2018 Annual Report
Dear Stockholders,
We at CareDx continue to build a leading company in transplant patient care. Our
focus is set on improving long-term outcomes by providing better matching
technology and better surveillance to the roughly 700,000 transplant patients globally.
In 2018, our company experienced significant growth and our revenues increased to
$76.6 million.
Last year was the launch year for AlloSure, our key growth driver. Only one year into
the launch we have provided roughly 3% of kidney transplant patients with an
AlloSure test result. With 100 centers using our technology, and nearly 50 transplant
centers participating in our K-OAR clinical trial, we have laid the foundation for future
adoption and adherence in the years to come. The establishment of the AlloSure
Routine Testing Schedule for AlloSure is set to improve the surveillance standard for
caregivers and patients with deeper insights into the health of the transplanted organ.
In 2018, we continued to grow AlloMap and also expanded our presence in the
pre-transplant field. Following the integration of the Illumina assets, we are now a
leading provider of PCR and NGS technology in the field of transplantation.
In the third quarter, CareDx turned a corner by generating positive operating cash
flow. We ended the year with cash and cash equivalents of $64.6 million and a
balance sheet that allows us to focus on the execution of our growth plans.
Thank you to all the employees and stockholders of CareDx. I look forward to your
continued partnership as we drive profitable growth along the transplant patient
journey.
With Best Wishes,
Peter Maag
CEO
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
(cid:3) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2018
(cid:4)
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)
3260 Bayshore Boulevard
Brisbane, California 94005
(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
Common Stock, par value $0.001 per share
Name of Each Exchange on Which Registered
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 (cid:5) No (cid:3)
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes (cid:5) No (cid:3)
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 (cid:3) No (cid:4)
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 (cid:3) No (cid:4)
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to
this Form 10-K. (cid:3)
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 (cid:4)
Non-accelerated filer (cid:4)
Accelerated filer
(cid:3)
Smaller reporting company(cid:3)
Emerging growth company(cid:3)
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. (cid:3)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:5) No (cid:3)
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, 2018 as reported by the Nasdaq Global Market on such date was approximately $321,787,874. 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 March 4, 2019 was 41,728,442.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s Proxy Statement relating to the 2019 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, 2018.
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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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,” “would,” “project,” “plan,” “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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our ability to generate revenue from sales of AlloMap®, AlloSure® and future testing services, if any,
and our ability to increase the commercial success of these testing services;
our ability to obtain, maintain and expand reimbursement coverage from payers for AlloMap, AlloSure
and other future testing services, if any;
our ability to generate revenue from sales of Olerup SSP®, Olerup SBTTM, QTYPE®, TruSight® HLA,
and future products, if any, and our ability to increase the commercial success of these products;
our ability to generate revenue from the license and commercialization agreement (the “License
Agreement”) with Illumina, Inc. (“Illumina”);
our plans and ability to develop and commercialize new solutions for the surveillance of heart, kidney,
and other solid organ transplant recipients;
our plans and ability to continue updating our products, services and technology to maintain our leading
position in transplantations;
the outcome or success of our clinical trial collaborations and registry studies;
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 defend against or settle any litigation brought against us or other legal matters
or disputes; and
our ability to comply with the requirements of being a public company.
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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 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.
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 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.
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ITEM 1. BUSINESS
Company Overview
PART I
CareDx, Inc. (“CareDx” or the “Company” or “we” or “us” and “our”) together with our subsidiaries, is a global
transplant diagnostics company with product offerings along the pre- and post-transplant continuum. We focus on
discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for
transplant patients. In diagnostic testing services, we offers AlloMap, which is a gene expression solution for heart
transplant patients and AlloSure, which is a donor-derived cell-free DNA (“dd-cfDNA”) solution initially
commercialized for kidney transplant patients. 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.
Testing Services
AlloMap
Our first commercialized testing solution, the AlloMap heart transplant molecular test, or AlloMap, 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 solution through ongoing studies to substantiate the clinical utility and
actionability of AlloMap, secure positive reimbursement decisions for AlloMap 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, in conjunction with other clinical
indicators, can help healthcare providers and their patients better manage long-term care following a heart
transplant. In particular, we believe AlloMap can improve patient care by helping healthcare providers avoid the use
of unnecessary, invasive surveillance biopsies and determine the appropriate dosage levels of immunosuppressants.
AlloMap has received 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for marketing and
sale as a test to aid in the identification of recipients with a low probability of moderate or severe acute cellular
rejection.
AlloMap has been a covered service for Medicare beneficiaries since January 1, 2006. The 2018 reimbursement rate
for AlloMap was $3,240, which represents a 14% increase over the 2017 reimbursement rate. AlloMap has also
received positive coverage decisions from many of the largest U.S. private payers, including Aetna, Anthem, Cigna,
Health Care Services Corporation (HCSC), Humana, Kaiser Foundation Health Plan, Inc., TRICARE, and
UnitedHealthcare.
We have also successfully completed a number of landmark clinical trials in the transplant field demonstrating the
clinical utility of AlloMap for surveillance of heart transplant recipients. We initially established the analytical and
clinical validity of AlloMap on the basis of our Cardiac Transplanted Organ Rejection Gene Expression
Observational (Deng, M. et al., Am J Transplantation 2006), or CARGO, study, which was published in the
American Journal of Transplantation. 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 surveillance were equivalent to
outcomes in recipients managed with biopsies. The results of our clinical trials have also been presented at major
medical society congresses and published in peer-reviewed publications in leading medical journals.
Since the launch of AlloMap in January 2005, we have performed more than 123,000 commercial AlloMap tests,
including 16,116 tests during 2018, from our Brisbane, California, laboratory. We estimate that there are
approximately 138 centers performing heart transplants in the United States. In 2018, 133 of these centers used
AlloMap.
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AlloSure
AlloSure, our surveillance solution for kidney transplant recipients, applies proprietary next generation sequencing
technology to measure dd-cfDNA in the blood stream emanating from the donor organ. We believe AlloSure may
help clinicians determine rejection-specific activity manifested as cell damage in the transplanted organ. We also
believe the use of AlloSure, 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 can improve
patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate
dosage levels of immunosuppressants. Effective October 9, 2017, AlloSure became available for commercial testing
with Medicare coverage and reimbursement. The Medicare reimbursement rate for AlloSure is $2,841. AlloSure
has also received payment from private payers on a case-by-case basis, while our Payer Relations team works to
establish positive coverage. However, no positive coverage decisions have been made to the date of this filing.
Prior to the commercialization of AlloSure, we generated a strong body of clinical evidence. In late 2015, we
announced the completion of analytical validation of AlloSure. Samples used in the analytical validation included
donor recipient pairs with unrelated donors, as well as closely related family members. A report describing the
analytical validation of AlloSure including clinical validation information for heart transplant, appeared in the
November 2016 issue of The Journal of Molecular Diagnostics. The Circulating Donor-Derived Cell-Free DNA in
Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients, or DART, trial, sponsored by us, was
conducted between April 2015 and January 2018. DART was a 14 center observational study of kidney transplant
recipients where blood specimens were drawn periodically after transplant during follow up visits and also after
treatment for acute rejection. By the time of completion of the first analysis, 384 patients were followed in DART
for up to 24 months. The results demonstrated that increased levels of dd-cfDNA, determined by the AlloSure assay,
discriminated active rejection of a kidney transplant more effectively than serum creatinine values. In collaboration
with clinical investigators, we published these findings in the scientific peer-reviewed Journal of the American
Society of Nephrology and the Journal Applied Laboratory Medicine in March 2017. A total of 2,109 patient visits
had been accrued in DART by January 2018. We plan to analyze and report on additional findings from this dataset
in 2019 and into the future.
In January 2018, we initiated the Kidney Allograft Outcomes AlloSure Registry study, or K-OAR, to develop
further data on the clinical utility of AlloSure for surveillance of kidney transplant recipients. As of December 31,
2018, 47 centers had been initiated as K-OAR sites and 748 patients had been enrolled.
Throughout 2018, there were 11,634 AlloSure patient test results provided from our Brisbane, California, laboratory.
In the fourth quarter of 2018, AlloSure was ordered by 100 kidney transplant centers in the United States.
HeartCare
In September, 2018, we 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 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 – a measure of immune activation, and (ii) AlloSure-Heart – a measure
of graft injury. HeartCare provides complementary information about distinct biological processes, such as immune
quiescence, active injury, Acute Cellular Rejection (“ACR”) and Antibody Mediated Rejection (“AMR”) in heart
transplant recipients.
Products
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 organs. Olerup SSP is used to type Human
Leukocyte Antigen, or HLA alleles based on sequence-specific primer, or SSP, technology. Olerup SBT is a
complete product range for sequence-based typing of HLA alleles. 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, or PCR, methodology. QTYPE received CE mark certification on April 10, 2018.
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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 next generation sequencing 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. 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.
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 most recently changed
our name to CareDx, Inc. Our principal executive offices are located at 3260 Bayshore Boulevard, Brisbane,
California and our telephone number is (415) 287-2300.
On June 10, 2014, we acquired ImmuMetrix, Inc., or IMX, a privately held development-stage company focused on
dd-cfDNA-based solutions in transplantation and other fields. Through this acquisition, we added to our existing
know-how, expertise and intellectual property in applying dd-cfDNA technology to the surveillance of transplant
recipients, which has contributed to the development of AlloSure. The intellectual property rights of IMX included
an exclusive license from 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.
On April 14, 2016, we acquired 98.3% of the outstanding common stock of Allenex AB, or Allenex. Our
combination with Allenex created an international transplant diagnostics company with product offerings along the
pre and post-transplant continuum. As a result of the acquisition we now have a presence and direct distribution
channels in the U.S. and Europe, with additional third party distributors in Europe and other markets around the
world. On March 15, 2018, we purchased the remaining 1.7% of outstanding common stock of Allenex.
On January 20, 2017, we acquired the business assets of Conexio Genomics Pty Ltd, Conexio, to offer a complete
product range for sequence-based typing of HLA alleles.
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 next generation sequencing, or 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. 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.
As of December 31, 2018, 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. We changed our internal organization structure in the
third quarter of 2018 and no longer operate in two reportable segments: Post-Transplant and Pre-Transplant. Sales
and other financial information by geographic area is provided in 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 2017 charges
for a heart transplant is $1.38 million and for a kidney transplant is $0.41 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 patients circumstances. Unsuccessful treatment of rejection can result in an additional transplant.
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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.
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.
Our Services and Products
Testing Services
We develop and provide a diagnostic surveillance testing service for heart and kidney transplant recipients.
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Our first commercialized testing solution, AlloMap, 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. AlloMap is designed to help health care providers and their patients to better manage long-term
care, avoid the use of invasive surveillance biopsies and determine the appropriate dosage levels of
immumosuppressant medications. AlloMap uses a sample of the patient’s blood. AlloMap may be used instead of a
surveillance heart biopsy to rule out acute cellular rejection in heart transplant recipients. AlloMap offers rapid,
high quality results, and we aim to return AlloMap results to the clinician within three business days after the blood
draw.
The test measures the molecular signatures that correlate with biological activity associated with moderate to severe
acute cellular rejection. Gene expression may indicate acute cellular rejection well before the evidence of damage is
visible from a tissue biopsy sample. AlloMap applies a proprietary mathematical algorithm comprised of the
expression of 20 genes, as measured by specific RNA levels. Of the 20 genes, 11 are informative and 9 are for
quality control. The algorithm then yields a single AlloMap score. AlloMap may be used for heart transplant
recipients 15 years of age or older, starting on day 55 post-transplant.
AlloMap provides a single integer score ranging from 0 to 40 and determines the probability of the absence of
moderate to severe acute cellular rejection. A key benefit of the AlloMap score is its negative predictive value, or
NPV. The NPV of AlloMap is the likelihood that a heart transplant recipient does not have acute rejection. The
NPV for recipients with an AlloMap score below the threshold value can be greater than 99% depending on the
actual score.
The clinical utility of AlloMap is well established. AlloMap is the first and only non-invasive method
recommended in the International Society for Heart & Lung Transplantation, or ISHLT, patient care guidelines for
surveillance of heart transplant recipients for rejection in non-infants. AlloMap has obtained 510(k) clearance from
the FDA as an In Vitro Diagnostic Multivariate Index Assay, or IVDMIA. In addition, the clinical utility of
AlloMap is supported by numerous clinical trials that we have sponsored, the results of which have been published
in leading peer-reviewed medical journals.
When incorporating AlloMap into their practice, clinicians may consider recipient history, a physical exam, graft
function and the results of AlloMap at each post-transplant clinic visit. If the recipient’s AlloMap score is below an
applicable threshold, in the absence of other clinical indicators of rejection, clinicians may elect not to conduct a
surveillance biopsy at that time. Where there are signs or indications of rejection, evidence of failure or impaired
function or an AlloMap score greater than the applicable threshold, a biopsy may be ordered.
AlloMap Score Variability, or AMV, is a service we offer that we believe provides useful, 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 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 test results within a 24-month
period. A low AMV may indicate a lower risk of future events, which suggests that a patient may be a potential
candidate for reduced immunosuppression. A high AMV may indicate a higher risk of future events, which suggests
a patient may merit more vigilant surveillance. The concept of AMV was developed over the course of several
years, beginning as an observation in clinical studies of low score variability among stable patients which suggested
that AMV might be a predictor of future clinical events and rejection episodes. The Cardiac Allograft Rejection
Gene Expression Observational II, or CARGO II, study included data which demonstrated that AMV may be useful
in estimating the probability of future adverse events, such as death, re-transplantation or graft failure in heart
transplant recipients who were undergoing surveillance with AlloMap testing more than 315 days following
transplantation.
AlloSure, our surveillance solution for kidney transplant recipients, applies proprietary next generation sequencing
technology to measure dd-cfDNA in the blood stream emanating from the donor organ. We believe AlloSure may
help clinicians determine rejection-specific activity manifested as cell damage in the transplanted organ. We also
believe the use of AlloSure, 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 can improve
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patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate
dosage levels of immunosuppressants.
HeartCare combines the gene expression profiling technology of AlloMap 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 – a measure of immune activity, and (ii) AlloSure-Heart – measures graft
injury. HeartCare provides complementary information about distinct biological processes, such as immune
quiescence, active injury, Acute Cellular Rejection (“ACR”) and Antibody Mediated Rejection (“AMR”) in heart
transplant recipients.
Clinical Trials of AlloMap and AlloSure
The clinical validation and utility of AlloMap 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 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
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 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 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 are
associated with active rejection of the kidney allograft. The DART study evidence suggests that AlloSure, 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 could help identify patients with new or ongoing organ injury. In the
DART study, to investigate the use of AlloSure 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 provides clear stratification of patients for probability of rejection;
Active rejection patients showed median AlloSure levels at 1.6%;
Antibody- mediated rejection, or ABMR, patients showed median AlloSure levels at 2.9%;
Non-rejection patients showed median AlloSure levels of 0.21%; and
AlloSure 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 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
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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.
The AlloSure 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 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 plans to enroll greater
than 1,000 renal transplant patients who will receive AlloSure long-term surveillance. The clinical outcomes of these
patients will be entered into a registry database. The study cohort will include 300 patients at centers that will obtain
planned renal surveillance biopsies at 12 months post-transplantation. The other greater than 700 patients will be
from centers that do not perform protocol surveillance biopsies. Outcomes in this greater than 700 patient sub-
cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes
of the 300 AlloSure tests from the 12 month surveillance biopsy centers.
A matched control cohort of 300 patients will be retrospectively selected from the subset of centers providing the
test cohort patients who have planned surveillance biopsies at 12 months post-transplantation. 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 number of renal allograft biopsies
performed during the first year. Outcomes will include patient survival, graft survival, serum creatinine and
estimated glomerular filtration rate, evaluated at years 1, 2 and 3 post-transplantation.
Products
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 organs.
Olerup SSP is used to type HLA alleles, based on SSP technology. Olerup SBT is a complete product range for
sequence-based typing of HLA alleles. 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. TruSight HLA is high resolution solution that uses NGS methodology.
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.
QTYPE was commercially launched at the end of September 2016. 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,
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SCORE6. QTYPE received CE mark certification on April 10, 2018. QTYPE is validated on a broad range of
instruments including the Roche LightCycler® 480 II, QuantStudio 6, 7 and ViiA-7.
TruSight HLA is a NGS-based high resolution typing solution that provides NGS-level resolution to HLA typing.
CareDx licensed the exclusive world-wide distribution rights to this product from Illumina in May 2018.
Our suite of AlloSeq products are development-stage NGS-based kitted solutions that we acquired as a result of our
May 2018 License Agreement with Illumina. These products include: AlloSeq HLA, 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 BMT, a NGS solution for chimerism testing for stem cell transplant
recipients. Our AlloSeq products are designed to run on Illumina’s NGS instrumentation. We intend to launch our
AlloSeq products in 2019.
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. Our ongoing efforts include:
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defining the clinical utility and protocol of AlloSure for kidney transplant patients;
increased understanding of biological processes of transplant rejection through analysis of
genes/metagenes of archived clinical trials, OAR registry and commercial laboratory testing to further
improve clinical utility of AlloMap;
validation and clinical utility studies of AlloSure for other organs such as heart, lung and liver;
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;
developing donor-derived cell-free DNA reagents and software for distribution outside the United
States;
developing solutions for monitoring the success of hematopoietic stem cell transplantation;
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;
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; and
integrating real world data to confirm and extend results from other clinical data sets.
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. This is the first report to establish clinical performance characteristics for this
emerging molecular biomarker in renal transplant patients with an analytically validated assay of dd-cfDNA in the
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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 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. The Centers
for Medicare & Medicaid Services (“CMS”), Medicare Administrative Contractor (MAC), Palmetto GBA
(Palmetto”), in October 2017, recommended Medicare coverage for AlloSure which is contingent on this further
data development. The K-OAR study commenced in January 2018. K-OAR is a 1, 2 and 3 year post-transplant
clinical outcomes study in patients managed with AlloSure surveillance compared to another 300 patients who will
serve as a comparative control group managed without AlloSure.
dd-cfDNA for Heart Transplants
We believe that the AlloSure dd-cfDNA-based solution could provide additional value to AlloMap testing for
clinicians caring for heart transplant patients, particularly in situations where a recipient’s AlloMap score suggests a
probability of acute rejection.
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
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 are offer HeartCare. HeartCare combines the gene expression profiling technology of AlloMap
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 – 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, Acute Cellular Rejection and Antibody
Mediated Rejection in heart transplant recipients.
We have established our proprietary strategy for quantification of donor specific dd-cfDNA and we have completed
initial proof of concept studies. We now offer AlloSure as a laboratory developed test for a limited number of heart
transplant centers and physicians as part of our Utility of Donor-Derived Cell-Free DNA in Association with Gene-
Expression profiling (AlloMap) in Heart Transplant Recipients, or D-OAR, study.
Product Advancement and Development
Ongoing research and development in the pre-transplant arena encompasses six areas. First, the last decade of next
generation 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 Olerup SSP and QTYPE kits. We have been updating,
and intend to continue to update, our HLA typing kits with newly identified alleles. Olerup SSP and QTYPE use
technology platforms that can readily accommodate this increase in HLA allele assays.
Second, 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.
Third, our NGS testing platform will be a technology departure from commonly used approaches for HLA typing.
This will enable the addition of non-HLA genes critical to transplant outcome. The addition of non-HLA genes will
have no impact on workflow and enable the inclusion of increasing content, as new transplant outcome related genes
are described.
Fourth, depending on the specific indication, different levels of HLA typing resolution and follow up confirmatory
testing are required. Olerup SSP and QTYPE flexible platforms are complemented with Olerup SBT and TruSight
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HLA, and our research and development staff weave together the three typing product offerings to effectively
address laboratory needs.
Fifth, the complexity of the HLA region benefits significantly from interpretive software solutions for the
laboratories. We are committed to ongoing upgrades to our software solutions to further simplify the use of the
various HLA kits.
Finally, our research and development staff in transplant environment is working closely together to advance the
synergies of products across the pre- and post-transplant continuum.
Reimbursement
We have been successful in achieving reimbursement for our testing services.
Reimbursement for AlloMap comes primarily from Medicare, private third party payers such as insurance
companies and managed care organizations, Medicaid and hospitals. A number of payers have adopted coverage
policies approving AlloMap for reimbursement. Such policies often approve reimbursement for tests performed
from six months or one year post-transplant through five years post-transplant. For 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.
Following the assignment of a Category 1 Current Procedural Terminology, or CPT code, for AlloMap 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 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. Effective January 1, 2018, Medicare reimburses $3,240 for
AlloMap testing of Medicare beneficiaries, which represents a 14% increase over the 2017 reimbursement rate.
Effective October 9, 2017, AlloSure is reimbursed for kidney transplant patients covered by Medicare. The
Medicare reimbursement rate for AlloSure is $2,841.
Medicare coverage and reimbursement was determined by the Molecular Diagnostic Services, or MolDX, Program
developed by Palmetto GBA (“Palmetto”). AlloSure began to be reimbursed at a rate of $2,841 for kidney
transplants patients covered by Medicare across the United States on October 9, 2017, the effective date of the
Palmetto local coverage determination, or LCD. AlloSure has also received payment from private payers on a case-
by-case basis, while our Payer Relations team works to establish positive coverage. However, no positive coverage
decisions have been made to the date of this filing.
Medicare
We are reimbursed by Medicare for AlloMap and AlloSure tests performed on patients covered by Medicare. Tests
performed on patients covered by Medicare represented 46%, 30% and 34% of all tests in 2018, 2017 and 2016,
respectively. Approximately 62%, 27% and 44% of all testing services revenue was derived from Medicare for the
years ended December 31, 2018, 2017 and 2016, respectively.
Private Payers and Medicaid Payers
We are reimbursed for a substantial portion of the AlloMap tests we perform on patients covered by private payers.
Coverage policies approving AlloMap for reimbursement have been adopted by many of the largest private payers,
including Aetna, Anthem, Cigna, Health Care Services (HCSC), Humana, Kaiser Foundation Health Plan, Inc.,
TRICARE, and UnitedHealthcare. Many other payers have positive coverage policies for AlloMap. With private
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payers and Medicaid payers that have not yet adopted positive coverage policies for AlloMap, we obtain
reimbursement from those payers on a case-by-case basis for a significant portion of claims.
As of yet, no private payers or Medicaid payers have adopted positive coverage policies for AlloSure. As a result,
we obtain reimbursement from those payers on a case-by-case basis.
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.
In 2013, we initiated a commercial agreement with Diaxonhit SA (“Diaxonit”), a leader in specialty in-vitro
diagnostics for transplantation, infectious diseases and cancer. The agreement carries a 10-year term and grants
Diaxonhit exclusive rights to promote AlloMap in Europe. Diaxonhit has agreed to commercialize AlloMap in all
countries in western and central Europe directly and through sub-partners. Under the terms of our agreement, we
provide Diaxonhit with training and a license to perform AlloMap. In Europe, we receive revenue in two ways: first,
through our sale of testing materials to Diaxonhit, and second, through royalties on Diaxonhit’s net earnings from
sales of AlloMap. Diaxonhit pays royalties to us as a percentage of the net earnings from sales, as defined in the
agreement, of AlloMap tests, in the mid to high teens. Diaxonhit made an upfront payment to us in cash of
approximately €387,500 ($408,000) and Diaxonhit’s publicly traded common stock with a value at the time of
€387,000 following execution of the agreement. Through Diaxonhit, we have also secured a dedicated laboratory,
the Strasbourg University Hospital Central Immunology Laboratory, or HUS, in France.
Testing and Laboratory Operations
Our laboratory operations, where we perform all AlloMap and AlloSure testing, are headquartered at our Brisbane,
California laboratory. 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 (“CAP”). We believe
that our laboratory capacity will be adequate to meet demand for AlloMap and AlloSure for the next few years.
When a clinician orders AlloMap, 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 is tested in triplicate, and the 11 informative genes are combined to produce the AlloMap 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 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 within our WebPortal within two
business days of receipt.
We rely solely on certain suppliers to provide some of the laboratory instruments and key reagents that we use to
perform AlloMap and AlloSure 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; Illumina, which supplies us with instruments,
laboratory reagents and consumables; Becton, Dickinson, 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.
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
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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 QMSx. 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 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.
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 AlloMap and AlloSure, 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.
As of December 31, 2018, the sales and marketing team consisted of 20 employees, including sales, marketing,
brand managers, and customer service representatives.
Competition
Because of our comprehensive portfolio of HLA typing products and surveillance diagnostic test services, 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. 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;
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technical performance and innovation to deliver new products that provide clinically actionable results;
reputation among customers as a provider of high value 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 heart transplant rejection generally involve evaluating biopsy samples to determine
the presence or absence of rejection, while existing diagnostic methods for kidney transplant rejection include
general, non-specific clinical chemistry tests, though biopsies are also a surveillance diagnostic tool. Both of 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 so hospitals may choose to rely on internally developed and/or internally performed
surveillance and diagnostic 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 AlloMap, AlloSure 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.
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 Life Technologies. 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 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 as we launch AlloSeq cfDNA and
AlloSeq BMT. 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.
Overall Competition
Our potential competitors may have widespread brand recognition and substantially greater financial, technical and
research and development resources and selling and marketing capabilities than we do. Other competitors may
develop products with prices lower than ours that could be viewed by clinicians and payers as functionally
equivalent to our solution, offer solutions that may be more accurate or effective than our solutions or offer solutions
at prices designed to promote market penetration, which could force us to lower the price of our current and future
solutions and affect our ability to achieve or maintain profitability.
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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.
Our core patent position for AlloMap 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. Our strategy is to continue to broaden our
intellectual property estate for AlloMap through data science discovery and protection of gene expression patterns
and their correlation with specific clinical states and outcomes, as well as the algorithms needed for clinical
assessment.
As of December 31, 2018, we had 23 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. 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 the area of dd-cfDNA-
based transplant diagnostics, we have filed a patent application to cover our research and development work in this
field. In connection with our June 2014 acquisition of IMX, we obtained an exclusive license from 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. As part of our
April 2016 acquisition of Allenex, we obtained an additional five U.S. patents on donor matching technology and
treatment for antibody mediated transplant rejection. We have six issued U.S. patents covering a method of
diagnosing or monitoring autoimmune or chronic inflammatory diseases, such as lupus, by detecting specific genes.
While we have clinical samples and patents covering lupus diagnostics, we do not intend to actively pursue the lupus
test opportunity.
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, AlloSeq, Olerup SSP, Olerup XM-ONE, QTYPE 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 AlloMap and 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.
In November 2004, we entered into a license agreement with Roche Molecular Systems, Inc., or Roche, as amended
from time to time, the Roche License. The Roche License grants us the right to use PCR and q-PCR for use in
clinical laboratory services. The Roche License is a non-exclusive license agreement in the United States covering
the claims in multiple Roche patents. Under the terms of the Roche License, we were required to report and pay
royalties, after adjustment due to a discount for combination services, in the mid-single digits on test revenues from
products using the licensed intellectual property on a quarterly basis until September 30, 2017, pursuant to a
Settlement Agreement and Mutual Release, dated September 11, 2014. Effective September 30, 2017, no royalties
are incurred by us under the Roche License.
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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 an annual license maintenance fee, six milestone
payments and royalties in the low single digits on net sales of products incorporating the licensed technology. The
license maintenance fee may be offset against earned royalty payments due on net sales in that year.
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.
Regulation
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. Almost all 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 2018 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 (“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 or AlloSure.
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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 (the “VALID Act of 2018”). For AlloSure 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
(“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. We have structured these arrangements
with terms intended to comply with the requirements of the applicable exceptions to the Stark Law and PORA.
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 $15,000 for each service arising out of the prohibited referral;
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exclusion from federal healthcare programs, including the Medicare and Medicaid programs; and
a civil penalty of up to $100,000 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 healthcare programs. Our
business is subject to compliance with these laws. 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 been recent public announcements by members of the U.S. Congress and President Trump and his
administration regarding their plans to repeal and replace the Affordable Care Act. We cannot predict the ultimate
form or timing of any repeal or replacement of the Affordable Care Act or the effect such repeal or replacement
would have on our business.
Anti-Kickback Statutes
The federal healthcare programs’ Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting,
offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral
of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a
federal healthcare program such as Medicare or Medicaid.
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’s intent requirement to mean that if any one
purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered businesses,
the statute has been violated. Penalties for violations include criminal penalties and civil sanctions such as fines,
imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. In addition,
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
referral of recipients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid
programs.
Federal False Claims Act
The False Claims Act’s “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 a
federal healthcare program. The qui tam provisions of the False Claims Act allow a private individual to bring
actions on behalf of the federal government alleging that the defendant has violated the 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
False Claims Act, and many of these state laws apply where a claim is submitted to any third-party payer and not
merely a federal healthcare program.
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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 $5,500 and $11,000 for each separate
instance of false claim. 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 causing
physicians to order excessive or unnecessary services, providing false documentation in support of claims,
kickbacks, off-label promotion of products, Stark Law violations and other improper referrals and CLIA violations,
in addition to the more predictable allegations as to misrepresentations with respect to the services rendered. Our
future activities relating to billing, compliance with the CLIA 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.
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 of 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.
Employees
At December 31, 2018, we had 231 employees, of which 227 were full-time employees. We had 69 employees in
manufacturing operations and support, 51 in research and development; 61 in sales and marketing and 50 in general
and administrative positions. As of December 31, 2018, 162 employees were located in the United States and 69
were located outside of the United States.
From time to time, we also employ independent contractors, consultants and temporary employees to support our
operations. Currently, the Olerup 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
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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.
ITEM 1A. 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
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, 2018, our net loss was $46.8 million. As of December 31,
2018, we had an accumulated deficit of $311.8 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 diagnostic solutions, including
additional expenses in connection with our continuing development and commercialization of AlloMap,
AlloSure, AlloSeq 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;
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 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.
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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, 2018, we had cash and cash equivalents of $64.6 million and an accumulated deficit of $311.8
million. We may require additional financing in the future to fund working capital and pay our obligations as they
come due. 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, 2018, revenue from Medicare for AlloMap and AlloSure represented 62% 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 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. 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 (“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. Effective January 1, 2018, under PAMA, the reimbursement rate for AlloMap is $3,240 for
Medicare beneficiaries, which represents a 14% increase over the 2017 reimbursement rate.
On September 26, 2017, we announced that the Molecular Diagnostic Services, or MolDX, Program developed by
Palmetto GBA (“Palmetto”) has set AlloSure reimbursement at $2,841. AlloSure 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.
However, if an AlloMap or AlloSure reimbursement rate that is significantly lower than the current rate is set bt
CMS or MolDx in the future, it could cause us to discontinue AlloMap or AlloSure 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
(“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 or AlloSure at the same payment
amount or with the same breadth of coverage in the future, if at all. Additional changes in the MAC processing
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Medicare claims for AlloMap and AlloSure 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 AlloMap and AlloSure tests, and products for
pre-transplant matching, 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. 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.
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;
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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 elsewhere in this Annual Report on 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. 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.
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 AlloMap, AlloSure, products and our
solutions in development outdated. We must continually innovate and expand our test offerings to address unmet
needs in monitoring transplant related conditions and in pre-transplant testing. AlloMap, AlloSure, products and our
solutions in development could become obsolete unless we continually innovate and expand our product offerings to
include new clinical applications. If we are unable to demonstrate the effectiveness of AlloMap, AlloSure, products
and future diagnostic solutions and tests, if any, compared to new methodologies and technologies, then sales of our
solutions and tests 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 and products and, subject to their development, our other solutions, and demonstrate the
clinical and diagnostic benefits of these solutions. We believe that clinicians, transplant centers and laboratories may
not use our solutions unless they determine, based on published peer-reviewed journal articles, the experience of
other clinicians or laboratory verification, that our solutions provide accurate, reliable and cost-effective information
that is useful in pre-transplant matching and monitoring their post-transplant recipients.
We estimate that there are approximately 138 centers managing heart transplant recipients in the United States. In
2018, AlloMap was used in 133 of these centers. However, not all clinicians in these centers are currently using our
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test. In order for AlloMap sales to grow, we must continue to market to and educate clinicians and administrators at
treatment centers that have used our test to increase the number of clinicians ordering our test, the number of
recipients tested and the number of tests per recipient. In addition, we must actively solicit additional treatment
centers to establish policies and procedures for ordering our test and to encourage clinicians at those centers to
incorporate our test into their standard clinical practice. Some of the challenges that our sales team must overcome
include explaining the clinical benefits of AlloMap, which is a highly technical product, and changing a 30-year
patient management paradigm of using biopsy as the basis of transplant recipient monitoring.
We estimate that there are approximately 240 centers managing kidney transplant recipients in the United States. In
the fourth quarter of 2018, AlloSure was used in 100 of these centers. In order for AlloSure sales to grow, we must
continue on our plan to market and educate clinicians and administrators at the treatment centers that have used our
test to spread awareness of its effectiveness in creating better long-term care plans for kidney transplant patients.
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 an accuracy, speed and/or cost
advantage 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.
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.
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If the use of AlloMap, AlloSure 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.
The results of our studies involving AlloMap and AlloSure have been presented at major medical society congresses
and published in peer-reviewed publications in leading medical journals. We need to maintain a continued presence
in peer-reviewed publications 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
AlloMap, AlloSure or our other 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 AlloMap, AlloSure 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 solutions unless they determine,
based on published peer-reviewed journal articles and the experience of other clinicians, that our diagnostic current
and future 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 solutions would suffer and our business would be harmed. While we have had success in generating peer-
reviewed publications regarding AlloMap and AlloSure, additional peer-reviewed publications regarding AlloMap,
AlloSure and our future 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 solutions or the technology underlying AlloMap, AlloSure or our future 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 and future tests based on donor-derived cell-free DNA (“dd-cfDNA”), we will
need to continue our efforts to complete and publicize research and trials, especially the Kidney Allograft Outcomes
AlloSure Registry (“K-OAR”) registry study, that provides evidence of the utility of dd-cfDNA and validate
AlloSure as a solution.
Transplant centers may not adopt AlloMap, AlloSure 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 cellular rejection in heart transplant recipients by utilizing
biopsies. Many clinicians use AlloMap in parallel with biopsies rather than as an alternative to biopsies. While we
do not market AlloMap as a biopsy alternative, per se, if treatment center administrators view our test as an
alternative to a biopsy and 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 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.
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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 AlloMap solution for heart transplant recipients competes against existing diagnostic tests utilized by
pathologists, which, in the case of heart transplant rejection, 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.
Competition for kidney surveillance diagnostics can also come from biopsies. 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, complete blood count, lipid profile and others that are widely
ordered by physician offices and routinely performed in clinical reference labs and hospital labs.
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
products including products offered by Thermo Fisher Scientific, Inc., or Thermo Fisher, as well as alternatives to
polymerase chain reaction (“PCR”) such as next generation sequencing (“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.
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 have greater brand recognition and 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 AlloMap and
AlloSure 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 AlloMap, AlloSure and our future 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 patients. 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.
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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 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 become 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 AlloMap and AlloSure depends, in large part, on our ability to perform AlloMap and AlloSure tests on
a timely basis and at a high quality standard, and on our reputation for such timeliness and quality. Failure to
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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. There can be no assurance that
we will be able to perform AlloMap, AlloSure 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 testing services revenue growth rates may not be indicative of future growth, and we may not grow at
all, and revenue may decline.
From 2017 to 2018, our testing services revenue grew from $33.1 million to $60.3 million, which represents annual
growth of 82%. 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 products and services;
the introduction and acceptance of new or enhanced products or services by us or by competitors;
our ability to maintain reimbursement for AlloMap and AlloSure 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 AlloMap, AlloSure 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.
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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. 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 AlloMap,
AlloSure, 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 AlloMap, AlloSure or future solutions
and comply with the required procedures, or that this laboratory would be willing or able to perform the tests for us
on commercially reasonable terms.
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 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
AlloMap, AlloSure 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;
expand our research and development activities;
sustain or achieve broader commercialization of AlloMap, AlloSure and our products or enhancements
to those tests and products;
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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. 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 and as we attempt to transition to a company with more than one commercialized
test. If we were to lose one or more of these key employees, we may experience difficulties in competing
effectively, developing our technologies and implementing our business strategies.
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 AlloMap, AlloSure 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.
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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 that prove unsuccessful;
retention of 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 occurred in
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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.
In addition, the marketing, sale and use of AlloMap, AlloSure and our other 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; 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. We do not have guaranteed supply agreements with Thermo Fisher, Becton,
Dickinson and Company, 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, is no longer in production.
Thermo Fisher has committed to provide service and support of this instrument through 2020. We believe that there
are relatively few suppliers other than Thermo Fisher, 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 Therapak
Corporation, or Therapak Corporation 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.
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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 agent 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.
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.
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 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 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.
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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.
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 in Europe with
Diaxonhit SA and are distributing AlloMap tests directly in Canada. We also currently distribute products direct in
Germany, Austria, Slovenia, Benelux, and in the Nordic countries, 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. 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 in Europe may be negatively affected by the financial instability of, and austerity measures
implemented by, several countries in Europe.
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;
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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, preferential bidding or import or export licensing
requirements;
political and economic instability, including 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.
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 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.
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
(“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. Although the effects of Brexit will depend on any agreements
between the UK and the EU, 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.
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
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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
its year end income tax provision in accordance with its understanding of the Tax Act and guidance available as of
the date of this filing 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. We 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 due to the valuation allowance.
The Tax Cuts and Jobs Act of 2017 also implemented 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. We have not made an
election with respect to GILTI as it is not applicable to us in 2018. 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 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
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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.
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
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 (“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 at least annually and more frequently 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.
Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.
Under the License and Commercialization Agreement (the “License Agreement”) with Illumina, Inc. (“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.
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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.
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 AlloMap, AlloSure 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 AlloMap and AlloSure 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. Throughout
2017, we did not recognize revenue for test results delivered without a contract for reimbursement, or an established
coverage policy and a history of payment. The revenue recognition criteria for cash basis payers changed effective
January 1, 2018 under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with
Customers, or ASC 606. Revenue for AlloMap and AlloSure tests is estimated based on historical reimbursements
received from payers.
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.
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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 AlloMap, AlloSure 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 AlloMap, AlloSure or future solutions will be provided in the future by any third-party payer.
Reimbursement for AlloMap and AlloSure comes primarily from Medicare, private third party payers such as
insurance companies and managed care organizations, Medicaid and hospitals. The reimbursement process can take
six months or more to complete depending on the payer. Coverage policies approving AlloMap have been adopted
by many of the largest private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation (HCSC),
Humana, Kaiser Foundation Health Plan, Inc., TRICARE, 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 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 AlloMap and AlloSure 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.
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Until 2016, AlloMap was billed using an unlisted Current Procedural Terminology (“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 test also has been assigned a
McKesson Diagnostics Z codeTM which is included on all Medicare claims. 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 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 AlloMap and AlloSure.
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.
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.
There have been recent public announcements by members of the U.S. Congress and President Trump and his
administration regarding their plans to repeal and replace the Affordable Care Act. We cannot predict the ultimate
form or timing of any repeal or replacement of the Affordable Care Act or the effect such repeal or replacement
would have on our business. Regardless of the impact of any or repeal or replacement 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 AlloMap and AlloSure. Federal
budgetary limitations and changes in healthcare policy, such as the creation of broad limits for diagnostic products
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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 AlloMap, AlloSure and our future diagnostic solutions,
increase costs, divert management’s attention and adversely affect our ability to generate revenue and achieve
profitability.
Risks Related to the Healthcare Regulatory Environment
In order to operate our laboratory, we have to comply with the CLIA and state laws governing clinical
laboratories.
We are subject to 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 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 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 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 February 2018
as a result of passing that inspection. We expect the next regular inspection under CLIA to occur in 2020. 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 or AlloSure, 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 (“LDTs”)
because it believes that laboratories certified as high complexity under 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 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 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.
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.
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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 the Congress decide to regulate AlloSure and other future solutions under development as medical
devices, it could require additional premarket clinical testing subsequent to commercialization in the case of
AlloSure and/or 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.
AlloMap, AlloSure and our other solutions, along with the manufacturing processes, packaging, labeling,
distribution, import, export, and advertising and promotional activities for such solutions or devices, 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 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;
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product seizure;
injunctions; and
imposition of civil or criminal penalties.
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 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 healthcare 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 healthcare 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
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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.
Foreign governments may impose reimbursement standards, which may adversely affect our future profitability.
When we market AlloMap, 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.
Changes in healthcare policy could increase our costs and subject us to additional regulatory requirements that
may interrupt commercialization of our current and future solutions.
Changes in healthcare policy could increase our costs, decrease our revenues and impact sales of and reimbursement
for our current and future solutions. In March 2010, the Affordable Care Act became law. This law substantially
changed the way healthcare is financed by both governmental and private insurers, and contained a number of
provisions that have impacted our business and operations, including those governing enrollment in federal
healthcare programs, reimbursement changes and fraud and abuse enforcement. Further, our combination with
Allenex will also change how these provisions could impact our business.
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 advanced diagnostic laboratory tests, or
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.
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.
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 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. Our strategy is to continue to broaden our intellectual
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property estate for AlloMap through the discovery and protection of gene expression patterns and their correlation
with specific clinical states and outcomes, as well as the algorithms needed for clinical assessment.
As of December 31, 2018, we had 23 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. 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.
As part of our April 2016 acquisition of Allenex, we obtained an additional five U.S. patents on donor matching
technology treatment for antibody mediated transplant rejection. We have six issued U.S. patents covering a method
of diagnosing or monitoring autoimmune or chronic inflammatory disease, such as lupus, by detecting specific
genes. While we have clinical samples and patents covering lupus diagnostics, we do not intend to actively pursue
the lupus test opportunity.
In the area of dd-cfDNA-based transplant diagnostics, we have submitted a patent application to cover some of our
research and development work in this field. There is no guarantee that the U.S. Patent and Trademark Office, or
PTO, will approve this application. We do not know what claims, if any, will be granted in our existing and future
applications. Our patents and patents that we exclusively license from others address fields that are rapidly evolving,
and, particularly with respect to dd-cfDNA-based transplant diagnostics, it is possible that other patents have and
will be granted to others that affect our ability to develop and commercialize our current and future solutions. If the
reviewers of our patent applications at the PTO refuse our claims, we may not be able to sufficiently protect our
intellectual property. Further, recent and future changes in the patent laws and regulations of the United States and
other jurisdictions may require us to modify our patent strategy and could restrict our ability to obtain additional
patents for our technology.
In connection with our June 2014 acquisition of IMX, 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.
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
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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. 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.
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.
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;
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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.
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. 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, AlloSeq, Olerup SSP, Olerup XM-ONE, Olerup SBT, QTYPE 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
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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.
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 IMX, 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 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.
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 2018 our stock price ranged from $5.18 to $30.02 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;
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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 FDA 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; 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;
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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;
any significant change in our management; 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, and entities affiliated
with them, beneficially own in the aggregate approximately 15.6% of our common stock as of December 31, 2018.
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 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
53
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.
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.
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 frequent 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.
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. We are continuing to implement new finance and accounting
systems as we grow our business and organization and to satisfy internal control and reporting requirements.
54
The effectiveness of our controls and procedures may in the future be limited by a variety of factors, including:
•
•
•
•
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.
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 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:
•
•
•
•
•
•
•
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 of the General
Corporation Law of the State of Delaware. 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
55
incorporation and bylaws may deter third parties from acquiring us, which may limit the market price of our
common stock.
We are an “emerging growth company,” and, because we are complying with certain reduced disclosure
requirements applicable to emerging growth companies, our common stock could be less attractive to investors.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act,
enacted in April 2012, and for as long as we continue to be an “emerging growth company,” we may continue to
choose to take advantage of exemptions from various reporting requirements applicable to other public companies
but not to “emerging growth companies,” including, but not limited to, not being required to comply with the auditor
attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation in our
periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote
on executive compensation and stockholder approval of any golden parachute payments not previously approved.
We will continue to be an “emerging growth company” until the earlier of (i) the last day of the fiscal year
(a) following the fifth anniversary of the completion of our initial public offering, (b) in which we have total annual
gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the
market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior
September 30th, and (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the
prior three-year period. We cannot predict if investors will find our common stock less attractive as a result of our
reliance on these exemptions. If some investors find our common stock less attractive as a result of any choices to
reduce future disclosure, there may be a less active trading market for our common stock, and our stock price may
be more volatile.
Under the JOBS Act, emerging growth companies that become public can delay adopting new or revised accounting
standards until such time as those standards apply to private companies. We irrevocably elected not to avail
ourselves of this exemption from new or revised accounting standards, and therefore, we are subject to the same new
or revised accounting standards as other public companies that are not emerging growth companies.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Our headquarters are located in Brisbane, 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, 2018:
Function
Location
United States
Brisbane, California...........Corporate headquarters, research & development and clinical laboratory
West Chester,
Pennsylvania ......................
Europe
Stockholm, Sweden ...........Research & development and product manufacturing
Vienna, Austria ..................Sales office and distribution
Australia
Fremantle ...........................Research & development and product manufacturing
Sales office and distribution
Square Footage
46,000
6,336
23,874
1,744
3,871
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
From time to time, we may become subject to legal proceedings and claims that arise in the ordinary course of
business. Although we do not believe that any matters presently pending will have a material adverse effect,
56
individually or in the aggregate, on our financial position, results of operations or liquidity, legal matters and
proceedings are inherently unpredictable and subject to significant uncertainties, some of which are beyond our
control. As such, there can be no assurance that the final outcome of these matters will not materially and adversely
affect our financial position, results of operations or liquidity.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
57
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock is traded 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 March 4, 2019, there were approximately 111 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.
Stock Performance Graph
We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended,
or the Exchange Act, and are not required to provide a performance graph.
Sales of Unregistered Securities
There were no sales of unregistered securities by us during the fourth quarter of 2018.
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
There were no repurchases of equity securities by us during the fourth quarter of 2018.
ITEM 6. SELECTED FINANCIAL DATA
The following selected historical financial data should be read in conjunction with “Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial
statements and related notes included elsewhere in this Annual Report on Form 10-K. The selected balance sheet
data at December 31, 2018 and 2017 and the selected statements of operations data for each of the years ended
December 31, 2018, 2017 and 2016 have been derived from our audited consolidated financial statements that are
included elsewhere in this Annual Report on Form 10-K. The financial data included in this report are historical and
are not necessarily indicative of results to be expected in any future period.
58
Statements of Operations Data:
2018
Year Ended December 31,
2017
2016
(In thousands, except share and per share data)
2015
2014
Revenue:
Testing revenue (1) ...................................... $
Product revenue............................................
License and other revenue............................
Total revenue .....................................................
Operating expenses:
Cost of testing ..............................................
Cost of product.............................................
Research and development...........................
Sales and marketing .....................................
General and administrative ..........................
Goodwill impairment ...................................
Change in estimated fair value of
contingent consideration ..............................
Total operating expenses ...................................
Income (loss) from operations...........................
Interest expense, net ..........................................
Debt extinguishment expenses ..........................
Other expense, net .............................................
Change in estimated fair value of common
stock warrant and derivative liabilities..............
Loss before income taxes ..................................
Income tax benefit .............................................
Net income (loss)...............................................
Net loss attributable to noncontrolling
interest ............................................................
Net income (loss) attributable to CareDx,
Inc. .....................................................................
Net (loss) income per share:
$
60,300 $
15,674
595
76,569
21,456
11,531
14,514
21,670
21,959
—
1,017
92,147
(15,578)
(3,701)
(5,780)
(178)
(22,978)
(48,215)
1,434
(46,781)
33,106 $
14,634
584
48,324
12,345
9,026
12,388
12,808
18,913
1,958
1,180
68,618
(20,294)
(5,863)
(459)
(1,031)
(29,622)
(57,269)
1,709
(55,560)
29,680 $
10,715
236
40,631
10,882
10,240
12,385
11,166
20,725
13,021
(456)
77,963
(37,332)
(1,860)
—
(1,920)
(250)
(41,362)
1,606
(39,756)
27,881 $
—
263
28,144
25,842
—
1,464
27,306
10,273
—
9,333
8,349
12,247
—
(126)
40,076
(11,932)
(1,587)
—
(188)
—
(13,707)
—
(13,707)
8,541
—
3,846
6,472
8,436
—
(1,239)
26,056
1,250
(2,116)
—
(78)
225
(719)
1,500
781
(25)
(91)
(287)
—
—
(46,756)
$
(55,469)
$
(39,469)
$
(13,707)
$
781
Basic............................................................. $
Diluted.......................................................... $
(1.31) $
(1.31) $
(2.38) $
(2.38) $
(2.39) $
(2.39) $
(1.16) $
(1.16) $
0.13
0.10
Shares used to compute net (loss) income per
share:
Basic............................................................. 35,638,956 23,332,503 16,496,911 11,860,885 5,815,928
Diluted.......................................................... 35,638,956 23,332,503 16,496,911 11,860,885 9,283,001
(1) On January 1, 2018, we adopted the new revenue accounting standard – ASC 606, using the modified
retrospective method. The impact of adopting ASC 606 is disclosed in Note 2 of the consolidated financial
statements included elsewhere in this Annual Report on Form 10-K.
59
Balance Sheet Data:
As of December 31,
2017
2018
(In thousands)
Cash and cash equivalents .......................................... $
Working capital ..........................................................
Total assets..................................................................
Total debt ....................................................................
Accumulated deficit....................................................
Total CareDx, Inc. stockholders’ (deficit) equity.......
64,616 $
61,610
130,697
—
(311,845)
95,928
16,895
(16,139)
83,565
34,059
(268,022)
(6,134)
60
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction 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 global transplant diagnostics company with product and service offerings along the pre- and post-
transplant continuum. We focus on discovery, development and commercialization of clinically differentiated, high-
value diagnostic solutions for transplant patients.
Testing Services
AlloMap
Our first commercialized testing solution, the AlloMap heart transplant molecular test, or AlloMap, 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 solution through ongoing studies to substantiate the clinical utility and
actionability of AlloMap, secure positive reimbursement decisions for AlloMap 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, in conjunction with other clinical
indicators, can help healthcare providers and their patients better manage long-term care following a heart
transplant. In particular, we believe AlloMap can improve patient care by helping healthcare providers avoid the use
of unnecessary, invasive surveillance biopsies and determine the appropriate dosage levels of immunosuppressants.
In 2008, AlloMap received 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for marketing
and sale as a test to aid in the identification of recipients with a low probability of moderate or severe acute cellular
rejection.
AlloMap has received positive coverage decisions for reimbursement from Medicare. The 2018 reimbursement rate
for AlloMap was $3,240, which represented a 14% increase over the 2017 reimbursement rate. AlloMap has also
received positive coverage decisions for reimbursement from many of the largest U.S. private payers, including
Aetna, Anthem, Cigna, Health Care Services Corporation (HCSC), Humana, Kaiser Foundation Health Plan, Inc.,
TRICARE and UnitedHealthcare.
We have also successfully completed a number of landmark clinical trials in the transplant field demonstrating the
clinical utility of AlloMap for surveillance of heart transplant recipients. We initially established the analytical and
clinical validity of AlloMap on the basis of our Cardiac Allograft Rejection Gene Expression Observational (Deng,
M. et al., Am J Transplantation 2006), or CARGO, study, which was published in the American Journal of
Transplantation. 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 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.
Since the launch of AlloMap in January 2005, we have performed more than 123,000 commercial AlloMap tests,
including 16,116 tests during 2018. During the year ended December 31, 2018, AlloMap was used in 133 of the
approximately 138 heart transplant centers in the United States.
61
AlloSure
AlloSure, our transplant surveillance solution which was commercially launched in October 2017, applies
proprietary next generation sequencing technology to measure donor-derived cell-free DNA, or dd-cfDNA, in the
blood stream emanating from the donor kidney. We believe AlloSure may help clinicians determine rejection-
specific activity manifested as cell damage in the transplanted heart, kidney, or other solid organ, irrespective of the
type of organ transplanted. We also believe the use of AlloSure, 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 can improve patient care by helping healthcare providers to reduce the use of
invasive biopsies and determine the appropriate dosage levels of immunosuppressants. Effective October 9, 2017,
AlloSure became available for commercial testing with Medicare coverage and reimbursement. The Medicare
reimbursement rate for AlloSure is $2,841. AlloSure has also received payment from private payers on a case-by-
case basis, but no positive coverage decisions have been made to the date of this filing.
Prior to the commercialization of AlloSure, we generated a strong body of clinical evidence. In late 2015, we
announced the completion of analytical validation of AlloSure. A report describing the analytical validation of
AlloSure including clinical validation detailing the quality, reality and consistency of analytical results information
for heart transplant, appeared in the November 2016 issue of The Journal of Molecular Diagnostics. The Circulating
Donor-Derived Cell-Free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients, or
DART, trial, sponsored by us, was conducted between April 2015 and January 2018. DART is a 14 center
observational study of kidney transplant recipients where blood specimens are drawn periodically after transplant
during follow up visits and also after treatment for acute rejection. By the time of completion of the first analysis,
384 patients were followed in DART for up to 24 months. The results demonstrated that increased levels of dd-
cfDNA, determined by the AlloSure assay, discriminated active rejection of a kidney transplant more effectively
than serum creatinine values. In collaboration with clinical investigators, we published these findings in the
scientific peer-reviewed Journal of the American Society of Nephrology and the Journal Applied Laboratory
Medicine in March 2017. A total of 2,109 patient visits had been accrued in DART by January 2019. We plan to
analyze and report on additional findings from this dataset in 2019 and into the future.
In 2018, we initiated the Kidney Allograft Outcomes AlloSure Registry, or K-OAR study, to develop further data on
the clinical utility of AlloSure for surveillance of kidney transplant recipients. As of December 31, 2018, 47 centers
have been initiated as K-OAR study sites.
During the year 2018, there were 11,634 AlloSure patient test results provided. In the fourth quarter of 2018,
AlloSure was ordered by 100 kidney transplant centers in the United States.
HeartCare
In September, 2018, we 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 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 – 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, Acute Cellular Rejection (“ACR”) and Antibody Mediated Rejection (“AMR”) in heart
transplant recipients.
Products
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 organs. We also help clinicians manage transplant
patients after the transplant has occurred.
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
62
certification on April 10, 2018. Olerup SSP is used to type Human Leukocyte Antigen, or 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, 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 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.
Fourth Quarter 2018 Highlights
•
Continued the acceleration of AlloSure penetration
−
−
In the fourth quarter of 2018, 100 U.S. transplant centers provided 4,575 AlloSure tests to
approximately 3,400 patients
Continued progress in AlloSure Registry (K-OAR) enrollment, with 47 centers initiated and 748
patients enrolled as of December 31, 2018
• Achieved total revenue of $23.5 million for the fourth quarter of 2018, increasing 88% year-over-year
−
−
Testing services revenue of $18.9 million, with 4,575 AlloSure and 4,057 AlloMap patient results
provided
Product revenue of $4.6 million
• Generated a net loss of $3.8 million, positive adjusted EBITDA of $0.8 million and positive net cash
from operations of $2.0 million in the fourth quarter of 2018
•
Strengthened balance sheet through public equity offering and repayment of all outstanding debt
−
Cash and cash equivalents of $64.6 million at December 31, 2018
Financial Operations Overview
Revenue
We derive our revenue from testing services, products sales and license and other revenues. On January 1, 2018, we
adopted the new revenue accounting standard Revenue from Contracts with Customers (Topic 606), or ASC 606,
using the modified retrospective method. Under the new accounting standard, revenue is recorded considering a
five-step 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. The adoption of ASC 606 resulted in a
one-time adjustment of $2.9 million to accounts receivable and accumulated deficit. This adjustment reflected the
estimated payments to be received for tests where the result had been delivered at December 31, 2017, but the
associated revenue had not been recognized by December 31, 2017, because payments had not been received. As of
December 31, 2018, we had received payments of $3.4 million for these tests and recorded a change in estimate of
$0.5 million as additional testing services revenue during 2018 year. Adoption of ASC 606 did not have any impact
on product and license revenue recognized in prior periods.
Testing Services Revenue
Our testing services revenue is derived from AlloMap and AlloSure tests, which represented 79%, 69% and 73% of
our total revenues for the years ended December 31, 2018, 2017 and 2016, 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
63
histories; (v) our ability to expand into markets outside of the United States; and (vi) how quickly we can
successfully commercialize new product offerings.
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.
During 2018 we performed 16,116 commercial AlloMap tests that are included in our estimated testing revenue. We
also recognized additional $0.5 million in revenue related to tests performed in prior period due to the change in
estimated transaction price in accordance with new revenue recognition standard ASC 606.
Since October 2017, when we launched AlloSure, we performed 282 commercial AlloSure tests as of December 31,
2017. During 2018 we performed 11,634 commercial AlloSure tests. All tests were performed from our Brisbane,
California laboratory.
Product Revenue
Our product revenue is derived primarily from sales of Olerup SSP, QTYPE, Olerup SBT and TruSight products.
Product revenue represented 20%, 30% and 26% of total revenue for the years ended December 31, 2018, 2017 and
2016, 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.
License and Other Revenue
License agreements may include non-refundable upfront payments, partial or complete reimbursement of research
and development costs, contingent payments based on the occurrence of specified events under the agreements,
license fees and royalties on sales of products or product candidates if they are successfully commercialized. Our
performance obligations under the collaboration and license agreements may include the transfer of intellectual
property rights in the form of licenses, obligations to provide research and development services and obligations to
participate on certain development committees with the collaboration partners. We make judgments that affect the
periods over which we recognize revenue. We review our estimated periods of performance based on the progress
under each arrangement and account for the impact of any change in estimated revenues.
Segment Reporting
We changed our segment reporting from two reportable segments: Post-Transplant and Pre-Transplant to one
reportable segment. In the third quarter of 2018, we completed a business reorganization to support our strategy to
become a global transplant care leader. The position of the head of the former Pre-Transplant segment was
eliminated, and global functional leaders were identified to manage sales and marketing, research and development,
manufacturing and quality and other global functions. These changes resulted in changes to the presentation of
financial information provided to our chief operating decision maker (the “CODM”), who is our chief executive
officer, for resource allocation and management performance assessment. The CODM continues to review revenue
and cost of sales by testing services and products, as reported in the consolidated statements of operations. Earnings
before interests, tax, depreciation and amortization, and operating results are reviewed at the consolidated level only.
Effective September 30, 2018, we report a single operating segment.
Goodwill Impairment
We test goodwill and indefinite-lived intangibles for impairment at least annually and more frequently if impairment
indicators are present. We recorded goodwill impairment charges related to our former Pre-Transplant reporting unit
64
of $13.0 million and $2.0 million as of December 31, 2016 and March 31, 2017, respectively. Goodwill allocated to
our former Pre-Transplant reporting unit was fully impaired at March 31, 2017. The remaining goodwill of $12.0
million relates to our former Post-Transplant reporting unit and it was not impaired. No impairment charges were
recorded in 2018.
Change in Estimated Fair Value of Contingent Consideration
We revalued our contingent consideration obligation liability in connection with our acquisition of IMX in 2014 at
the end of each reporting period through the settlement date. Changes in the fair value of our contingent
consideration obligation were recognized as a component of operating expense within our consolidated statements
of operations. We achieved the contingent consideration obligation milestone of 2,500 commercial AlloSure tests
and issued 227,848 shares of our common stock in the three month period ended June 30, 2018. We recorded $1.0
million expense related to changes in fair value of contingent consideration from January 1, 2018 to the date of the
shares issuance. There is no contingent consideration obligation outstanding as of December 31, 2018.
Debt Extinguishment Expenses
In connection with the repayment and conversion to shares of common stock of all outstanding debt obligations
during 2018, we recorded $2.8 million loss on the conversion of the convertible debt financing with JGB (the “JGB
Debt”) as the difference between the value of the shares of common stock issued on the days of conversion and the
amount of principal debt converted on those days, net of the allocated debt discount and derivative liability balances.
During the same period we also recorded a $3.0 million loss on debt extinguishment of the credit agreement with
Perceptive Credit Holdings II, LP, or Perceptive, or the Perceptive Credit Agreement.
Other Expense, Net
Other expense includes gains and losses on foreign currency transactions and other miscellaneous expenses. During
the year ended December 31, 2018, the other expense charge of $0.2 million primarily consisted franchise taxes
paid.
Change in Estimated Fair Value of Common Stock Warrant and Derivative Liabilities
We recorded $23.0 related to changes in fair value of common stock warrants and derivative liabilities, as these
financial instruments are classified in liabilities during the year ended December 31, 2018. Common stock warrants
issued in connection with our debt and equity financings are considered freestanding financial instruments and are
analyzed as to whether they meet equity or liability classification in accordance with United States generally
accepted accounting principles, or US GAAP. Warrants that meet liability classification are remeasured at each
period end with changes in fair value recorded in our consolidated statements of operations until these warrants are
exercised or expire. On January 1, 2018, we adopted Accounting Standards Update No. 2017-11, Accounting for
Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral of
Mandatorily Redeemable Financial Instruments of Certain Mandatorily Redeemable Noncontrolling Interests with a
Scope Exception, and this resulted in the liability balance for our warrants issued to JGB being reclassified to equity
on the date of adoption.
The JGB Debt included certain embedded derivatives that required bifurcation, including settlement and penalty
provisions. The embedded derivative was remeasured at each reporting period with changes recorded in change in
estimated fair value of common stock warrant liability and derivative liability in the consolidated statements of
operations. As of March 27, 2018, the JGB Debt was fully converted to shares of our common stock and the
derivative was extinguished.
On April 17, 2018, we entered into the Perceptive Credit Agreement for an initial term loan of $15.0 million, which
included an embedded derivative that required bifurcation related to early repayment provision. We recorded
changes in the fair value of the derivative liabilities in the change in estimated value of common stock warrant
liability and derivative liability in our consolidated statements of operations. All amounts owing under the
Perceptive Credit Agreement were fully paid off on November 20, 2018 and the derivative was extinguished.
65
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, products and license 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 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
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 a
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 of 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 test result to the healthcare provider. Amounts received may vary amongst payers
based on coverage practices and policies of the payer. We determine an estimate of a transaction price by financial
class of payers. Transaction prices are determined for each financial class using history of reimbursements,
including analysis of an average reimbursement per test and a percentage of tests reimbursed. We estimate revenue
for non-contracted payers and self-payers using this methodology. The estimate requires significant judgment.
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 process for determining the appropriate transaction price involves judgment, and considers such factors as,
historical payment trends, current economic conditions and regulatory changes. The ultimate amounts of collections
could be different from the amounts we estimate.
During 2018, we recognized $0.5 million additional revenue related to the change in estimate of reimbursement of
testing services as we collected more than we estimated for tests performed in prior year.
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
66
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.
License and Other Revenue
We generate revenue from license agreements. License agreements may include non-refundable upfront payments,
partial or complete reimbursement of research and development costs, contingent payments based on the occurrence
of specified events under the agreements, license fees and royalties on sales of products or product candidates if they
are successfully commercialized. Our performance obligations under the agreements may include the transfer of
intellectual property rights in the form of licenses, obligations to provide research and development services and
obligations to participate on certain development committees. We make judgments to determine if performance
obligations are distinct or should be combined and the transaction price allocated to each performance obligation,
which affect the periods over which revenue is recognized. We periodically review our estimated periods of
performance based on the progress under each arrangement and accounts for the impact of any change in estimated
periods of performance on a prospective basis. We constrain variable consideration, such as milestones, if it is
probable that a significant portion of revenue would be reversed. Our deferred revenue relates to one performance
obligation, which should be recognized over time.
We did not recognize any revenue connected with milestones during the twelve months ended December 31, 2018
or 2017.
Business Combinations
In accordance with ASC Topic 805, Business Combinations, we determine and allocate the purchase price of an
acquired business to the tangible and identifiable intangible assets acquired and liabilities assumed based on their
estimated fair values as of the business combination date, including identifiable intangible assets that either arise
from a contractual or legal right or 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 we expect to make as of the acquisition date. We remeasured this
liability each reporting period and record changes in the fair value as a component of operating expenses.
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.
Acquired Intangible Assets
Amortizable intangible assets may include customer relationships, developed technology, trademarks, contracts and
acquired in-process technology assets 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.
67
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 decides to bypass
this option, it proceeds to 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 the third quarter of 2018, we changed our segments and reporting units. During that period, we determined that
we operate in one reportable segment. Prior to September 30, 2018 we had two reporting units – Post and Pre-
transplant. We recorded goodwill impairment charges of $13.0 million and $2.0 million for the periods ended
December 31, 2016 and December 31, 2017, respectively. The impairment charges resulted in full impairment of
goodwill related to our former Pre-transplant reporting unit as of March 31, 2017. No goodwill impairment related
to former Post-transplant reporting unit was recorded in prior periods. See Note 6 for additional discussion
regarding the impairment charge recorded.
In connection with our annual goodwill assessment on December 1, 2018, we performed a qualitative assessment at
the consolidated level 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, 2018, 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.
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 Warrant Liability
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 (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 the 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. Refer to Note 4 of the
consolidated financial statements included elsewhere in this Annual Report on Form 10-K for key assumptions used
to value outstanding warrant liability.
Derivative Liability
The JGB Debt included certain embedded derivatives that required bifurcation, including settlement and penalty
provisions. The combined embedded derivative liability was remeasured on a quarterly basis 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 Monte Carlo simulation model to estimate the fair value of our embedded
derivative liability. The Monte Carlo simulation model uses multiple input assumptions to simulate the likelihood
that market conditions will be achieved through 100,000 random trials. These assumptions included the expected
term of the embedded derivative, the volatility of our stock prices and our peers’ stock prices over such expected
term, likelihood, timing, and amount of future equity financing rounds, the likelihood of any prepayment or default
events, the likelihood of monthly redemptions by the JGB Debt holders and the likelihood and ability of JGB to
convert the debt into equity. In each iteration of the simulations, these assumptions were used to simulate our stock
price drawing from a risk neutral distribution, the occurrence of a conversion event, the occurrence of a prepayment
event, the occurrence of a default event, and any resulting payoff from such event. The average present value over
all iterations of the simulation was then calculated. The assumptions used in this simulation model were reviewed
on a quarterly basis and adjusted, as needed.
As of March 27, 2018, the JGB Debt was fully converted to shares of our common stock. The change in the fair
market value of the derivative liability through March 27, 2018 of $2.5 million was recorded in change in estimated
fair value of common stock warrant liability and derivative liability in the consolidated statements of operations.
In April, 2018, we entered into the Perceptive Credit Agreement, which included an embedded derivative related to
early repayment provisions that required bifurcation. This embedded derivative of $0.2 million was extinguished in
November 2018, when the outstanding debt was fully paid off.
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
The Number of AlloMap and AlloSure Tests We Receive and Report
The growth of our testing services business is tied to the number of AlloMap and AlloSure patient samples we
receive and patient results we report. Historically, less than two percent of AlloMap patient samples received are not
69
reported due to improper sampling, damage in transit or other causes. 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.
The Number of Diagnostic Products We Sell
The growth of our product revenues is tied to the sales of the Olerup SSP, QTYPE, Olerup SBT and TruSight HLA
product lines. The product sales organizations are located in Stockholm, Sweden; Vienna, Austria; Fremantle,
Australia and West Chester, Pennsylvania. Products are sold directly to customers in 14 countries. We also use
distributors to sell products in approximately 60 countries.
Continued Adoption of and Reimbursement for AlloMap
AlloMap test volume and the corresponding reimbursement revenue has generally increased over time since the
launch of AlloMap, as Medicare provided reimbursement and payers adopt coverage policies and fewer payers
consider AlloMap 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
reimbursement, achieve broader reimbursement from third party payers and to expand the number of tests per
patient and the base of healthcare providers.
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. 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 testing of Medicare beneficiaries, and increase from the 2017
reimbursement rate of $2,840. AlloMap has also received positive coverage decisions for reimbursement from
many of the largest U.S. private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation
(HCSC), Humana, Kaiser Foundation Health Plan, Inc., TRICARE and UnitedHealthcare.
Reimbursement for AlloSure
On September 26, 2017 we received notice that the Molecular Diagnostics Services, or MolDX, Program developed
by Palmetto had set AlloSure reimbursement at $2,841. Effective October 9, 2017, AlloSure was made available for
commercial testing with Medicare coverage and reimbursement. We believe the use of AlloSure, 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 can improve patient care by helping healthcare providers to
reduce the use of invasive biopsies and determine the appropriate dosage levels of immunosuppressants.
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 organs. Olerup SSP is used to type Human
Leukocyte Antigen, or HLA, alleles based on sequence-specific primer, or SSP, technology. Olerup SBT is a
complete product range for sequence-based typing of HLA alleles. 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.
In May 2018, we entered into a License Agreement with Illumina, which provides us with worldwide distribution,
development and commercialization rights to Illumina’s next generation sequencing (“NGS”) product line for use in
transplantation diagnostic testing. As a result, from June 1, 2018, we are the exclusive worldwide distributor of
Illumina’s TruSight HLA v1 and v2 product line. In addition, we were also granted the exclusive right to develop
and commercialize other NGS product lines for use in the Field, as defined in the agreement.
70
Development of Additional Products
We rely on sales of AlloMap, AlloSure, Olerup SSP, Olerup SBT, QTYPE and TruSight HLA to generate the
majority of our revenue. 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
products and diversifying our sources of revenue.
Timing of Research and Development Expenses
Our spending on research and development may vary substantially from quarter to quarter. We also expend funds to
secure clinical samples that can be used in discovery, product development, clinical validation, utility and outcome
studies. The timing of these research and development activities is difficult to predict. If a substantial number of
clinical samples are acquired in a given quarter or if a high-cost experiment is conducted in one quarter versus the
next, the timing of these expenses will affect our financial results. 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, 2018 and 2017
(In thousands)
Revenue:
Year Ended December 31,
2017
2018
Change
Testing revenue ............................................................................ $
Product revenue............................................................................
License and other revenue............................................................
Total revenue .....................................................................................
Operating expenses:
Cost of testing...............................................................................
Cost of product .............................................................................
Research and development...........................................................
Sales and marketing .....................................................................
General and administrative...........................................................
Goodwill impairment charge........................................................
Change in estimated fair value of contingent
consideration .............................................................................
Total operating expenses ...................................................................
Loss from operations .........................................................................
Interest expense, net...........................................................................
Debt extinguishment expenses ..........................................................
Other expense, net .............................................................................
Change in estimated fair value of common stock
warrant and derivative liabilities ....................................................
Income tax benefit .............................................................................
Net loss ..............................................................................................
Net loss attributable to noncontrolling interest..................................
Net loss attributable to CareDx, Inc. ................................................. $
60,300 $
15,674
595
76,569
21,456
11,531
14,514
21,670
21,959
—
1,017
92,147
(15,578)
(3,701)
(5,780)
(178)
(22,978)
1,434
(46,781)
(25)
(46,756) $
33,106 $
14,634
584
48,324
12,345
9,026
12,388
12,808
18,913
1,958
1,180
68,618
(20,294)
(5,863)
(459)
(1,031)
(29,622)
1,709
(55,560)
(91)
(55,469) $
27,194
1,040
11
28,245
9,111
2,505
2,126
8,862
3,046
(1,958)
(163)
23,529
4,716
2,162
(5,321)
853
6,644
(275)
8,779
66
8,713
71
Testing Services Revenue
Testing services revenue increased by $27.2 million, or 82%, for the year ended December 31, 2018, compared to
the same period in 2017. This increase is mainly due to the 11,634 AlloSure test results provided in the year ended
December 31, 2018, compared to 282 AlloSure tests provided in the year ended December 31, 2017 following the
commercial launch of AlloSure in October 2017. Additionally, AlloMap test results increased to 16,116 in the year
ended December 31, 2018, compared to 15,312 in the same period in 2017, and the Medicare reimbursement rate for
AlloMap increased from $2,841 to $3,240 on January 1, 2018. Furthermore, in the year ended December 31, 2018,
we recognized $0.5 million testing services revenue related to payments received in excess of the $2.9 million
accounts receivable adjustment recorded on January 1, 2018 upon adoption of the new revenue recognition standard,
ASC 606.
Furthermore, the adoption of the new revenue standard had a $1.6 million favorable impact on our Testing Revenue,
as compared to the revenue that would have been recognized under the prior guidance for the year ended December
31, 2018.
Product Revenue
Product revenue increased by $1.0 million, or 7%, for the year ended December 31, 2018, compared to the same
period in 2017. The increase was due to sales of the TruSight HLA products related to the License Agreement with
Illumina, which was signed in May 2018, and increased sales of QTYPE, partially offset by a decrease in sales of
Olerup SSP and Olerup SBT products.
License and Other Revenue
License and other revenue increased by less than $0.1 million for the year ended December 31, 2018.
Cost of Testing Services
Cost of testing increased by approximately $9.1 million, or 74%, for the year ended December 31, 2018, compared
to the same period in 2017, primarily due to the increase in test results provided for AlloSure, which was launched
in October 2017, and AlloMap.
Cost of Product
Cost of product increased by $2.5 million, or 28%, for the year ended December 31, 2018, compared to the same
period in 2017. The increase in revenue, a change in the mix of products, and the addition of sales of TruSight HLA
products, which were purchased directly from Illumina, led to an increase of $2.1 million. Furthermore, in the year
ended December 31, 2018 there was an increase in scrap and obsolescence provision of $0.4 million.
Research and Development
Research and development expenses increased by $2.1 million, or 17%, for the year ended December 31, 2018,
compared to the same period in 2017. This increase is primarily due to an increase of $0.9 million in stock-based
compensation expense, an increase of $0.6 million in clinical trial costs, an increase of $0.5 million in personnel
costs, and an increase of $0.1 million in consulting and professional fees.
Sales and Marketing
Sales and marketing expenses increased by approximately $8.9 million, or 69%, for year ended December 31, 2018,
compared to the same period in 2017, primarily due to an increase in personnel related expenses of $4.3 million,
higher conference fees and travel costs of $2.0 million associated with several key transplant industry events,
increased stock-based compensation expenses of $0.8 million, higher consulting and professional fees of $0.7
million, and higher marketing related costs of $0.4 million.
General and Administrative
General and administrative expenses increased by $3.0 million, or 16%, for the year ended December 31, 2018,
compared to the same period in 2017. This primarily reflects an increase of $2.7 million in stock-based
compensation expense, an increase of $1.8 million in personnel related expenses, higher travel expenses of $0.2
72
million, and higher facilities and software related costs of $0.2 million, partially offset by a decrease in consulting
and professional fees of $1.6 million, and a decrease in audit fees of $0.8 million.
Goodwill Impairment
In the three months ended March 31, 2017, we determined that the decrease in our market capitalization constituted
an indicator of impairment and therefore a goodwill impairment test was completed as of March 31, 2017. We
recorded a goodwill impairment charge of $2.0 million and wrote off the remaining goodwill in the former Pre-
Transplant reporting unit as of March 31, 2017. No impairment was identified in the year ended December 31, 2018.
Change in Estimated Fair Value of Contingent Consideration
In accordance with the IMX acquisition agreement, we estimated the contingent consideration liability fair value at
each period end based on our common stock price at the end of the period and a probability of meeting the
contractual milestone related to the number of commercial tests performed by June 2020. The contingent
consideration liability was settled in the six months ended June 30, 2018, with the achievement of the contractual
milestone of 2,500 commercial AlloSure tests. Changes in fair value of the contingent liability were $1.0 million
expense and $1.2 million expense for the years ended December 31, 2018 and 2017 respectively. The $1.0 million
expense reflected an increase in our share price from January 1, 2018 to the date of the issuance of the 227,848
shares and settlement of the liability. The $1.2 million expense reflected an increase in our share price in the year
ended December 31, 2017 and an increase in our estimate of the probability of meeting the milestone under our
business combination agreement with IMX.
Interest Expense, Net
Interest expense decreased by $2.2 million for the year ended December 31, 2018, compared to the same period in
2017.
The interest expense of $3.7 million in the year ended December 31, 2018, consisted of $2.5 million of interest
expense and debt discount amortization related to the JGB Debt, $1.2 million of interest expense and debt
amortization recorded in relation to the Perceptive Credit Agreement entered into on April 17, 2018 and $0.2 million
of interest expense recorded in relation to the Allenex Notes, the Danske Bank Term Loan and the SSP Primers
Loan. These interest expense amounts were partially offset by interest income of $0.2 million earned on cash and
cash equivalent balances.
The interest expense of $5.9 million in the year ended December 31, 2017, consisted of $4.2 million of interest
expense and debt discount amortization related to the JGB Debt, $0.6 million of interest expense recorded in relation
to deferred purchase consideration owed to the former shareholders of Allenex, $0.9 million in interest expense
recorded on the Allenex Notes, the Danske Bank Term Loan and the SSP Primers Loan and $0.2 million of interest
expense recorded on the East West Bank Debt.
The JGB Debt was entered into on March 15, 2017 and during the three months ended March 31, 2018 was
converted into shares of our common stock. The deferred purchase consideration was related to the acquisition of
Allenex and was settled in November 2017. The SSP Primers Loan was repaid in February 2018 and the Allenex
Notes and Danske Bank Term Loan were repaid in April 2018. The outstanding indebtedness under the East West
Bank Debt was repaid in March 2017. On April 17, 2018, we entered into the Perceptive Credit Agreement for an
initial term loan of $15.0 million. The obligations under the Perceptive Credit Agreement were fully repaid on
November 20, 2018.
73
Debt Extinguishment Expenses
Debt extinguishment expenses increased by $5.3 million in the year ended December 31, 2018 compared to the
same period in 2017. In the year ended December 31, 2018, debt extinguishment expenses of $5.8 million consisted
of a loss of $2.8 million on the conversion of the JGB Debt in the three months ended March 31, 2018 and a $3.0
million loss on the debt extinguishment of the Perceptive Credit Agreement. In the year ended December 31, 2017,
debt extinguishment expenses of $0.5 million consisted of a $0.3 million loss on a $1.2 million conversion of JGB
debt and $0.2 million of debt extinguishment fees on East West Bank debt.
Other Expense, Net
Other expense decreased by $0.8 million in the year ended December 31, 2018, compared to the same period in
2017. In the year ended December 31, 2018, the other expense charge of $0.2 million primarily consisted franchise
taxes paid. In the year ended December 31, 2017, the other expense charge of $1.0 million consisted mainly of a
foreign exchange loss of $0.6 million, $0.2 million for franchise taxes and $0.2 million in JGB Debt issuance costs.
Change in Estimated Fair Value of Common Stock Warrant and Derivative Liabilities
The change in estimated fair value of common stock warrant liability and derivative liability was $23.0 million
expense in the year ended December 31, 2018 and $29.6 million expense in 2017.
The $23.0 million expense in the year ended December 31, 2018, consisted of a remeasurement charge of $25.6
million related to the changes in fair value of common stock warrant liability, partially offset by a $2.6 million gain
recorded for the changes in fair value of the JGB Debt embedded derivative between January 1, 2018 and the debt
conversion date of March 27, 2018.
The $25.6 million remeasurement charge in the year ended December 31, 2018 reflects changes in the fair value of
our common stock warrant liability and also a charge for warrants exercised during the period. In the year ended
December 31, 2018, we recorded a revaluation charge of $7.3 million on the 0.4 million common stock warrants
outstanding at December 31, 2018, which had an average fair value of $24.14 compared to $6.49 at December 31,
2017. In the year ended December 31, 2018, approximately 1.7 million warrants with an average exercise price of
$2.86 per share and a December 31, 2017 fair value of $5.70 per share were exercised. The average market price of
our common stock on the days of exercise was $19.54 per share, resulting in a charge of $18.3 million.
In the year ended December 31, 2017, the $29.6 million charge consisted of changes in fair value of common stock
warrant liability expenses of $16.9 million and changes in fair value of the JGB Debt embedded derivative liability
of $12.7 million of expense.
The $16.9 million expense related to our common stock warrant liability was due to:
•
•
•
Changes in the valuation of warrants due to the change in the share price of our common stock during the
year. The price of our common stock increased from $2.70 on December 30, 2016 to $7.34 on December
29, 2017;
The adjustment in the exercise price of the Private Placement and Placement Agent warrants from $4.00
and $3.99 per share, respectively, to $1.12 per share, effective July 3, 2017, as a result of the issuance of
1,022,544 shares at a price of $1.12 pursuant to amendments to the Conditional Share Purchase
Agreements (as discussed below);
In connection with the issuance of the JGB Debt, on March 15, 2017, we issued warrants to JGB to
purchase up to an aggregate of 1,250,000 shares of our common stock; and
• Adjustments to the quantity and exercise price of the JGB warrants as a result of the issuance of 1,022,544
shares at a price of $1.12 pursuant to the Conditional Share Purchase Agreements. The shares issuable upon
the exercise of the warrants increased from 1,250,000 shares to 1,296,679 shares and the exercise price of
the warrants decreased from $5.00 to $4.82 per share, effective July 3, 2017. In addition, as a result of the
2017 Public Offering, the shares issuable upon exercise of the warrants increased to 1,338,326 shares and
the exercise price decreased to $4.67 per share, effective October 10, 2017.
74
The JGB Debt included certain embedded derivatives that require bifurcation, including settlement and penalty
provisions. The $12.7 million expense related to the JGB debt embedded derivative reflects the change in the fair
value of the derivative liability from the JGB Debt issuance date of March 15, 2017 to December 31, 2017. We
utilized the Monte Carlo simulation model to estimate the fair value of the embedded derivative liability for the
measurement at issuance and subsequent remeasurement at December 31, 2017.
The $12.7 million increase in the fair value of the derivative liability mainly reflects the increase in the price of our
common stock from $2.15 on March 15, 2017 to $7.34 on December 31, 2017 and the increase in the derivative
liability related to the conversion of the JGB Debt into shares of our common stock during the term of the debt.
As of January 1, 2018, we adopted the new accounting standard and reclassified the outstanding common stock
warrants issued in connection with the JGB Debt to equity. The JGB Warrants were not remeasured through
earnings after January 1, 2018. This common stock warrant issued in connection with the JGB Debt were exercised
in August 2018. Warrants issued in connection with the Private Placement Warrants continue to be classified as
liability and will be remeasured at the end of each reporting period until expired or exercised. Changes in the
common stock fair value, estimated volatility and expected contractual term will significantly impact the fair value
of the warrant liability.
Income Tax Benefit
For the year ended December 31, 2018, we recorded an income tax benefit of $1.4 million on a loss before income
taxes of $48.2 million. For the year ended December 31, 2017, we recorded an income tax benefit of $1.7 million
on a loss before income taxes of $57.3 million. For both the 2018 and 2017 years, the income tax benefit is a result
of the tax impact of the losses related to our foreign operations. The effective tax rate for the year ended December
31, 2018 defers from the federal statutory tax rate. This is a result of the full valuation allowance against U.S.
deferred tax assets due to the lack of future source of taxable income and tax benefit as a result of losses in our
foreign operations in the current year.
75
Comparison of the Years Ended December 31, 2017 and 2016
(In thousands)
Year Ended December 31,
2017
2016
Change
Revenue:
Testing revenue ................................................... $
Product revenue ...................................................
Collaboration and license revenue.......................
Total revenue ............................................................
Operating expenses:
Cost of testing......................................................
Cost of product ....................................................
Research and development ..................................
Sales and marketing.............................................
General and administrative..................................
Goodwill impairment charge...............................
Change in estimated fair value of contingent
consideration.....................................................
Total operating expenses...........................................
Loss from operations.................................................
Interest expense, net..................................................
Debt extinguishment expenses..................................
Other expense, net.....................................................
Change in estimated fair value of common stock
warrant and derivative liabilities............................
Income tax benefit.....................................................
Net loss......................................................................
Net loss attributable to noncontrolling interest.........
Net loss attributable to CareDx, Inc.......................... $
33,106 $
14,634
584
48,324
29,680 $
10,715
236
40,631
3,426
3,919
348
7,693
12,345
9,026
12,388
12,808
18,913
1,958
1,180
68,618
(20,294)
(5,863)
(459)
(1,031)
10,882
10,240
12,385
11,166
20,725
13,021
(456)
77,963
(37,332)
(1,860)
—
(1,920)
1,463
(1,214)
3
1,642
(1,812)
(11,063)
1,636
(9,345)
17,038
(4,003)
(459)
889
(29,622)
1,709
(55,560)
(91)
(55,469) $
(250)
1,606
(39,756)
(287)
(39,469) $
(29,372)
103
(15,804)
196
(16,000)
Testing Services Revenue
Testing services revenue increased by $3.4 million, or 12%, in 2017 compared to the same period in 2016 mainly
due to the increase in AlloMap test volume representing $1.8 million, as well as increased AlloMap cash collections
of $1.1 million. AlloMap tests results delivered increased by 1,164, or 8%, in 2017 compared to 2016.
AlloSure was launched in October 2017 and contributed $0.5 million of testing services revenue.
Product Revenue
Product revenue increased by $3.9 million, or 37%, in 2017, compared to 2016. The increase in product revenue
mainly reflects product revenue not being comparatively included in the year ended December 31, 2016, as the
Allenex acquisition occurred on April 14, 2016.
License and Other Revenue
License and other revenue increased by $0.3 million in 2017, compared to 2016, reflecting additional royalty
payments received under our services agreement with CardioDx, Inc.
Cost of Testing Services
Cost of testing services increased by approximately $1.5 million, or 13%, in 2017 compared to 2016 primarily due
to higher headcount related expenses of $1.1 million and laboratory material costs of $0.6 million. These increases
76
were partially offset by a decrease in royalty payments to Roche of $0.2 million, as from September 30, 2017, no
further royalties were due.
Cost of Product
Cost of product decreased $1.2 million or 12%, in 2017 compared to 2016. The decrease primarily relates to a net
$3.6 million decrease in the charge recorded for the amortization of acquisition-related mark-up in the value of
inventory. In 2016, a charge of $4.0 million was recorded related to inventory purchased in the Allenex acquisition.
In 2017, a charge of $0.4 million was recorded related to the inventory purchased in the Conexio asset acquisition.
This decrease was partially offset by the effect of the cost of product not being comparatively included. The cost of
product related to the Allenex and Conexio acquisitions are not comparatively included because the Allenex
acquisition occurred on April 14, 2016 and the Conexio acquisition occurred on January 20, 2017.
Research and Development
Research and development expenses increased less than $0.1 million, or 1%, in 2017 compared to 2016. This
increase is primarily due to a $1.0 million increase for product related development costs, which are not
comparatively included in the twelve months ended December 31, 2016, as the Allenex acquisition occurred on
April 14, 2016, partially offset by a decrease of $0.9 million of AlloSure development expenditures.
Sales and Marketing
Sales and marketing expenses increased by approximately $1.6 million, or 15%, in 2017 compared to 2016. The
increase primarily reflects an increase of $0.9 million in the product sales and marketing payroll related expenses,
due mainly to product related results not being comparatively included in the twelve months ended December 31,
2016. We incurred an additional $0.6 million related to headcount increases for customer service and sales
operations personnel.
General and Administrative
General and administrative expenses decreased by approximately $1.8 million, or 9%, in 2017 compared to 2016.
The decrease primarily reflects a reduction in audit, tax and other professional and consulting fees incurred in 2016,
primarily in connection with our acquisition of Allenex.
Goodwill impairment
On January 1, 2017, we adopted ASU 2017-04, which eliminated the Step 2 requirement of the goodwill impairment
test. Instead, the goodwill impairment test is performed by comparing the fair value of a reporting unit with its
carrying amount. In the three months ended March 31, 2017, we determined that the decrease in our market
capitalization constituted an indicator of impairment and therefore a goodwill impairment test was completed as of
March 31, 2017. The goodwill impairment test determined that the fair value of the former Pre-Transplant reporting
unit was $3.5 million, which was lower than its carrying value. Accordingly, we recorded a goodwill impairment
charge of $2.0 million for the three months ended March 31, 2017, which represented the remaining goodwill
balance in the former Pre-Transplant reporting unit. No additional goodwill impairment was recorded in the year
ended December 31, 2017. During the year ended December 31, 2016, we recorded goodwill impairment charges
related to our former Pre-Transplant reporting unit of $13.0 million. The impairment test performed in December
2016 indicated a reduction in our forecasted revenue and operating results for the former Pre-transplant reporting
unit. This was the primary cause of the reduction in fair value of the former Pre-Transplant reporting unit, which
triggered the impairment charge recorded in 2016.
Change in Fair Value of Contingent Consideration
We revalued the contingent consideration liability for the years ended December 31, 2017 and 2016 and recognized
a non-cash loss of $1.2 million and a non-cash gain of $0.5 million, respectively, as a result of management’s
estimate of the probability meeting the milestone under our business combination agreement with ImmuMetrix, Inc.
increasing to 100% at December 31, 2017, and our common stock price increasing by $4.67 and decreasing by $3.70
for the years ended December 31, 2017 and 2016, respectively.
77
Interest Expense, Net
Interest expense increased by $4.0 million for the year ended December 31, 2017 compared to the same period in
2016. The increase primarily consists of:
•
•
•
•
$1.6 million of interest expense due to the higher principal balance and interest rate of the JGB Debt, which
was outstanding from March 15, 2017 to December 31, 2017 as compared to the East West Bank Debt
which was outstanding for all of 2016 and from January 1, 2017 to March 15, 2017;
$1.8 million in increased debt discount amortization due to the higher debt discount applicable to the JGB
Debt as compared to the debt discount applicable to the East West Bank Debt;
$0.4 million in increased interest expense on Danske Bank debt and the Allenex Promissory Notes recorded
in 2017, but not comparatively included in 2016 due to the acquisition of Allenex that occurred on April
14, 2016; and
$0.2 million in increased interest expense due to the commencement of interest accruing from January 1,
2017 on the deferred purchase consideration payable related to the Allenex acquisition.
Debt Extinguishment Expenses
In the year ended December 31, 2017, debt extinguishment expenses of $0.5 million consisted of a $0.3 million loss
on a $1.2 million conversion of JGB debt and $0.2 million of debt extinguishment fees on East West Bank debt. In
the year ended December 31, 2016 no debt extinguishment expenses were recorded.
Other Expense, Net
Other expense decreased by $0.9 million in the year ended December 31, 2017, compared to the same period in
2016. In the year ended December 31, 2017, the other expense charge of $1.0 million consisted mainly of a foreign
exchange loss of $0.6 million, $0.2 million for franchise taxes and $0.2 million in JGB Debt issuance costs. In the
year ended December 31, 2016, the other expense charge of $1.9 million consisted mainly of a $2.1 million charge
in 2016 to expense financing costs associated with a proposed six-month bridge loan that did not materialize.
Change in Estimated Fair Value of Common Stock Warrant and Derivative Liabilities
The change in the estimated fair value of common stock warrant and derivative liabilities was due to a $29.6 million
expense in 2017 compared to a $0.3 million expense in 2016.
For the twelve months ended December 31, 2017, the $29.6 million charge comprised common stock warrant
liability expenses of $16.9 million and $12.7 million of expense related to the JGB Debt embedded derivative
liability.
The $16.9 million expense related to our common stock warrant liability was due to:
•
•
•
Changes in the valuation of warrants due to the change in the share price of our common stock during the
year. The price of our common stock increased from $2.70 on December 30, 2016 to $7.34 on December
29, 2017;
The adjustment in the exercise price of the Private Placement Warrants and Placement Agent Warrants
from $4.00 and $3.99 per share, respectively, to $1.12 per share, effective July 3, 2017, as a result of the
issuance of 1,022,544 shares at a price of $1.12 pursuant to amendments to the Conditional Share Purchase
Agreements (as discussed below);
In connection with the issuance of the JGB Debt, on March 15, 2017, we issued warrants to JGB to
purchase up to an aggregate of 1,250,000 shares of our common stock; and
• Adjustments to the quantity and exercise price of the JGB warrants as a result of the issuance of 1,022,544
shares at a price of $1.12 pursuant to the Conditional Share Purchase Agreements. The shares issuable
upon the exercise of the JGB Warrants increased from 1,250,000 shares to 1,296,679 shares and the
exercise price of the JGB Warrants decreased from $5.00 to $4.82 per share, effective July 3, 2017. In
addition, as a result of the 2017 Public Offering, the shares issuable upon exercise of the warrants
78
increased to 1,338,326 shares and the exercise price decreased to $4.67 per share, effective October 10,
2017.
The JGB Debt includes certain embedded derivatives that require bifurcation, including settlement and penalty
provisions. The $12.7 million expense related to the JGB Debt embedded derivative reflects the change in the fair
value of the derivative liability from the JGB Debt issuance date of March 15, 2017 to December 31, 2017. We
utilized the Monte Carlo simulation model to estimate the fair value of the embedded derivative liability for the
measurement at issuance and subsequent remeasurement at December 31, 2017.
The $12.7 million increase in the fair value of the derivative liability mainly reflects the increase in the price of our
common stock from $2.15 on March 15, 2017 to $7.34 on December 31, 2017 and the increase in the derivative
liability related to the conversion of the JGB Debt into shares of our common stock during the term of the debt.
Income Tax Benefit
For the year ended December 31, 2017, we recorded an income tax benefit of $1.7 million on a loss before income
taxes of $57.3 million. The effective tax rate for the twelve months ended December 31, 2017 differs from the
federal statutory tax rate as a result of the income tax expense and benefit related to the warrant revaluation expense
and remeasurement of the deferred tax asset, partially offset by valuation allowance.
Liquidity and Capital Resources
We have incurred significant losses and negative cash flows from operations since our inception and had an
accumulated deficit of $311.8 million at December 31, 2018. As of December 31, 2018, we had cash and
cash equivalents of $64.6 million, and no debt outstanding.
JGB Debt
On March 1, 2018, we notified JGB of our intent to prepay on April 13, 2018, in full the outstanding principal and
interest under the JGB Debt. During the three months ended, March 31, 2018, JGB converted all outstanding $26.7
million of principal and accrued interest of the JGB Debt into an aggregate of 6,161,331 shares of our common
stock. Restricted cash of $9.4 million was released from any restrictions after the conversion and included in our
cash and cash equivalent balance as of March 31, 2018.
Perceptive Credit Agreement
On April 17, 2018, we entered into the Perceptive Credit Agreement for a term loan of $15.0 million and repaid the
outstanding indebtedness under the Allenex Notes, the Danske Bank Term Loan and the Danske Credit Facility. On
November 20, 2018, we paid off all obligations owing under, and terminated, the Perceptive Credit Agreement.
Allenex Notes, Danske Bank Term Loan and Danske Credit Facility
All outstanding amounts under the Allenex Notes of $4.4 million and Danske Bank Term Loan and Danske Credit
Facility of $6.7 million were repaid on April 17, 2018.
Going Concern
As of December 31, 2018, we had cash and cash equivalents of $64.6 million. We may require future additional
financing to fund working capital and pay our obligations as they come due. Additional financing might include a
combination of equity security offerings, debt arrangements or collaborations. 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 believe that our existing cash balance and expected revenue along with the net proceeds from any future equity
financing available under our effective Form S-3 filed with SEC in August 2018, will be sufficient to meet our
anticipated cash requirements for a period of at least 12 months from the issuance date of our consolidated financial
statements.
79
The following table summarizes our cash flows for the years ended December 31, 2018, 2017 and 2016:
2018
Year Ended December 31,
2017
(in thousands)
2016
Net cash (used in) provided by:
Operating activities................................................................... $
Investing activities....................................................................
Financing activities...................................................................
(4,007) $
(7,929)
50,268
(14,307) $
(6,105)
29,379
(16,523)
(21,121)
24,927
Effect of exchange rate changes on cash, cash equivalents and
restricted cash.................................................................................
Net increase (decrease) in cash, cash equivalents and restricted
cash ................................................................................................
2
106
83
$
38,334
$
9,073
$
(12,634)
Cash Flows from Operating Activities
Net cash used in operating activities consists of our net loss, adjusted for certain non-cash items in the consolidated
statements of operations and changes in operating assets and liabilities.
Net cash used in operating activities for the year ended December 31, 2018 was $4.0 million. Our net loss of $46.8
million was our primary use of cash in operating activities and included the following noncash items: $23.0 million
loss on the change in fair value of warrants and derivative liabilities, $7.1 million stock-based compensation
expense, $4.2 million of depreciation and amortization expense, $5.8 million loss on debt extinguishment expenses,
$2.2 million amortization expense related to the JGB Debt discount, $1.2 million loss related to the revaluation of
the contingent consideration, and $0.2 million on amortization of inventory fair market value adjustment. Net
operating assets and liabilities decreased by $0.9 million.
Net cash used in operating activities for the year ended December 31, 2017 was $14.3 million. Our net loss of $55.5
million was our primary use of cash in operating activities and included a number of noncash items. Our noncash
items included $29.6 million loss on the revaluation of warrants and derivative liabilities to estimated fair value,
$3.8 million of depreciation and amortization, $3.5 million amortization of debt discount and noncash interest
expense, $2.0 million of goodwill impairment, and $1.2 million loss related to the revaluation of the contingent
consideration. Net operating assets and liabilities decreased by $1.1 million.
Net cash used in operating activities for the year ended December 31, 2016 was $16.5 million. Our net loss of $39.8
million was our primary use of cash in operating activities. Our net loss also included a number of noncash items
including $13.0 million of goodwill impairment related to our purchase of Allenex, $4.2 million of amortization of
inventory fair market value adjustment, $2.9 million of depreciation and amortization, $2.0 million of stock based
compensation expense, and $0.5 million on a revaluation gain on a contingent consideration liability related to our
acquisition of IMX in June 2014.
Cash Flows from Investing Activities
For the year ended December 31, 2018, net cash used in investing activities was $7.9 million and consisted of $5.2
million related to the acquisition of intangible assets per the Illumina License Agreement, $2.0 million for purchases
of property and equipment and $0.7 million for the acquisition of the Allenex minority interest.
For the year ended December 31, 2017, net cash used in investing activities was $6.1 million, which was primarily
due to the $5.4 million repayment of the deferred purchase obligation related to the Allenex acquisition and $0.5
million related to the acquisition of the assets of Conexio.
For the year ended December 31, 2016, net cash used in investing activities was $21.1 million, which was mainly
the cash paid to acquire Allenex of $20.6 million, net of cash acquired of $0.6 million.
80
Cash Flows from Financing Activities
Net cash provided by financing activities for the year ended December 31, 2018 was $50.3 million and primarily
related to $52.9 million net proceeds from the 2018 Public Offering, $14.3 million net proceeds from the Perceptive
Credit Agreement, cash proceeds of $11.0 million from the exercise of warrants, $1.5 million cash proceeds from
the exercise of stock options, and $0.3 million proceeds from issuance of common stock under employee stock
purchase plan. Cash received was partially offset by $28.1 million of principal payments of the promissory notes
issued to FastPartner AB and Mohammed Al Amoudi, Danske Bank Term Loan, the SSP Primers Loan, and the
Perceptive Credit Agreement, $0.7 million of taxes paid related to the net share settlement of restricted stock units,
$0.7 million repayment of the Danske Credit Facility, and $0.2 million of acquisition of Conexio.
Net cash provided by financing activities for the year ended December 31, 2017 was $29.4 million, which primarily
reflected the proceeds from the 2017 Public Offering of $18.3 million, the JGB Debt proceeds of $24.0 million, $1.0
million related to the exercise of warrants and $0.3 million of proceeds from exercise of stock options. These
amounts were offset by $12.8 million of East West Bank Debt extinguishments, $1.5 million principal payments on
Danske debt, and $0.1 million of capital lease obligations.
Net cash provided by financing activities for the year ended December 31, 2016 of $24.9 million consisted primarily
of $20.6 million from the issuance of equity securities in private financing transactions, $7.9 million in proceeds
received from the Public Offering an underwritten public offering completed on September 26, 2016, net of issuance
costs, and $0.3 million from the issuance of common stock under the employee stock purchase plan and the exercise
of stock options, partly offset by $3.9 million of principal payments on debt and capital lease obligations.
Contractual Obligations
We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide
the information required under this item.
Off-Balance Sheet Arrangements
As of December 31, 2018, we had no off-balance sheet arrangements as defined under Regulation S-K 303(a)(4) of
the Exchange Act, and the instructions thereto.
JOBS Act Accounting Election
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS
Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards
issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.
We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,
therefore, will be subject to the same new or revised accounting standards as other public companies that are not
emerging growth companies.
Foreign Operations
The accompanying consolidated balance sheets contain certain recorded assets in foreign countries, namely
Stockholm, Sweden, Vienna, Austria and Fremantle, 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.
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 and cash equivalents of $64.6
million and $16.9 million at December 31, 2018 and December 31, 2017, respectively, which consisted of bank
deposits and money market funds. Additionally, we had no outstanding debt and $34.1 million as of December 31,
2018 and December 31, 2017, respectively. Such variable interest-bearing instruments carry a degree of risk.
However, we have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in
81
interest rates. A hypothetical 50 basis point increase or decrease in interest rates during any of the periods presented
would have an approximate impact of less than $0.3 million on our consolidated financial statements.
Foreign Currency Exchange Risk
We have operations in Sweden, Austria, 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, 2018, would have negatively impacted our financial results for the year ended December
31, 2018 by $0.3 million and our product revenue by $0.9 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.
82
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 (Deficit) .......................
Consolidated Statements of Cash Flows..........................................................................................................
Notes to Consolidated Financial Statements....................................................................................................
Page No.
84
86
87
88
89
90
91
83
Report of Deloitte & Touche LLP, Independent Registered Public Accounting Firm
To the stockholders and the Board of Directors of CareDx, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of CareDx, Inc. and its subsidiaries (the "Company")
as of December 31, 2018, the related consolidated statements of operations, comprehensive loss, convertible
preferred stock and stockholders’ equity (deficit) and cash flows for the year then ended, 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, 2018, and the results of its operations
and its cash flows for the year then ended, in conformity with U.S. generally accepted accounting principles.
Change in Accounting Principles
As discussed in Note 2 to the financial statements, the Company has changed its method of accounting for revenue
in fiscal year 2018 due to the adoption of ASC Topic 606, Revenue from Contracts with Customers.
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 audit. We are a public accounting firm registered with
the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent
with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our 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 the financial statements are free of material
misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audit we are required to obtain an
understanding of internal control over financial reporting but not for expressing an opinion on the effectiveness of
the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audit 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 audit
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 audit provides a reasonable basis
for our opinion.
/s/ Deloitte & Touche LLP
San Jose, CA
March 6, 2019
We have served as the Company's auditor since 2018.
84
Report of Ernst & Young LLP, Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of CareDx, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of CareDx, Inc. (the Company) as of December 31,
2017, the related consolidated statements of operations, comprehensive loss, convertible preferred stock and
stockholders’ equity (deficit) and cash flows for each of the two years in the period ended December 31, 2017, and
the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the consolidated financial position of the Company at
December 31, 2017, and the consolidated results of its operations and its cash flows for each of the two years in the
period ended December 31, 2017, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with
the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with
respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the
effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements,
whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included
examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis
for our opinion.
/s/ Ernst & Young LLP
We have served as the Company’s auditor from 2009 to 2018.
Redwood City, California
March 22, 2018
85
CareDx, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share data)
Assets
Current assets:
Cash and cash equivalents...........................................................................................
Accounts receivable ....................................................................................................
Inventory .....................................................................................................................
Prepaid and other assets ..............................................................................................
Total current assets ............................................................................................................
Property and equipment, net..............................................................................................
Intangible assets, net..........................................................................................................
Goodwill ............................................................................................................................
Restricted cash...................................................................................................................
Total assets ........................................................................................................................ $
$
Liabilities and stockholders’ equity (deficit)
Current liabilities:
$
Accounts payable ........................................................................................................
Accrued compensation ................................................................................................
Accrued and other liabilities........................................................................................
Deferred revenue .........................................................................................................
Deferred purchase consideration .................................................................................
Derivative liability.......................................................................................................
Current portion of long-term debt ...............................................................................
Total current liabilities ......................................................................................................
Deferred rent, net of current portion..................................................................................
Deferred revenue, net of current portion ...........................................................................
Deferred tax liability..........................................................................................................
Long-term debt, net of current portion ..............................................................................
Contingent consideration...................................................................................................
Common stock warrant liability ........................................................................................
Other liabilities ..................................................................................................................
Total liabilities...................................................................................................................
Commitments and contingencies (Note 8)
Stockholders’ equity (deficit):
Preferred stock: $0.001 par value; 10,000,000 shares authorized at December 31,
2018 and 2017; no shares issued and outstanding at December 31, 2018 and
2017 ..........................................................................................................................
Common stock: $0.001 par value; 100,000,000 shares authorized at December 31,
2018 and 2017; 41,384,960 and 28,825,019 shares issued and outstanding
at December 31, 2018 and 2017, respectively..........................................................
Additional paid-in capital............................................................................................
Accumulated other comprehensive loss ......................................................................
Accumulated deficit ....................................................................................................
Total CareDx, Inc. stockholders’ equity (deficit)..............................................................
Noncontrolling interest................................................................................................
Total stockholders’ equity (deficit) ...................................................................................
Total liabilities and stockholders’ equity (deficit)............................................................. $
As of December 31,
2018
2017
64,616 $
9,760
4,943
1,795
81,114
4,134
33,252
12,005
192
130,697 $
4,711 $
9,156
5,408
39
190
—
—
19,504
470
691
2,968
—
—
10,003
1,133
34,769
16,895
2,991
5,529
1,352
26,767
2,075
33,139
12,005
9,579
83,565
3,391
5,013
3,735
39
407
14,600
15,721
42,906
913
730
4,933
18,338
1,672
18,712
1,315
89,519
—
—
41
412,010
(4,278)
(311,845)
95,928
—
95,928
130,697 $
29
264,204
(2,345)
(268,022)
(6,134)
180
(5,954)
83,565
The accompanying notes are an integral part of these consolidated financial statements.
86
CareDx, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share data)
Revenue:
Testing revenue ............................................................................ $
Product revenue............................................................................
License and other revenue............................................................
Total revenue .....................................................................................
Operating expenses:
Cost of testing services.................................................................
Cost of product .............................................................................
Research and development...........................................................
Sales and marketing .....................................................................
General and administrative...........................................................
Goodwill impairment ...................................................................
Change in estimated fair value of contingent consideration ........
Total operating expenses ...................................................................
Loss from operations .........................................................................
Interest expense, net...........................................................................
Debt extinguishment expenses ..........................................................
Other expense, net .............................................................................
Change in estimated fair value of common stock warrant and
derivative liabilities ........................................................................
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):
Year Ended December 31,
2017
2016
2018
60,300 $
15,674
595
76,569
21,456
11,531
14,514
21,670
21,959
—
1,017
92,147
(15,578)
(3,701)
(5,780)
(178)
(22,978)
(48,215)
1,434
(46,781)
(25)
(46,756) $
33,106 $
14,634
584
48,324
12,345
9,026
12,388
12,808
18,913
1,958
1,180
68,618
(20,294)
(5,863)
(459)
(1,031)
(29,622)
(57,269)
1,709
(55,560)
(91)
(55,469) $
29,680
10,715
236
40,631
10,882
10,240
12,385
11,166
20,725
13,021
(456)
77,963
(37,332)
(1,860)
—
(1,920)
(250)
(41,362)
1,606
(39,756)
(287)
(39,469)
Basic ............................................................................................. $
Diluted.......................................................................................... $
(1.31) $
(1.31) $
(2.38) $
(2.38) $
(2.39)
(2.39)
Weighted-average shares used to compute net loss per share
attributable to CareDx, Inc.:
Basic ............................................................................................. 35,638,956 23,332,503 16,496,911
Diluted.......................................................................................... 35,638,956 23,332,503 16,496,911
The accompanying notes are an integral part of these consolidated financial statements.
87
CareDx, Inc.
Consolidated Statements of Comprehensive Loss
(In thousands)
Net loss ................................................................................. $
Other comprehensive loss:
Foreign currency translation adjustments, net of tax ......
Net Comprehensive loss .......................................................
Comprehensive loss attributable to noncontrolling interest,
net of tax ........................................................................
Comprehensive loss attributable to CareDx, Inc. ................. $
Year ended December 31,
2017
(55,560) $
2018
(46,781) $
2016
(39,756)
(1,933)
(48,714)
1,306
(54,254)
(3,727)
(43,483)
(25)
(48,689) $
(99)
(54,155) $
(355)
(43,128)
The accompanying notes are an integral part of these consolidated financial statements.
88
CareDx, Inc.
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Convertible
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive
Income
Accumulated
Deficit
Noncontrolling
Interest
Total
Stockholders’
Equity
(Deficit)
—
11,902,363
12
202,566
—
(173,084 )
—
1,375,029
1
7,204
5
—
—
13,064
—
—
Balance at December 31, 2015 .................................
Issuance of common stock in connection
with business acquisition .............................
Issuance of preferred stock through private
placement and subsequent financing .......... 4,630,145
Conversion of convertible private placement
and subsequent financing preferred stock
to common stock.......................................... (4,630,145 )
Issuance of common stock through private
placement and subsequent financing ..........
Issuance of common stock through public
offering.........................................................
Issuance of common stock under equity
incentive plans .............................................
Issuance of common stock for Board of
Director services ..........................................
Issuance of common stock for cash upon
exercise of stock options..............................
Employee and non-employee share-based
compensation expense .................................
Noncontrolling interest upon acquisition........
Foreign currency translation adjustment.........
Net loss ...........................................................
Balance at December 31, 2016 .................................
—
—
—
—
—
—
—
—
—
—
Issuance of common stock in connection
with public offering .....................................
Issuance of common stock in connection
with business acquisition .............................
Conversion of convertible debt
to common stock..........................................
Issuance of common stock under employee
benefit plans.................................................
Issuance of common stock for Board of
Director services .............................................
Issuance of common stock for cash upon
exercise of stock options..............................
Issuance of common stock for cash upon
exercise of warrants .....................................
Issuance of common stock upon exercise of
warrants...........................................................
Employee and non-employee share-based
compensation expense .................................
Foreign currency translation adjustment.........
Net loss ...........................................................
Balance at December 31, 2017 .................................
Adoption of ASC 606 .....................................
Reclassification of warrants from liability to
equity (Note 2) ................................................
Issuance of common stock in connection
with public offering, net of offering costs
of $3.8 million
........................................................................
Conversion of convertible debt.......................
Issuance of common stock under ESPP..........
RSU settlements, net of shares withheld ........
Issuance of common stock for services ..........
Issuance of common stock for cash upon
exercise of stock options..............................
Issuance of common stock for cash upon
exercise of warrants .....................................
Employee share-based compensation
expense............................................................
Non-employee share-based compensation
expense............................................................
Noncontrolling interest upon acquisition........
Issuance of common stock for contingent
consideration...................................................
Issuance of warrants in connection with
Perceptive Debt...............................................
Foreign currency translation adjustment.........
Net loss ...........................................................
Balance at December 31, 2018 .................................
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
5
1
2
—
—
—
—
2,595
7,923
304
304
19
—
—
—
—
21 $
1,694
—
—
—
235,673 $
—
—
(3,659 )
—
(3,659 ) $
—
—
—
(39,469 )
(212,553 ) $
—
634
(68 )
(287 )
279 $
6
2
—
—
—
—
—
—
—
—
—
29 $
—
—
2
6
—
—
—
1
3
—
—
—
—
—
—
—
41 $
18,323
1,144
1,676
94
245
262
989
4,306
1,492
—
—
264,204 $
—
6,550
52,547
38,846
287
(698 )
273
1,479
38,709
5,868
1,009
(537 )
2,689
784
—
—
412,010 $
—
—
—
—
—
—
—
—
—
1,314
—
(2,345 ) $
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(55,469 )
(268,022 ) $
2,933
—
—
—
—
—
—
—
—
—
—
—
—
—
(1,933 )
—
(4,278 ) $
—
—
(46,756 )
(311,845 ) $
—
—
—
—
—
—
—
—
—
(8 )
(91 )
180 $
—
—
—
—
—
—
—
—
—
—
—
(155 )
—
—
—
(25 )
- $
29,494
7,205
13,064
5
2,596
7,925
304
304
19
1,694
634
(3,727 )
(39,756 )
19,761
18,329
1,146
1,676
94
245
262
989
4,306
1,492
1,306
(55,560 )
(5,954 )
2,933
6,550
52,549
38,852
287
(698 )
273
1,480
38,712
5,868
1,009
(692 )
2,689
784
(1,933 )
(46,781 )
95,928
(5 )
4,630,145
—
926,029
—
2,283,392
—
—
—
—
—
—
—
—
93,806
61,921
5,688
—
—
—
—
21,278,373 $
—
4,992,840
—
1,022,544
—
288,022
—
166,067
—
115,948
—
70,809
—
890,416
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
28,825,019 $
—
—
2,300,000
6,161,331
76,710
178,150
50,509
—
473,812
—
3,091,581
—
—
—
—
—
—
—
227,848
—
—
—
—
—
—
—
41,384,960 $
The accompanying notes are an integral part of these consolidated financial statements.
89
CareDx, Inc.
Consolidated Statements of Cash Flows
Operating activities:
Net loss ........................................................................................................................... $
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization ...............................................................................
Amortization of inventory fair market value adjustment .......................................
Loss on disposal of property and equipment..........................................................
Stock-based compensation expense .......................................................................
Amortization of deferred revenue ..........................................................................
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 ................................
Non-cash goodwill impairment ..............................................................................
Debt extinguishment expenses ...............................................................................
Changes in operating assets and liabilities:
Accounts receivable .......................................................................................
Inventory ........................................................................................................
Prepaid and other assets .................................................................................
Accounts payable ...........................................................................................
Accrued compensation...................................................................................
Accrued royalties ...........................................................................................
Accrued and other liabilities ..........................................................................
Change in deferred revenue ...........................................................................
Change in deferred taxes................................................................................
Net cash used in operating activities .....................................................
Investing activities:
Purchase of property and equipment ..............................................................................
Acquisition of intangible assets ......................................................................................
Acquisition of Allenex AB and noncontrolling interests, net of cash acquired .............
Acquisition of assets of Conexio Genomics Pty Ltd. .....................................................
Net cash used in investing activities......................................................
Financing activities:
Proceeds from issuance of common stock, net of issuance costs ...................................
Proceeds from debt, net of issuance costs ......................................................................
Principal payments on debt and capital lease obligations ..............................................
Contingent payments related to the acquisition of Conexio Genomics Pty Ltd.............
Change in short-term credit facility................................................................................
Proceeds from private placement and subsequent financing, net of issuance costs .......
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................................
Change in bank overdraft obligation ..............................................................................
Net cash provided by 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 .............................................................................................................. $
Supplemental disclosures of cash flow information
Shares issued in lieu of cash payment..................................................................................... $
Deferred purchase consideration............................................................................................. $
Accrued interest capitalized to debt principal......................................................................... $
Common stock issued for acquisition ..................................................................................... $
Debt assumed as part of acquisition........................................................................................ $
Conversion of convertible private placement and subsequent financing
preferred stock to common stock ......................................................................................... $
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.............................................................. $
Common stock shares issued for contingent consideration .................................................... $
Cash, Cash Equivalents and Restricted Cash as of:
Cash and cash equivalents....................................................................................................... $
Restricted cash ........................................................................................................................
Total cash, cash equivalents, and restricted cash at the end of the period .............................. $
2018
Year Ended December 31,
2017
2016
(46,781 ) $
(55,560 ) $
(39,756 )
4,215
234
—
7,138
—
22,978
1,017
2,232
—
5,831
(3,967 )
363
(502 )
(168 )
4,291
—
758
(39 )
(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 )
—
3,759
418
10
1,744
(32 )
29,622
1,180
3,452
1,958
274
(109 )
1,025
(84 )
292
1,065
(263 )
(970 )
—
(2,088 )
(14,307 )
(186 )
—
(5,404 )
(515 )
(6,105 )
18,328
24,002
(14,359 )
—
—
—
989
262
94
—
63
50,268
29,379
2
38,334
26,474
64,808 $
106
9,073
17,401
26,474 $
1,774 $
3,270 $
— $
— $
— $
— $
— $
— $
38,852 $
361 $
341 $
784 $
2,689 $
64,616 $
192
64,808 $
1,145 $
— $
984 $
— $
— $
— $
— $
— $
— $
— $
— $
16,895 $
9,579
26,474 $
2,920
4,175
—
1,998
(45 )
250
(456 )
(101 )
13,021
—
1,047
492
999
(620 )
977
21
(105 )
—
(1,340 )
(16,523 )
(549 )
—
(20,572 )
—
(21,121 )
7,926
—
(3,944 )
—
—
20,622
—
19
304
—
—
24,927
83
(12,634 )
30,035
17,401
867
—
5,700
—
7,205
13,421
13,064
—
—
—
—
—
17,258
143
17,401
The accompanying notes are an integral part of these consolidated financial statements.
90
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 global transplant diagnostics
company with product offerings along the pre- and post-transplant continuum. The Company focuses on discovery,
development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant
patients. In diagnostic testing services, the Company offers AlloMap, which is a gene expression solution for heart
transplant patients and AlloSure, which is a donor-derived cell-free DNA (“dd-cfDNA”) solution initially used for
kidney transplant patients. 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.
Testing Services
AlloMap is a covered service for Medicare beneficiaries since January 1, 2006. The 2018 the reimbursement rate for
AlloMap was $3,240, which represents a 14% increase over the 2017 reimbursement rate. AlloMap has also
received positive coverage decisions from many of the largest U.S. private payers.
In October 2017, the Company commercially launched AlloSure, its proprietary next generation sequencing-based
test that measures dd-cfDNA after transplantation. The Medicare reimbursement rate for AlloSure is $2,841.
AlloSure has also received payments from private payers on a case-by-case basis, however, no positive coverage
decisions have been made for AlloSure in 2018.
Products
Olerup SSP is used to type Human Leukocyte Antigen (“HLA”) alleles, based on the sequence specific primer
(“SSP”) technology. Olerup SBT is a complete product range for sequence-based typing of HLA alleles. 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. The Company received CE mark
certification for QTYPE on April of 2018.
In May 2018, the Company entered into a License and Commercialization Agreement (the “License Agreement”)
with Illumina, Inc. (“Illumina”), which provides the Company with worldwide distribution, development and
commercialization rights to Illumina’s next generation sequencing (“NGS”) product line for use in transplantation
diagnostic testing. Refer to Note 5 for additional details.
In the third quarter of 2018, the Company changed its internal organizational structure and no longer operates in two
reportable segments: Post-Transplant and Pre-Transplant. The Company’s Chief Operating Decision Maker
(“CODM”) did not change as a result of this reorganization and continues to be the Chief Executive Officer
(“CEO”) of the Company. This change is reflective of the Company’s CODM’s review of the operating performance
and allocation of resources at the consolidated level. Refer to Note 16 for additional details.
The Company’s headquarters are in Brisbane, California. The primary operations are in Brisbane, U.S., Stockholm,
Sweden and Fremantle, Australia.
Liquidity and Going Concern
The Company has incurred significant losses and negative cash flows from operations since its inception and had an
accumulated deficit of $311.8 million at December 31, 2018. As of December 31, 2018, the Company had cash and
cash equivalents of $64.6 million.
The Company may require additional financing in the future to fund working capital and the Company’s future
products development. Additional financing might include issuance of equity securities, debt, or cash. There can be
no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its
operations or on terms favorable to the Company. The Company believes its existing cash balance and expected
revenues will be sufficient to meet its anticipated cash requirements for the next 12 months.
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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. In April 2016, the Company acquired 98.3% of the
controlling interest of CareDx International AB, formerly Allenex AB (“Allenex”) and recorded noncontrolling
interest of 1.7%. On March 15, 2018, the Company acquired the remaining noncontrolling interest in Allenex and
has not reported any noncontrolling interest balances since that date.
The Company recorded debt extinguishment expenses on the conversion of debt in other expense, net in its
consolidated statements of operations in its Annual Report on Form 10-K for the year ended December 31, 2017 and
in its Quarterly Reports on Form 10-Q in 2018. These extinguishments expenses on the conversion of debt have
been reclassified from other expense, net to debt extinguishment expenses for all periods presented in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2018.
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; 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 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 and various bank
deposit accounts. These financial instruments are held in Company accounts at eight 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
AlloMap and AlloSure tests provided for patients located in the U.S. and billed to various third-party payers, and
from sales of products to distributors, strategic partners and transplant laboratories in Europe, the Middle East,
Africa, the U.S., Latin America and other geographic regions. The Company has not experienced any significant
credit losses and does not require collateral on receivables. For the years ended December 31, 2018, 2017 and 2016,
approximately 48%, 27% and 44%, respectively, of total revenue was billed to Medicare. No other payers
represented more than 10% of total revenue for the years ended December 31, 2018, 2017 and 2016.
As of December 31, 2018 and 2017, approximately 27% and 16%, respectively, of accounts receivable was due
from Medicare. No other payer represented more than 10% of accounts receivable at either December 31, 2018 or
2017.
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.
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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 $0.2 million is classified as long-term
restricted cash on the accompanying consolidated balance sheets.
A restricted cash balance of $9.4 million related to the debt obligation with JGB (the “JGB Debt”) was released
upon the full conversion of the JGB Debt to common stock during the three months ended March 31, 2018, and is no
longer classified as restricted cash.
Inventory
Inventory is finished goods, work in progress, and raw materials and consists of reagent plates, testing devices,
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. Inventories at the Company’s Stockholm, Sweden, and Fremantle,
Australia locations are stated at the lower of purchased cost, determined on an average cost basis, or net realizable
value. Inventories at the Company’s other locations 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
three 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.
Assets held under capital leases are recorded at the lower of the net present value of the minimum lease payments or
the fair market value of the leased asset at the inception of the lease. Amortization expense is computed using the
straight-line method over the shorter of the estimated useful lives of the assets or the period of the related lease.
The Company capitalizes certain costs incurred for software developed or obtained for internal use. These costs
include software licenses, consulting services, and direct materials, as well as employee payroll and payroll-related
costs. Capitalized internal-use software costs are depreciated over three years.
Business Combinations
The Company determines and allocates the purchase price of an acquired business to the tangible and identifiable
intangible assets acquired and liabilities assumed based on their estimated fair values as of the business combination
date, including identifiable intangible assets, which either arise from a contractual or legal right or 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.
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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.
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.
The Company tests amortizable intangible assets for impairment on an annual basis and in between annual tests if it
becomes aware of events or changes that would indicate that it is more likely than not that the fair value of the assets
is below their carrying amounts. The amortizable intangible assets annual impairment test is performed as of
December 1 of each fiscal year. If the fair value exceeds the carrying value, then there is no impairment.
Impairment losses on indefinite-lived intangible assets are recognized based solely on a comparison of the fair value
of an asset to its carrying value, without consideration of any recoverability test. The Company has not identified
any such impairment losses to date.
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 the third quarter of 2018, the Company changed its reportable segments and reporting units. During that period,
the Company determined that it operates in one reportable segment and one reporting unit. Prior to September 30,
2018 the Company had two reporting units – Post and Pre-transplant. The Company recorded goodwill impairment
charges of $13.0 million and $2.0 million for the periods ended December 31, 2016 and December 31, 2017,
respectively. The impairment charges resulted in full impairment of goodwill related to the Company’s former Pre-
transplant reporting unit as of March 31, 2017. No goodwill impairment related to former Post-transplant reporting
unit was recorded in prior periods. See Note 6 for additional discussion regarding the impairment charge recorded.
In connection with the Company’s annual goodwill assessment on December 1, 2018, 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
94
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, 2018, 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, 2018, 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.
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 Warrant Liability and Derivative Liabilities
Common Stock Warrant Liability
On January 1, 2018, the Company adopted Accounting Standard Update (“ASU”) No. 2017-11, Accounting for
Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral of
Mandatorily Redeemable Financial Instruments of Certain Mandatorily Redeemable Noncontrolling Interests with a
Scope Exception. The Company determined that the common stock warrants issued to JGB (the “JGB Warrants”)
meet equity classification criteria under the new standard and reclassified $6.6 million (the fair value of the JGB
Warrants as of January 1, 2018) from warrant liability to equity (additional paid in capital). As of September 30,
2018, the JGB Warrants were fully exercised.
The warrant issued to Perceptive Credit Holdings II, LP (“Perceptive” and such warrant the “Perceptive Tranche A
Warrant”), on April 17, 2018, also met the equity classification as noted in Note 13.
The new standard did not impact the classification of the other warrants included in the warrant liability balance as
these financial instruments have other than down-round anti-dilution adjustments features. Outstanding warrants
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liabilities are remeasured each reporting period with changes in fair value recorded in change in estimated fair value
of common stock warrant liability and derivative liability in the consolidated statement of operations. Refer to Note
4 for valuation methodology and assumptions used to estimate the warrant liability’s fair value.
Derivative Liability
The JGB Debt included certain embedded derivatives that required bifurcation, including settlement and penalty
provisions. The combined embedded derivative was remeasured at each reporting period with changes recorded in
change in estimated fair value of common stock warrant liability and derivative liabilities in the consolidated
statements of operations. As of March 27, 2018, the JGB Debt was fully converted to shares of the Company’s
common stock. The change in the fair market value of the derivative liability through March 27, 2018 was recorded
in change in estimated fair value of common stock warrant liability and derivative liabilities in the consolidated
statements of operations.
On April 17, 2018, the Company entered into the Perceptive Credit Agreement, which included an embedded
derivative that required bifurcation related to early repayment provisions. This embedded derivative fair value of
$0.2 million was recorded as debt issuance discount. Refer to Note 10 for additional details. The derivative was
remeasured at the end of each reporting period with changes recorded in change in estimated fair value of common
stock warrant liability and derivative liabilities in the consolidated statements of operations. The embedded
derivative liability of $0.2 million was extinguished on November 20, 2018, when the Company paid off all
obligations under the Perceptive Credit Agreement.
Revenue
The Company recognizes revenue from testing services, products, and license 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 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
AlloMap and AlloSure 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 a 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 of time.
The healthcare providers that order the tests and on whose behalf CareDx 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 AlloMap or AlloSure 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. Transaction prices are determined for each financial class using
history of reimbursements, including analysis of an average reimbursement per test and a percentage of tests
reimbursed. The Company estimates revenue for non-contracted payers and self-payers using this methodology.
The estimate requires significant judgment. 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.
96
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. As of December 31, 2018, the Company had received payments of
$0.5 million more than estimated as of December 31, 2017, related to tests performed in prior periods. This change
in estimate was included in testing services revenue in the year ended December 31, 2018, when cash was collected.
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. 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.
License and Other Revenue
The Company generates revenue from license agreements. License agreements may include non-refundable upfront
payments, partial or complete reimbursement of research and development costs, contingent payments based on the
occurrence of specified events under the agreements, license fees and royalties on sales of products or product
candidates if they are successfully commercialized. The Company’s performance obligations under the agreements
may include the transfer of intellectual property rights in the form of licenses, obligations to provide research and
development services and obligations to participate on certain development committees. The Company makes
judgments to determine if performance obligations are distinct or should be combined and the transaction price
allocated to each performance obligation, which affect the periods over which revenue is recognized. The Company
periodically reviews its estimated periods of performance based on the progress under each arrangement and
accounts for the impact of any change in estimated periods of performance on a prospective basis. The Company
constrains variable consideration, such as milestones, if it is probable that a significant portion of revenue would be
reversed. The Company’s deferred revenue relates to one performance obligation, which should be recognized over
time. The Company did not recognize any revenue connected with milestones during the years ended December 31,
2018, 2017 or 2016.
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. Prior to adoption of the new revenue guidance, the Company recorded costs of
testing associated with performing tests (except royalties) in the period when tests were performed without
consideration of whether revenue was recognized in the same period. With the adoption of the new revenue
standard on January 1, 2018, revenue and cost of testing services for tests performed are recognized in the same
period. 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.
97
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 product and 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 record 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
current operations.
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Comprehensive Loss
Comprehensive loss consists of net loss and other losses affecting stockholders’ equity (deficit) 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.
Recent Accounting Pronouncements
On January 1, 2018, the Company adopted the new revenue accounting standard Revenue from Contracts with
Customers (Topic 606) ("ASC 606") using the modified retrospective method. The adoption of ASC 606 resulted in
a one-time adjustment of $2.9 million to accounts receivable and accumulated deficit on January 1, 2018. The
adjustment reflects the estimated payments to be received for tests where the result had been delivered at December
31, 2017, but associated revenue had not been recognized by December 31, 2017, because payment had not been
received. As of December 31, 2018, the Company had received payments of $3.4 million for these tests and
recorded additional testing revenue of $0.5 million as a change in estimate. The new standard did not impact the
Company’s product revenue or license and other revenue, nor did it impact contract assets or contract liabilities.
The following table summarizes the impact of the ASC 606 adoption on accounts receivable as of December 31,
2018 (in thousands):
Balance Sheets
Accounts Receivable ....................
$
9,760
$
5,424
$
4,336
Balance as Reported
Balance without the
adoption of ASC 606
Impact of Adoption of
ASC 606
The following table summarizes the impact to the consolidated statements of operations in accordance with the new
revenue standard requirements for the year ended December 31, 2018 (in thousands):
Statements of Operations
Testing revenue.............................
Product revenue ............................
License and other revenue ............
Balance As Reported
Year Ended December 31, 2018
Balance without the
adoption of ASC 606
Revenue Impact of
adoption of ASC 606
$
$
60,300
15,674
595
76,569
$
$
58,661
15,674
595
74,930
$
$
1,639
—
—
1,639
In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (Topic 842)
(“ASC 842”), which, for operating leases, requires the lessee to recognize a right-of-use (“ROU”) asset and a lease
liability, initially measured at the present value of the lease payments, in its balance sheet. The guidance also requires
a lessee to recognize single lease costs, calculated so that the cost of the lease is allocated over the lease term, generally
on a straight-line basis. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842,
Leases. Additionally, the FASB issued ASU, No. 2018-11, Leases (Topic 842): Targeted Improvements, which offers
a practical expedient for transitioning at the adoption date. These ASUs will be effective for the Company on January
1, 2019 and the Company has chosen to use this practical expedient and recognize a cumulative-effect adjustment to
the opening balance of the accumulated deficit. The Company has also chosen to apply the package of practical
expedients for existing leases, which provides relief from reassessing: (i) whether a contract is or contains a lease, (ii)
lease classification, and (iii) whether initial direct costs (IDCs) can be capitalized. The Company has also made some
accounting policy elections to: (i) allow the Company not to separate nonlease components from lease components,
and instead to account for those as a single lease component, and (ii) elect not to recognize a ROU asset and a lease
liability for leases with a term of 12 months or less (“short-term leases”).
The Company has substantially completed an evaluation of the impact of adopting this guidance will have on its
consolidated financial statements and disclosures. The Company believes the most significant changes to the
consolidated financial statements will be the recognition of ROU assets and offsetting lease liabilities related to
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operating leases in the consolidated balance sheet. Upon adoption of ASC 842 on January 1, 2019, the Company
anticipates that it will record a ROU asset of approximately $3.0 million and a lease liability of approximately $4.0
million.
The Company does not expect the standard to have a material impact on the consolidated statement of cash flows or
the consolidated statement of operations. The Company is currently working to complete the implementation of new
processes and information technology tools to assist in its ongoing lease data collection and analysis, and updating
its accounting policies and internal controls in connection with the adoption of the new standard.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of
Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force) (“ASU 2016-15”), to
reduce the diversity in practice with respect to the presentation of certain cash flows. The ASU is effective for
interim and annual periods beginning after December 15, 2017. The Company adopted ASU 2016-15 on January 1,
2018 on a retrospective basis. The adoption of ASU 2016-15 did not have a material impact on the Company’s
consolidated financial statements.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a
consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”). This guidance requires that a statement of
cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally
described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash
and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-
of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for all
interim and annual reporting periods beginning after December 15, 2017. The Company adopted ASU 2016-18 on
January 1, 2018 on a retrospective basis and included restricted cash together with cash and cash equivalents in its
consolidated statements of cash flows.
In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718): Scope of
Modification Accounting (“ASU 2017-09”). The amendments provide guidance about how to account for changes
to terms or conditions of a share-based payment award required under modification accounting. ASU 2017-09 is
effective for all interim and annual reporting periods beginning after December 15, 2017. The Company adopted
ASU 2017-09 on January 1, 2018 on a prospective basis and the adoption of ASU 2017-09 did not have a material
impact to the consolidated financial statements.
In July 2017, the FASB issued ASU No. 2017-11, Accounting for Certain Financial Instruments with Down Round
Features and Replacement of the Indefinite Deferral of Mandatorily Redeemable Financial Instruments of Certain
Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). ASU 2017-11 is
effective for all interim and annual reporting periods beginning on or after December 15, 2018 with early adoption
permitted. The Company adopted ASU 2017-11 on January 1, 2018, and the adoption resulted in the JGB common
stock warrant liability balance being reclassified to additional paid in capital (Refer to Note 13).
In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income
(Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (“ASU 2018-
02”). The amendments in ASU 2018-02 allow a reclassification from accumulated other comprehensive income to
retained earnings for certain tax effects resulting from the Tax Cuts and Jobs Act (the “Tax Act”). ASU 2018-02
will become effective for all interim and annual reporting periods beginning after December 15, 2018 and may be
applied retrospectively or as of the beginning of the period of adoption. The Company does not expect that the
adoption of the new standard will have a material impact on its consolidated financial statements.
In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements
to Nonemployee Share Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 is effective for all interim and
annual reporting periods beginning on or after December 15, 2018. The Company will adopt ASU 2018-07 on
January 1, 2019. The Company is in the process of assessing the impact that the ASU will have in its consolidated
financial statements and disclosures.
In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal – Use Software
(Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement
100
That Is a Service Contract (“ASU 2018-15”). ASU 2018-15 is 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 plans to adopt the standard during 2019. The Company expects the new standard will impact
its prospective consolidated financial statements after adoption related to implementation costs in a cloud computing
arrangement if and when entered by the Company.
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 for common share
equivalents as their effect would have been antidilutive.
For the years ended December 31, 2018, 2017 and 2016, 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...................................................................
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 to CareDx, Inc. .............................
Net loss per share attributable to CareDx, Inc.:
Basic................................................................................................ $
Diluted............................................................................................. $
$
2018
Year Ended December 31,
2017
2016
(46,756)
$
(55,469)
$
(39,469)
(46,756)
$
(55,469)
$
(39,469)
35,638,956
35,638,956
23,332,503
16,496,911
23,332,503
16,496,911
(1.31) $
(1.31) $
(2.38) $
(2.38) $
(2.39)
(2.39)
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 convertible notes.....................
Shares of common stock subject to contingent
consideration ................................................................................
Restricted stock units ......................................................................
Total common stock equivalents.....................................................
2018
Year Ended December 31,
2017
2016
2,501,057
1,941,472
1,757,309
656,289
—
3,678,957
6,127,021
3,259,926
—
—
227,845
436,176
4,125,710 12,411,471
968,364
227,845
306,245
5,551,325
The Company issued 4,630,145 shares of preferred stock pursuant to the Private Placement and Subsequent
Financing (as described in Note 11), which were completed on April 14, 2016 and June 15, 2016, respectively. All
of the preferred stock was converted to common stock upon receipt of the approval of the Private Placement by the
Company’s stockholders (the “Requisite Stockholder Approval”) on June 16, 2016. As of December 31, 2016, there
was no preferred stock outstanding. On September 26, 2016, the Company completed the Public Offering (the
101
“2016 Public Offering”), pursuant to which the Company issued and sold an aggregate of 2,250,000 shares of
common stock.
On October 10, 2017, the Company completed an underwritten public offering (the “2017 Public Offering”),
pursuant to which the Company issued and sold an aggregate of 4,992,840 shares. 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. In the three months ended June 30, 2018, the Company achieved the milestone of performing 2,500
commercial AlloSure 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.
4. FAIR VALUE MEASUREMENTS
The Company records its financial assets and liabilities at fair value except for its debt, which was recorded at
amortized cost. 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 fair value of the Company’s financial assets and liabilities measured on a recurring
basis, as of December 31, 2018 and 2017 (in thousands):
December 31, 2018
Fair Value Measured Using
(Level 1)
(Level 2)
(Level 3)
Total
Balance
Assets
Money market funds ..................................... $ 59,471 $
Liabilities
Common stock warrant liability....................
—
— $
— $ 59,471
— $ 10,003 $ 10,003
102
Assets
Money market funds............................................... $
Liabilities
Contingent consideration........................................ $
Common stock warrant liability .............................
Derivative Liability ................................................
Total liabilities........................................................ $
December 31, 2017
Fair Value Measured Using
(Level 1)
(Level 2)
(Level 3)
Total
Balance
13,097
$
—
$
—
$
13,097
—
—
—
—
$
$
—
—
—
—
$
$
1,672
18,712
14,600
34,984
$
$
$
1,672
18,712
14,600
34,984
The following table presents the issuances, changes in fair value and classifications of the Company’s Level 3
financial instruments that are measured at fair value on a recurring basis (in thousands):
(Level 3)
Common
Contingent
Consideration
Liability
Stock
Warrant
Liability
JGB Debt
derivative
Liability
Perceptive
Derivative
Liability
Total
Balance as of December 31, 2016 ................................. $
Issuance of JGB Debt and warrants...............................
Exercise of warrants ......................................................
Conversion of JGB Debt ...............................................
Change in estimated fair value ......................................
Balance as of December 31, 2017 ................................. $
Exercise of warrants ......................................................
Extinguishment of derivative liabilities.........................
Reclassification to equity (Note 2) ................................
Issuance of Perceptive derivative liability.....................
Issuance of shares of common stock .............................
Change in estimated fair value ......................................
Balance as of December 31, 2018 ................................. $
492 $
—
—
—
5,208 $
900
(4,306)
—
— $
2,290
—
(402)
1,180 16,910 12,712
1,672 $ 18,712 $ 14,600 $
—
— (12,066)
—
—
—
(2,534)
— $
— (27,714)
—
(6,550)
—
—
—
(2,689)
—
1,017 25,555
— $ 10,003 $
— $ 5,700
3,190
—
(4,306)
—
(402)
—
— 30,802
— $ 34,984
— (27,714)
(202) (12,268)
(6,550)
—
245
245
—
(2,689)
(43) 23,995
— $ 10,003
The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period.
There were no transfers between Level 1, Level 2 and Level 3 categories during the periods presented.
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. At
December 31, 2018 and 2017, money market funds were included as cash and cash equivalents in the
consolidated balance sheets.
Contingent consideration liability— As of December 31, 2017, 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 fair value of the contingent consideration was
estimated using the closing market price of the common stock multiplied by management’s estimate of
the probability of achievement of the contingency condition disclosed above, as of each period end.
The probability of achievement of a contingency condition was a significant input in the Level 3
103
•
•
•
measurement and was 100% in presented periods. Increases (decreases) in the estimation of the
probability percentage resulted in a directionally similar impact to the fair value of the contingent
consideration liability. The Company achieved the contingent consideration milestone of 2,500
commercial tests and issued the 227,848 shares on May 22, 2018. There is no contingent consideration
outstanding at December 31, 2018.
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.
JGB Debt derivative liability— The Company utilized the Monte Carlo Simulation Model to estimate
the fair value of the compound derivative liability recorded in connection with the JGB Debt. The
Monte Carlo Simulation Model used multiple input assumptions to simulate the likelihood that market
conditions will be achieved through 100,000 random trials. These assumptions included the expected
term of the embedded derivative, the volatility of the Company’s stock prices and its peers’ stock prices
over such expected term, likelihood, timing, and amount of future equity financing rounds, the
likelihood of any prepayment or default events, the likelihood of monthly redemptions by the JGB Debt
holders, and the likelihood and ability of JGB to convert the debt into equity. In each iteration of the
simulations these assumptions were used to simulate the Company’s stock price drawing from a risk
neutral distribution, the occurrence of a conversion event, the occurrence of a prepayment event, the
occurrence of a default event, and any resulting payoff from such event. The average present value over
all iterations of the simulation was then calculated. Increases (decreases) in the assumptions discussed
above resulted in a directionally similar impact to the fair value of the derivative liability. The
assumptions used in this simulation model were reviewed on a quarterly basis and adjusted, as needed.
For the year ended December 31, 2017 and from January 1, 2018 to March 27, 2018, the Company
recorded the changes in fair value of the derivative liability of $12.7 million income and of $2.5 million
income, respectively, in the change in estimated value of common stock warrant liability and derivative
liability in its consolidated statements of operations. The derivative liability was remeasured and fully
extinguished upon the final JGB Debt conversion on March 27, 2018 (see Note 10).
Perceptive Credit Agreement derivative liability – The Company used a net present value analysis to
estimate the fair value of the embedded derivative liability recorded in connection with the Perceptive
Credit Agreement. The assumptions used in the analysis were the discount rate, the probability of early
repayment during the term of the Perceptive Credit Agreement and the expected term of the derivative.
An increase in the discount rate will result in a decrease in liability and an increase in the probability of
early repayment will result in an increase in liability. The assumptions used in this analysis were
reviewed on a quarterly basis and adjusted, as needed. The derivative liability was remeasured and fully
extinguished upon the repayment of the Perceptive Credit Agreement on November 20, 2018 (see Note
10).
104
Common Stock Warrant and Derivative Liability Valuation Assumptions:
December 31, 2018
December 31, 2017
Private Placement Common Stock Warrant
Liability
Stock Price............................................................... $
Exercise Price .......................................................... $
Remaining term (in years) .......................................
Volatility..................................................................
Risk-free interest rate ..............................................
Subsequent Financing Common Stock Warrant
Liability
Stock Price............................................................... $
Exercise Price .......................................................... $
Remaining term (in years) .......................................
Volatility..................................................................
Risk-free interest rate ..............................................
Placement Agent Common Stock Warrant
Liability
Stock Price............................................................... $
Exercise Price .......................................................... $
Remaining term (in years) .......................................
Volatility..................................................................
Risk-free interest rate ..............................................
JGB Common Stock Warrant Liability
Stock Price............................................................... $
Exercise Price .......................................................... $
Remaining term (in years) .......................................
Volatility..................................................................
Risk-free interest rate ..............................................
JGB Derivative Liability
Stock Price............................................................... $
Remaining term (in years) .......................................
Volatility..................................................................
Risk-free interest rate ..............................................
25.14 $
1.12 $
4.29
79.00 %
2.46 %
— $
— $
—
— %
— %
25.14 $
1.12 $
2.29
86.00 %
2.44 %
— $
— $
—
— %
— %
— $
—
— %
— %
7.34
1.12
5.29
66.00 %
2.21 %
7.34
4.00
5.46
65.00 %
2.21 %
7.34
1.12
3.29
82.00 %
1.99 %
7.34
4.67
4.71
30.00 %
1.89 %
7.34
2.16
69.00 %
2.14 %
Warrants liabilities exercised during 2018 were remeasured at the exercise date. Their fair value approximate their
intrinsic value, which was recorded to additional paid in capital in the consolidated statements of stockholders’
equity (deficit).
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.
5. BUSINESS COMBINATIONS AND ASSET ACQUISITIONS
Business Combinations
Allenex
On April 14, 2016, the Company acquired 98.3% of the outstanding common stock of Allenex, a transplant
diagnostic company based in Stockholm, Sweden that developed, manufactured and sold products that help match
donor organs with potential recipients prior to transplantation. Allenex had a presence and direct distribution
channels in the United States and Europe, with additional third party distributors in Europe and other markets
around the world. Under the terms of the Conditional Share Purchase Agreements entered into on December 16,
105
2015, as amended, and the tender offer prospectus dated March 7, 2016, and as a result of the tender offer, the
aggregate purchase consideration paid by the Company was approximately $34.1 million and consisted of (i) $26.9
million of cash, of which $5.7 million (which represents SEK 50,620,000 as of the acquisition date) was the fair
value of deferred purchase consideration originally payable to Midroc Invest AB, FastPartner AB (“Fast Partner”)
and Xenella Holding AB, the former majority shareholders of Allenex (the “Former Majority Shareholders”) by no
later than March 31, 2017, subject to certain contingencies being met, and (ii) the issuance of 1,375,029 shares of
the Company’s common stock valued at $7.2 million.
Of the total cash consideration, $8.0 million of cash payable to the Former Majority Shareholders was deposited into
an escrow account by the Company and subsequently invested in the Company by the Former Majority Shareholders
through a purchase of the Company’s equity securities in a private placement. Upon the completion of such private
placement, certain contingencies in the Conditional Share Purchase Agreements were waived. On June 8, 2016, the
Company delisted Allenex’s common stock from Nasdaq Stockholm.
The date by which the deferred purchase consideration was due to the Former Majority Shareholders was
subsequently extended to July 1, 2017. In addition, interest began accruing on the Company’s obligations to the
Former Majority Shareholders (the “Deferred Obligation”) at a rate of 10.0% per year commencing on January 1,
2017. On July 1, 2017, the Deferred Obligation totaled $6.3 million. On July 1, 2017, the Conditional Share
Purchase Agreements were amended in order to, among other things: (i) convert approximately $1.1 million of the
Deferred Obligation into 1,022,544 shares of the Company’s common stock at a per share price equal to $1.12; (ii)
require that the Company make an immediate cash payment of $0.5 million thereby reducing the Deferred
Obligation by $0.5 million; (iii) extend the maturity date of a portion of the obligations, totaling approximately $2.9
million, under the Conditional Share Purchase Agreements to March 31, 2019; and (iv) provide that approximately
$2.1 million of the Deferred Obligation would become payable on December 31, 2017 unless converted into shares
of the Company’s common stock prior to that date, which issuance of shares was subject to approval by the
Company’s stockholders. Interest began to accrue on the Deferred Obligation at a rate of 10% per annum
commencing on July 1, 2017. On November 14, 2017, the Company further amended the Conditional Share
Purchase Agreements with the Former Majority Shareholders, and, as a result, the Company paid the total remaining
deferred purchase consideration of $4.7 million, plus accrued interest.
The Company has accounted for the Allenex transaction as a business combination in exchange for total
consideration of approximately $34.1 million. Under business combination accounting, the total purchase price was
allocated to Allenex’s net tangible and identifiable intangible assets based on their estimated fair values as of April
14, 2016.
The fair value of the remaining 1.7% of noncontrolling interest in Allenex was purchased on March 15, 2018. The
fair value of the noncontrolling interest was determined based on the number of outstanding shares comprising the
noncontrolling interest and Allenex’s stock price of SEK 2.48 per share as of the acquisition date (April 14, 2016).
The noncontrolling interest was presented as a component of stockholders’ equity on the Company’s consolidated
balance sheets at December 31, 2017.
Conexio
On January 20, 2017, the Company acquired the business assets of Conexio Genomics Pty. Ltd (“Conexio”). Prior
to the acquisition, the Company was the exclusive distributor of the Conexio SBTTM product line for all countries
excluding Australia. The Company purchased rights to many of the assets, such as machinery, facilities leases,
know-how and the opportunity to retain key Conexio employees to continue producing and selling SBT products.
The Company paid $0.4 million in cash and makes quarterly payments of 20% of the gross revenue from the sale of
SBT products up to an aggregate total of $0.7 million. During the year ended December 31, 2018, the Company
paid an aggregate of $0.2 million, representing the December 2017 quarterly payment and the March, June and
September 2018 quarterly payments. The Company also assumed all obligations under the lease of the Conexio
facilities, and any liabilities for product warranty claims up to $35,000. The Company accounted for this transaction
as a business combination.
As of December 31, 2018, the estimated fair value of remaining obligations to Conexio of $0.2 million is recorded
in deferred purchase consideration in the Company’s consolidated balance sheet.
106
The following table summarizes the fair values of the assets acquired and liabilities assumed as of the acquisition
date (in thousands):
Inventory ....................................................................................... $
Property, plant and equipment ......................................................
Intangible assets ............................................................................
Goodwill........................................................................................
Assumed liabilities ........................................................................
Total acquisition consideration ..................................................... $
Total
1,040
97
155
85
(82)
1,295
The following table presents details of the identified intangible assets acquired at the acquisition date (in thousands):
Completed technology ........................................ $
Customer relationships .......................................
Total.................................................................... $
127
28
155
Estimated Fair
Value
Estimated
Useful Life
(Years)
4
4
Goodwill recorded from the acquisition of the Conexio business assets is primarily related to expected synergies.
The goodwill resulting from the acquisition is not deductible for tax purposes. The post-acquisition results of
operations of the Conexio business assets for the period from January 20, 2017 through December 31, 2018 are
included in the Company’s consolidated statements of operations.
Pro Forma Impact of the Acquisition of Allenex (unaudited)
The following table presents pro forma results of operations and gives effect to the Allenex transaction as if the
transaction had been consummated on January 1, 2016. The unaudited pro forma results of operations have been
prepared for comparative purposes only and are not necessarily indicative of what would have occurred had the
business combination been completed at the beginning of the period or of the results that may occur in the future.
Furthermore, the pro forma financial information does not reflect the impact of any reorganization or operating
efficiencies resulting from combining the two companies (in thousands) as of December 31, 2016.
Revenue:
Testing revenue ..................................................................................................................... $
Product revenue.....................................................................................................................
Other revenue ........................................................................................................................
Total revenue .............................................................................................................................. $
Net loss ....................................................................................................................................... $
Total
2016
29,680
15,101
407
45,188
(32,319)
The unaudited pro forma financial information for the years ended December 31, 2016 is prepared using the
acquisition method of accounting and has been adjusted to give effect to the pro forma events that are: (i) directly
attributable to the acquisition, (ii) factually supportable, and (iii) expected to have a continuing impact on the
combined results. The pro forma adjustments directly attributable to the acquisition exclude acquisition-related
expenses of $4.3 million and $2.1 million of expenses related to a potential financing that did not eventuate.
The total revenue of Allenex for the period from April 14, 2016 through December 31, 2016 was $10.7 million and
the net loss for this period was $17.9 million, of which $13.0 million was a goodwill impairment charge.
107
Asset Acquisition
Illumina License and Commercialization Agreement
On May 4, 2018, the Company entered into the 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 v1 and v2 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’s specific information and projections, which are not observable
in the market and are thus considered Level 3 measurements as defined by U.S. GAAP.
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 becomes 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
technological feasibility at the date of acquisition. The fair value of the products was also determined using the
multi-period excess earnings method under income approach. The rate of 30% and 40% for the AlloSeq HLA
acquired in-process technology and the AlloSeq BMT acquired in-process technology, respectively, was utilized to
discount the cash flows to the present value. The acquired in-process technology will not be amortized until
completion of development of the related products. Upon completion, each acquired in-process technology product
will be amortized over its estimated useful life.
108
The following table summarizes the fair values of the intangible assets acquired as of the closing date (in thousands):
Estimated Fair
Value
Estimated
Useful Life
(Years)
Customer relationships: TruSight HLA................... $
Acquired in-process technology: AlloSeq HLA......
Acquired in-process technology: AlloSeq BMT .....
Total......................................................................... $
380
2,719
2,103
5,202
2.6
—
—
6. GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill is recorded when the purchase consideration of an acquired business exceeds the fair value of the net
assets acquired.
The following table presents details of the Company’s goodwill for the year ended December 31, 2017 (in
thousands):
Former Post-
Transplant
Former Pre-
Transplant
Total
Balance as of December 31, 2016 ..................................................... $
Goodwill acquired .............................................................................
Goodwill impairment.........................................................................
Foreign currency translation adjustments ..........................................
Balance as of December 31, 2017 ..................................................... $
12,005 $
—
—
—
12,005 $
1,834 $
85
(1,958)
39
— $
13,839
85
(1,958)
39
12,005
As of December 31, 2018, the Company’s goodwill carrying amount of $12 million remains the same.
The Company tested its goodwill for impairments as of December 1, 2016 and estimated the fair value of the former
Pre-Transplant reporting unit was $1.7 million, which was lower than its carrying value. Based on the analysis, the
implied fair value of the goodwill was lower than the carrying value of the former Pre-Transplant reporting unit,
resulting in a goodwill impairment charge of $13.0 million for the period ended December 31, 2016. The significant
assumptions utilized in the 2016 discounted cash flow analysis for the former Pre-Transplant reporting unit were a
discount rate of 16.8%, a terminal growth rate of 3.2%, and a capitalization multiple of 7.37.
On January 1, 2017, the Company adopted ASU 2017-04, Intangibles—Goodwill and Other (Topic 350):
Simplifying the Test for Goodwill Impairment, which eliminated the Step 2 requirement of the goodwill impairment
test. Instead, the goodwill impairment test is performed by comparing the fair value of a reporting unit with its
carrying amount. The Company determined that the decrease in its market capitalization in the first quarter of 2017
constituted an indicator of impairment and therefore a goodwill impairment test was completed as of March 31,
2017. The goodwill impairment test determined that the fair value of the former Pre-Transplant reporting unit was
$3.5 million, which was lower than its carrying value. Accordingly, the Company recorded a goodwill impairment
charge of $2.0 million as of March 31, 2017, which represented the remaining goodwill balance in the former Pre-
Transplant reporting unit. The significant assumptions utilized in the March 31, 2017 discounted cash flow analysis
for the former Pre-Transplant reporting unit were a discount rate of 16.6%, a terminal growth rate of 3.2% and a
capitalization multiple of 7.48.
As of December 31, 2017, the remaining goodwill amount of $12.0 million was related to the former Post-
Transplant reportable segment only. Management performed a goodwill impairment analysis and concluded that
goodwill was not impaired.
109
On December 1, 2018, with consideration to the change to one reporting unit (see Note 16) 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, 2018, no
impairment of goodwill has been identified.
Intangible Assets
The following tables present details of the Company’s intangible assets as of December 31, 2018 (in thousands):
December 31, 2018
Acquisition
Cost
Accumulated
Amortization
Foreign
Currency
Translation
Net
Carrying
Amount
Weighted
Average
Remaining
Useful Life
(In Years)
Intangible assets with finite lives:
Customer relationships: Allenex................................ $ 12,650 $
28
Customer relationships: Conexio...............................
Customer relationships: TruSight HLA.....................
380
11,650
Developed technology: Olerup SSP ..........................
4,510
Acquired technology: QTYPE...................................
127
Acquired technology: Olerup SBT ............................
6,650
Acquired technology(cid:12)dd-cfDNA.............................
Trademarks ................................................................
2,260
Total intangible assets with finite lives .................. $ 38,255 $
2,719
Acquired in-process technology: AlloSeq HLA........
Acquired in-process technology: AlloSeq BMT .......
2,103
Total intangible assets ............................................. $ 43,077 $
(2,198) $
(6)
(86)
(3,065)
(671)
(28)
(635)
(454)
(7,143) $
—
—
(7,143) $
(1,129) $
(2)
—
(998)
(407)
(6)
—
(140)
9,323
20
294
7,587
3,432
93
6,015
1,666
(2,682) $ 28,430
—
—
2,719
2,103
(2,682) $ 33,252
12.0
2.0
2.0
7.0
12.0
2.0
11.8
12.0
—
—
The following tables present details of the Company’s intangible assets as of December 31, 2017 (in thousands):
December 31, 2017
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
Remaining
Useful Life
(In Years)
Customer relationships: Allenex.......................... $
Customer relationships: Conexio.........................
Developed technology: Olerup SSP ....................
Acquired technology: QTYPE.............................
Acquired technology: Olerup SBT ......................
Acquired technology: dd-cfDNA.........................
Trademarks ..........................................................
Total intangible assets.......................................... $
12,650 $
28
11,650
4,510
127
6,650
2,260
37,875 $
(1,394) $
(3)
(1,942)
(376)
(14)
(127)
(310)
(4,166) $
(250) $
1
(258)
(84)
5
—
16
(570) $
11,006
26
9,450
4,050
118
6,523
1,966
33,139
13.0
8.1
8.0
13.0
8.1
12.9
13.0
110
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 expense was $2.4 million for the year ended December 31, 2018, of which $1.4
million, and $1.0 million were amortized to cost of product and sales and marketing expenses, respectively.
Amortization expense was $2.6 million for the year ended December 31, 2017, of which $1.5 million, $1.0 million
and $0.1 million were amortized to cost of product, sales and marketing and cost of testing services, respectively.
Amortization expense was $1.7 million for the year ended December 31, 2016, of which $1.0 million and $0.7
million were amortized to cost of product and sales and marketing expenses, respectively.
Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of
product and sales and marketing expenses in the consolidated statements of operations. The acquired in process
technology of $6.7 million achieved technological feasibility in the fourth quarter of 2017, with the launch of
AlloSure.
The following table summarizes the Company’s estimated future amortization expense of intangible assets with
finite lives as of December 31, 2018 (in thousands):
Years Ending December 31,
2019 ............................................................................. $
2020 .............................................................................
2021 .............................................................................
2022 .............................................................................
2023 .............................................................................
Thereafter.....................................................................
Total future amortization expense ............................... $
Cost of
Product
Sales and
Marketing
Total
1,925 $
1,925
1,878
1,878
1,878
7,643
17,127 $
1,073 $
1,073
916
916
916
6,409
11,303 $
2,998
2,998
2,794
2,794
2,794
14,052
28,430
7. BALANCE SHEET COMPONENTS
Inventory
Inventory consisted of the following (in thousands):
Finished goods............................................................... $
Work in progress ...........................................................
Raw materials ................................................................
Total inventory .............................................................. $
2,506 $
651
1,786
4,943 $
2,569
1,471
1,489
5,529
December 31,
2018
2017
Property and Equipment, Net
Property and equipment consisted of the following (in thousands):
December 31,
2018
2017
Leasehold improvements..................................................................................... $
Furniture and fixtures ..........................................................................................
Computer and office equipment ..........................................................................
Machinery and equipment ...................................................................................
Construction in progress......................................................................................
$
Less: Accumulated depreciation and amortization .............................................
Property and equipment, net................................................................................ $
5,187
720
4,488
6,961
878
18,234
(14,100)
4,134
$
$
$
5,194
825
4,734
6,806
—
17,559
(15,484)
2,075
111
Depreciation expense was $1.2 million in each of the years ended December 31, 2018, 2017 and 2016. In the year
ended December 31, 2018, the Company recorded a write-off of $2.4 million of property and equipment cost and
accumulated depreciation. The assets written-off mainly consisted of laboratory equipment that were fully
depreciated and not in use.
Assets purchased under capital leases, included above in machinery and equipment, and computer and office
equipment, were $0.6 million and $1.4 million at December 31, 2018 and 2017, respectively. Accumulated
amortization was $0.2 million and $1.3 million at December 31, 2018 and 2017, respectively. Related amortization
expense, included in depreciation and amortization expense, was $153,047, $135,000 and $204,000 for the years
ended December 31, 2018, 2017 and 2016, respectively.
Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
December 31,
2018
2017
Clinical studies .................................................................................................... $
Professional fees..................................................................................................
Test sample processing fees ................................................................................
Deferred rent – current portion............................................................................
Accrued royalty ...................................................................................................
Customer overpayments and refunds due ...........................................................
Capital leases – current portion ...........................................................................
Software implementation costs ...........................................................................
Uninvoiced receipts .............................................................................................
Accrued interest payable .....................................................................................
Other accrued expenses .......................................................................................
Total accrued and other liabilities ....................................................................... $
1,815
822
657
432
285
184
172
58
—
—
983
5,408
$
$
1,115
475
633
419
—
270
13
94
253
81
382
3,735
8. COMMITMENTS AND CONTINGENCIES
Leases
The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating
lease agreements in Brisbane, California; West Chester, Pennsylvania; Fremantle, Australia; and Stockholm,
Sweden. The lease for the Company’s facility in Vienna, Austria is on a month-to-month basis. The facility leases
expire at various dates through 2020. In the normal course of business, it is expected that these leases will be
renewed or replaced by leases on other properties.
Rent expense under the non-cancelable operating leases was $2.0 million, $1.7 million and $1.5 million in 2018,
2017 and 2016, respectively. Future minimum lease commitments under these operating and capital leases on
December 31, 2018, are as follows (in thousands):
Years ending December 31,
2019 .......................................................................................... $
2020 ..........................................................................................
2021 ..........................................................................................
2022 and thereafter ...................................................................
Total minimum lease payments ................................................ $
Less: amounts representing interest..........................................
Present value of minimum lease payments...............................
Less: current portion of obligations under capital leases..........
Long-term portion of obligations under capital leases ............. $
Capital Leases Operating leases
2,161
2,045
10
7
4,223
193 $
193
67
—
453 $
(32)
421
(172)
249
112
The current portion of obligations under capital leases is included in accrued and other liabilities on the balance
sheets. The long-term portion is included in other liabilities on the balance sheets.
See Note 10 for the aggregate annual payment schedule for the Company’s outstanding debt.
Royalty Commitments
Roche Molecular Systems, Inc. (“Roche”)
In November 2004, the Company entered into a license agreement with Roche pursuant to which Roche granted the
Company the right to use certain Roche technology relating to PCR and quantitative real-time PCR in clinical
laboratory services, including in connection with AlloMap. This is a non-exclusive license agreement in the United
States covering claims in multiple Roche patents.
Under the license agreement, the Company incurred royalty expenses as a percentage of AlloMap revenue and
classifies those expenses as a component of cost of testing services in the consolidated statements of operations.
Royalty expenses in connection with the Roche agreement were $0.9 million and $1.1 million for the years ended
December 31, 2017 and 2016, respectively. Effective September 30, 2017, no future royalties are payable by the
Company under the Roche agreement.
The Board of Trustees of the Leland Stanford Junior University (“Stanford”)
In June 2014, the Company entered into a license agreement with Stanford, or 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 payment amounts and royalties in the low single digits of net sales of products
incorporating the licensed technology. The license maintenance fee may be offset against earned royalty payments
due on net sales in that year.
In 2017, the Company paid Stanford $0.1 million in aggregate for license maintenance fees and for the completion
of the Company’s first commercial sale. Commercial sales of AlloSure, which incorporates the licensed technology
from Stanford, began in October 2017. The Company incurred royalties of $0.7 million in the year ended December
30, 2018.
Conexio
On January 20, 2017, the Company acquired the business assets of Conexio, which included machinery, facilities
leases, know-how and the opportunity to retain key Conexio employees to continue producing and selling the SBT
line of products. The Company makes quarterly payments to Conexio of 20% of the gross revenue from the sale of
the SBT products using the purchased assets up to an aggregate total of $0.7 million. During the years ended
December 31, 2018 and 2017, the Company paid $0.2 million and $0.4 million, respectively.
Illumina
On May 4, 2018, the Company entered into the License Agreement with Illumina. The License Agreement requires
the Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. In
the year ended December 31, 2018, the Company paid no royalties to Illumina.
Other Commitments
Pursuant to the License Agreement with Illumina, 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. The Company expects to meet
these purchase commitments and did not record any contingent losses related to these future products’ purchases.
Litigation and Indemnification Obligations
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
113
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. The Company is not involved in any litigations as of December 31, 2018.
In the normal course of business, the Company enters into contracts and agreements that contain a variety of
representations and warranties and provide for indemnification for certain liabilities. The exposure under these
agreements is unknown because it involves claims that may be made against the Company in the future but have not
yet been made. To date, the Company has not paid any claims or been required to defend any action related to its
indemnification obligations. However, the Company may record charges in the future as a result of these
indemnification obligations. The Company also has indemnification obligations to its directors and executive
officers for specified events or occurrences, subject to some limits, while they are serving at the Company’s request
in such capacities. There have been no claims to date and the Company believes the fair value of these
indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these
agreements as of December 31, 2018 and as of December 31, 2017.
9. LICENSING AND OTHER REVENUE
Diaxonhit
In June 2013, the Company entered into an exclusive Distribution and Licensing Agreement with Diaxonhit, SA
(“Diaxonhit”), a French public company, whereby Diaxonhit agreed to have the AlloMap test performed in a
European laboratory and commercialize the test in the European Economic Area (“EEA”). The agreement will
expire at the later of the last-to-expire patent in the EEA or ten years from the first commercial sale of the test in the
EEA, which occurred in 2014.
Consideration under the agreement included an upfront cash payment of approximately €387,500 ($408,000) that is
designated to offset royalties earned by the Company. The Company is entitled to receive royalties from Diaxonhit
as a percent of net sales, as defined in the agreement, of AlloMap tests in the mid to high teens. Approximately,
€250,000 ($263,000) of the upfront payments is refundable under certain circumstances. Upon confirmation that the
CE mark was in place, the Company also received an equity payment of Diaxonhit common stock with a value of
€387,500 ($408,000). The Company sold the shares of common stock in July 2013 for total consideration of
$467,000. The CE mark is a mandatory conformity marking for certain products sold within the EEA.
Other performance obligations for which the Company may recognize revenue includes agreed-upon per unit pricing
for the supply of AlloMap products, and additional royalties that are payable upon the achievement of various sales
milestones by Diaxonhit. Commercial sales of the AlloMap test began in the EEA in June 2014. Total revenue
recognized from this arrangement for the years ended December 31, 2018, 2017 and 2016 was $39,000, $39,000 and
$2,000, respectively.
CardioDx, Inc.
In 2005, the Company entered into a services agreement with what at the time was a related party, CardioDx, Inc.
(“CDX”), whereby the Company provided CDX with biological samples and related data and performed laboratory
services on behalf of CDX. Each company granted the other a worldwide license under certain of its intellectual
property rights. Pursuant to this agreement, CDX pays royalties to the Company in an amount equal to a low single-
digit percentage of the cash collected from sales of CDX licensed products. The royalty obligation to the Company
continues until 2019. The Company recognizes royalty revenues when payments are received as it was assessed that
collection was not able to be estimated. Royalty revenues were $0.3 million, $0.5 million and $0.2 million for the
years ended December 31, 2018, 2017 and 2016, respectively, and are included in license and other revenue on the
consolidated statements of operations. The Company had no receivable balances from CDX at December 31, 2018
and 2017, and does not expect to record future revenue from CDX.
114
10. DEBT
The Company did not have any outstanding debt as of December 31, 2018.
Debt consisted of the following (in thousands):
JGB Debt ..........................................................................................................................
Danske Bank Term Loan & Credit Facility......................................................................
SSP Primers Loan.............................................................................................................
Current portion of long-term debt..................................................................................
JGB Debt ..........................................................................................................................
FastPartner Subordinated Promissory Notes ....................................................................
Al Amoudi Subordinated Promissory Notes ....................................................................
Long-term debt, net of current portion ..........................................................................
$
$
$
$
December 31, 2017
7,743
6,763
1,215
15,721
14,168
2,400
1,770
18,338
Unamortized debt discount and issuance costs as of December 31, 2017 were $4.6 million. Total interest accrued on
debt as of December 31, 2017was $0.3 million. The long-term accrued interest balance of $0.2 million as of
December 31, 2017, was recorded in accrued and other liabilities and in other liabilities long-term in the
consolidated balance sheet.
Perceptive Credit Agreement
On April 17, 2018, the Company entered into a the Perceptive Credit Agreement for an initial term loan of $15.0
million (“Tranche A Term Loan”) with a second tranche of $10.0 million that would have been available at the
Company’s option, subject to the satisfaction of customary conditions (the “Tranche B Term Loan” and, together
with the “Tranche A Term Loan”, the “Term Loam”). Approximately $11.1 million of the proceeds of the Tranche
A Term Loan were used to fully repay the Company’s outstanding indebtedness, including accrued interest, with
FastPartner AB, Mohammed Al Amoudi and Danske Bank A/S (“Danske”) on April 17, 2018.
The Term Loan was secured by substantially all of the Company’s assets and a pledge of 65% of the equity interests
of CareDx International AB. The Term Loan accrued interest per annum at 9.00% (the “Applicable Margin”) plus
the greater of the one-month LIBOR or 1.5%.
The Company paid a fee of $0.3 million to Perceptive in its capacity as the administrative agent under the Security
Agreement. In addition, on April 17, 2018, the Company issued to Perceptive the Perceptive Tranche A Warrant to
purchase up to 140,000 shares of common stock of the Company at an initial exercise price of $8.60. The Perceptive
Tranche A Warrant was exercised in full on October 22, 2018 on a cashless basis. Perceptive received 91,705 shares
in connection with this transaction.
The Perceptive Credit Agreement contained financial covenants related to minimum cash balance and trailing
twelve month revenue. As of November 20, 2018 (the repayment date of the Perceptive Credit Agreement), the
Company was in compliance with the financial covenants.
115
The following table summarizes the Company’s carrying value of the Perceptive Credit Agreement (in thousands)
on April 17, 2018, the issuance date (in thousands):
April 17, 2018
Debt principal ................................................................................................ $
Less:
Issuance cost ........................................................................................
Discount related to issued warrants .....................................................
Embedded derivative liability..............................................................
Total debt discount ........................................................................................
Carrying value ............................................................................................... $
15,000
(669)
(784)
(245)
(1,698)
13,302
On November 20, 2018, the Company paid off all obligations owing under, and terminated, the Perceptive Credit
Agreement. The secured interests were terminated in connection with the Company’s payoff of all of its obligations.
In connection with the repayment of the Perceptive Credit Agreement, the Company incurred a $1.2 million
prepayment penalty and a $0.4 million exit fee; the unamortized debt discount of $1.6 million and the embedded
derivative liability of $0.2 million were extinguished. 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
On March 15, 2017, the Company entered into a Securities Purchase Agreement (the “Securities Purchase
Agreement”) with JGB pursuant to which the Company issued to JGB debentures (the “Debentures”) with an
aggregate principal amount of $27.8 million and warrants to purchase 1,250,000 shares of the Company’s common
stock (the “JGB Warrants”) for net proceeds of $24.0 million (the “Financing”). The Company used $11.2 million
of the net proceeds from the Financing to repay its existing indebtedness under the Loan Agreement with East West
Bank and was required to maintain restricted cash of $9.4 million.
Under the Securities Purchase Agreement, the Debentures would have matured on February 28, 2020, accrued
interest at 9.5% per year and were convertible into an aggregate of approximately 6,092,105 shares of the
Company’s common stock at a price of $4.56 per share (the “Conversion Price”), subject to adjustment for accrued
and unpaid interest and upon the occurrence of certain transactions, at the holder’s option.
Additionally, after September 1, 2017, upon the satisfaction of certain conditions, including the volume weighted-
average price of the Company’s common stock exceeding 250% of the Conversion Price for twenty consecutive
trading days, the Company could have required that the Debentures be converted into shares of the Company’s
common stock, subject to certain limitations. Commencing on March 1, 2018, each of the holders of the Debentures
had the right, at its option, to require the Company to redeem up to $937,500 of the outstanding principal amount of
its Debenture per month. The Company was required to promptly, but in any event no more than one trading day
after the holder delivers a redemption notice to the Company, pay the applicable redemption amount in cash or, at
the Company’s election and subject to certain conditions, in shares of the Company’s common stock. If the
Company elected to pay the redemption amount in shares of the Company’s common stock, then the shares would
have been delivered based on a price equal to the lowest of (a) 88% of the average of the three lowest volume
weighted-average prices of the Company’s common stock over the prior 20 trading days, (b) 88% of the prior
trading day’s volume weighted-average price, or (c) the Conversion Price.
After either a change of control transaction, as defined in the Debentures, or February 28, 2018, subject to the
satisfaction of certain conditions, the Company could have redeemed all of the then outstanding principal amount of
the Debentures for cash by paying the outstanding principal balance, accrued and unpaid interest, and a payment
premium. The payment premium would have been calculated by multiplying the outstanding balance and the
following percentage: (i) 15% if the Debentures were prepaid on or prior to March 1, 2018, (ii) 8% if the Debentures
were prepaid after March 1, 2018 but prior to March 1, 2019, and (iii) 5% if the Debentures were prepaid on or after
March 1, 2019.
The Company’s obligations under the Debentures could have been accelerated upon the occurrence of certain events
of default as specified in the agreement. In the event of default and acceleration of the Company’s obligations, the
116
Company would have been required to pay (i) 115% of all amounts of principal and interest then outstanding under
the Debentures in cash if the Debenture is accelerated prior to March 1, 2018, (ii) 108% of all amounts of principal
and interest then outstanding under the Debentures in cash if the Debentures were accelerated after March 1, 2018,
but prior to March 1, 2019, and (iii) 105% of all amounts of principal and interest then outstanding under the
Debentures in cash if the Debentures were accelerated after March 1, 2019. The Company’s obligations under the
Debentures were secured under a Security Agreement by a senior lien on all of the Company’s assets, other than its
interest in CareDx International AB (formerly known as Allenex AB), which was subject to a negative pledge
prohibiting the incurrence of additional or replacement debt.
The Debentures contained customary affirmative and restrictive covenants and representations and warranties,
including financial reporting obligations, a restriction on the Company’s ability to pay cash dividends on its
common stock and limitations on indebtedness, liens, investments, distributions, transfers, corporate changes,
deposit accounts and subsidiaries. The Company was also required to maintain a minimum cash amount at all times,
achieve commercialization of AlloSure by a certain date and achieve certain gross profit targets for sales of its
AlloMap product.
In connection with the Financing, on March 15, 2017, the Company and the Purchasers entered into a Registration
Rights Agreement (the “Registration Rights Agreement”) pursuant to which, among other things, the Company
agreed to prepare and file one or more registration statements with the SEC for the purpose of registering for resale
any shares of Common Stock that may be issued by the Company upon the conversion or redemption of the
Debentures or the exercise of the JGB Warrants.
The Debentures included certain embedded derivatives that require bifurcation, including settlement and penalty
provisions. The embedded derivatives were remeasured at each reporting period and the change in fair value was
recognized in the consolidated statements of operations. See also Note 4, Fair Value Measurements.
The following table summarizes the Company’s carrying value of the JGB Debt (in thousands) on the March 15,
2017 issuance date:
Debt Principal.............................................................................................. $
Less: Issuance cost ......................................................................................
Original issue discount ...........................................................................
Original warrant valuation .....................................................................
Embedded Derivative Liability ..............................................................
Total debt discount ......................................................................................
Carrying Value ............................................................................................ $
March 15, 2017
27,780
(998)
(2,780)
(900)
(2,290)
(6,968)
20,812
As a result of the issuance of 1,022,544 shares of the Company’s common stock issued at a price per share equal to
$1.12 pursuant to the amendments to the Conditional Share Purchase Agreements, the conversion price of the
Debentures decreased from $4.56 per share to $4.40 per share, effective July 3, 2017, as described in Note 13.
As a result of the 2017 Public Offering in accordance with the anti-dilution provisions in the JGB Warrants and the
Debentures, effective October 5, 2017, the conversion price of the Debentures decreased from $4.40 per share to
$4.34 per share. On October 5, 2017, JGB elected to convert $1.3 million of outstanding principal under the
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. As a result of the sale of the 651,240 shares of common stock pursuant to the
underwriters’ full exercise of their option to purchase additional shares in accordance with the anti-dilution
provisions in the JGB Warrants and the Debentures, effective October 10, 2017, the conversion price of the
Debentures was decreased from $4.34 per share to $4.33 per share. As of December 31, 2017, the JGB Debt had an
outstanding principal balance of $26.5 million.
On March 1, 2018, the Company notified JGB of its intent to prepay on April 13, 2018 in full the outstanding
principal and interest under the Debentures. Pursuant to the terms of the Debentures, on April 13, 2018, the
Company would have been obligated to pay the full amount of the outstanding principal balance of the Debentures,
117
plus accrued and unpaid interest thereon and a prepayment premium equal to 8% of the outstanding principal
balance in cash. In February and March 31, 2018, JGB converted the remaining $26.7 million of principal and
accrued interest of the JGB Debt into an aggregate of 6,161,331 shares of the Company’s common stock. In
connection with these conversions in the three months ended March 31, 2018, 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 recorded as debt extinguishment expenses in the consolidated statements
of operations.
Danske Bank Term Loan and Credit Facility
On June 25, 2013, Allenex entered into the Term Loan Facility with Danske in an aggregate principal amount of up
to SEK 71,000,000 (approximately $7.8 million). The Term Loan Facility was available for utilization in advances
of a minimum of SEK 5,000,000 (approximately $0.5 million in U.S. dollars) and if more, integral multiples of SEK
1,000,000 (approximately $0.1 million). The interest rate applicable to each advance shall be the percentage rate per
annum calculated as the aggregate of (i) Stockholm Interbank Offered Rate (“STIBOR”) (as defined in the Term
Loan Facility) and (ii) the Margin (as described in the Term Loan Facility) at 3% conditional on the fulfillment of
certain criteria. In March 2015, Allenex entered into a first amendment to the Term Loan Facility, pursuant to
which additional loans were granted. In August 2015, Allenex entered into a second amendment to the Term Loan
Facility, pursuant to which the term of the Term Loan Facility was extended. In December 2015, Allenex entered
into a waiver and amendment agreement relating to the Term Loan Facility, pursuant to which the change of control
provision was waived and amended. In March 2016, Allenex entered into another amendment to the Term Loan
Facility, which modified the repayment schedule for advances under the Term Loan Facility.
On June 18, 2015, Allenex also entered into a short term credit facility with Danske with total available credit of
SEK 8,000,000 (approximately $0.9 million). As of August 4, 2016, the available credit under the short term credit
facility with Danske was increased to SEK 10,000,000 (approximately $1.2 million).
A quarterly debt covenant in the Term Loan Facility with Danske was violated on March 31, 2017, June 30, 2017, and
September 30, 2017. The Company obtained a waiver for these violations. The waiver was conditional upon, among
other things, the Company making a principal repayment of SEK 6,000,000 (approximately $0.7 million) by October
31, 2017. This amount was paid on October 31, 2017. The Company was not in compliance with certain debt
covenants as of December 31, 2017 or March 31, 2018. The Company repaid the full outstanding amount of SEK
47,000,000 (approximately $5.6 million) plus accrued interest of SEK 142,000 (approximately $17,000), under the
Danske Term Loan and Credit Facility on April 17, 2018.
FastPartner Subordinated Promissory Notes
On June 28, 2013, Allenex issued a SEK 9,400,000 (approximately $1.0 million) subordinated promissory note to
FastPartner, which had an interest rate of 10.00%. On December 29, 2015, Allenex issued a SEK 2,000,000
(approximately $0.2 million) subordinated promissory note to FastPartner, which had an annual interest rate of
10.00%.
On March 7, 2016, Allenex issued a SEK 4,000,000 (approximately $0.4 million) subordinated promissory note to
FastPartner, which had an annual interest rate of 10.00%. Pursuant to an intercreditor agreement, until the Term
Loan Facility with Danske is repaid, FastPartner may not demand or receive payment of its subordinated promissory
note, or foreclose on any collateral securing Allenex’s obligations under the subordinated promissory note, without
Danske’s prior written consent. Allenex’s obligations under the promissory note are secured by a pledge of Allenex
shares to FastPartner. The full amount of the subordinated promissory note was due July 1, 2017.
On July 1, 2017, the Company entered into a note agreement with FastPartner (the “FastPartner Note Agreement”)
pursuant to which, among other things, Allenex and FastPartner agreed that all amounts owed under the above
subordinated promissory notes would be governed by the FastPartner Note Agreement and to defer repayment of the
principal outstanding amount of SEK 15,400,000 (approximately $1.9 million) plus accrued interest of $0.5 million
until March 31, 2019. Interest began accruing on such amount at a rate of 10% per annum, and in the event the
Company makes any cash amortization repayments to JGB of the JGB Debt, or any replacement debt, Allenex will
repay in cash a portion of the amount outstanding under the FastPartner Note Agreement equal to 8% of any such
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cash amortization repayment. As of each of March 31, 2018 and December 31, 2017, the principal outstanding
amount remained at SEK 19,757,000 (approximately $2.4 million). The Company repaid the full amount
outstanding of SEK 21,300,000 (approximately $2.5 million), including accrued interest of SEK 1,600,000
(approximately $0.2 million), under the FastPartner Note Agreement on April 17, 2018.
Mohammed Al Amoudi Subordinated Promissory Note
On June 28, 2013, Allenex issued a SEK 10,600,000 (approximately $1.2 million) subordinated promissory note to
Mohammed Al Amoudi, which provides for an annual interest rate of 10.00%. Pursuant to an intercreditor
agreement, until the Term Loan Facility with Danske is repaid, Mohammed Al Amoudi may not demand or receive
payment of his subordinated promissory note, or foreclose on any collateral securing Allenex’s obligations under the
subordinated promissory note, without Danske’s prior written consent. Allenex’s obligations under the promissory
note are secured by a pledge of Allenex shares to Mohammed Al Amoudi. The full amount of the subordinated
promissory note was due July 1, 2017.
On July 1, 2017, the Company entered into a note agreement with Mohammed Al Amoudi (the “Al Amoudi Note
Agreement”) pursuant to which, among other things, Allenex and Mohammed Al Amoudi agreed to defer repayment
of the principal outstanding amount of SEK 10,600,000 (approximately $1.3 million) plus accrued interest of $0.5
million until March 31, 2019. Interest began accruing on such amount at a rate of 10% per annum, and in the event
the Company makes any cash amortization repayments to JGB of the JGB Debt, or any replacement debt, Allenex
will repay in cash a portion of the amount outstanding under the Al Amoudi Note Agreement equal to 6% of any
such cash amortization repayment. As of each of March 31, 2018 and December 31, 2017, the principal outstanding
amount remained at SEK 14,575,000 (approximately $1.7 million). The Company repaid the full amount
outstanding of SEK 15,700,000 (approximately $1.9 million), including accrued interest of SEK 1,200,000
(approximately $0.1 million) under the Al Amoudi Note Agreement on April 17, 2018.
Loan Agreement with SSP Primers Aktieboulag
On February 25, 2015, Allenex entered into a SEK 14,000,000 (approximately $1.5 million) loan agreement with
SSP Primers Aktieboulag, pursuant to which SEK 4,000,000 (approximately $0.4 million) was paid on March 7,
2016. The loan amount outstanding as of December 31, 2017 was SEK 10,000,000 (approximately $1.2 million)
plus accrued interest of SEK 650,000 (approximately $0.1 million) and was fully paid on February 26, 2018.
11. STOCKHOLDERS’ EQUITY
Private Placement Transaction and Subsequent Financing
On April 14, 2016, the Company completed a Private Placement transaction for the offering of 591,860 units
(“Units”) to certain accredited investors (the “Private Placement”). Each Unit was comprised of: (i) one share of
common stock, (ii) five shares of Series A Preferred, and (iii) three warrants, each to purchase one share of common
stock. The purchase price was $23.94 per Unit (the equivalent of $3.99 per share of common stock, assuming
conversion of the Series A Preferred). The aggregate gross proceeds to the Company from the Private Placement
were approximately $14.2 million, of which $1.8 million was paid in satisfaction of placement agents, escrow agent,
legal fees as well as other direct issuance costs. The Company and certain stockholders representing a majority of
the Company’s outstanding shares of common stock entered into voting agreements on April 14, 2016, pursuant to
which each stockholder agreed to vote certain of its shares of the Company’s common stock in favor of granting the
Company the Requisite Stockholder Approval.
The proceeds from the Private Placement were allocated between the common stock, preferred stock and warrants
issued based on their relative fair values. The estimated fair values of the common stock, preferred stock and
warrants were $1.9 million, $9.3 million and $3.0 million, respectively, as of the transaction date. The warrants
were recorded as a liability and are subject to ongoing remeasurement. The shares of Series A Preferred were
initially recorded as temporary equity upon the closing of the Private Placement and subsequently reclassified to
common stock after their conversion to common stock on June 16, 2016. See Note 13 for a description of the
accounting of for the warrants.
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Concurrent to the Private Placement, the Company also entered into commitment letters pursuant to which the
Former Majority Shareholders agreed to purchase the Company’s equity securities in the Subsequent Financing,
which investment was completed on June 15, 2016. In the Subsequent Financing, the Company issued to the
Former Majority Shareholders 334,169 Units, which consisted of (i) an aggregate of 334,169 shares of common
stock, (ii) an aggregate of 1,670,845 shares of Series A Preferred that were all converted into shares of the
Company’s common stock upon obtaining the Requisite Stockholder Approval on June 16, 2016, and (iii) 1,002,507
warrants, each of which is exercisable for one share of the Company’s common stock. The aggregate gross
proceeds to the Company from the Subsequent Financing were $8.0 million.
The proceeds from the Subsequent Financing were allocated between the common stock, preferred stock and
warrants issued based on their relative fair values. The estimated fair values of the common stock, preferred stock
and warrants were $1.0 million, $5.3 million and $1.7 million, respectively, as of the transaction date. The warrants
were recorded as a liability and are subject to ongoing remeasurement. The shares of Series A Preferred were
initially recorded as temporary equity upon the closing of the Subsequent Financing and subsequently reclassified to
common stock after their conversion to common stock on June 16, 2016.
Following the closing of the Private Placement, the Company agreed to a number of requirements, including
submitting the Private Placement to the Company’s stockholders for approval, which was obtained on June 16,
2016, and granting certain registration rights, including the registration of shares sold in the Private Placement on a
registration statement on Form S-3. On May 27, 2016, the Company filed a registration statement on Form S-3 with
the SEC to register for resale the shares of common stock issued or issuable upon conversion of the Series A
Preferred and upon exercise of the warrants sold in the Private Placement. The registration statement on Form S-3
was declared effective by the SEC on July 12, 2016.
Upon obtaining the Requisite Stockholder Approval on June 16, 2016, each share of Series A Preferred was
converted into one share of the Company’s common stock. In addition to the warrants issued to certain accredited
investors in the Private Placement, on April 14, 2016, the Company issued warrants to purchase an aggregate of
200,000 shares of common stock to certain of its placement agents (the “Placement Agent Warrants”). All of the
warrants issued in the Private Placement and the Placement Agent Warrants became exercisable once the Company
obtained the Requisite Stockholder Approval on June 16, 2016.
The Company engaged M.M. Dillon & Co. Group (“M.M. Dillon”), an investment banking firm, to act as one of its
financial advisors and placement agents in connection with the Private Placement and Subsequent Financing of the
Company’s common stock and the consummation of any private placement of its securities that the Company may
choose to pursue. A member of the Company’s board of directors is a managing director of M.M. Dillon, and as
such, the Company considered M.M. Dillon to be a related party. As a result of the Private Placement and
Subsequent Financing, the Company paid approximately $1.1 million in placement fees to its placement agents, of
which $0.2 million pertained to fees paid to M.M. Dillon. Additionally, M.M. Dillon also received Placement Agent
Warrants to purchase 100,000 shares of the Company’s common stock.
2016 Public Offering
On September 26, 2016, the Company completed a public offering (“the 2016 Public Offering”) pursuant to which
the Company issued and sold an aggregate of 2,250,000 shares of common stock at a public offering price of $4.00
per share. The aggregate gross proceeds were $9.0 million, and $7.8 million net of issuance costs.
2017 Public Offering
On October 10, 2017, the Company sold in the 2017 Public Offering (“the 2017 Public Offering”) an aggregate of
4,992,840 shares of its common stock, including 651,240 shares sold pursuant to the underwriters’ full exercise of
their option to purchase additional shares to cover over-allotments, at a public offering price of $4.00 per share.
Net proceeds from the 2017 Public Offering were $18.3 million, after deducting underwriting discounts and
commissions and estimated offering expenses payable by the Company.
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JGB Debt
On October 5, 2017, JGB converted $1.25 million of outstanding principal under the 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 the three months ended March 31, 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 (“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.
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 $0.3
million for the year ended December 31, 2018.
13. WARRANTS
The Company issues common stock warrants in connection with debt or equity financings to a lender, a placement
agent or an investor. 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 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.
Private Placement, Placement Agent and Subsequent Financing Warrants
The warrants issued in the Private Placement and the Placement Agent Warrants (as described in Note 11) are
considered freestanding instruments that are contingently redeemable and classified as liabilities on the Company’s
consolidated balance sheet as of December 31, 2018. The warrants became exercisable to purchase common stock
after the Company obtained the Requisite Stockholder Approval on June 16, 2016. Upon the closing of the Private
Placement on April 14, 2016, the Company recorded an estimated fair value of $3.3 million relating to warrants to
purchase 1,975,580 shares of common stock that were issued in the Private Placement. The warrants were
comprised of warrants to purchase 1,775,580 shares of common stock that were issued to certain accredited
investors measured at an estimated fair value of $3.0 million, and Placement Agent Warrants to purchase 200,000
shares of common stock measured at an estimated fair value of $0.3 million. The Placement Agent Warrants were
issued for services performed by placement agents as part of the Private Placement and were treated as equity
issuance costs and were recorded in stockholders’ equity on the Company’s consolidated balance sheets to offset the
Private Placement proceeds allocated to the Series A Preferred and common stock.
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Additional warrants were issued on June 15, 2016 to the Former Majority Shareholders upon the closing of the
Subsequent Financing (as described in Note 11). The warrants issued in the Subsequent Financing were also
considered freestanding instruments being accounted for using the same methodology as described above. On June
15, 2016, the Company recorded an estimated fair value of $1.7 million for warrants to purchase an aggregate of
1,002,507 shares of common stock issued in the Subsequent Financing.
The initial total estimated fair value of the warrant liability was $5.0 million following the closings of the Private
Placement, the issuance of Placement Agent Warrants and the Subsequent Financing on April 14, 2016. As of
December 31, 2017, the total estimated fair value of the warrant liability was $12.2 million. The corresponding
remeasurement charge of $11.3 million for the same year, was recorded in change in estimated fair value of
common stock warrant and derivative liabilities on the Company’s consolidated statements of operations.
In connection with the 2016 Public Offering, in accordance with the anti-dilution provisions in the warrants issued
in connection with the Private Placement and the Subsequent Financing, the exercise price of the 1,775,580 and
1,002,507 Private Placement and Subsequent Financing warrants, respectively, was adjusted from $4.98 per share to
$4.00 per share, which was the price paid by investors in the 2016 Public Offering.
In connection with the issuance of 1,022,544 shares of the Company’s common stock at $1.12 in connection with
the amendments to the Conditional Share Purchase Agreement, the exercise prices of the warrants issued in the
Private Placement and Placement Agent Warrants were adjusted from $4.00 and $3.99 per share, respectively, to
$1.12 per share.
JGB Warrants
In connection with the issuance of the JGB Debt (as described in Note 10), the Company issued the 1,250,000
warrants (the “JGB Warrants”). The exercise price of the JGB Warrants was $5.00 per share, and the JGB Warrants
are exercisable from September 16, 2017 through September 15, 2022. Warrants were accounted as liabilities and
the initial estimated fair value of the common stock warrant liability was $0.9 million. As of December 31, 2017,
the estimated fair value of the common stock warrant liability was $6.6 million. The corresponding remeasurement
expense for the year ended December 31, 2017 $5.7 million, and was recorded in change in estimated fair value of
common stock warrant and derivative liabilities on the Company’s consolidated statements of operations.
Pursuant to an agreement with the Former Majority Shareholders, the aggregate number of shares of common stock
issuable upon exercise of the JGB Warrants increased from 1,250,000 shares to 1,296,679 shares and the exercise
price of the JGB Warrants decreased from $5.00 to $4.82 per share, effective July 3, 2017.
As a result of the 2017 Public Offering, effective October 5, 2017, the aggregate number of shares of common stock
issuable upon exercise of the JGB Warrants increased from 1,296,679 shares to 1,332,620 shares and the exercise
price of the JGB Warrants decreased from $4.82 to $4.69 per share. As a result of the sale of the 651,240 shares of
common stock pursuant to the underwriters’ full exercise of their option to purchase additional shares to cover over-
allotments in the 2017 Public Offering, effective October 10, 2017, the aggregate number of shares of common
stock issuable upon exercise of the JGB Warrants increased from 1,332,620 shares to 1,338,326 shares and the
exercise price of the JGB Warrants decreased from $4.69 to $4.67 per share.
On January 1, 2018, the Company adopted new accounting guidance (refer to Note 2) and reclassified the warrants
to purchase 1,338,326 shares of common stock issued to JGB from liability to equity at the fair value of $6.6
million. As of September 30, 2018, the JGB Warrants were fully exercised.
Perceptive Tranche A Warrant
In connection with the Perceptive Credit Arrangement (as described in Note 10), on April 17, 2018, the Company
issued the Perceptive Tranche A Warrant to purchase up to 140,000 shares of common stock of the Company at an
initial exercise price of $8.60. The Perceptive Tranche A Warrant met the equity classification in accordance with
ASU No. 2017-11 as described in Note 2. The Perceptive Tranche A Warrants were exercised in full on October 22,
2018 on a cashless basis. Perceptive received 91,705 shares of common stock in connection with this transaction.
122
As of December 31, 2018, outstanding warrants to purchase common stock were:
Classified
as
Original
Term
Exercise
Price
Number of
Shares
Underlying
Warrants
Original issue date:
August 2009 .............................................. Equity 10 years $
9 years $
July 2010 ................................................... Equity
7 years $
August 2012 .............................................. Equity
5 years $
January 2015 ............................................. Equity
7 years $
April 2016 (a) ............................................ Liability
5 years $
April 2016 (b)............................................ Liability
33,473
21.78
21.78
6,694
21.78 167,182
6.96
34,483
1.12 323,021
91,436
1.12
656,289
(a)
(b)
Issued on April 14, 2016 in connection with the Private Placement to certain accredited investors. In accordance with the
anti-dilution provisions, the exercise price of the warrants issued in connection with such private placement was adjusted
from $4.98 to $4.00, which was the price paid by investors in the Company’s underwritten public offering of common
stock, which closed on September 26, 2016. As a result of the issuance of 1,022,544 shares of the Company’s common
stock at $1.12 in connection with the amendments to the Conditional Share Purchase Agreement, the exercise price was
adjusted from $4.00 to $1.12, effective July 3, 2017.
Issued on April 14, 2016 in connection with the Private Placement to placement agents. As a result of the issuance of
1,022,544 shares of the Company’s common stock at $1.12 in connection with the amendments to the Conditional Share
Purchase Agreement, the exercise price was adjusted from $3.99 to $1.12, effective July 3, 2017.
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 287,491 shares of
common stock reserved for future issuance under the 2014 Plan as of December 31, 2018.
2016 Inducement Plan
On April 21, 2016, the Company adopted the 2016 Inducement Equity Incentive Plan (the “Inducement 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 Inducement Plan was adopted to accommodate a reserve of additional shares of
common stock for issuance to new employees hired by the Company from Allenex. The terms in the Inducement
Plan are substantially similar to the Company’s 2014 Plan. There were 34,687 shares of common stock reserved for
future issuance under the Inducement Plan as of December 31, 2018.
The Inducement 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 Inducement Plan starting June 2016.
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Stock Options and Restricted Stock Units (“RSUs”)
The following table summarizes options and RSUs activity under the Company’s 2014 Equity Incentive Plan and
2016 Inducement Plan and related information:
Shares
Available
for Grant
Stock
Options
Weighted-
Average
Exercise
Price
Number of
RSU
Shares
Outstanding
156,429 1,941,473
Balance—December 31, 2017 ...................................
—
Additional options authorized.................................... 1,957,075
—
(25,509)
Common stock awards for services ...........................
—
(847,734)
RSUs granted .............................................................
RSUs vested...............................................................
—
—
Options granted.......................................................... (1,116,683) 1,116,683
Options exercised.......................................................
— (472,645)
Repurchases of common stock under employee
incentive plans ...........................................................
RSUs forfeited ...........................................................
Options forfeited ........................................................
Options expired..........................................................
Balance—December 31, 2018 ...................................
—
—
(82,576)
(1,878)
67,656
46,490
82,576
1,878
322,178 2,501,057 $
Weighted-
Average
Grant Date
Fair Value
4.39
—
—
13.89
8.59
—
—
4.21 439,926
—
—
—
—
— 847,734
— (272,806)
—
—
14.78
3.13
—
—
— (46,490)
—
5.26
3.51
—
9.10 968,364 $
—
5.63
—
—
11.49
The total intrinsic value of options exercised was $6.8 million, $0.2 million and less than $0.1 million in the years
ended December 31, 2018, 2017 and 2016, respectively.
The total fair value of RSUs vested during 2018 was $2.3 million. As of December 31, 2018, the total intrinsic value
of outstanding RSUs was approximately $24.3 million and there were $8.5 million of unrecognized compensation
costs related to RSUs, which are expected to be recognized over a weighted-average period of 3.20 years.
Options outstanding that have vested and are expected to vest at December 31, 2018 are as follows:
Vested ........................................................................ 1,020,905 $
Expected to Vest ........................................................ 1,301,026
Total ........................................................................... 2,321,931
5.26
11.77
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual Life
(Years)
Number of
Shares
Issued
Aggregate
Intrinsic
Value
(In thousands)
20,299
17,728
38,027
6.72 $
9.04
$
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, 2018 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, 2018, 2017 and 2016 using the Black-Scholes Model was $9.05, $1.60 and $2.05, respectively.
The total fair value of options that vested during 2018 was $1.2 million. As of December 31, 2018, there were
approximately $8.7 million of unrecognized compensation costs related to stock options, which are expected to be
recognized over a weighted-average period of 3.25 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
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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 month 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 2018 that ended on June 30, 2018, 42,534 shares were purchased for aggregate
proceeds of $0.3 million from the issuance of shares, which occurred on July 2, 2018. The Company issued 76,710
shares and 71,639 shares of common stock during the years ended December 31, 2018 and December 31, 2017,
respectively, pursuant to the ESPP. The Company received proceeds of $0.3 million and $0.1 million from the
purchases of shares during the years ended December 31, 2018 and 2017, respectively. As of December 31, 2018,
the Company had 372,568 shares available for issuance under the ESPP.
Board of Directors Stock Awards Granted for Services
For the years ended December 31, 2018, 2017 and 2016, 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, 2018, there were a total of 246,398 shares issued to the Company’s directors, for a total fair value
of $1.1 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, 2018, 2017 and 2016, respectively, which was included in general
and administrative expense in the consolidated statements of operations.
Valuation Assumptions
The estimated fair value of employee stock options and ESPP shares was estimated using the Black-Scholes Model
based on the following weighted average assumptions.
Year Ended December 31,
2018
2017
2016
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......................................
5.9
69.69 %
2.77 %
— %
0.5
59.94 – 105.32 %
1.61 – 2.14 %
— %
5.9
57.34 %
2.01 %
— %
5.9
42.10 %
1.52 %
— %
0.5
0.5
62.27 – 98.58 % 77.05 – 90.81 %
0.37 – 0.49 %
— %
0.65 – 1.13 %
— %
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.
125
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, 2018, 2017 and 2016, included in the consolidated statements of
operations as follows (in thousands):
2018
Year Ended December 31,
2017
2016
Cost of testing............................................................................. $
Research and development.........................................................
Sales and marketing ...................................................................
General and administrative.........................................................
$
821 $
1,631
986
3,700
7,138 $
188 $
405
157
994
1,744 $
144
449
156
1,249
1,998
No tax benefit was recognized related to share-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 share-based compensation costs were capitalized for the
periods presented.
15. INCOME TAXES
Loss before income taxes for the years ended December 31, 2018, 2017 and 2016 is summarized as follows (in
thousands):
United States................................................... $
Foreign............................................................
$
Year Ended December 31,
2018
2017
(41,109) $
(7,106)
(48,215) $
(50,132) $
(7,137)
(57,269) $
2016
(21,753)
(19,609)
(41,362)
The components of the provision for (benefit from) income taxes are summarized as follows (in thousands):
Current
Federal.......................................................................
State...........................................................................
Foreign ......................................................................
Total Current ..................................................................
Deferred
Federal.......................................................................
State...........................................................................
Foreign ......................................................................
Total Deferred.................................................................
Income tax benefit ..........................................................
$
$
2018
As of December 31,
2017
2016
24 $
—
139
163
13
4
(1,614)
(1,597)
(1,434) $
74 $
(4)
68
138
42
1
(1,890)
(1,847)
(1,709) $
49
11
32
92
(251)
(49)
(1,398)
(1,698)
(1,606)
126
The Company's actual provision for tax differed from the amounts computed by applying the U.S. federal income
tax rates of 21% and 34% to loss before income taxes as a result of the following:
2018
Year Ended December, 31,
2017
2016
Federal tax rate...........................................................
Stock-based compensation.........................................
Change in valuation allowance ..................................
Foreign rate differential .............................................
Warrant revaluation ...................................................
Interest expense..........................................................
Acquisition costs........................................................
Goodwill impairment .................................................
Impact of 2017 Tax Cuts and Jobs Act on change in
deferred tax assets ......................................................
Other ..........................................................................
Effective income tax rate......................................
21.0%
1.3%
-9.4%
2.4%
-10.0%
-1.7%
—
—
—
-0.6%
3.0%
34.0%
-0.2%
38.0%
-1.1%
-17.5%
-1.8%
0.0%
-1.2%
-46.5%
-0.7%
3.0%
34.0%
-0.5%
-16.8%
-1.3%
-0.2%
0.0%
-1.2%
-10.8%
—
0.7%
3.9%
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 ...........................
Other.........................................................
Gross deferred tax assets ...............................
Valuation allowance.................................
Total deferred tax assets ................................
Deferred tax liabilities:
Purchased intangibles...............................
Other.........................................................
Total deferred tax liabilities...........................
Net deferred tax liabilities ............................. $
As of December 31,
2018
2017
52,135 $
6,235
3,068
1,571
812
63,821
(60,327)
3,494
(6,429)
(33)
(6,462)
(2,968) $
49,374
5,798
583
1,184
633
57,572
(54,934)
2,638
(7,554)
(17)
(7,571)
(4,933)
The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both
positive and negative, including (1) cumulative results of operations in recent years, (2) sources of recent losses, (3)
estimates of future taxable income and (4) 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 $5.4
million and decreased by $21.4 million during the years ended December 31, 2018 and 2017, respectively.
As of December 31, 2018, the Company had domestic federal net operating loss carryforwards of $207.5 million,
domestic state net operating loss carryforwards of $80.9 million, and foreign net operating loss carryforwards of
$8.7 million that can reduce future taxable income. The domestic federal and state net operating loss carryforwards
will begin to expire in 2019 and 2028, respectively. The foreign net operating loss carryforwards can be carried
forward indefinitely.
As of December 31, 2018, the Company had credit carryforwards of approximately $4.6 million and $5.8 million
available to reduce future taxable income, if any, for domestic federal and California state income tax purposes,
127
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. The Company has not performed a Section 382 analysis subsequent to the 2007 tax year to
determine if a change occurred and whether the use of net operating loss carryforwards and credit carryforwards will
be limited to offset future taxable income. For financial statement purposes, the Company has included the federal
and state net operating losses and credits in the deferred tax assets with a full valuation allowance. 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.................................................................
Additions (decreases) based on tax positions related
to prior years............................................................
Balance at the end of the year .................................... $
2018
Year Ended December 31,
2017
2016
3,164 $
5,252 $
285
186
—
3,449 $
(2,274)
3,164 $
2,431
332
2,489
5,252
Approximately $0.5 million of the $3.4 million of net unrecognized tax benefit as of December 31, 2018, if
recognized, would impact the Company's effective tax rate. During the year ended December 31, 2018, 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, 2018, December 31, 2017 and December 31, 2016 the Company had $0.3 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 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 this filing 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. 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 due to the valuation allowance.
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 CODM, or decision making group, whose function is to allocate resources to and
128
assess the performance of the operating segments. The Company has identified its CEO 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 previously operated and reported its operating results in two reportable segments: Post-Transplant
and Pre-Transplant. In the third quarter of 2018, the Company completed a business reorganization to support the
Company’s strategy to become a global transplant care leader. The position of the head of the former Pre-Transplant
segment was eliminated, and global functional leaders who report to CODM were identified to manage sales and
marketing, research and development, manufacturing and quality and other global functions. These changes resulted
in changes to the presentation of financial information provided to the CODM for resource allocation and
management performance assessment. The CODM continues to review revenue and cost of sales by testing services
and products, as reported in the consolidated statements of operations. Earnings before interests, taxes, depreciation
and amortization and operating results are reviewed at the consolidated level only. Effective September 30, 2018,
the Company reports a single operating segment.
As of December 31, 2018 and 2017, there are no changes to the segment financial information reporting, except that
the Company does not report results of former Post and Pre-Transplant segments. Such information is no longer
prepared and therefore has not been provided to the CODM since the Company completed its reorganization during
the reporting period ending September 30, 2018.
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):
Years Ended December 31,
2017
2016
2018
Testing services revenue
United States .......................................................... $
Rest of World.........................................................
$
59,683 $
617
60,300 $
32,598 $
508
33,106 $
29,492
188
29,680
Product revenue
United States .......................................................... $
Europe ....................................................................
Rest of World.........................................................
$
5,881 $
7,506
2,287
15,674 $
4,189 $
7,980
2,465
14,634 $
3,006
6,270
1,439
10,715
License and other revenue
United States .......................................................... $
Europe ....................................................................
$
499 $
96
595 $
498 $
86
584 $
194
42
236
Total United States................................................. $
Total Europe........................................................... $
Total Rest of World ............................................... $
66,063 $
7,602 $
2,904 $
37,285 $
8,066 $
2,973 $
32,692
6,312
1,627
Total ....................................................................... $
76,569 $
48,324 $
40,631
129
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions
(in thousands):
December 31, 2018 December 31, 2017
Long-lived assets:
United States ............................................... $
Europe.........................................................
Rest of World..............................................
Total ................................................................. $
3,235 $
625
274
4,134 $
1,206
776
93
2,075
130
17. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
The following table presents selected unaudited consolidated financial data for each of the eight quarters in the two-
year period ended December 31, 2018. The Company believes this information reflects all recurring adjustments
necessary to fairly present this information when read in conjunction with the Company’s consolidated financial
statements and the related notes. Net loss per share attributable to CareDx, Inc., basic and diluted, for the four
quarters of each fiscal year may not sum to the total for the fiscal year because of the different number of shares
outstanding during each period. The results of operations for any quarter are not necessarily indicative of the results
to be expected for any future period.
Quarter Ended:
March 31
June 30
September 30 December 31
(In thousands, except share and per share data)
14,053 $
2018
Consolidated Statements of Operations Data:
Total revenue ....................................................................... $
Net loss attributable to CareDx, Inc.
used to compute basic net loss per share .......................... $
Net loss per common share
attributable to CareDx, Inc., basic .................................... $
Net loss per common share
attributable to CareDx, Inc., diluted ................................. $
Shares used in calculation of net loss per
share attributable to CareDx, Inc., basic........................... 29,615,441 35,549,837 37,154,293 40,104,341
Shares used in calculation of net income loss
per share attributable to CareDx, Inc., diluted.................. 29,615,441 35,549,837 37,154,293 40,104,341
(19,970) $
(14,062) $
21,184 $
17,823 $
(8,969) $
(0.54) $
(0.54) $
(0.40) $
(0.40) $
(0.30) $
(0.30) $
23,509
(3,755)
(0.09)
(0.09)
11,584 $
2017
Consolidated Statements of Operations Data:
Total revenue ....................................................................... $
Net loss attributable to CareDx, Inc.
used to compute basic net loss per share .......................... $
Net loss per common share
attributable to CareDx, Inc., basic .................................... $
Net loss per common share
attributable to CareDx, Inc., diluted ................................. $
Shares used in calculation of net loss per
share attributable to CareDx, Inc., basic........................... 21,343,782 21,412,480 22,526,615 27,983,033
Shares used in calculation of net income loss
per share attributable to CareDx, Inc., diluted.................. 21,343,782 21,412,480 22,526,615 27,983,033
(14,268) $
12,191 $
12,046 $
(3,968) $
(5,562) $
(0.63) $
(0.63) $
(0.19) $
(0.19) $
(0.26) $
(0.26) $
12,503
(31,671)
(1.13)
(1.13)
131
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, 2018. 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, 2018, 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 our internal control over financial reporting as of December 31, 2018. 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 its internal controls over financial reporting were effective as of December
31, 2018.
Report of the Independent Registered Public Accounting Firm
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm
due to an exemption established by the JOBS Act for “emerging growth companies.”
Changes in Internal Control over Financial Reporting
None.
ITEM 9B. OTHER INFORMATION
None.
132
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, 2018
in connection with the Annual Meeting of Stockholders to be held in 2019, or the 2019 Proxy Statement. To the
extent that we do not file the 2019 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 2019 Proxy
Statement. The 2019 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year
ended December 31, 2018. To the extent that we do not file the 2019 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 2019
Proxy Statement. The 2019 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal
year ended December 31, 2018. To the extent that we do not file our 2019 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 2019
Proxy Statement. The 2019 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal
year ended December 31, 2018. To the extent that we do not file the 2019 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 2019 Proxy
Statement. The 2019 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year
ended December 31, 2018. To the extent that we do not file the 2019 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.
133
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).
134
Exhibit
Number
2.1†
2.2
3.1
3.2
4.1
4.2
4.3#
4.4#
4.5#
4.6#
4.7#
Description
Agreement and Plan of Merger,
dated May 17, 2014, by and
between Registrant, Monitor
Acquisition Corporation,
ImmuMetrix, Inc. and Mattias
Westman, as Holders’ Agent.
Amendment No. 1 to
Agreement and Plan of Merger,
dated June 9, 2014, by and
between the Registrant,
Monitor Acquisition
Corporation, ImmuMetrix, Inc.
and Mattias Westman, as
Holders’ Agent.
Amended and Restated
Certificate of Incorporation of
the Registrant.
Amended and Restated Bylaws
of the Registrant.
Form of Registrant’s common
stock certificate.
Sixth Amended and Restated
Investors Rights Agreement,
dated July 1, 2009, as amended
on March 29, 2012, June 10,
2014, and July 14, 2014,
between the Registrant and
certain holders of the
Registrant’s capital stock
named therein.
1998 Equity Incentive Plan and
forms of agreements
thereunder.
2008 Equity Incentive Plan and
forms of agreements
thereunder.
ImmuMetrix, Inc. 2013 Equity
Incentive Plan
2014 Equity Incentive Plan and
forms of agreements, as
amended.
Form
S-1/A
Incorporated by Reference
File No.
Exhibit
Filing Date
333-196494
2.1
07/15/2015
S-1/A
333-196494
2.2
06/25/2014
10-Q
001-36536
10-Q
001-36536
10-K
001-36536
10-K
001-36536
3.1
3.4
4.1
4.2
08/28/2014
08/28/2014
03/31/2015
03/31/2015
S-1
333-196494
10.2
06/03/2014
S-1
333-196494
10.3
06/03/2014
S-1
8-K
333-196494
10.19
06/03/2014
001-36536
10.1
06/26/2018
Form of Option Agreement
under the 2014 Equity Incentive
Plan for New Options.
SC TO-
I
005-88252
99(d)(3)
10/12/2017
135
Exhibit
Number
4.8#
Description
2014 Employee Stock Purchase
Plan and forms of agreements
thereunder.
4.9#
2016 Inducement Equity
Incentive Plan.
4.10#
Form of Warrant.
4.11
10.1#
10.2#
10.3#
10.4#
10.5#
10.6#
10.7#
10.8#
10.9#
Form of Common Stock
Purchase Warrant issued to the
Purchasers on March 15, 2017.
Chief Executive Employment
Agreement, dated September
19, 2012, by and between the
Registrant and Peter Maag.
Offer Letter, dated July 31,
2006, by and between the
Registrant and James Yee.
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 Michael Bell,
dated as of April 21, 2017.
Offer Letter, between the
Registrant and Sasha King,
dated October 20, 2017.
Offer Letter, dated November
16, 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.
Form of Indemnification
Agreement between the
Registrant and each of its
directors and executive officers.
Incorporated by Reference
Form
S-8
File No.
333-197493
Exhibit
4.5
Filing Date
7/18/2014
S-8
8-K
8-K
333-211538
001-36536
001-36536
4.1
10.3
4.2
5/23/2016
4/14/2016
3/15/2017
S-1
333-196494
10.6
06/03/2014
S-1
333-196494
10.7
06/03/2014
10-K
001-36536
10.15
03/31/2015
10-K
001-36536
10.14
03/31/2015
10-K
001-36536
10.43
04/21/2017
10-K
001-36536
10.6
03/22/2018
8-K
001-36536
10.1
11/26/2018
S-1
333-196494
10.11
06/03/2014
S-1
333-196494
10.1
06/03/2014
10.10#
Executive Incentive
Compensation Plan.
10-K
001-36536
4.1
03/31/2015
136
Exhibit
Number
10.11 # Outside Director Compensation
Description
Form
10-K
Incorporated by Reference
File No.
001-36536
Exhibit
10.18
Filing Date
03/31/2015
10.12
10.13†
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.
PCR Patent License
Agreement, dated November
16, 2004, by and between the
Registrant and Roche
Molecular Systems, Inc., and
amendments thereto.
10.14† Distribution and Licensing
Agreement, dated June 20,
2013, by and between the
Registrant and Diaxonhit SA.
S-1
333-196494
10.12
06/03/2014
S-1
333-196494
10.14
06/03/2014
S-1/A
333-196494
10.15
06/25/2014
10.15† Amended and Restated
S-1/A
333-196494
10.17
07/15/2014
Exclusive Agreement, dated
January 27, 2014, by and
between the Board of Trustees
of the Leland Stanford Junior
University and ImmuMetrix,
Inc.
Settlement Agreement and
Mutual Release, dated
September 11, 2014, by and
between the Registrant and
Roche Molecular Systems, Inc.
10.16†
10-Q
001-36536
10.14.1
11/14/2014
10.17† Business Sale Agreement,
10-Q
011-36536
10.6
06/09/2017
between CareDx Pty Ltd and
Conexio Genomics Pty Ltd.,
dated as of January 12, 2017.
10.18
Sales Agreement, dated August
31, 2018 by and between the
Registrant and Jeffries LLC.
S-3
333-227168
1.1
08/31/2018
137
Exhibit
Number
10.19†
Description
Form
File No.
Exhibit
Filing Date
Incorporated by Reference
License and Commercialization
Agreement, dated May 4, 2018,
between the Registrant and
Illumina, Inc.
10-Q/A
001-36536
10.3
10/09/2018
21.1*
Subsidiaries of the Registrant.
23.1*
23.2*
24.1*
31.1*
31.2*
Consent of Deloitte & Touche
LLP, Independent Registered
Public Accounting Firm.
Consent of Ernst & Young
LLP, Independent Registered
Public Accounting Firm.
Power of Attorney (see
page 139 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.
32.1** Certification Pursuant to 18
U.S.C. § 1350 (Section 906 of
Sarbanes-Oxley Act of 2002).
101.INS* XBRL Instance Document
101.SCH* XBRL Taxonomy Extension
Schema
101.CAL* XBRL Taxonomy Extension
Calculation Linkbase
101.DEF* XBRL Taxonomy Extension
Definition Linkbase
101.LAB* XBRL Taxonomy Extension
Label Linkbase
101.PRE* XBRL Taxonomy Extension
Presentation Linkbase
†
#
*
**
Confidential treatment has been granted with respect to certain portions of this Exhibit. Omitted portions have
been filed separately with the SEC.
Indicates management contract or compensatory plan or arrangement.
Filed herewith.
Furnished herewith.
138
ITEM 16. FORM 10-K SUMMARY
None.
139
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/ PETER MAAG
Peter Maag
Chief Executive Officer
Date: March 6, 2019
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and
appoints Peter Maag and Michael Bell, 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
/s/ PETER MAAG
Peter Maag
Title
Chief Executive Officer
and Director
(Principal Executive Officer)
Date
March 06, 2019
/s/ MICHAEL BELL
Michael Bell
Chief Financial Officer
(Principal Financial and Accounting Officer)
March 06, 2019
/s/ MICHAEL D. GOLDBERG
Michael D. Goldberg
/s/ GEORGE W. BICKERSTAFF, III
George W. Bickerstaff, III
/s/ FRED E. COHEN
Fred E. Cohen
/s/ RALPH SNYDERMAN
Ralph Snyderman
/s/ WILLIAM HAGSTROM
William Hagstrom
Director
Director
Director
Director
Director
March 06, 2019
March 06, 2019
March 06, 2019
March 06, 2019
March 06, 2019
140
CORPORATE INFORMATION
Executive Team
Peter Maag, PhD
Chief Executive Officer
Reginald Seeto, MD, BS
President and Chief Business Officer
James Yee, MD
Executive Vice President and
Chief Medical Officer
Michael Bell
Chief Financial Officer
Sasha King
Chief Commercial Officer
Board of Directors
Peter Maag, PhD
Chief Executive Officer
CareDx, Inc.
Michael Goldberg, MBA
Chairman of the Board
CareDx, Inc.
Audit Committee*
Compensation Committee,
Nominating/Corporate Governance
Fred E. Cohen, MD, DPhil
Senior Managing Director
Vida Ventures
Compensation Committee*,
Science and Technology Committee*
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 A. Hagstrom
CEO, Octave Bioscience
Audit Committee,
Compensation Committee
*Indicates Chairperson of the Committee
Annual Stockholders Meeting
June 17, 2019 at 10AM PST
3260 Bayshore Blvd,
Brisbane, CA 94005
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
Integrated Corporate Relations, Inc.
685 Third Ave 2nd Floor
New York, NY 10017
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 information on factors
that could affect results is included in
the 2018 Form 10-K included in this
annual report.
CareDx, Inc
3260 Bayshore Blvd
Brisbane, CA 94005
Tel 415.287.2300
Fax 415.287.2450
WWW.CAREDX.COM
SKU: 001CSN3D11
2018 Annual Report