr, Inc. in May
2019 and XynManagement in August 2019.
Cost of Testing Services
Cost of testing services increased by $14.3 million, or 48%, for the year ended December 31, 2020, compared to the year ended
December 31, 2019, primarily due to an increase in testing volume, the cost of providing RemoTraC and increased utilization of
mobile phlebotomy.
Cost of Product
Cost of product increased by $0.9 million, or 7%, for the year ended December 31, 2020, compared to the year ended
December 31, 2019. The increase is primarily due to increased sales and amortization of intangibles.
Cost of Digital and Other
Cost of digital and other increased by $2.4 million, or 83%, for the year ended December 31, 2020, compared to the year ended
December 31, 2019, primarily due to the acquisitions of Ottr, Inc. in May 2019 and XynManagement in August 2019.
Research and Development
Research and development expenses increased by $18.2 million, or 59%, for the year ended December 31, 2020, compared to
the year ended December 31, 2019, primarily due to an increase in personnel-related costs of $7.8 million, an increase of $4.8
million in clinical studies, an increase in consulting and outside service fees of $2.7 million, an increase in reagents and
consumables of $2.4 million and an increase in license and collaboration fees of $1.1 million, partially offset by lower travel
costs of $0.4 million.
Sales and Marketing
Sales and marketing expenses increased by approximately $15.0 million, or 38%, for the year ended December 31, 2020,
compared to the year ended December 31, 2019, primarily due to an increase in personnel-related costs of $9.9 million, stock-
based compensation expense of $1.8 million, $1.8 million of speaker programs and sponsorships and consulting and outside
service fees of $1.1 million.
General and Administrative
General and administrative expenses increased by $12.3 million, or 34%, for the year ended December 31, 2020, compared to
the year ended December 31, 2019. This increase was primarily due to legal fees of $6.0 million related to litigation and general
legal expenses, an increase of $4.5 million in personnel-related costs, an increase of $2.1 million of consulting and outside
service fees and $0.5 million of software expense, partially offset by lower stock-based compensation expense of $1.2 million.
Change in Estimated Fair Value of Common Stock Warrant Liability
The change in estimated fair value of common stock warrant liability decreased from income of $0.3 million for the year ended
December 31, 2019 to an expense of $1.5 million for the year ended December 31, 2020, resulting in a net change of $1.8
million.
The $1.5 million expense in the year ended December 31, 2020 reflects a remeasurement gain of $6.2 million for the change in
the fair value of our common stock warrant liability and a remeasurement charge of $7.7 million for warrants exercised during
the year. In the year ended December 31, 2020, warrants to purchase approximately 314,000 shares of common stock with an
average exercise price of $1.12 per share were exercised.
The expense for the change in estimated fair value of common stock warrants decreased by $23.3 million, or 101%, for the year
ended December 31, 2019, compared to the same period in 2018. The income in 2019 was $0.3 million, comprised of a $3.4
million remeasurement gain related to the change in fair value of our common stock warrant liability, partially offset by a $3.1
million remeasurement charge for warrants exercised during the period.
CARES Act Provider Relief Fund
The CARES Act Provider Relief Fund increased by $4.8 million, or 100%, for the year ended December 31, 2020, compared to
the year ended December 31, 2019, primarily due to the CARES Act payment we received in April 2020.
72 Income Tax Benefit
For the year ended December 31, 2020, we recorded an income tax benefit of $1.0 million on a loss before income taxes of
$19.8 million primarily attributable to the recognition of deferred tax assets from foreign losses and recognition of previous
unrecognized tax benefits. The effective tax rate for the year ended December 31, 2020 differs from the federal statutory tax
rate as a result of the income tax expense related to non-deductible executive compensation and the increase in valuation
allowance.
For the year ended December 31, 2019, we recorded an income tax benefit of $2.0 million on a loss before income taxes of
$23.9 million primarily attributable to the recognition of deferred tax assets from foreign losses and recognition of previous
unrecognized tax benefits. The effective tax rate for the year ended December 31, 2019 differs from the federal statutory tax
rate as a result of the income tax expense related to non-deductible executive compensation and the increase in valuation
allowance.
Comparison of the Years Ended December 31, 2019 and 2018
For a discussion regarding our financial condition and results of operations for the year ended December 31, 2019 as compared
to the year ended December 31, 2018, please refer to the discussion under the heading “Results of Operations—Comparison of
the Ended December 31, 2019 and 2018” in Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31,
2019, filed with the SEC on February 28, 2020.
Liquidity and Capital Resources
We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit
of $352.5 million at December 31, 2020. As of December 31, 2020, we had cash, cash equivalents and marketable securities of
$224.7 million, and no debt outstanding.
The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the
potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread
pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could in
the future negatively affect our liquidity.
Since March 31, 2020, and in response to the outbreak of the COVID-19 pandemic, we have increased our cash and cash
equivalents. With our continuing growth, we may require additional financing in the future to fund working capital and our
future products developments. Additional financing might include issuance of equity securities, including through underwritten
public offerings or “at-the-market” offerings, debt offerings or financings or a combination of these financings. There can be no
assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms
favorable to us. We believe our existing cash balance and expected cash from existing operations, including cash from current
license agreements and future license and collaboration agreements, or a combination of these, will be sufficient to meet our
anticipated cash requirements for the next 12 months, as well as beyond the next 12 months.
CMS Accelerated and Advance Payment Program for Medicare Providers
On March 27, 2020, the U.S. government enacted the CARES Act. Pursuant to the CARES Act, CMS expanded its current
Accelerated and Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by
the COVID-19 pandemic. CMS was authorized to provide accelerated or advance payments during the period of the public
health emergency to any Medicare provider who submits a request to the appropriate Medicare Administrative Contractor and
meets the required qualifications. During April 2020, we received an advance payment from CMS of approximately
$20.5 million and recorded the payment as Deferred revenue - CMS advance payment on our consolidated balance sheet.
During December 2020, we reassessed the Deferred revenue - CMS advance payment and determined to repay the entire
amount in January 2021. We recorded the amount as Refund liability - CMS advance payment on the consolidated balance
sheet as of December 31, 2020. On January 19, 2021, we repaid the CMS advance payment of approximately $20.5 million to
CMS in full.
At-the-Market Equity Offering
On August 31, 2018, we entered into a sales agreement, or the Sales Agreement, with Jefferies, LLC, or Jefferies, as sales
agent, pursuant to which we may offer and sell, from time to time, through Jefferies, up to $50.0 million in shares of our
common stock, by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated
under the Securities Act of 1933, as amended. During April 2020, we issued and sold 1,000,000 shares of our common stock
under the Sales Agreement. The shares were sold at an average price of $24.24 per share for aggregate net proceeds to us of
approximately $23.5 million, after deducting sales commissions and offering costs payable by us.
73 CARES Act Provider Relief Fund for Medicare Providers
Pursuant to the CARES Act, the U.S. Department of Health & Human Services, or HHS, distributed an initial tranche of
$30.0 billion in funds to healthcare providers that received Medicare fee-for-service, or FFS, reimbursements in 2019. These
payments to healthcare providers are not loans and will not be required to be repaid. As a condition to receiving these
payments, providers must agree to certain terms and conditions and submit sufficient documentation demonstrating that the
funds are being used for healthcare-related expenses or lost revenue attributable to the COVID-19 pandemic. Due to the recent
enactment of legislation and absence of definitive guidance, there is a high degree of uncertainty around the CARES Act’s
implementation and we continue to assess the impact on our business. Furthermore, HHS has indicated that it, along with the
Office of Inspector General, will be closely monitoring and auditing providers to ensure that recipients comply with the terms
and conditions of relief programs and to prevent fraud and abuse. All providers will be subject to civil and criminal penalties for
any deliberate omissions, misrepresentations or falsifications of any information given to HHS. Providers will be distributed a
portion of the initial $30.0 billion of funds based on their share of total Medicare FFS reimbursements made by the U.S. in
2019. During April 2020, we received a payment of approximately $4.8 million, representing our portion of the initial tranche
of funds, recorded in other income (expense), net on the consolidated statement of operations.
Underwritten Public Offering of Common Stock
On June 15, 2020, we sold 4,492,187 shares of common stock (which included shares sold pursuant to the underwriters’ full
exercise of an overallotment option granted to the underwriters in connection with the offering) through an underwritten public
offering at a price of $32.00 per share for aggregate net proceeds of $134.6 million.
Public Offering of Common Stock
On January 25, 2021, we sold 1,923,077 shares of our common stock through an underwritten public offering at a public
offering price of $91.00 per share. The net proceeds to us from the offering were approximately $164.0 million, after deducting
underwriting discounts and commissions and estimated offering expenses.
On February 11, 2021, we sold 288,461 shares of our common stock pursuant to the underwriters' full exercise of an
overallotment option granted to the underwriters in connection with the offering. The net proceeds to us from the full exercise
of the underwriters' overallotment option were approximately $24.7 million. The aggregate net proceeds to us, including shares
sold pursuant to the underwriters' full exercise of the overallotment option, were approximately $188.7 million, after deducting
underwriting discounts and commissions and estimated offering expenses.
Cash Flows
The following table summarizes our cash flows for the years ended December 31, 2020, 2019 and 2018:
Year Ended December 31,
2020
2019
2018
(in thousands)
Net cash provided by (used in):
Operating activities
Investing activities
Financing activities
$
33,431 $
(2,769) $
(100,394)
163,149
(22,579)
(132)
Effect of exchange rate changes on cash, cash equivalents and restricted cash
Net increase (decrease) in cash, cash equivalents and restricted cash
$
274
96,460 $
(849)
(26,329) $
(4,007)
(7,929)
50,268
2
38,334
Cash Flows from Operating Activities
Net cash provided by (used in) operating activities consists of net loss, adjusted for certain noncash items in the consolidated
statements of operations and changes in operating assets and liabilities.
Net cash provided by operating activities for the year ended December 31, 2020 was $33.4 million. Our net loss of $18.7
million was our primary use of cash in operating activities and included $4.8 million of cash provided by the CARES Act
Provider Relief Fund. Our net loss also included the following noncash items: $23.4 million in stock-based compensation
expense, $7.0 million of depreciation and amortization expense, amortization of right-of-use assets of $2.5 million and a $1.5
million loss on the revaluation of common stock warrant liability to estimated fair value. Net operating assets decreased by $3.1
million, offset by an increase in Refund liability - CMS advance payment of $20.5 million.
74 Net cash used in operating activities for the year ended December 31, 2019 was $2.8 million. Our net loss of $22.0 million was
our primary use of cash in operating activities and included the following noncash items: $22.4 million stock-based
compensation expense, $5.5 million of depreciation and amortization expense, $1.6 million non-cash lease expense and other
miscellaneous items totaling $0.1 million. Net operating assets and liabilities decreased by $10.4 million.
Cash Flows from Investing Activities
For the year ended December 31, 2020, net cash used in investing activities was $100.4 million and consisted of $90.0 million
related to the purchase of marketable securities, $7.1 million related to additions of capital expenditures, net, $2.0 million
related to payments for the license and commercialization agreement with Cibiltech and $1.3 million related to payments for
acquired intangibles.
For the year ended December 31, 2019, net cash used in investing activities was $22.6 million and consisted of $18.2 million
for the acquisition of Ottr, Inc. and XynManagement, $2.2 million related to additions of capital expenditures, $1.2 million
related to the acquisition of intangible assets, and $1.0 million related to our investment in equity securities.
Cash Flows from Financing Activities
Net cash provided by financing activities for the year ended December 31, 2020 was $163.1 million and primarily related to
$134.7 million of proceeds from the issuance of shares of common stock in an underwritten offering, net of issuance costs,
$23.5 million of proceeds from the issuance of shares of common stock in an “at-the-market” equity offering, net of issuance
costs, proceeds from exercises of stock options of $8.0 million, proceeds from issuances of shares of common stock under our
employee stock purchase plan of $1.4 million and proceeds from exercises of warrants of $0.4 million. These proceeds were
partially offset by taxes paid related to net share settlements of restricted stock units of $4.5 million.
Net cash used by financing activities for the year ended December 31, 2019 was $0.1 million and primarily related to $4.2
million of taxes paid related to the net share settlement of restricted stock units and other miscellaneous payments totaling $0.3
million, offset by $3.6 million cash proceeds from the exercise of stock options, and $0.8 million cash proceeds from issuance
of common stock under employee stock purchase plan.
For a discussion regarding our cash flows for the year ended December 31, 2018, please refer to the discussion under the
heading “Results of Operations—Liquidity and Capital Resources” in Item 7 of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, filed with the SEC on February 28, 2020.
Contractual Obligations
For a discussion regarding our significant contractual obligations as of December 31, 2020 and the effect those obligations are
expected to have on our liquidity and cash flows in future periods, please refer to Note 9 of the consolidated financial
statements, and “Results of Operations—Liquidity and Capital Resources”, respectively, included elsewhere in this Annual
Report on Form 10-K.
Off-Balance Sheet Arrangements
Not required.
Foreign Operations
The accompanying consolidated balance sheets contain certain recorded assets in foreign countries, namely Sweden, Austria
and Australia. Although these countries are considered economically stable and we have experienced no notable burden from
foreign exchange transactions, export duties or government regulations, unanticipated events in foreign countries could have a
material adverse effect on our operations.
75 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
We are exposed to market risks in the ordinary course of our business. We had cash, cash equivalents and marketable securities
of $224.7 million and $38.2 million at December 31, 2020 and December 31, 2019, respectively, which consisted of bank
deposits, money market funds and corporate debt securities. However, we have not been exposed to, nor do we anticipate being
exposed to, material risks due to changes in interest rates. A hypothetical 100 basis point increase or decrease in interest rates
during any of the periods presented would have an approximate impact of $2.2 million on our consolidated financial statements.
Foreign Currency Exchange Risk
We have operations in Sweden, Austria and Australia and sell to other countries throughout the world. As a result, we are
subject to significant foreign currency risks, including transacting in foreign currencies, investment in a foreign entity, as well
as assets and debts denominated in foreign currencies. Our testing services revenue is primarily denominated in U.S. dollars.
Our product revenue is denominated primarily in U.S. dollars and the Euro. Consequently, our revenue denominated in foreign
currency is subject to foreign currency exchange risk. A portion of our operating expenses are incurred outside of the U.S. and
are denominated in Swedish Krona, the Euro, and the Australian dollar, which are also subject to fluctuations due to changes in
foreign currency exchange rates. An unfavorable 10% change in foreign currency exchange rates for our assets and liabilities
denominated in foreign currencies at December 31, 2020, would have negatively impacted our financial results for the year
ended December 31, 2020 by $0.3 million and our product revenue by $1.0 million. Currently, we do not have any near-term
plans to enter into a formal hedging program to mitigate the effects of foreign currency volatility. We will continue to reassess
our approach to managing our risk relating to fluctuations in foreign currency exchange rates.
76 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
CareDx, Inc.
Index to Consolidated Financial Statements
Reports of Independent Registered Public Accounting Firms
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Page No.
78
81
82
83
84
85
86
77 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of CareDx, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of CareDx, Inc. and subsidiaries (the "Company") as of
December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive loss, convertible preferred
stock and stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2020, and the
related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and
its cash flows for each of the three years in the period ended December 31, 2020, in conformity with accounting principles
generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the Company's internal control over financial reporting as of December 31, 2020, based on criteria established in
Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated February 24, 2021, expressed an unqualified opinion on the Company's internal control over
financial reporting.
Change in Accounting Principles
As discussed in Note 2 to the consolidated financial statements, the Company has changed its method of accounting for leases
in fiscal year 2019 due to the adoption of Accounting Standards Codification Topic 842, Leases.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on
the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to
error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial
statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included
examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that
was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that
are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The
communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and
we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the
accounts or disclosures to which it relates.
Revenue Recognition – Testing Services Revenue – Refer to Note 2 to the consolidated financial statements
Critical Audit Matter Description
During the year ended December 31, 2020, the Company’s revenue from testing services was $163.6 million. As discussed in
Note 2, the Company’s testing services revenue is recognized upon the delivery of test results to the prescribing physician, at
which time the Company bills for its services. The Company recognizes revenue related to billings based on transaction prices
estimated as the amount that will ultimately be realized.
The transaction price estimate represents differences between amounts billed and the estimated consideration the Company
expects to receive based on historical collection experience and other anticipated adjustments, including anticipated payer
denials. In determining the amount to recognize for a delivered test, the Company considers factors such as payment history,
amount collected per test, payer coverage, and whether there is a reimbursement contract between the payer and the Company.
The Company also considers whether historical collections per test are indicative of future collections or if there are any current
or expected developments or changes that could affect reimbursement rates, which is an estimate that requires significant
judgment by the Company.
78 We identified management’s estimation of the transaction price for revenue recorded as a critical audit matter due to the
significant judgments required by management to estimate payer behavior. This required a high degree of auditor judgment and
an increased extent of effort, including the involvement of more experienced engagement team members, when performing
audit procedures to evaluate the estimated transaction prices.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to management judgments in the estimate of transaction prices for testing services revenue,
included the following, among others:
• We understood and tested the design, implementation, and operating effectiveness of controls over management’s
determination of the assumptions used and the related review and approval of the transaction price estimate.
• We tested the methodology used by the Company to estimate transaction prices.
• We tested the assumptions used by management to calculate transaction prices by:
•
•
•
•
Testing the mathematical accuracy of management’s calculation.
Testing the historical cash receipts from payers used in the estimate of transaction prices, by making
selections and agreeing the selected information to source documents.
Testing management’s ability to estimate transaction prices accurately by comparing recorded revenue to cash
receipts received through December 2020.
Evaluating trends in revenue and accounts receivable compared to previous periods to identify any evidence
that may contradict management’s assertion regarding estimated transaction price.
/s/ Deloitte & Touche LLP
San Jose, California
February 24, 2021
We have served as the Company's auditor since 2018.
79 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of CareDx, Inc.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of CareDx, Inc. and subsidiaries (the “Company”) as of December
31, 2020, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material
respects, effective internal control over financial reporting as of December 31, 2020, based on criteria established in Internal
Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the consolidated financial statements as of and for the year ended December 31, 2020, of the Company and our
report dated February 24, 2021, expressed an unqualified opinion on those financial statements and included an explanatory
paragraph related to the Company’s change in method of accounting for leases in fiscal year 2019 due to the adoption of
Accounting Standards Codification (ASC) Topic 842, Leases.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s
Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s
internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk
that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the
assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit
provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures
that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and
dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with authorizations of management and directors of the
company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or
disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Deloitte & Touche LLP
San Jose, California
February 24, 2021
80 CareDx, Inc.
Consolidated Balance Sheets
(In thousands, except share data)
Assets
Current assets:
Cash and cash equivalents
Marketable securities
Accounts receivable
Inventory
Prepaid and other current assets
Total current assets
Property and equipment, net
Operating leases right-of-use assets
Intangible assets, net
Goodwill
Restricted cash
Other assets
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued compensation
Accrued and other liabilities
Refund liability - CMS advance payment (Note 1)
Total current liabilities
Deferred tax liability
Common stock warrant liability
Deferred payments for intangible assets
Operating lease liability, less current portion
Other liabilities
Total liabilities
Commitments and contingencies (Note 9)
Stockholders’ equity:
$
$
$
As of December 31,
2020
2019
134,669 $
90,034
34,624
10,012
3,758
273,097
10,704
15,228
44,355
23,857
270
1,000
368,511 $
9,653 $
18,466
20,602
20,496
69,217
1,299
447
3,560
16,069
240
90,832
38,223
—
24,057
6,014
3,628
71,922
4,430
4,730
45,541
23,857
256
1,000
151,736
5,506
12,484
16,838
—
34,828
1,973
6,607
5,207
2,370
1,751
52,736
Preferred stock: $0.001 par value; 10,000,000 shares authorized at December 31, 2020 and 2019;
no shares issued and outstanding at December 31, 2020 and 2019
—
—
Common stock: $0.001 par value; 100,000,000 shares authorized at December 31, 2020 and 2019;
49,441,166 and 42,498,430 shares issued and outstanding at December 31, 2020 and 2019,
respectively
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
49
632,253
(2,096)
(352,527)
277,679
368,511 $
42
437,976
(5,205)
(333,813)
99,000
151,736
$
The accompanying notes are an integral part of these consolidated financial statements.
81 CareDx, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share data)
Year Ended December 31,
2020
2019
2018
Revenue:
Testing services revenue
Product revenue
Digital and other revenue
Total revenue
Operating expenses:
Cost of testing services
Cost of product
Cost of digital and other
Research and development
Sales and marketing
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Interest income (expense), net
Debt extinguishment expenses
Change in estimated fair value of common stock warrant and derivative
liabilities
CARES Act Provider Relief Fund
Other expense, net
Total other income (expense)
Loss before income taxes
Income tax benefit
Net loss
Net loss attributable to noncontrolling interest
Net loss attributable to CareDx, Inc.
Net loss per share attributable to CareDx, Inc. (Note 3):
Basic
Diluted
Weighted-average shares used to compute net loss per share attributable to
CareDx, Inc.:
Basic
Diluted
$
163,610 $
104,550 $
19,302
9,282
18,279
4,239
192,194
127,068
43,932
13,847
5,338
48,941
53,858
48,806
29,622
12,919
2,914
30,711
38,894
36,540
214,722
(22,528)
151,600
(24,532)
271
—
(1,495)
4,813
(811)
2,778
985
—
319
—
(719)
585
(19,750)
(23,947)
1,036
1,979
60,300
15,674
595
76,569
21,456
11,531
—
14,514
21,670
22,976
92,147
(15,578)
(3,701)
(5,780)
(22,978)
—
(178)
(32,637)
(48,215)
1,434
(18,714)
(21,968)
(46,781)
—
—
(25)
$
(18,714) $
(21,968) $
(46,756)
$
$
(0.40) $
(0.40) $
(0.52) $
(0.52) $
(1.31)
(1.31)
46,481,772
42,151,617
35,638,956
46,481,772
42,151,617
35,638,956
The accompanying notes are an integral part of these consolidated financial statements.
82 CareDx, Inc.
Consolidated Statements of Comprehensive Loss
(In thousands)
Year ended December 31,
2020
2019
2018
$
(18,714) $
(21,968) $
(46,781)
Net loss
Other comprehensive loss:
Foreign currency translation adjustments, net of tax
Net comprehensive loss
Comprehensive loss attributable to noncontrolling interest, net of tax
3,109
(927)
(15,605)
(22,895)
—
—
(1,933)
(48,714)
(25)
Comprehensive loss attributable to CareDx, Inc.
$
(15,605) $
(22,895) $
(48,689)
The accompanying notes are an integral part of these consolidated financial statements.
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e
h
T
84
CareDx, Inc.
Consolidated Statements of Cash Flows
(In thousands)
Year Ended December 31,
2019
2018
2020
$
(18,714) $
(21,968) $
(46,781)
Operating activities:
Net loss
Adjustments to reconcile net loss to net cash provided by (used in) operating
activities:
Stock-based compensation
Amortization of inventory fair market value adjustment
Loss on disposal of property and equipment
Depreciation and amortization
Amortization of right-of-use assets
Revaluation of warrants and derivative liabilities to estimated fair value
Revaluation of contingent consideration to estimated fair value
Amortization of debt discount and noncash interest expense
Debt extinguishment expenses
Changes in operating assets and liabilities:
Accounts receivable
Inventory
Prepaid and other assets
Accounts payable
Accrued compensation
Accrued and other liabilities
Operating lease liabilities, net
Refund liability - CMS advance payment
Change in deferred taxes
Net cash provided by (used in) operating activities
Investing activities:
Purchases of marketable securities
Additions of capital expenditures, net
Acquisition of intangible assets
Acquisition of business
Investment in equity securities
23,401
—
—
7,006
2,538
1,495
309
—
—
(10,402)
(3,196)
(41)
4,389
5,737
2,911
(1,475)
20,496
(1,023)
33,431
(90,034)
(7,110)
(3,250)
—
—
Net cash used in investing activities
(100,394)
Financing activities:
Proceeds from issuance of common shares in public equity offering, net of
issuance costs paid
Proceeds from issuance of common shares in "at-the-market" equity
offering, net of issuance costs paid
Proceeds from debt, net of issuance costs
Principal payments on debt and finance lease obligations
Contingent payments related to acquisition of Conexio Genomics Pty Ltd.
Change in short-term credit facility
Proceeds from exercise of warrants
Proceeds from exercise of stock options
Proceeds from issuance of common stock under employee stock purchase plan
Taxes paid related to net share settlement of restricted stock units
Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
Net increase (decrease) in cash, cash equivalents and restricted cash
Cash, cash equivalents, and restricted cash at beginning of period
Cash, cash equivalents, and restricted cash at end of period
Supplemental disclosures of cash information
Cash paid for interest
Cash paid for income taxes
Supplemental disclosures of cash flow information
Shares issued in lieu of payment
Deferred payments for intangible assets
Operating lease right-of-use assets
Purchases of capital expenditures in accounts payable and accrued liabilities
Issuance of common stock upon conversion of convertible debt
Offering costs included in accounts payable
ESPP shares included in accrued compensation
Common stock warrants issued upon debt financing
Contingent consideration
134,684
23,451
—
(183)
—
—
352
8,006
1,368
(4,529)
163,149
274
96,460
38,479
134,939 $
10
80
$
$
315
$
— $
$
55
$
274
— $
— $
800
$
— $
— $
$
$
$
$
$
$
$
$
$
$
$
$
22,417
—
160
5,523
1,621
(319)
210
—
—
(12,675)
(1,270)
(829)
1,351
3,115
3,029
(1,854)
—
(1,280)
(2,769)
—
(2,201)
(1,148)
(18,230)
(1,000)
(22,579)
—
—
—
(172)
(225)
—
105
3,553
760
(4,153)
(132)
(849)
(26,329)
64,808
38,479 $
22
$
— $
$
209
$
7,207
$
6,138
$
576
— $
— $
703
$
— $
$
1,442
7,138
234
—
4,215
—
22,978
1,017
2,232
5,831
(3,967)
363
(502)
(168)
4,291
719
—
—
(1,607)
(4,007)
—
(2,035)
(5,202)
(692)
—
(7,929)
52,910
—
14,282
(28,089)
(225)
(677)
10,998
1,480
287
(698)
50,268
2
38,334
26,474
64,808
1,774
—
—
—
—
—
38,852
361
341
784
2,689
The accompanying notes are an integral part of these consolidated financial statements.
85 CareDx, Inc.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
CareDx, Inc. (“CareDx” or the “Company”) together with its subsidiaries, is a leading precision medicine company focused on
the discovery, development and commercialization of clinically differentiated, high-value healthcare diagnostic solutions for
transplant patients and caregivers. The Company’s headquarters are in South San Francisco, California. The primary operations
are in Brisbane, California; Omaha, Nebraska; Fremantle, Australia and Stockholm, Sweden.
The Company’s commercially available testing services consist of AlloSure® Kidney, which is a donor-derived cell-free DNA
(“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, which is a gene expression solution for heart transplant
patients, and AlloSure® Heart, a dd-cfDNA test which can identify underlying cell injury leading to organ rejection. The
Company has initiated several clinical studies to generate data on its existing and planned future testing services. In April 2020,
the Company announced its first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of
engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants. The Company also
offers high quality products that increase the chance of successful transplants by facilitating a better match between a donor and
a recipient of stem cells and organs. In 2019, the Company began providing digital solutions to transplant centers following the
acquisitions of Ottr Complete Transplant Management (“Ottr, Inc.”) and XynManagement, Inc. (“XynManagement”).
Testing Services
AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017. The Medicare reimbursement rate
for AlloSure Kidney is currently $2,841. AlloSure Kidney has received positive coverage decisions from Blue Cross Blue
Shield (“BCBS”) of South Carolina, BCBS of Kansas City and Capital Health, and is reimbursed by other private payers on a
case-by-case basis.
AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for
AlloMap Heart is currently $3,240. AlloMap Heart has also received positive coverage decisions for reimbursement from many
of the largest U.S. private payers, including Aetna, Cigna, Health Care Services Corporation, Humana, Kaiser Foundation
Health Plan, Inc. and UnitedHealthcare.
In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In
November 2020, Noridian Healthcare Solutions, the Company's Medicare Administrative contractor, issued a parallel coverage
policy granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The
Medicare reimbursement rate for AlloSure Heart is currently $2,753.
Clinical Studies
In January 2018, the Company initiated the Kidney Allograft Outcomes AlloSure Kidney Registry study (“K-OAR”), to
develop additional data on the clinical utility of AlloSure Kidney for surveillance of kidney transplant recipients. K-OAR is a
multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,700 renal transplant patients
who will receive AlloSure Kidney long-term surveillance.
In September 2018, the Company initiated the Surveillance HeartCare™ Outcomes Registry (“SHORE”). SHORE is a
prospective, multi-center, observational registry of patients receiving HeartCare for surveillance. HeartCare combines the gene
expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure® Heart in one surveillance solution.
In February 2019, AlloSure® Lung became available for lung transplant patients through a compassionate use program while
the test is undergoing further studies. In June 2020, the Company submitted an AlloSure Lung application to the Palmetto
MolDx Technical Assessment program seeking coverage and reimbursement for Medicare beneficiaries.
In September 2019, the Company announced the commencement of the Outcomes of KidneyCare on Renal Allografts
(“OKRA”) study, which is an extension of K-OAR. OKRA is a prospective, multi-center, observational, registry of patients
receiving KidneyCare for surveillance. KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene
expression profiling technology of AlloMap Kidney and the predictive artificial intelligence technology of KidneyCare iBox
developing a multimodality surveillance solution. The Company has not yet made any applications to private payers for
reimbursement coverage of AlloMap Kidney or KidneyCare iBox. Enrollment for OKRA was negatively affected by the
COVID-19 restrictions during the year 2020, and the study has been delayed by six months; however, the collection of samples
are at normal levels as a result of the introduction of RemoTraC.
86 Products
The Company’s suite of AlloSeq products are commercial next generation sequencing (“NGS”)-based kitted solutions that the
Company has developed as a result of its license agreement with Illumina, Inc. (“Illumina”). These products include: AlloSeq™
Tx, a high-resolution Human Leukocyte Antigen (“HLA”) typing solution, AlloSeq™ cfDNA, a surveillance solution designed
to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq™ HCT, a solution for chimerism
testing for stem cell transplant recipients.
The Company's other HLA typing products include: TruSight HLA, a NGS-based high resolution typing solution; Olerup SSP®,
based on the sequence specific primer (“SSP”) technology; and QTYPE®, which uses real-time polymerase chain reaction
(“PCR”) methodology, to perform HLA typing at a low to intermediate resolution for samples that require a fast turnaround
time.
Digital and Other
Following the acquisitions of both Ottr, Inc. and XynManagement, the Company is a leading provider of transplant patient
tracking software (“Ottr software”), as well as of transplant quality tracking and waitlist management solutions. Ottr software
provides comprehensive solutions for transplant patient management and enables integration with electronic medical record
("EMR") systems providing patient surveillance management tools and outcomes data to transplant centers. XynManagement
provides two unique solutions, XynQAPI software (“XynQAPI”) and XynCare. XynQAPI simplifies transplant quality tracking
and Scientific Registry of Transplant Recipients (“SRTR”) reporting. XynCare includes a team of transplant assistants who
maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility.
In September 2020, the Company launched AlloCare, a mobile app that provides a patient-centric resource for transplant
recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health
metrics.
COVID-19 Pandemic
On January 30, 2020, the World Health Organization (the “WHO”) announced a global health emergency because of a new
strain of coronavirus (“COVID-19”) originating in Wuhan, China and the risks to the international community as the virus
spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based
on the rapid increase in exposure globally. The full impact of the COVID-19 pandemic, including the impact associated with
preventative and precautionary measures that the Company, other businesses and governments are taking, continues to evolve
as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company, but
the pandemic may materially affect the Company's financial condition, liquidity and future results of operations.
In the final weeks of March and during April 2020, with hospitals increasingly caring for COVID-19 patients, hospital
administrators chose to limit or even defer, non-emergency procedures. Immunosuppressed transplant patients either self-
prescribed or were asked to avoid transplant centers and caregiver visits to reduce the risk of contracting COVID-19. As a
result, with transplant surveillance visits down, the Company experienced a slowdown in testing services volumes in the final
weeks of March and during April 2020. As a response to the COVID-19 pandemic, and to enable immune-compromised
transplant patients to continue to have their blood drawn, in late March 2020, the Company launched RemoTraC, a remote
home-based blood draw solution using mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other
standard monitoring tests. To date, more than 150 transplant centers can offer RemoTraC to their patients and over 6,000
kidney, heart and lung transplant patients have enrolled. Based on existing and new relationships with partners, the Company
has established a nationwide network of more than 10,000 mobile phlebotomists. Following the introduction of RemoTraC and
with the easing of stay-at-home restrictions and the opening up of many hospitals to non-COVID-19 patients, the Company’s
testing services volumes returned to levels consistent with those experienced immediately prior to the COVID-19 pandemic,
and through December 31, 2020, volumes continued to be at or above those levels since May 2020.
In spite of the resurgence of COVID-19 infection rates, which resulted in increased stay-at-home and renewed travel
restrictions, the Company did not experience a decrease in testing services volumes. The Company’s product business
experienced a reduction in forecasted sales volume throughout the second and third quarters of 2020, as it was unable to
undertake onsite discussions and demonstrations of its recently launched NGS products, including AlloSeq Tx 17, which was
awarded CE mark authorization in May 2020. The Company's product business maintained normal sales volumes during the
fourth quarter of 2020.
87 The Company is maintaining its testing, manufacturing, and distribution facilities while implementing specific protocols to
reduce contact among employees. In areas where COVID-19 impacts healthcare operations, the Company’s field-based sales
and clinical support teams are supporting providers through telephone and online platforms. In August 2020, the state of
California released revised criteria for loosening and tightening restrictions on certain activities on generally a county-by-
county basis. Under the updated executive orders, San Mateo County, where the Company's laboratory and headquarters are
located, continues to be subject to certain restrictions. These orders and others may be further modified, amended and adopted
depending upon the COVID-19 transmission rates in our county and state, as well as other factors.
In addition, the Company has created a COVID-19 task force that is responsible for crisis decision making, employee
communications, enforcing pre-arrival temperature checking, daily health check-ins and enhanced safety training/protocols in
its offices for employees that do not work from home.
Liquidity and Capital Resources
The Company has incurred significant losses and negative cash flows from operations since its inception and had an
accumulated deficit of $352.5 million at December 31, 2020. As of December 31, 2020, the Company had cash, cash
equivalents and marketable securities of $224.7 million.
On March 27, 2020 the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).
Pursuant to the CARES Act, the Centers for Medicare & Medicaid Services (“CMS”) expanded its current Accelerated and
Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by the COVID-19
pandemic. CMS is authorized to provide accelerated or advance payments during the period of the public health emergency to
any Medicare provider who submits a request to the appropriate Medicare Administrative Contractor and meets the required
qualifications. During April 2020, the Company received an advance payment from CMS of approximately $20.5 million, and
recorded the payment as Deferred revenue - CMS advance payment on the Company's consolidated balance sheet.
During December 2020, the Company reassessed the Deferred revenue - CMS advance payment and determined to repay the
entire amount in January 2021. The Company recorded the amount as Refund liability - CMS advance payment on the
consolidated balance sheet as of December 31, 2020. Refer to Note 8, Balance Sheet Components, for further explanation.
At-the-Market Equity Offering
On August 31, 2018, the Company entered into a sales agreement (the “Sales Agreement”) with Jefferies, LLC, as sales agent
(“Jefferies”), pursuant to which the Company may offer and sell, from time to time, through Jefferies, up to $50.0 million in
shares of its common stock, by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415
promulgated under the Securities Act of 1933, as amended. During April 2020, the Company issued and sold 1,000,000 shares
of its common stock under the Sales Agreement. The shares were sold at an average price of $24.24 per share for aggregate net
proceeds to the Company of approximately $23.5 million, after deducting sales commissions and offering costs payable by the
Company.
CARES Act Provider Relief Fund for Medicare Providers
Pursuant to the CARES Act, the U.S. Department of Health & Human Services (“HHS”) distributed an initial tranche of
$30.0 billion in funds to healthcare providers that received Medicare fee-for-service (“FFS”) reimbursements in 2019. These
payments to healthcare providers are not loans and will not be required to be repaid. As a condition to receiving these
payments, providers must agree to certain terms and conditions and submit sufficient documentation demonstrating that the
funds are being used for healthcare-related expenses or lost revenue attributable to the COVID-19 pandemic. Due to the recent
enactment of legislation and absence of definitive guidance, there is a high degree of uncertainty around the CARES Act’s
implementation and the Company continues to assess the impact on its business. Furthermore, HHS has indicated that it, along
with the Office of Inspector General, will be closely monitoring and auditing providers to ensure that recipients comply with the
terms and conditions of relief programs and to prevent fraud and abuse. All providers will be subject to civil and criminal
penalties for any deliberate omissions, misrepresentations or falsifications of any information given to HHS. Providers will be
distributed a portion of the initial $30.0 billion of funds based on their share of total Medicare FFS reimbursements made by the
U.S. in 2019. During April 2020, the Company received a payment of approximately $4.8 million, representing its portion of
the initial tranche of funds, recorded in other income (expense), net on the consolidated statement of operations.
Underwritten Public Offering of Common Stock
On June 15, 2020, the Company sold 4,492,187 shares of common stock (which included shares sold pursuant to the
underwriters’ full exercise of an overallotment option granted to the underwriters in connection with the offering) through an
underwritten public offering at a price of $32.00 per share for aggregate net proceeds of $134.6 million.
88 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its subsidiaries.
Intercompany transactions have been eliminated.
Correction to Presentation
The presentation of certain prior period amounts within the accompanying consolidated statements of operations have been
corrected, including creating separate line items for the presentation of cost of testing services, cost of product and cost of
digital and other, which were previously reported, in aggregate, in total cost of revenue of $45.5 million and $33.0 million for
the years ended December 31, 2019 and 2018, respectively. These corrections had no effect on loss from operations, loss before
taxes, or net loss. The Company evaluated these corrections, considering both qualitative and quantitative factors, and
concluded they are immaterial to previously issued financial statements.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and
the reported amounts of revenues and expenses in the consolidated financial statements and accompanying notes. On an
ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing
revenue; standalone fair value of digital revenue performance obligations; accrued expenses for clinical studies; inventory
valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities
acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of
contingent consideration recorded in connection with a business combination; the grant date fair value assumptions used to
estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets
(including goodwill); and legal contingencies. Actual results could differ from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents, marketable securities
and accounts receivable. The Company’s policy is to invest its cash and cash equivalents in money market funds, obligations of
U.S. government agencies and government-sponsored entities, commercial paper, corporate debt securities and various bank
deposit accounts. These financial instruments are held in Company accounts at nineteen financial institutions. The
counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing.
The Company is exposed to credit risk in the event of default by the financial institutions to the extent of amounts recorded on
the balance sheets that may be in excess of insured limits.
The Company is also subject to credit risk from its accounts receivable, which are derived from revenue earned from AlloSure
Kidney and AlloMap Heart tests provided for patients located in the U.S. and billed to various third-party payers, from sales of
products to distributors, strategic partners and transplant laboratories in Europe, Asia, the Middle East, Africa, the U.S., Latin
America and other geographic regions, and from sales of digital solutions software. The Company has not experienced any
significant credit losses and does not require collateral on receivables. For the years ended December 31, 2020, 2019 and 2018,
approximately 57%, 55% and 48%, respectively, of total revenue was billed to Medicare. No other payers represented more
than 10% of total revenue for the years ended December 31, 2020, 2019 and 2018.
As of December 31, 2020 and 2019, approximately 28% and 36%, respectively, of accounts receivable was due from Medicare.
No other payer represented more than 10% of accounts receivable at either December 31, 2020 or 2019.
Cash and Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date
of purchase. Cash equivalents consist primarily of amounts invested in money market funds.
Restricted Cash
As a condition of the lease agreements for certain facilities and an agreement with the State of Florida Medicaid, the Company
must maintain letters of credit, minimum collateral requirements and a surety bond. These agreements are collateralized by
cash. The cash used to support these arrangements of $0.3 million is classified as long-term restricted cash on the
accompanying consolidated balance sheets.
89 Marketable Securities
The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of
purchase to be marketable securities. As of December 31, 2020, the Company’s marketable securities consisted of corporate
debt securities with maturities of greater than three months but less than twelve months at the time of purchase. These
marketable securities are classified as current assets on the consolidated balance sheet.
The Company classifies its marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at
each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity.
Marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to
maturity, which is included in interest income (expense), net on the consolidated statements of operations. Realized gains and
losses and declines in value judged to be other-than-temporary, if any, on marketable securities are included in interest income
(expense), net. The cost of securities sold will be determined using specific identification.
Inventory
Inventory is finished goods, work in progress, and raw materials and consists of reagent plates, laboratory supplies, reagents
and finished goods kits. Inventories are used in connection with tests performed, and kits produced and may also be used for
research and product development efforts. Laboratory supplies subsequently designated for research and product development
use are expensed. Obsolete or damaged inventories are written off and excluded from the physical inventory. Certain
inventories are stated at the lower of purchased cost, determined on an average cost basis, or net realizable value. Other
inventories are stated at the lower of actual purchased cost, determined on a first-in, first-out basis, or net realizable value.
Property and Equipment, net
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the
straight-line method over the estimated useful lives of the assets. The estimated useful life is generally five years for machinery,
computer and office equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized over the
shorter of their estimated useful lives or the remaining lease term.
The Company capitalizes certain costs incurred for software developed or obtained for internal use (including hosting
arrangements). These costs include software licenses and consulting services, as well as employee payroll and payroll-related
costs. Capitalized internal-use software costs are usually amortized over a period of three to five years.
Business Combinations
The Company determines and allocates the purchase price of an acquired business to the assets acquired and liabilities assumed
based on their estimated fair values as of the business combination date, including separately identifiable intangible assets,
which are separable from goodwill. The Company bases the estimated fair value of identifiable intangible assets acquired in a
business combination on independent valuations that use information and assumptions provided by management, which
consider management’s best estimates of inputs and assumptions that a market participant would use. The Company allocates
any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired
and liabilities assumed to goodwill. The use of alternative valuation assumptions, including estimated revenue projections,
growth rates, royalty rates, cash flows, discount rates, estimated useful lives and probabilities surrounding the achievement of
contingent milestones could result in different purchase price allocations and amortization expense in current and future
periods.
In those circumstances where an acquisition involves a contingent consideration arrangement that meets the definition of a
liability under Accounting Standard Codification (“ASC”), Topic 480, Distinguishing Liabilities from Equity, the Company
recognizes a liability equal to the fair value of the contingent payments that the Company expects to make as of the acquisition
date. The Company remeasures this liability each reporting period and records changes in the fair value as a component of
operating expenses. In circumstances where the contingent consideration is classified as equity, the Company recognizes it at
fair value at the acquisition date. Contingent consideration classified as equity is not subsequently remeasured.
Transaction costs associated with acquisitions are expensed as incurred in general and administrative expenses. Results of
operations and cash flows of acquired companies are included in the Company’s operating results from the date of acquisition.
90 Acquired Intangible Assets
Amortizable intangible assets include customer relationships, developed technology, trademarks, contracts and assets acquired
as part of a business combination or asset acquisition. Intangible assets subject to amortization are amortized over their
estimated useful lives. Acquired in-process technology assets are considered to be indefinite-lived until the completion or
abandonment of the associated research and development efforts. If and when development is complete, which generally occurs
if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would
then be amortized based on their respective estimated useful lives at that point in time.
Impairment of Goodwill, Intangible Assets and Long-lived Assets
Goodwill
Goodwill recorded in a business combination is not subject to amortization. Instead, it is tested for impairment on an annual
basis and whenever events or changes in circumstances indicate its carrying amount may not be recoverable.
The Company’s annual impairment test date is December 1st. A qualitative assessment is initially made to determine whether it
is necessary to perform a quantitative assessment. A qualitative assessment includes, among others, consideration of: (i) past,
current and projected future earnings; (ii) recent trends and market conditions; and (iii) valuation metrics involving similar
companies that are publicly-traded and acquisitions of similar companies, if available. If this qualitative assessment indicates
that it is more likely than not that an impairment exists, or if the Company decides to bypass this option, it proceeds to the
quantitative assessment. The quantitative assessment consists of a comparison between the estimated fair value of the
Company’s reporting unit and its respective carrying amount including goodwill. Where the carrying value of the reporting unit
exceeds its estimated fair value, the Company will record an impairment charge based on that difference. The impairment
charge will be limited to the amount of goodwill allocated to that reporting unit.
When necessary, to determine the reporting unit’s fair value under the quantitative approach, the Company uses a combination
of income and market approaches, such as estimated discounted future cash flows of that reporting unit, multiples of earnings or
revenues, and analysis of recent sales or offerings of comparable entities. The Company also considers its market capitalization
on the date of the analysis to ensure the reasonableness of the reporting unit’s fair value.
In connection with the Company’s annual goodwill assessment on December 1, 2020, the Company performed a qualitative
assessment taking into consideration past, current and projected future earnings, recent trends and market conditions; and its
market capitalization. Based on this analysis, the Company concluded that it was more likely than not that the fair value of the
reporting unit exceeded its carrying amount. As such, it was not necessary to perform the quantitative goodwill impairment
assessment at that time. As of December 31, 2020, no impairment of goodwill has been identified.
Intangible assets not subject to amortization
The Company evaluates the carrying value of intangible assets not subject to amortization, related to acquired in-process
technology assets, which are considered to be indefinite-lived until the completion or abandonment of the associated research
and development efforts. Accordingly, amortization of the acquired in-process technology assets will not occur until the
products reach commercialization.
During the period the assets are considered indefinite-lived, they are tested for impairment on an annual basis, as well as
between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate
that the fair value of the acquired in-process technology assets are less than their carrying amounts. An impairment loss would
be recorded when the fair value of an acquired in-process technology asset is less than its carrying value. If and when
development is complete, which generally occurs when the products are made commercially available, the associated acquired
in-process technology asset will be deemed finite-lived and will then be amortized based on its estimated useful life.
As of December 31, 2020, no impairment of acquired in-process technology assets has been identified.
Intangible assets and long-lived assets subject to amortization
The Company evaluates its finite-lived intangible assets and its long-lived assets for indicators of possible impairment when
events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company then
compares the carrying amounts of the assets with the future net undiscounted cash flows expected to be generated by such asset.
If an impairment exists, the Company measures the impairment based on the excess carrying value of the asset over the asset’s
fair value determined using discounted estimates of future cash flows. The Company has not identified any such impairment
losses to date.
91 Fair Value of Financial Instruments
Fair value is defined as the price that would be received from selling an asset or the price paid to transfer a liability in an orderly
transaction between market participants at the measurement date. When determining fair value, the Company considers the
principal or most advantageous market in which the Company would transact, and it takes into consideration the assumptions
that market participants would use when pricing the asset or liability. The Company’s assessment of the significance of a
particular input to the fair value measurement of an asset or liability requires management to make judgments and to consider
specific characteristics of that asset or liability.
The carrying amounts of certain financial instruments of the Company, including cash equivalents, accounts receivable,
accounts payable and accrued liabilities, approximate fair value due to their short maturities. The carrying amount of the
contingent consideration liability also represents its fair value.
Common Stock Warrants
Common stock warrants issued with debt, equity or as standalone financing instruments are recorded as either liabilities or
equity in accordance with the respective accounting guidance. Warrants recorded as equity are recorded at their relative fair
value determined at the issuance date and are not remeasured after that. Warrants recorded as liabilities are recorded at their fair
value and remeasured on each reporting date with changes recorded in change in estimated fair value of common stock warrant
liability and derivative liability in the consolidated statements of operations.
The Company utilizes a binomial-lattice pricing model, or the Monte Carlo Simulation Model, that involves a market condition
simulation to estimate the fair value of the warrants. The application of the Monte Carlo Simulation Model requires the use of a
number of complex assumptions including the Company's stock price, expected life of the warrants, stock price volatility
determined from the Company's historical stock prices and stock prices of peer companies in the diagnostics industry, and risk-
free rates based on the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to
the expected life of the warrants. Increases (decreases) in these assumptions result in a directionally similar impact to the fair
value of the common stock warrant liability.
Leases
Effective January 1, 2019, the Company adopted ASC Topic 842, Leases (“ASC 842”). The Company determines if an
arrangement is or contains a lease at contract inception. The Company leases office space and equipment primarily through
operating leases with a limited number of finance leases. A right-of-use (“ROU”) asset, representing the underlying asset during
the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the
consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases,
expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is
recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the
shorter of the estimated useful life of the asset or the lease term. Short-term leases with an initial term of 12 months or less are
not recorded on the balance sheet.
The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily
determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by
using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments
for a similar term and in a similar economic environment.
As of December 31, 2020, the Company’s leases have remaining terms of 0.01 years to 8.17 years, some of which include
options to extend the lease term. The Company’s lease terms may include renewal options that are reasonably certain to be
exercised and termination options that are reasonably certain not to be exercised. Certain finance leases also include bargain
purchase options of the leased equipment.
Revenue
The Company recognizes revenue from testing services, product sales, and digital and other revenue in the amount that reflects
the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its customers. Revenue
is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying
the performance obligations in the contract, determining the transaction price, allocating the transaction price to the
performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
92 Testing Services Revenue
AlloSure Kidney, AlloMap Heart and AlloSure Heart patient tests are ordered by healthcare providers. The Company receives a
test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to
be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory.
Testing services represent one performance obligation in a contract and are performed when results of the test are provided to
the healthcare provider, at a point in time.
The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not
responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company
receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party
payers upon delivery of an AlloSure Kidney, AlloMap Heart or AlloSure Heart test result to the healthcare provider. Amounts
received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio
approach, a practical expedient under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of
payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per
test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and
self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes
analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment.
The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a
revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected
or changes made to contracted rates.
Product Revenue
Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue
recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified
required terms of order, including the number of products ordered. Transaction prices are determinable and products are
delivered and risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement.
Digital and Other Revenue
Digital revenue is mainly derived from perpetual software license agreements entered into with various transplant centers
(customers). The main performance obligations in connection with the Company's perpetual software license agreement are the
following: (i) implementation services and delivery of the perpetual software license are considered a single performance
obligation, and (ii) post contract support ("PCS"). The Company allocates the transaction price to each performance obligation
based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with
perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct
performance obligation in each agreement.
Perpetual software license agreements typically require advance payments from customers upon the achievement of certain
milestones. The Company records deferred revenue in relation to these agreements when cash payments are received, or
invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as
performance obligations are fulfilled.
In addition, the Company derives digital revenue from software subscriptions. The Company generally bills software
subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription
term.
Cost of Testing Services
Cost of testing services reflects the aggregate costs incurred in delivering the Company’s testing services. The components of
cost of testing services are materials and service costs, direct labor costs, stock-based compensation, equipment and
infrastructure expenses associated with testing samples, shipping, logistics and specimen processing charges to collect and
transport samples, and allocated overhead including rent, information technology, equipment depreciation, utilities and
royalties. Royalties for licensed technology, calculated as a percentage of testing services revenues, are recorded as license fees
in cost of testing services at the time the testing services revenues are recognized.
Cost of Product
Cost of product reflects the aggregate costs incurred in delivering the Company’s products to customers. The components of
cost of product are materials costs, manufacturing and kit assembly costs, direct labor costs, equipment and infrastructure
expenses associated with preparing kitted products for shipment, shipping, and allocated overhead including rent, information
technology, equipment depreciation and utilities. Cost of product also includes amortization of acquired developed technology
and adjustments to inventory values, including write-downs of impaired, slow moving or obsolete inventory.
93 Cost of Digital and Other
Cost of digital and other primarily consists of personnel-related costs associated with developing, installing and maintaining
software, depreciation of servers and equipment, amortization of acquired intangible assets, support of the functionality of the
software's platforms, including stock-based compensation expenses, and allocated costs of facilities and information
technology.
Research and Development Expenses
Research and development expenses, including clinical operations, represent costs incurred to develop diagnostic products and
services, high quality evidence to support use of the Company’s tests, as well as continued efforts related to improving the
Company’s existing products and digital solutions service lines. These expenses include payroll and related expenses,
consulting expenses, laboratory supplies, clinical studies and certain allocated expenses as well as amounts incurred under
certain collaborative agreements. Research and development costs are expensed as incurred. The Company records accruals for
estimated study costs comprised of work performed by contract research organizations under contract terms.
Stock-based Compensation
The Company uses the Black-Scholes Model, which requires the use of estimates such as stock price volatility and expected
option lives, to value employee stock options. The Company estimates the expected option lives using historical data, volatility
using its own historical stock prices and stock prices of peer companies in the diagnostics industry, risk-free rates using the
implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected option
lives, and dividend yield using the Company’s expectations and historical data. The fair value of each restricted stock unit is
calculated based upon the closing price of the Company’s common stock on the date of the grant.
The Company uses the straight-line attribution method for recognizing compensation expense. Compensation expense is
recognized on awards ultimately expected to vest and reduced for forfeitures that are estimated at the time of grant and revised,
if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on the
Company’s historical experience.
Compensation expense for stock options issued to nonemployees is calculated using the Black-Scholes Model and is recorded
over the service performance period using the straight-line attribution method. Options subject to vesting are required to be
periodically remeasured over their service performance period, which is generally the same as the vesting period.
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are
determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates
in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when
necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all
tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company’s assessment of an
uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount
of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. As of each balance sheet date,
unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the
sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and
measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax
benefit may change as new information becomes available.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiaries is the local currency for each entity, including the Swedish
Krona, Australian dollar and the Euro. The revenue and expenses of such subsidiaries have been translated into U.S. dollars at
average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the
balance sheet date. The resulting cumulative translation adjustments are reported in other comprehensive loss. Foreign currency
translation gains and losses on revenue and expenses are recognized in the consolidated statements of operations.
Comprehensive Loss
Comprehensive loss consists of net loss and other losses affecting stockholders’ equity that, under U.S. GAAP, are excluded
from net income or loss. For the Company, such items consist of foreign currency losses on the translation of foreign assets and
liabilities.
94 Recent Accounting Pronouncements
In October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2020-10, Codification Improvements, which contains amendments that improve the consistency of the ASC by including all
disclosure guidance in the appropriate Disclosure Section (Section 50). The FASB provided transition guidance for all the
amendments in this ASU. The amendments in Sections B and C (Section A has been removed) of this ASU are effective for
annual periods beginning after December 15, 2020 for public business entities. Early application of the amendments in this
ASU is permitted for public business entities for any annual or interim period for which financial statements have not been
issued. The amendments in this ASU should be applied retrospectively. The Company plans to adopt this new standard on
January 1, 2021. The Company is in the process of assessing the impact that this new standard will have in its consolidated
financial statements and disclosures.
In November 2018, the FASB issued ASU No. 2018-18 Collaborative Arrangements - Clarifying the Interaction between Topic
808 (Collaborative Arrangements) and Topic 606 (Revenue from Contracts with Customers) (“ASU 2018-18”), which clarifies
the interaction between ASC 808, Collaborative Arrangements and ASC 606, Revenue from Contracts with Customers (“ASC
606”). The ASU clarifies that certain transactions between participants in a collaborative arrangement should be accounted for
under ASC 606 when the counterparty is a customer. In addition, the ASU precludes an entity from presenting consideration
from a transaction in a collaborative arrangement as revenue if the counterparty is not a customer for that transaction. The
Company adopted the standard on January 1, 2020. The adoption of the new standard did not have a significant impact on the
Company’s consolidated financial statements.
In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal – Use Software (ASC
Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a
Service Contract (“ASU 2018-15”). ASU 2018-15 became effective for fiscal years beginning after December 15, 2019 and
interim periods therein. Early adoption of ASU 2018-15 is permitted, including adoption in any interim period. The Company
adopted the standard on January 1, 2020. The adoption of the new standard did not have a significant impact on the Company's
consolidated financial statements.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (ASC Topic 820) (“ASU 2018-13”), which
modifies, removes and adds certain disclosure requirements on fair value measurements based on the FASB Concepts
Statement, Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements. ASU 2018-13 is
effective for the Company’s interim and annual reporting periods during the year ending December 31, 2020, and all annual and
interim reporting period thereafter. The amendments on changes in unrealized gains and losses, the range and weighted-average
of significant unobservable inputs used to develop Level 3 fair value measurements and the narrative description of
measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the
initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their
effective date. Early adoption is permitted upon issuance of ASU 2018-13. An entity is permitted to early adopt any removed or
modified disclosures upon issuance of ASU 2018-13 and delay adoption of the additional disclosures until their effective date.
The Company adopted the standard on January 1, 2020. The adoption of the new standard did not have a significant impact on
the Company's consolidated financial statements.
In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (ASC Topic 326)
(“ASU 2016-13”), which amends the FASB’s guidance on the impairment of financial instruments. The ASU adds to U.S.
GAAP an impairment model known as the current expected credit loss (“CECL”) model, which is based on expected losses
rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of lifetime expected
credit losses, which the FASB believes will result in more timely recognition of such losses. The new CECL standard is
effective for public companies for annual reporting periods beginning after December 15, 2019, and interim periods therein.
ASU 2016-13 has a greater impact on banks. However, nonbank entities that have financial instruments or other assets such as
trade receivables, contract assets, lease receivables, financial guarantees, loans and loan commitments, and held-to-maturity
debt securities are subject to the CECL model. The Company adopted the standard on January 1, 2020. The adoption of the new
standard did not have an impact on the Company’s consolidated financial statements.
95 3. NET LOSS PER SHARE ATTRIBUTABLE TO CAREDX, INC.
Basic and diluted net loss per share attributable to CareDx, Inc. have been computed by dividing the net loss by the weighted-
average number of common shares outstanding during the period, without consideration of common share equivalents as their
effect would have been antidilutive.
For the years ended December 31, 2020, 2019 and 2018, all common share equivalents have been excluded from the calculation
of diluted net loss per share, as their effect would be antidilutive.
The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except
shares and per share data):
Numerator:
Net loss attributable to CareDx, Inc. used to compute basic net loss per share
$
(18,714) $
(21,968) $
(46,756)
Year Ended December 31,
2020
2019
2018
Net loss attributable to CareDx, Inc. used to compute diluted net loss per share $
Denominator:
Weighted-average shares used to compute basic net loss per share attributable
to CareDx, Inc.
Weighted-average shares used to compute diluted net loss per share attributable
(18,714) $
(21,968) $
(46,756)
46,481,772
42,151,617
35,638,956
46,481,772
42,151,617
35,638,956
to CareDx, Inc.
Net loss per share attributable to CareDx, Inc.:
Basic
Diluted
$
$
(0.40) $
(0.40) $
(0.52) $
(0.52) $
(1.31)
(1.31)
The following potentially dilutive securities have been excluded from diluted net loss per share because their effect would be
antidilutive:
Shares of common stock subject to outstanding options
Shares of common stock subject to outstanding common stock warrants
Shares of common stock subject to contingent consideration
Restricted stock units
Total common stock equivalents
Year Ended December 31,
2020
2019
2018
2,670,398
2,609,848
2,501,057
6,264
—
1,878,866
4,555,528
355,240
656,289
10
1,516,285
4,481,383
—
968,364
4,125,710
During 2017 and the three months ended March 31, 2018, 6,415,039 shares of common stock were issued due to the conversion
of the JGB Debt (as defined below). In the three months ended June 30, 2018, the Company achieved the milestone of
performing 2,500 commercial AlloSure Kidney tests resulting in the issuance of 227,848 shares of common stock to the former
owners of ImmuMetrix, Inc. (“IMX”) that was accounted for as contingent consideration.
On November 13, 2018, the Company completed an underwritten public offering (the “2018 Public Offering”) pursuant to
which the Company issued and sold an aggregate of 2,300,000 shares.
During April 2020, the Company issued and sold 1,000,000 shares of its common stock under the Sales Agreement pursuant to
an “at-the-market” equity offering.
On June 15, 2020, the Company completed an underwritten public offering (the “2020 Public Offering”) pursuant to which the
Company sold 4,492,187 shares of common stock.
96 4. FAIR VALUE MEASUREMENTS
The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of
the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued
liabilities, approximate fair value due to their relatively short maturities. Fair value is defined as the price that would be
received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the
reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation
methodologies in measuring fair value as follows:
•
•
•
Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities.
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted
prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that
are observable or can be corroborated by observable market data for substantially the full term of the
assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
The following table sets forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of
December 31, 2020 and 2019 (in thousands):
Assets
Cash equivalents:
Money market funds
Liabilities
Common stock warrant liability
Assets
Cash equivalents:
Money market funds
Liabilities
Common stock warrant liability
December 31, 2020
Fair Value Measured Using
(Level 1)
(Level 2)
(Level 3)
Total
Balance
$
$
$
$
85,797 $
— $
— $
85,797
— $
— $
447 $
447
December 31, 2019
Fair Value Measured Using
(Level 1)
(Level 2)
(Level 3)
Total
Balance
29,177 $
— $
— $
29,177
— $
— $
6,607 $
6,607
The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3
financial instruments that are measured at fair value on a recurring basis (in thousands):
Common Stock Warrant Liability
Balance as December 31, 2018
Exercise of warrants
Change in estimated fair value
Balance as December 31, 2019
Exercise of warrants
Change in estimated fair value
Balance as December 31, 2020
(Level 3)
10,003
(3,077)
(319)
6,607
(7,655)
1,495
447
$
$
$
97 As of December 31, 2020, the Company had one investment in convertible preferred shares carried at cost. See Note 7,
"Goodwill and Intangible Assets”. In the event the Company had to calculate the fair value of this investment, it would be based
on Level 3 inputs. This investment is not considered material to the Company's consolidated financial statements.
In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The
valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation
hierarchy are summarized below:
•
•
•
Money market funds—Investments in money market funds are classified within Level 1. Money
market funds are valued at the closing price reported by the fund sponsor from an actively traded
exchange. At December 31, 2020 and 2019, money market funds were included as cash and cash
equivalents in the consolidated balance sheets.
Marketable securities—Investments in marketable securities are classified within Level 2. The
securities are valued using third-party pricing sources. The pricing services utilize industry standard
valuation models, including both income and market-based approaches, for which all significant
inputs are observable, either directly or indirectly.
Common stock warrant liability—The Company utilizes a binomial-lattice pricing model (the
“Monte Carlo Simulation Model”) that involves a market condition simulation to estimate the fair
value of the warrants. The application of the Monte Carlo Simulation Model requires the use of a
number of complex assumptions including the Company’s stock price, expected life of the warrants,
stock price volatility determined from the Company’s historical stock prices and stock prices of peer
companies in the diagnostics industry, and risk-free rates based on the implied yield currently
available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected life of
the warrants. Increases (decreases) in the assumptions discussed above result in a directionally
similar impact to the fair value of the common stock warrant liability.
Common Stock Warrant Liability Valuation Assumptions:
Private Placement Common Stock Warrant Liability
Stock Price
Exercise Price
Remaining term (in years)
Volatility
Risk-free interest rate
December 31,
2020
2019
$
$
72.45
1.12
$
$
21.57
1.12
2.28
73.00 %
0.14 %
3.29
81.00 %
1.62 %
Warrants liabilities exercised during 2020 and 2019 were remeasured at the exercise date. Their fair value approximates their
intrinsic value, which was recorded to additional paid in capital in the consolidated statements of stockholders’ equity.
The Company’s liabilities classified as Level 3 were valued based on unobservable inputs and management’s judgment due to
the absence of quoted market prices, inherent lack of liquidity and the long-term nature of the financial instruments.
98 5. CASH AND MARKETABLE SECURITIES
Cash, Cash Equivalents and Restricted Cash
A reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets to the amount
reported within the consolidated statements of cash flows is shown in the table below (in thousands):
Cash and cash equivalents
Restricted cash
December 31, 2020 December 31, 2019 December 31, 2018
64,616
$
134,669 $
38,223 $
270
256
192
64,808
Total cash, cash equivalents, and restricted cash at the end of the period $
134,939 $
38,479 $
Marketable Securities
All marketable securities were considered held-to-maturity at December 31, 2020. There were no marketable securities at
December 31, 2019. As of December 31, 2020 some of the Company’s marketable securities were in an unrealized loss
position. The Company determined that it had the positive intent and ability to hold until maturity all marketable securities that
have been in a continuous loss position, thus there was no recognition of any other-than-temporary impairment as of
December 31, 2020. All marketable securities with unrealized losses as of each balance sheet date have been in a loss position
for less than twelve months.
The amortized cost, gross unrealized holding losses, and fair value of the Company’s marketable securities by major security
type at each balance sheet date are summarized in the table below (in thousands):
Short-term marketable securities:
Corporate debt securities
Total short-term marketable securities
December 31, 2020
Unrealized
Holding Losses
Fair Value
Amortized Cost
$
$
90,034 $
90,034 $
(136) $
(136) $
89,898
89,898
Contractual maturities of the short-term marketable securities as of December 31, 2020 are as follows (in thousands):
Within one year
After one year through five years
After five years through ten years
After ten years
Total
$
90,034
—
—
—
$
90,034
99 6. BUSINESS COMBINATIONS
Ottr, Inc.
On May 7, 2019, the Company acquired 100% of the outstanding common stock of Ottr, Inc. for total consideration of
$16.1 million. Ottr, Inc. was formed in 1993 and is a leading provider of organ transplant patient tracking software. The Ottr
software provides comprehensive solutions for transplant patient management and enables integration with EMR systems
providing patient surveillance management tools and outcomes data to transplant centers.
The Company accounted for the transaction as a business combination using the acquisition method of accounting. Results of
operations of Ottr, Inc. have been included with the Company’s results since the date of the acquisition. Acquisition-related
costs of $0.6 million associated with the acquisition were expensed as incurred, and classified as part of general and
administrative expenses in the consolidated statement of operations.
Goodwill of $10.2 million arising from the acquisition primarily consists of synergies from integrating the Ottr software with
transplant center EMR systems and the current testing solutions offered by the Company. Goodwill synergies also arise from
acquired workforce know-how of transplant centers workflow. None of the goodwill is expected to be deductible for income tax
purposes. All of the goodwill has been assigned to the Company’s existing operating segment.
The following table summarizes the consideration paid for Ottr, Inc. and the provisional amounts of the assets acquired and
liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
Consideration
Cash
Accrued purchase consideration
Total consideration
Recognized amounts of identifiable assets acquired and liabilities assumed
Current assets
Fixed assets
Identifiable intangible assets
Current liabilities
Total identifiable net assets acquired
Goodwill
Total consideration
Total
$
$
16,037
111
16,148
$
1,525
35
6,600
(2,210)
5,950
10,198
16,148
$
The allocation of the purchase price to assets acquired and liabilities assumed was based on the Company’s best estimate of the
fair value of such assets and liabilities as of the acquisition date.
The fair value of the acquired current liabilities as of June 30, 2019 included a preliminary deferred revenue balance of
$2.3 million. During the three months ended September 30, 2019, the Company recorded an adjustment of $0.5 million to the
initial valuation amount of deferred revenue, decreasing its balance to $1.8 million as of the acquisition date. This change is a
result of updated assumptions and methodologies for acquired software maintenance contracts. As part of this adjustment,
goodwill decreased by approximately $0.5 million.
At the acquisition date, the Company estimated net deferred tax assets of approximately $0.2 million arising from temporary
differences related to assets acquired and liabilities assumed. The Company estimated that Ottr, Inc. had net operating losses
(“NOLs”) carryforward of approximately $6.9 million, $4.3 million of which will begin to expire in 2033, and the remaining
$2.6 million will be carried forward indefinitely. A full valuation allowance of $0.2 million was recognized as of the acquisition
date resulting in no impact from deferred taxes to Ottr, Inc.’s opening balance. An Internal Revenue Code Section 382 study for
NOLs was finalized during the third quarter of 2019 and deferred taxes acquired were finalized as of December 31, 2019.
100 The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Customer relationships
Developed technology
Trademark
Total
Estimated Fair
Value
Estimated
Useful Lives
(Years)
$
$
4,200
2,300
100
6,600
15
10
2
Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be
derived from sales of Ottr, Inc.’s products to existing customers. The customer relationships’ fair value has been estimated
utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected
cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other
assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life
was determined based on the distribution of the present value of the cash flows attributable to the intangible asset.
The acquired developed technology represents the fair value of Ottr, Inc.’s proprietary software. The trademark acquired
consists primarily of the Ottr, Inc. brand and markings. The fair value of both the developed technology and the trademark were
determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be
the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of
15.0% and 1.0% were used to estimate the fair value of the developed technology and the trademark, respectively.
The Company utilized a discount rate of 14.5% in estimating the fair value of these three intangible assets. Unaudited
supplemental pro forma information is not disclosed because it is considered immaterial.
XynManagement
On August 26, 2019, the Company acquired 100% of the outstanding common stock of XynManagement for total cash
consideration of $2.0 million. As a result of the acquisition, the Company recognized contingent consideration of $1.4 million,
including liability and equity components, goodwill of $1.7 million and intangible assets of $2.1 million. Goodwill synergies
arise from acquired workforce know-how of transplant centers workflow. The goodwill for this acquisition is not deductible for
income tax purposes. The contingent consideration relates to potential future cash payments upon reaching specified revenue
and non-financial targets.
101 7. GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified
intangible assets acquired.
Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or earlier upon the occurrence of
certain events or substantive changes in circumstances. There were no indicators of impairment in the year ended December 31,
2020.
The following table presents details of the Company’s goodwill as of December 31, 2020 and 2019 ($ in thousands):
Balance as of January 1,
Goodwill acquired
Balance as of December 31,
2020
2019
$
$
23,857 $
—
23,857 $
12,005
11,852
23,857
On December 1, 2020, the Company performed a qualitative assessment of its reporting unit taking into consideration past,
current and projected future earnings, recent trends and market conditions, and its market capitalization. Based on this analysis,
the Company concluded that it was more likely than not that the fair value of the reporting unit exceeded its carrying amount.
As such, it was not necessary to perform the quantitative goodwill impairment assessment at this time. As of December 31,
2020, no impairment of goodwill has been identified.
Intangible Assets
The following tables present details of the Company’s intangible assets as of December 31, 2020 (dollar amounts in thousands):
Intangible assets with finite lives:
Acquired and developed technology
Customer relationships
Commercialization rights
Trademarks and tradenames
Total intangible assets with finite lives
Acquired in-process technology
Total intangible assets
December 31, 2020
Gross Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net
Carrying
Amount
$
$
31,209 $
18,168
8,079
2,360
59,816
1,250
61,066 $
(8,991) $
(4,684)
(1,039)
(804)
(15,518)
—
(15,518) $
(725) $
(449)
—
(19)
(1,193)
—
(1,193) $
21,493
13,035
7,040
1,537
43,105
1,250
44,355
Weighted
Average
Remaining
Useful Life
(In Years)
9.1
10.9
8.7
9.9
The following tables present details of the Company’s intangible assets as of December 31, 2019 (dollar amounts in thousands):
Intangible assets with finite lives:
Acquired and developed technology
Customer relationships
Commercialization rights
Trademarks and tradenames
Total intangible assets with finite lives
Acquired in-process technology
Total intangible assets
December 31, 2019
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
$
$
29,106 $
18,168
8,079
2,360
57,713
2,103
59,816 $
(6,473) $
(3,397)
(231)
(618)
(10,719)
—
(10,719) $
(1,852) $
(1,498)
—
(206)
(3,556)
—
(3,556) $
20,781
13,273
7,848
1,536
43,438
2,103
45,541
Weighted
Average
Remaining
Useful Life
(In Years)
8.2
10.1
9.7
9.1
102 Acquisition of intangible assets
In June 2020, the Company commercially launched AlloSeq HCT, a NGS solution for chimerism testing for stem cell transplant
recipients. This technology can provide better sensitivity and data analysis compared to current solutions on the market.
AlloSeq HCT, previously included in Acquired in-process technology as of December 31, 2019, is included in Acquired and
developed technology as of December 31, 2020.
Illumina License and Commercialization Agreement
On May 4, 2018, the Company entered into a license agreement with Illumina, which provides the Company with certain
worldwide distribution, development and commercialization rights to Illumina’s NGS product line for use in the field of bone
marrow and solid organ transplantation diagnostic testing (the “Field”). As a result, from June 1, 2018, the Company is the
exclusive worldwide distributor of Illumina’s TruSight HLA product line. In addition, the Company was also granted the
exclusive right to develop and commercialize other NGS product lines for use in the Field.
The License Agreement required the Company to make a $5.0 million initial cash payment to Illumina and further requires the
Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. Pursuant to the
License Agreement, the Company is obligated to complete timely development and commercialization of other NGS product
lines for use in the Field, and has agreed to minimum purchase commitments of finished products and raw materials from
Illumina through 2023.
As the License Agreement did not meet the definition of a business combination under ASC Topic 805, Business
Combinations, the Company accounted for the transaction as an asset acquisition. In an asset acquisition goodwill is not
recognized, but rather any excess consideration transferred over the fair value of the net assets acquired is allocated on a relative
fair value basis to the identifiable assets acquired.
Costs relating to the assets acquired were $5.2 million, comprising of the cash consideration of $5.0 million and associated
transaction costs of $0.2 million. A deferred tax balance was not required to be established on the License Agreement date as
the book and tax basis of the intangible assets was equivalent to the amount paid.
The allocation of the purchase price to identified intangible assets acquired was based on the Company’s best estimate of the
fair value of such assets as of the acquisition date. Significant assumptions utilized in the valuation of identified intangible
assets were based on company-specific information and projections, which are not observable in the market and are thus
considered Level 3 measurements as defined by U.S. GAAP. The Company determined the estimated fair values using Level 3
inputs after review and consideration of relevant information, including discounted cash flows, quoted market prices and
estimates made by management.
Customer relationships represent the fair value of future projected revenue that is expected to be derived from sales of TruSight
HLA products to existing customers of Illumina. The customer contracts and related relationships value has been estimated
utilizing a multi-period excess earnings method under income approach, which reflects the present value of the projected cash
flows that are expected to be generated by the customer relationships less charges representing the contribution of other assets
to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was
determined based on the life of the products, assuming that the existing customers will remain with the Company until the
products become obsolete. The Company utilized a discount rate of 18% in estimating the fair value of the customer
relationships.
The acquired in-process technology represents the fair value of products in development that have not reached commercial
production at the date of acquisition. The fair value of the products was also determined using the multi-period excess earnings
method under income approach. A discount rate of 40% for the AlloSeq HCT acquired in-process technology was utilized to
discount the cash flows to the present value.
In November 2019, the acquired in-process technology intangible for AlloSeq Tx commenced commercial production. As of
December 31, 2019; such acquired in-process technology has been classified as an intangible assets with finite live, and is being
amortized over a useful life of 14 years.
The following table summarizes the fair values of the intangible assets acquired as of the closing date ($ in thousands):
Customer relationships: TruSight HLA
Acquired in-process technology: AlloSeq HCT
Total
Estimated Fair
Value
Estimated
Useful Life
(Years)
$
$
380
2,103
2,483
2.6
—
103 Cibiltech License and Commercialization Agreement
Effective April 30, 2019, the Company entered into a license and commercialization agreement (the “Cibiltech Agreement”)
with Cibiltech SAS (“Cibiltech”). Cibiltech is a French company engaged in the development and support of predictive
medicine and artificial intelligence software, services and technology, with an emphasis on personalized patient care and
clinical research, including its proprietary software and service offering known in the U.S. as KidneyCare iBox for the
predictive analysis of post-transplantation kidney allograft loss. The Cibiltech Agreement provides the Company with an
irrevocable, non-transferable right to commercialize Cibiltech’s proprietary software in the field of transplantation in the U.S.
for a period of ten years. The Company estimated the fair value of the acquired commercialization rights intangible asset based
on expected contractual payments discounted to present value using a discount rate of 6%. In September 2019, the Company
initiated the OKRA clinical study, which incorporates KidneyCare iBox. On such date, the Company commenced amortization
of the acquired commercialization intangible asset.
On July 26, 2019, pursuant to the Cibiltech Agreement, the Company purchased $1.0 million of convertible preferred shares of
Cibiltech, which is recorded in other assets. The Company does not have a significant influence on Cibiltech’s operations. The
net carrying amount of intangible assets and the related amortization expense of intangible assets may change due to the effects
of foreign currency fluctuations as a result of acquiring an entity with a functional currency other than the U.S. dollar.
Amortization of Intangible Assets
Amortization expense was $4.8 million, $3.6 million and $2.4 million for the years ended December 31, 2020, 2019 and 2018,
respectively. For the year ended December 31, 2020, $1.3 million, $1.7 million, $0.3 million and $1.5 million were amortized
to cost of testing services, cost of product, cost of digital and other and sales and marketing, respectively. For the year ended
December 31, 2019, $0.7 million, $1.4 million, $0.2 million and $1.3 million were amortized to cost of testing services, cost of
product, cost of digital and other and sales and marketing, respectively. For the year ended December 31, 2018, $0.5 million,
$1.5 million, $0.0 million and $1.0 million were amortized to cost of testing services, cost of product, cost of digital and other
and sales and marketing, respectively.
Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of testing
services, cost of product, cost of digital and other and sales and marketing expenses in the consolidated statements of
operations.
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of
December 31, 2020 (in thousands):
Years Ending December 31,
2021
2022
2023
2024
2025
Thereafter
Total future amortization expense
Cost of Testing
Services
Cost of
Product
Cost of Digital
and Other
Sales and
Marketing
Total
$
$
1,316 $
1,316
1,316
1,316
1,316
5,457
12,037 $
1,847 $
1,847
1,847
1,847
1,847
4,340
13,575 $
345 $
345
345
345
345
1,192
2,917 $
1,392 $
1,374
1,374
1,374
1,374
7,688
14,576 $
4,900
4,882
4,882
4,882
4,882
18,677
43,105
104 8. BALANCE SHEET COMPONENTS
Inventory
Inventory consisted of the following (in thousands):
Finished goods
Work in progress
Raw materials
Total inventory
Property and Equipment, Net
Property and equipment consisted of the following (in thousands):
Machinery and equipment
Leasehold improvements
Computer and office equipment
Internally developed software
Furniture and fixtures
Construction in progress
Property and equipment
Less: Accumulated depreciation and amortization
Property and equipment, net
December 31,
2020
2019
1,702 $
2,936
5,374
10,012 $
1,236
1,189
3,589
6,014
December 31,
2020
2019
9,325 $
8,096
5,414
2,312
683
1,873
27,703 $
(16,999)
10,704 $
7,546
5,458
4,996
—
683
840
19,523
(15,093)
4,430
$
$
$
$
$
Depreciation expense was $1.9 million, $1.6 million and $1.2 million for the years ended December 31, 2020, 2019 and 2018,
respectively.
Assets purchased under finance leases, included above in machinery and equipment, and computer and office equipment, were
$0.6 million at each of December 31, 2020 and 2019. Accumulated depreciation was $0.4 million at each of December 31, 2020
and 2019. Related amortization expense, included in depreciation and amortization expense, was $0.1 million, $0.2 million and
$0.2 million for the years ended December 31, 2020, 2019 and 2018, respectively.
Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
Clinical studies
Deferred revenue
Short-term lease liability
Deferred payments for intangible assets
Professional fees
Accrued royalty
Contingent consideration
Test sample processing fees
Other accrued expenses
Total accrued and other liabilities
December 31,
2020
2019
6,733 $
3,530
2,033
2,000
1,529
1,072
738
416
2,551
20,602 $
3,068
3,686
3,017
2,098
766
547
810
835
2,011
16,838
$
$
105 CMS Accelerated and Advance Payment Program for Medicare Providers
On March 27, 2020, the U.S. government enacted the CARES Act. Pursuant to the CARES Act, CMS expanded its current
Accelerated and Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by
the COVID-19 pandemic. CMS was authorized to provide accelerated or advance payments during the period of the public
health emergency to any Medicare provider who submits a request to the appropriate Medicare Administrative Contractor and
meets the required qualifications. During April 2020, the Company received an advance payment from CMS of approximately
$20.5 million and recorded the payment as Deferred revenue - CMS advance payment on the Company's consolidated balance
sheet.
During December 2020, the Company reassessed the Deferred revenue - CMS advance payment and determined to repay the
entire amount in January 2021. The Company recorded the amount as Refund liability - CMS advance payment on the
consolidated balance sheet as of December 31, 2020.
9. COMMITMENTS AND CONTINGENCIES
Leases
The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease
agreements in South San Francisco, California; Brisbane, California; West Chester, Pennsylvania; Fremantle, Australia; and
Stockholm, Sweden; and Vienna, Austria. The Company also leases equipment under finance lease agreements.
On January 2, 2020, the Company executed the second amendment to the operating lease agreement for the building located at
Brisbane, California. The building is mainly utilized for laboratory operations and research and development. The lease will be
extended for a period of eight years and two months starting on January 1, 2021. The Company has determined that the
amendment constitutes a lease modification effective January 1, 2020. At the inception of the lease modification, the ROU asset
increased by $13.0 million.
The Company's facility leases expire at various dates through 2029. In the normal course of business, it is expected that these
leases will be renewed or replaced by leases on other properties.
As of December 31, 2020, the carrying value of the ROU asset was $15.2 million. The related current and non-current liabilities
as of December 31, 2020 were $2.0 million and $16.1 million, respectively. The current and non-current lease liabilities are
included in accrued and other current liabilities and operating lease liability, less current portion, respectively, in the
consolidated balance sheets.
The following table summarizes the lease cost for the year ended December 31, 2020 (in thousands):
Operating lease cost
Finance lease cost
Total lease cost
Finance lease cost includes interest from the lease liability and amortization of the ROU asset.
Other information:
Weighted-average remaining lease term - Operating leases (in years)
Weighted-average remaining lease term - Finance leases (in years)
Weighted-average discount rate - Operating leases (%)
Weighted-average discount rate - Finance leases (%)
$
$
4,441
205
4,646
7.30
0.42
10.5 %
5.4 %
Rent expense under the non-cancelable operating leases was $4.9 million, $2.3 million and $2.0 million for the years ended
December 31, 2020, 2019 and 2018, respectively.
106 Future minimum lease commitments under these operating and finance leases on December 31, 2020, are as follows
(in thousands):
Years ending December 31,
2021
2022
2023
2024
2025
Thereafter
Total minimum lease payments
Finance
Leases
Operating
Leases
71 $
—
—
—
—
—
71 $
4,562
5,014
3,769
3,892
4,037
10,256
31,530
$
$
The current portion of obligations under finance leases is included in accrued and other liabilities, and the long-term portion of
finance leases are included in other liabilities within the consolidated balance sheets.
Royalty Commitments
The Board of Trustees of the Leland Stanford Junior University (“Stanford”)
In June 2014, the Company entered into a license agreement with Stanford (the “Stanford License”), which granted the
Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA.
Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone
payments and royalties in the low single digits of net sales of products incorporating the licensed technology.
Illumina
On May 4, 2018, the Company entered into the License Agreement with Illumina (the “Illumina Agreement”). The Illumina
Agreement requires the Company to pay royalties in the mid-single to low-double digits on sales of products covered by the
Illumina Agreement.
Cibiltech Commitments
Pursuant to the Cibiltech Agreement, the Company will share an agreed-upon percentage of revenue with Cibiltech, if and when
revenues are generated from KidneyCare iBox.
Tax Commitments
As of December 31, 2020, the Company had gross unrecognized tax benefits of $4.4 million, which include penalties and
interest of $0.2 million. Approximately $0.2 million has been recorded as a noncurrent liability. At this time, the Company is
unable to make a reasonably reliable estimate of the timing of payments in individual years in connection with these tax
liabilities.
Other Commitments
Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw
materials from Illumina through 2023.
The Company has also committed to make potential future payments to third parties as part of its collaboration and licensing
agreements. Payments under these agreements generally become due and payable only upon achievement of specific project
milestones.
Litigation and Indemnification Obligations
In response to the Company's false advertising suit filed against Natera Inc. (“Natera”), on April 10, 2019, Natera filed a
counterclaim against the Company on February 18, 2020, in the U.S. District Court for the District of Delaware (the “Court”)
alleging the Company made false and misleading claims about the performance capabilities of AlloSure. The suit seeks
injunctive relief and unspecified monetary relief. On September 30, 2020, Natera requested leave of Court to amend its
counterclaims to include additional allegations regarding purportedly false claims the Company made with respect to AlloSure;
the Court granted Natera’s request. Trial is currently scheduled to begin on July 26, 2021.
107 In addition, in response to the Company's patent infringement suit filed against Natera on March 26, 2019, Natera filed suit
against the Company on January 13, 2020, in the Court alleging, among other things, that AlloSure infringes Natera’s U.S.
Patent 10,526,658. On March 25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also
infringes Natera’s U.S. Patent 10,597,724. The suit seeks a judgment that the Company has infringed Natera’s patents, an order
preliminarily and permanently enjoining the Company from any further infringement of such patents and unspecified damages.
The Company intends to defend both of these matters vigorously, and believes that the Company has good and substantial
defenses to the claims alleged in the suits, but there is no guarantee that the Company will prevail. The Company has not
recorded any liabilities for these suits.
From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range
of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best
estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with
no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss
contingency when both of the following conditions are met: (i) information available prior to issuance of the consolidated
financial statements indicates that it is probable that a liability had been incurred at the date of the consolidated financial
statements and (ii) the range of loss can be reasonably estimated.
10. DEBT
The Company did not have any outstanding debt as of December 31, 2020.
Perceptive Credit Agreement
On April 17, 2018, the Company entered into a credit agreement with Perceptive Credit Holdings II, LP (the “Perceptive Credit
Agreement”) for an initial term loan of $15.0 million. On November 20, 2018, the Company paid off all obligations owing
under, and terminated, the Perceptive Credit Agreement. The Perceptive Credit Agreement debt extinguishment resulted in a
$3.0 million loss that was included in debt extinguishment expenses, in the consolidated statements of operations.
JGB Debt
In February and March 31, 2018, JGB Collateral LLC and certain of its affiliates (“JGB”) converted the remaining
$26.7 million of principal and accrued interest of the Company’s convertible debt (the “JGB Debt”) into an aggregate of
6,161,331 shares of the Company’s common stock. In connection with these conversions, the Company recognized $6,000 to
common stock and $38.8 million to additional paid in capital; the unamortized debt discount of $2.7 million was extinguished;
and the compound derivative liability of $12.1 million was also extinguished. The JGB Debt conversion resulted in a
$2.8 million loss on debt extinguishment that was included in debt extinguishment expenses in the consolidated statements of
operations for the year ended December 31, 2018.
11. STOCKHOLDERS’ EQUITY
JGB Debt
On October 5, 2017, JGB converted $1.3 million of outstanding principal under certain debentures into shares of common
stock. Accordingly, the Company issued 288,022 shares of common stock to JGB at a price per share of $4.34. In 2018, JGB
converted the remaining $26.7 million of outstanding principal and accrued interest for a total issuance of 6,161,331 shares of
the Company’s common stock at a price per share of $4.33.
Contingent Consideration Liability
The Company had a contingent obligation to issue 227,845 shares of the Company’s common stock to the former owners of
IMX, in conjunction with its acquisition of IMX in June 2014. The shares were issuable upon the Company completing 2,500
commercial tests involving the measurement of dd-cfDNA in organ transplant recipients in the United States by June 10,
2020. The Company achieved the contingent consideration milestone of 2,500 commercial tests and issued the 227,848 shares
in May 2018.
2018 Public Offering
On November 16, 2018, the Company sold in the 2018 Public Offering an aggregate of 2,300,000 shares of its common stock,
including 300,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares at a public
offering price of $24.50 per share. Total net proceeds received were $52.9 million net of underwriter’s fees and issuance costs.
108 At-the-Market Equity Offering
On August 31, 2018, the Company entered into the Sales Agreement with Jefferies, as sales agent, pursuant to which the
Company may offer and sell, from time to time, through Jefferies, up to $50.0 million in shares of its common stock, by any
method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act
of 1933, as amended. During April 2020, the Company issued and sold 1,000,000 shares of its common stock under the Sales
Agreement. The shares were sold at an average price of $24.24 per share for aggregate net proceeds to the Company of
approximately $23.5 million, after deducting sales commissions and offering costs payable by the Company.
Underwritten Public Offering of Common Stock
On June 15, 2020, the Company sold in the 2020 Public Offering an aggregate of 4,492,187 shares of its common stock,
including 585,937 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares at a public
offering price of $32.00 per share. Total net proceeds received were $134.6 million net of underwriter's fees and issuance costs.
The Company did not issue preferred stock during the years ended December 31, 2020, 2019 and 2018.
12. 401(K) PLAN
The Company sponsors a 401(k) defined contribution plan covering all U.S. employees under the Internal Revenue Code of
1986, as amended. Employee contributions are voluntary and are determined on an individual basis subject to the maximum
allowable under federal tax regulations. On January 1, 2018, the Company began to make contributions to the employee plan.
The Company incurred expenses related to contributions to the plan of $0.7 million, $0.6 million and $0.3 million for the years
ended December 31, 2020, 2019 and 2018, respectively.
13. WARRANTS
The Company issues common stock warrants in connection with debt or equity financings to lenders, placement agents and
investors. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity
or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features
that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception
criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value
recorded in the consolidated statements of operations until expired or exercised. Warrants that are classified as equity are valued
at their relative fair value on the date of issuance, recorded in additional paid in capital and not remeasured.
During the year ended December 31, 2020, warrants to purchase approximately 314,000 shares of common stock were
exercised for cash proceeds of $0.4 million. During the year ended December 31, 2020, a warrant to purchase approximately
34,000 shares of common stock was exercised on a cashless basis and approximately 24,000 shares were issued pursuant to the
exercise.
During the year ended December 31, 2019, warrants to purchase approximately 94,000 shares of common stock were exercised
for cash proceeds of $0.1 million. During the year ended December 31, 2019, approximately 207,400 warrants were exercised
on a cashless basis and approximately 49,000 shares were issued pursuant to the exercises.
As of December 31, 2020, outstanding warrants to purchase common stock were:
Original issue date:
April 2016
Classified as
Original
Term
Exercise
Price
Liability
7 years $
1.12
Number of
Shares
Underlying
Warrants
6,264
6,264
109 14. STOCK INCENTIVE PLANS
2014 Equity Incentive Plan
The Company grants stock based awards under 2014 Equity Inceptive Plan (the “2014 Plan”) that allows for issuance of stock
options, restricted stock units (“RSUs”) and other stock awards to the Company’s employees, directors, and consultants. Stock
options granted under the 2014 Plan may be exercised when vested and generally expire ten years from the date of the grant or
three months from the date of termination of employment. Vesting periods vary based on awards granted, however, certain
stock-based awards may vest immediately or may accelerate based on performance-driven measures. Stock option awards
generally vest over four years with first year annual cliff vesting. The RSUs generally vest annually over four years in equal
increments. There were 513,437 shares of common stock reserved for future issuance under the 2014 Plan as of December 31,
2020.
2016 Inducement Plan
On April 21, 2016, the Company adopted the 2016 Inducement Equity Incentive Plan (the “2016 Plan”), pursuant to which the
Company may grant stock awards of up to a total of 155,500 shares of common stock to new employees of the Company. The
2016 Plan was adopted to accommodate a reserve of additional shares of common stock for issuance to new employees hired by
the Company from Allenex AB. The terms in the 2016 Plan are substantially similar to the 2014 Plan. There were 62,752 shares
of common stock reserved for future issuance under the 2016 Plan as of December 31, 2020.
The 2016 Plan allows RSUs to be granted in addition to stock options. The RSUs vest annually over four years in equal
increments. The Company began granting RSUs pursuant to the 2016 Plan starting June 2016.
2019 Inducement Equity Incentive Plan
The Company grants stock based awards under 2019 Inducement Equity Incentive Plan (the “2019 Plan”) that allows for
issuance of stock options, RSUs and other stock awards to new employees of the Company. Stock options granted under the
2019 Plan may be exercised when vested and generally expire ten years from the date of the grant or three months from the date
of termination of employment. Vesting periods vary based on awards granted, however, certain stock-based awards may vest
immediately or may accelerate based on performance-driven measures. Stock option awards generally vest over four years with
first year annual cliff vesting. The RSUs generally vest annually over four years in equal increments. The terms in the 2019
Plan are substantially similar to the 2014 Plan. There were 96,779 shares of common stock reserved for future issuance under
the 2019 Plan as of December 31, 2020.
Stock Options and RSUs
The following table summarizes option and RSUs activity under the Company’s 2014 Plan, 2016 Plan and 2019 Plan, and
related information:
Shares
Available
for Grant
Stock
Options
Outstanding
Weighted-
Average
Exercise
Price
Number of
RSU Shares
Weighted-
Average
Grant Date
Fair Value
504,775
2,609,848 $
16.47
1,516,285 $
22.51
Balance—December 31, 2019
Additional options authorized
Common stock awards for services
RSUs granted
RSUs vested
Options granted
Options exercised
1,699,549
(11,116)
(1,287,234)
—
(1,082,339)
—
—
—
—
1,082,339
—
(688,818)
Repurchases of common stock under employee
incentive plans
RSUs forfeited
Options forfeited
Options expired
Balance—December 31, 2020
169,706
346,656
306,075
26,896
672,968
—
—
(306,075)
(26,896)
2,670,398 $
—
—
—
—
29.11
11.58
—
—
24.46
19.18
21.92
—
—
1,287,234
(577,997)
—
—
—
(346,656)
—
—
1,878,866 $
—
—
31.71
22.28
—
—
—
25.06
—
—
28.42
110 The total intrinsic value of options exercised was $19.2 million, $15.1 million and $6.8 million for the years ended
December 31, 2020, 2019 and 2018, respectively.
The total fair value of RSUs vested during 2020 was $15.7 million. As of December 31, 2020, the total intrinsic value of
outstanding RSUs was approximately $136.0 million and there were $39.8 million of unrecognized compensation costs related
to RSUs, which are expected to be recognized over a weighted-average period of 3.00 years.
Options outstanding that have vested and are expected to vest at December 31, 2020 are as follows:
Vested
Expected to Vest
Total
Number of
Shares Issued
(In thousands)
987,653 $
1,553,039
2,540,692
Weighted
Average
Exercise
Price
14.64
26.16
Weighted
Average
Remaining
Contractual Life
(Years)
Aggregate
Intrinsic Value
(In thousands)
6.47 $
8.76
57,101
71,883
$
128,984
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the
fair value of the Company’s common stock at December 31, 2020 for stock options that were in-the-money.
The weighted-average grant-date fair value of options to purchase common stock granted for the years ended December 31,
2020, 2019 and 2018 using the Black-Scholes Model was $18.97, $17.74 and $9.05, respectively.
The total fair value of options that vested during 2020 was $9.0 million. As of December 31, 2020, there were approximately
$23.9 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a
weighted-average period of 2.85 years.
2014 Employee Stock Purchase Plan
The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common
stock based on a percentage of their compensation, but not greater than 15% of their earnings; provided, however, an eligible
employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the
fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering
periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value
of the common stock on the first day of the offering period or on the exercise date.
During the offering period in 2020 that ended on June 30, 2020, 38,576 shares were purchased for aggregate proceeds of $0.7
million from the issuance of shares, which occurred on July 1, 2020. The Company issued 76,723 shares and 51,712 shares of
common stock during the years ended December 31, 2020 and December 31, 2019, respectively, pursuant to the ESPP. The
Company received proceeds of $1.4 million and $0.8 million from the purchases of shares during the years ended December 31,
2020 and 2019, respectively. As of December 31, 2020, the Company had 511,933 shares available for issuance under the
ESPP.
Board of Directors Stock Awards Granted for Services
For the years ended December 31, 2020, 2019 and 2018, the Company paid a portion of its directors’ compensation through the
award of fully vested common shares. The stock awards are classified as equity, and compensation expense was recognized
upon the issuance of the shares at the grant date price per share, which is the fair value. As of December 31, 2020, there were a
total of 265,083 shares issued to the Company’s directors, for a total fair value of $1.7 million. Stock-based compensation
expense associated with the awards was $0.3 million, $0.2 million and $0.3 million for the years ended December 31, 2020,
2019 and 2018, respectively, which was included in general and administrative expense in the consolidated statements of
operations.
111 Valuation Assumptions
The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing
model based on the following weighted average assumptions:
Employee stock options
Expected term (in years)
Expected volatility
Risk-free interest rate
Expected dividend yield
Employee stock purchase plan
Expected term (in years)
Expected volatility
Risk-free interest rate
Expected dividend yield
Year Ended December 31,
2020
2019
2018
5.98
75.56 %
0.69 %
— %
5.97
70.78 %
2.32 %
— %
5.90
69.69 %
2.77 %
— %
0.5
0.5
0.5
62.56% – 93.17%
70.80% – 76.66% 59.94% – 105.32%
0.17% – 1.57%
2.10% – 2.51%
1.61% – 2.14%
— %
— %
— %
Risk-free Interest Rate: The Company based the risk-free interest rate over the expected term of the award based on the constant
maturity rate of U.S. Treasury securities with similar maturities as of the date of grant.
Volatility: The Company used an average historical stock price volatility of its own stock and those comparable public
companies that were deemed to be representative of future stock price trends.
Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are
expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical
exercise patterns and termination behavior.
Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future.
Stock-Based Compensation Expense
The following table summarizes stock-based compensation expense relating to employee and nonemployee stock-based awards
for the years ended December 31, 2020, 2019 and 2018, included in the consolidated statements of operations as follows (in
thousands):
Cost of testing services
Cost of product
Cost of digital and other
Research and development
Sales and marketing
General and administrative
Total
Year Ended December 31,
2020
2019
2018
$
1,493 $
1,751 $
391
449
4,676
5,795
10,597
280
152
4,422
4,008
11,804
$
23,401 $
22,417 $
761
60
—
1,631
986
3,700
7,138
No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable
income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax
assets. In addition, no amounts of stock-based compensation costs were capitalized for the periods presented.
112 15. INCOME TAXES
Loss before income taxes for the years ended December 31, 2020, 2019 and 2018 is summarized as follows (in thousands):
United States
Foreign
Total loss before income taxes
As of December 31,
2020
2019
2018
$
(14,233) $
(19,386) $
(41,109)
(5,517)
(4,561)
(7,106)
$
(19,750) $
(23,947) $
(48,215)
The components of the provision for (benefit from) income taxes are summarized as follows (in thousands):
Current
Federal
State
Foreign
Total current income tax expense (income tax benefit)
Deferred
Federal
State
Foreign
Total deferred income tax benefit
Income tax benefit
As of December 31,
2020
2019
2018
$
(58) $
(571) $
1
160
103
91
(52)
(1,178)
(1,139)
1
83
(487)
(558)
(47)
(887)
(1,492)
$
(1,036) $
(1,979) $
24
—
139
163
13
4
(1,614)
(1,597)
(1,434)
The Company's actual provision for tax differed from the amounts computed by applying the U.S. federal income tax rates of
21% in each of the years ended 2020, 2019 and 2018, to loss before income taxes as a result of the following:
Federal tax statutory rate
Stock-based compensation
Change in valuation allowance
Foreign rate differential
Warrant revaluation
Interest expense
Non-deductible executive compensation
Research credits
Changes in net operating loss carryforwards, including expirations
Other
Effective income tax rate
Year Ended December 31,
2020
2019
2018
21.0 %
13.5 %
(34.4) %
1.8 %
(1.7) %
(0.3) %
(6.8) %
3.9 %
6.9 %
1.2 %
5.2 %
21.0 %
9.9 %
(16.6) %
0.3 %
0.3 %
(0.2) %
(7.6) %
2.6 %
(1.5) %
0.1 %
8.3 %
21.0 %
1.3 %
(9.4) %
2.4 %
(10.0) %
(1.7) %
(0.7) %
0.4 %
— %
(0.3) %
3.0 %
113 Deferred income tax assets and liabilities consist of the following: (in thousands):
Deferred tax assets:
Net operating loss carryforwards
Tax credit carryforwards
Accruals
Property and equipment
Lease liability
Other
Gross deferred tax assets
Valuation allowance
Total deferred tax assets
Deferred tax liabilities:
Purchased intangibles
Operating leases right-of-use assets
Other
Total deferred tax liabilities
Net deferred tax liabilities
As of December 31, 2020
2020
2019
$
60,578 $
56,735
8,507
4,598
1,047
4,408
4,302
83,440
(72,860)
10,580
(7,683)
(3,708)
(488)
(11,879)
$
(1,299) $
7,239
2,649
1,078
1,015
2,224
70,940
(64,412)
6,528
(7,589)
(878)
(34)
(8,501)
(1,973)
The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and
negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future
taxable income and (iv) the length of net operating loss carryforward periods. The Company believes that based on the history
of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be
able to realize its U.S. net deferred tax assets. The Company has also placed a valuation allowance on the net deferred tax assets
of its Australian operations. Accordingly, the U.S. and Australia net deferred tax assets have been offset by a full valuation
allowance. The valuation allowance increased by $8.4 million and $4.1 million during the years ended December 31, 2020 and
2019, respectively.
As of December 31, 2020, the Company had domestic federal net operating loss carryforwards of $239.0 million, domestic state
net operating loss carryforwards of $93.9 million, and foreign net operating loss carryforwards of $15.3 million that can reduce
future taxable income. Of the $239.0 million of federal net operating losses, $32.6 million is carried forward indefinitely. The
remaining domestic federal and state net operating loss carryforwards will begin to expire in 2021 and 2029, respectively. The
foreign net operating loss carryforwards can be carried forward indefinitely.
As of December 31, 2020, the Company had credit carryforwards of approximately $6.9 million and $7.6 million available to
reduce future taxable income, if any, for domestic federal and California state income tax purposes, respectively. The domestic
federal credit carryforwards begin to expire in 2021. California credits have no expiration date.
Utilization of the Company's net operating loss and credit carryforwards may be subject to a substantial annual limitation due to
the ownership change limitations provided by the Internal Revenue Code of 1986, as amended and similar state provisions.
Based on a preliminary review of the Company's equity transactions since inception, the Company believes a portion of its net
operating loss carryforwards and credit carryforwards may be limited due to equity financings which occurred in 2000, 2004,
2007, 2014 and through the current period.
A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands):
Balance at the beginning of the year
Additions based on tax positions related to the current year
Decreases based on tax positions related to prior years
Balance at the end of the year
Year Ended December 31,
2020
2019
2018
$
3,650 $
3,449 $
3,164
824
(58)
667
(466)
285
—
$
4,416 $
3,650 $
3,449
114 None of the $4.4 million net unrecognized tax benefit as of December 31, 2020, if recognized, would impact the Company's
effective tax rate. During the year ended December 31, 2020, given the Company's valuation allowance, the uncertain tax
benefits would not have impacted the effective tax rate.
The Company recognizes interest and penalties related to unrecognized tax benefits as a component of income tax expense. As
of December 31, 2020 and December 31, 2019, the Company had in each year $0.2 million of cumulative interest and penalties
related to unrecognized tax benefits. The Company does not anticipate a significant change in the unrecognized tax benefits
over the next twelve months.
The Company files U.S., state and foreign income tax returns in jurisdictions with varying statutes of limitations. Due to net
operating loss and credit carryovers, the domestic federal and state income tax returns are subject to tax authority examination
from inception. In foreign jurisdictions where the Company files income tax returns, the statutes of limitations with respect to
these jurisdictions vary from jurisdiction to jurisdiction and range from 3 to 6 years.
On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”), was signed into law making significant changes to
the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for
tax years beginning after December 31, 2017. The Company calculated the impact of the Tax Act in its year end income tax
provision in accordance with its understanding of the Tax Act and guidance available as of the date of the filing of the
Company's Annual Report on Form 10-K for the year ended December 31, 2017, which did not result in any additional income
tax expense in the fourth quarter of 2017. The enactment of the Tax Act also requires companies to recognize the effects of
changes in tax laws and rates on deferred tax assets and liabilities and the retroactive effects of changes in tax laws in the period
in which the new legislation is enacted. Consequently, the Company accounted for a provisional estimated reduction of the U.S.
deferred tax assets from $72.5 million to approximately $45.9 million with a corresponding decrease of $27.0 million to the
Company’s valuation allowance in 2018. The Company completed its analysis of the impacts of the 2017 Tax Act in the fourth
quarter of 2018 with no net change to its provisional estimates.
Starting in 2018, companies may be subject to global intangible low tax income (“GILTI”), which is a tax on foreign income in
excess of a deemed return on tangible assets of foreign corporations as well as the new base erosion anti-abuse tax (“BEAT”)
under the Tax Act. GILTI will be effectively taxed at a tax rate of 10.5%. Due to the complexity of the GILTI tax rules,
companies are allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable
income related to GILTI as a current-period expense when incurred or (2) factoring such amounts into a company’s
measurement of its deferred taxes. The Company has not made an election with respect to GILTI and does not believe that
GILTI will have a material impact on the Company’s 2020 taxes. The Company will continue to review the GILTI and BEAT
rules to determine their applicability to the Company and the impact that the rules may have on the Company's results of
operations and financial condition.
115 16. SEGMENT REPORTING
Operating segments are defined as components of an enterprise for which separate financial information is available that is
evaluated regularly by the Company's Chief Operating Decision Maker (“CODM”), or decision making group, whose function
is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief
Executive Officer as the CODM. In determining its reportable segments, the Company considered the markets and types of
customers served and the products or services provided in those markets. The Company operates in a single reportable segment.
Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for
testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
Testing services revenue
United States
Rest of World
Product revenue
United States
Europe
Rest of World
Digital and other revenue
United States
Europe
Rest of World
Total United States
Total Europe
Total Rest of World
Total
Year Ended December 31,
2020
2019
2018
$
163,221 $
104,056 $
59,683
389
494
617
$
163,610 $
104,550 $
60,300
$
9,219 $
8,078 $
7,475
2,608
7,690
2,511
5,881
7,506
2,287
$
$
$
$
$
$
19,302 $
18,279 $
15,674
9,063 $
4,062 $
87
132
100
77
9,282 $
4,239 $
499
96
—
595
181,503 $
116,196 $
66,063
7,562 $
3,129 $
7,790 $
3,082 $
7,602
2,904
$
192,194 $
127,068 $
76,569
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in
thousands):
Long-lived assets:
United States
Europe
Rest of World
Total
December 31, 2020 December 31, 2019
$
$
9,888 $
351
465
10,704 $
3,346
509
575
4,430
116 17. SUBSEQUENT EVENTS
CMS Accelerated and Advance Payment Program for Medicare Providers
As discussed in Note 8, on January 19, 2021, the Company repaid the $20.5 million Refund liability - CMS advance payment.
After repayment, the remaining balance was $0.0 million.
Underwritten Public Offering of Common Stock
On January 25, 2021, the Company sold 1,923,077 shares of its common stock through an underwritten public offering at a
public offering price of $91.00 per share. The net proceeds to the Company from the offering were approximately
$164.0 million, after deducting underwriting discounts and commissions and estimated offering expenses.
On February 11, 2021, the Company sold 288,461 shares of its common stock pursuant to the underwriters' full exercise of an
overallotment option granted to the underwriters in connection with the offering. The net proceeds to the Company from the full
exercise of the underwriters' overallotment option were approximately $24.7 million. The aggregate net proceeds to the
Company, including the shares sold pursuant to the underwriters' full exercise of the overallotment option, were approximately
$188.7 million, after deducting underwriting discounts and commissions and estimated offering expenses.
TransChart LLC
In January 2021, the Company acquired TransChart LLC (“TransChart”) for cash. TransChart provides EMR software to
hospitals throughout the U.S. to care for patients who have or may need an organ transplant. TransChart builds on the
Company's digital offerings, which include Ottr, Inc. transplant electronic medical record software and XynQAPI transplant
quality management solutions.
Given the timing of the closing of this transaction, the Company is currently in the process of valuing the assets acquired and
liabilities assumed in the business combination. As a result, the Company is not yet able to provide the amounts to be
recognized as of the acquisition date for the major classes of assets acquired and liabilities assumed and other related
disclosures. The Company will disclose this and other related information in the Company's Form 10-Q for the quarter ended
March 31, 2021.
117 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of its disclosure
controls and procedures, as such terms are defined in Rules 13a-15(b) and 15d-15(e) promulgated under the Exchange Act, as
of December 31, 2020. In designing and evaluating the disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the
desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are
resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and
procedures relative to their costs. Based on such evaluation, the 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 and are
effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the
Exchange Act, is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and
communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow
timely discussion regarding required disclosure.
Management’s Annual Report on Internal Control over Financial Reporting
Management, including our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining
adequate internal control over financial reporting. Our internal control system was designed to provide reasonable assurance to
our management and board of directors regarding the preparation and fair presentation of published consolidated financial
statements in accordance with accounting principles generally accepted in the United States.
Management assessed the effectiveness of the Company's internal control over financial reporting as of December 31, 2020. In
making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway
Commission, or COSO, in the 2013 Internal Control-Integrated Framework. Based on our assessment, management has
concluded the Company maintained effective internal control over financial reporting as of December 31, 2020.
Attestation Report of the Independent Registered Public Accounting Firm
The effectiveness of our internal control over financial reporting as of December 31, 2020 has been audited by Deloitte &
Touche LLP, an independent registered public accounting firm, as stated in their report, which appears herein.
Changes in Internal Control over Financial Reporting
None.
ITEM 9B. OTHER INFORMATION
None.
118 PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is incorporated by reference from the information contained in our Definitive Proxy
Statement to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020 in connection with
the Annual Meeting of Stockholders to be held in 2021, or the 2021 Proxy Statement. To the extent that we do not file the 2021
Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information
required by this Item 10.
We have adopted a Code of Business Conduct and Ethics that applies to all of our officers and employees (including our
principal executive officer, principal financial officer, principal accounting officer or controller and other employees who
perform financial or accounting functions), agents and representatives, including our independent directors and consultants,
who are not employees of ours, with regard to their CareDx-related activities. Our Company’s Code of Business Conduct and
Ethics is available on its website at www.caredx.com under the heading “Compliance” under the section titled “Company”. We
will post on this section of our website any amendment to our Code of Business Conduct and Ethics, as well as any waivers of
our Code of Business Conduct and Ethics that are required to be disclosed by the rules of the SEC or The Nasdaq Stock Market
LLC.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference from the information contained in the 2021 Proxy Statement.
The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020.
To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this Annual Report on
Form 10-K that includes the information required by this Item 11.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by this item is incorporated by reference to from the information contained in the 2021 Proxy
Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended
December 31, 2020. To the extent that we do not file our 2021 Proxy Statement by such date, we will file an amendment to this
Annual Report on Form 10-K that includes the information required by this Item 12.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated by reference to from the information contained in our 2021 Proxy
Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended
December 31, 2020. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this
Annual Report on Form 10-K that includes the information required by this Item 13.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is incorporated by reference from the information contained in the 2021 Proxy
Statement. The 2021 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended
December 31, 2020. To the extent that we do not file the 2021 Proxy Statement by such date, we will file an amendment to this
Annual Report on Form 10-K that includes the information required by this Item 14.
119 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1) Financial Statements:
PART IV
Our Financial Statements are listed in the “Index to Consolidated Financial Statements” of CareDx, Inc. Part II, Item 8 of this
Annual Report on Form 10-K.
(a)(2) Financial Statement Schedules
All financial statement schedules have been omitted because they are not required, not applicable, or the required information is
included in the consolidated financial statements or notes thereto included in this Annual Report on Form 10-K.
(a)(3) Exhibits
The following exhibits are incorporated by reference or are filed with this report, in each case as indicated therein (numbered in
accordance with Item 601 of Regulation S-K).
Exhibit
Number
3.1
3.2
4.1
4.2#
4.3#
4.4#
4.5#
4.6
4.7#
4.8*
10.1#
10.2#
10.3#
10.4#
10.5#
10.6#
10.7#
10.8#
10.9#
10.10#
10.11
Description
Amended and Restated Certificate of Incorporation of the
Registrant.
Amended and Restated Bylaws of the Registrant.
Form of Registrant’s common stock certificate.
2014 Equity Incentive Plan and forms of agreements, as
amended.
Form of Option Agreement under the 2014 Equity
Incentive Plan for New Options.
2014 Employee Stock Purchase Plan and forms of
agreements thereunder.
2016 Inducement Equity Incentive Plan.
Form of Warrant.
2019 Inducement Equity Incentive Plan.
Description of Securities of CareDx, Inc.
Executive Chair Agreement, dated October 29, 2020, by
and between the Registrant and Peter K. Maag, Ph.D.
Offer Letter, dated October 18, 2011, by and between the
Registrant and Michael D. Goldberg.
Offer Letter, dated April 8, 2014, by and between the
Registrant and George Bickerstaff, III.
Offer Letter, between the Registrant and Sasha King,
dated October 20, 2017.
Offer Letter, dated November 13, 2018, between the
Registrant and Reginald Seeto, MBBS.
Form of Change of Control and Severance Agreement
between the Registrant and each of its executive officers.
Amendment to Change of Control and Severance
Agreement, dated October 29, 2020, by and between
CareDx, Inc. and Reginald Seeto, MBBS.
Form of Indemnification Agreement between the
Registrant and each of its directors and executive officers.
Executive Incentive Compensation Plan.
Outside Director Compensation Policy.
Lease, dated April 27, 2006, as amended on November
10, 2010, by and between the Registrant and BMR-
Bayshore Boulevard LLC, for office and laboratory space
located at 3260 Bayshore Boulevard, Brisbane, California
94005.
Form
10-Q
10-Q
10-K
8-K
Incorporated by Reference
File No.
001-36536
Exhibit
3.1
Filing Date
8/28/2014
001-36536
001-36536
001-36536
3.4
4.1
10.1
8/28/2014
3/31/2015
6/26/2018
SC TO-I
005-88252
99(d)(3)
10/12/2017
S-8
S-8
8-K
8-K
333-197493
4.5
7/18/2014
333-211538
001-36536
001-36536
4.1
10.3
10.1
5/23/2016
4/14/2016
9/4/2019
8-K
001-36536
10.2
10/29/2020
10-K
001-36536
10.15
3/31/2015
10-K
001-36536
10.14
3/31/2015
10-K
001-36536
10.6
3/22/2018
8-K
S-1
8-K
001-36536
10.1
11/26/2018
333-196494
10.11
6/3/2014
001-36536
10.1
10/29/2020
S-1
333-196494
10.1
6/3/2014
10-K
001-36536
10.19
3/31/2015
S-1
333-196494
10.12
6/3/2014
120 Incorporated by Reference
Form
10-Q
File No.
001-36536
Exhibit
10.1
Filing Date
4/30/2020
10-Q
001-36536
10.2
4/30/2020
S-1/A
333-196494
10.17
7/15/2014
S-3
333-227168
1.2
8/31/2018
10-Q/A
001-36536
10.3
10/9/2018
Exhibit
Number
10.12+
10.13+
10.14†
10.15
10.16†
21.1*
23.1*
24.1*
31.1*
31.2*
32.1**
101.INS*
Description
Second Amendment to Lease, dated January 2, 2020, by
and between the Registrant and BMR-Bayshore
Boulevard LP (formerly known as BMR-Bayshore
Boulevard LLC), for office and laboratory space located
at 3260 Bayshore Boulevard, Brisbane, California 94005.
Consent to Sub-Sublease Agreement, dated as of October
30, 2019, by and among AP3-SF2 CT South, LLC,
SuccessFactors, Inc., Medeor Therapeutics, Inc. and
CareDx, Inc. for office space located at One Tower Place,
9th Floor, South San Francisco, California 94080.
Amended and Restated Exclusive Agreement, dated
January 27, 2014, by and between the Board of Trustees
of the Leland Stanford Junior University and
ImmuMetrix, Inc.
Sales Agreement, dated August 31, 2018 by and between
the Registrant and Jeffries LLC.
License and Commercialization Agreement, dated May 4,
2018, between the Registrant and Illumina, Inc.
Subsidiaries of the Registrant.
Consent of Deloitte & Touche LLP, Independent
Registered Public Accounting Firm.
Power of Attorney (see page 115 of this Annual Report on
Form 10-K).
Principal Executive Officer’s Certifications Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Principal Financial Officer’s Certifications Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
Certification Pursuant to 18 U.S.C. § 1350 (Section 906
of Sarbanes-Oxley Act of 2002).
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104
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_____________________
†
+
#
*
Confidential treatment has been granted with respect to certain portions of this Exhibit. Omitted portions have been
filed separately with the SEC.
Non-material schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant
hereby undertakes to furnish supplementally copies of any of the omitted schedules and exhibits upon request by the
SEC.
Indicates management contract or compensatory plan or arrangement.
Filed herewith.
**
Furnished herewith.
ITEM 16. FORM 10-K SUMMARY
None.
121 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
CAREDX, INC.
By:
/s/ Reginald Seeto, MBBS
Reginald Seeto, MBBS
President and Chief Executive
Officer
Date: February 24, 2021
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints
Reginald Seeto and Marcel Konrad, and each of them, his true and lawful attorneys-in-fact, each with full power of substitution,
for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with
exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying
and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue
hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following
persons, on behalf of the registrant on the dates and the capacities indicated.
Signature
Title
/s/ REGINALD SEETO, MBBS
Reginald Seeto, MBBS
President, Chief Executive Officer and
Director
(Principal Executive Officer)
Date
February 24, 2021
/s/ MARCEL KONRAD
Marcel Konrad
/s/ PETER MAAG, PH.D.
Peter Maag, Ph.D.
/s/ GEORGE W. BICKERSTAFF, III
George W. Bickerstaff, III
/s/ FRED E. COHEN
Fred E. Cohen
/s/ GRACE COLÓN
Grace Colón
/s/ CHRISTINE M. COURNOYER
Christine M. Cournoyer
/s/ MICHAEL D. GOLDBERG
Michael D. Goldberg
/s/ RALPH SNYDERMAN
Ralph Snyderman
/s/ WILLIAM HAGSTROM
William Hagstrom
Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
February 24, 2021
Executive Chair and Director
February 24, 2021
Director
Director
Director
Director
Director
Director
Director
February 24, 2021
February 24, 2021
February 24, 2021
February 24, 2021
February 24, 2021
February 24, 2021
February 24, 2021
122 CORPORATE INFORMATION
Executive Team
Reginald Seeto, MBBS
President and Chief Executive Officer
Ankur Dhingra
Chief Financial Officer
Sasha King
Chief Marketing Officer
Annual Stockholders Meeting
June 15, 2021 at 10AM PST
Virtual Meeting via live webcast at:
http://www.virtualshareholdermeeting.com/CDNA2021
Exchange
Nasdaq Global Market
Ticker Symbol CDNA
Transfer Agent
Computershare Trust Company, N.A.
PO Box 30170
College Station, TX 77842
Legal Counsel
Paul Hastings LLP
1117 S. California Avenue
Palo Alto, CA 94034
Independent Registered
Public Accounting Firm
Deloitte
225 West Santa Clara Street, Suite 600
San Jose, CA 95113
Investor Relations
Gilmartin Group
1628 Tiburon Blvd
Belvedere Tiburon, CA 94902
Note on Forward-Looking Statements
This annual report contains forward-looking
statements within the meaning of the
federal securities laws. Results could differ
materially. Further infomation on factors
that could accect results is included in
the 2020 Form 10-K included in this
annual report.
Board of Director
Peter Maag, PhD
Executive Chair of the Board
CareDx, Inc.
Michael D. Goldberg, MBA
Lead Independent Director
Audit Committee
Compensation Committee,
Nominating/Corporate Governance
Fred E. Cohen, MD, DPhil
Senior Managing Director
Vida Ventures
Compensation Committee*,
Science and Technology Committee
Grace Colón, PhD
President & CEO Incarda Therapeutics, Inc.
Compensation Committee,
Science and Technology Committee*
Chris M. Cournoyer
Audit Committee,
Science and Technology Committee
Reginald Seeto, MBBS
President and Chief Executive Officer
CareDx, Inc.
Ralph Snyderman, MD
Chancellor Emeritus & James B. Duke
Professor of Medicine
Duke University
Nominating/Corporate Governance
Committee*,
Science and Technology Committee
George W. Bickerstaff, III
Managing Director
MM Dillon & Co.
Audit Committee*
William Hagstrom
CEO, Octave Bioscience
Audit Committee,
Compensation Committee
*Indicates Chairperson of the Committee
CareDx, Inc
1 Tower Place, 9th Floor
South San Francisco, CA 94080
Tel 415.287.2300
Fax 415.287.2450
WWW.CAREDX.COM
BR14167L-0521-10K
2020 Annual Report