10-Q 1 cdna-10q_20180630.htm 10-Q cdna-10q_20180630.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2018

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

 

94-3316839

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

3260 Bayshore Boulevard

Brisbane, California 94005

(Address of principal executive offices and zip code)

(415) 287-2300

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes   No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).  Yes   No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

 

 

Non-accelerated filer

 

(Do not check if a smaller reporting company)

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   No

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

There were 36,346,124 shares of the registrant’s Common Stock issued and outstanding as of August 6, 2018.

 

 

 

 

 

 


 

CareDx, Inc.

TABLE OF CONTENTS

 

 

 

Page No.

PART I. FINANCIAL INFORMATION

 

3

Item 1. Unaudited Condensed Consolidated Financial Statements

 

3

Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017

 

3

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2018 and 2017

 

4

Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017

 

5

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017

 

6

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

32

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

46

Item 4. Controls and Procedures

 

47

 

 

 

PART II. OTHER INFORMATION

 

48

Item 1. Legal Proceedings

 

48

Item 1A. Risk Factors

 

48

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

49

Item 3. Defaults Upon Senior Securities

 

49

Item 5. Other Information

 

49

Item 6. Exhibits

 

49

Signatures

 

51

 

 

 

 

2


 

PART I. FINANCIAL INFORMATION

ITEM 1.

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

CareDx, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share data)

 

 

June 30, 2018

 

 

December 31, 2017

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

16,246

 

 

$

16,895

 

Accounts receivable

 

 

8,072

 

 

 

2,991

 

Inventory

 

 

4,666

 

 

 

5,529

 

Prepaid and other assets

 

 

1,593

 

 

 

1,352

 

Total current assets

 

 

30,577

 

 

 

26,767

 

Property and equipment, net

 

 

2,360

 

 

 

2,075

 

Intangible assets, net

 

 

34,760

 

 

 

33,139

 

Goodwill

 

 

12,005

 

 

 

12,005

 

Restricted cash

 

 

177

 

 

 

9,579

 

Total assets

 

$

79,879

 

 

$

83,565

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,480

 

 

$

3,391

 

Accrued payroll liabilities

 

 

5,576

 

 

 

5,013

 

Accrued and other liabilities

 

 

4,703

 

 

 

3,735

 

Deferred revenue

 

 

39

 

 

 

39

 

Deferred purchase consideration

 

 

378

 

 

 

407

 

Derivative liability

 

 

 

 

 

14,600

 

Current debt

 

 

 

 

 

15,721

 

Total current liabilities

 

 

14,176

 

 

 

42,906

 

Deferred rent, net of current portion

 

 

686

 

 

 

913

 

Deferred revenue, net of current portion

 

 

711

 

 

 

730

 

Deferred tax liability

 

 

3,693

 

 

 

4,933

 

Long-term debt, net of current portion

 

 

13,337

 

 

 

18,338

 

Contingent consideration

 

 

 

 

 

1,672

 

Common stock warrant liability

 

 

16,800

 

 

 

18,712

 

Other liabilities

 

 

1,524

 

 

 

1,315

 

Total liabilities

 

 

50,927

 

 

 

89,519

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock: $0.001 par value; 10,000,000 shares authorized at June 30, 2018

   and December 31, 2017; no shares issued and outstanding at June 30, 2018

   and December 31, 2017

 

 

 

 

 

 

Common stock: $0.001 par value; 100,000,000 shares authorized at June 30, 2018

   and December 31, 2017; 35,975,493 shares and 28,825,019 shares issued and

   outstanding at June 30, 2018 and December 31, 2017, respectively

 

 

36

 

 

 

29

 

Additional paid-in capital

 

 

321,144

 

 

 

264,204

 

Accumulated other comprehensive loss

 

 

(4,108

)

 

 

(2,345

)

Accumulated deficit

 

 

(288,120

)

 

 

(268,022

)

Total CareDx, Inc. stockholders' equity (deficit)

 

 

28,952

 

 

 

(6,134

)

Noncontrolling interest

 

 

 

 

 

180

 

Total stockholders’ equity (deficit)

 

 

28,952

 

 

 

(5,954

)

Total liabilities and stockholders’ equity

 

$

79,879

 

 

$

83,565

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

CareDx, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Testing services revenue

 

$

13,997

 

 

$

8,420

 

 

$

24,601

 

 

$

16,322

 

Product revenue

 

 

3,550

 

 

 

3,376

 

 

 

6,857

 

 

 

7,043

 

License and other revenue

 

 

276

 

 

 

250

 

 

 

418

 

 

 

265

 

Total revenue

 

 

17,823

 

 

 

12,046

 

 

 

31,876

 

 

 

23,630

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of testing services

 

 

4,568

 

 

 

3,011

 

 

 

8,680

 

 

 

6,068

 

Cost of product

 

 

2,639

 

 

 

2,178

 

 

 

4,911

 

 

 

4,505

 

Research and development

 

 

3,496

 

 

 

3,118

 

 

 

6,864

 

 

 

6,401

 

Sales and marketing

 

 

5,860

 

 

 

3,270

 

 

 

9,945

 

 

 

6,492

 

General and administrative

 

 

5,596

 

 

 

4,132

 

 

 

10,903

 

 

 

10,634

 

Goodwill impairment

 

 

 

 

 

 

 

 

 

 

 

1,958

 

Change in estimated fair value of contingent consideration

 

 

873

 

 

 

(64

)

 

 

1,017

 

 

 

(285

)

Total operating expenses

 

 

23,032

 

 

 

15,645

 

 

 

42,320

 

 

 

35,773

 

Loss from operations

 

 

(5,209

)

 

 

(3,599

)

 

 

(10,444

)

 

 

(12,143

)

Interest expense

 

 

(424

)

 

 

(1,691

)

 

 

(3,119

)

 

 

(2,481

)

Other expense, net

 

 

(42

)

 

 

(188

)

 

 

(2,851

)

 

 

(874

)

Change in estimated fair value of common stock warrant liability and derivative liability

 

 

(8,768

)

 

 

1,067

 

 

 

(7,447

)

 

 

5,195

 

Loss before income taxes

 

 

(14,443

)

 

 

(4,411

)

 

 

(23,861

)

 

 

(10,303

)

Income tax benefit

 

 

381

 

 

 

376

 

 

 

805

 

 

 

659

 

Net loss

 

 

(14,062

)

 

 

(4,035

)

 

 

(23,056

)

 

 

(9,644

)

Net loss attributable to noncontrolling interest

 

 

 

 

 

(67

)

 

 

(25

)

 

 

(114

)

Net loss attributable to CareDx, Inc.

 

$

(14,062

)

 

$

(3,968

)

 

$

(23,031

)

 

$

(9,530

)

Net loss per share attributable to CareDx, Inc. (Note 3):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

Diluted

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

Weighted average shares used to compute net loss per share attributable to CareDx, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

Diluted

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4


 

CareDx, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

(In thousands)

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Net loss

 

$

(14,062

)

 

$

(4,035

)

 

$

(23,056

)

 

$

(9,644

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(1,625

)

 

 

670

 

 

 

(1,762

)

 

 

934

 

Net comprehensive loss

 

 

(15,687

)

 

 

(3,365

)

 

 

(24,818

)

 

 

(8,710

)

Comprehensive loss attributable to noncontrolling interest, net of tax

 

 

 

 

 

(72

)

 

 

(25

)

 

 

(124

)

Comprehensive loss attributable to CareDx, Inc.

 

$

(15,687

)

 

$

(3,293

)

 

$

(24,793

)

 

$

(8,586

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5


 

CareDx, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

Operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(23,056

)

 

$

(9,644

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

2,025

 

 

 

1,821

 

Amortization of inventory fair market value adjustment

 

 

189

 

 

 

170

 

Loss on conversion of JGB debt to shares of common stock

 

 

2,806

 

 

 

 

Amortization of debt discount and noncash interest expense

 

 

2,132

 

 

 

1,769

 

Revaluation of common stock warrant liability and derivative liability to estimated fair value

 

 

7,447

 

 

 

(5,195

)

Stock-based compensation

 

 

3,217

 

 

 

886

 

Revaluation of contingent consideration to estimated fair value

 

 

1,017

 

 

 

(285

)

Goodwill impairment charge

 

 

 

 

 

1,958

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(2,280

)

 

 

(152

)

Inventory

 

 

333

 

 

 

252

 

Prepaid and other assets

 

 

(296

)

 

 

(189

)

Accounts payable

 

 

195

 

 

 

422

 

Accrued payroll liabilities

 

 

686

 

 

 

(486

)

Accrued and other liabilities

 

 

92

 

 

 

(710

)

Change in deferred revenue

 

 

(19

)

 

 

(12

)

Change in deferred taxes

 

 

(892

)

 

 

(542

)

Net cash used in operating activities

 

 

(6,404

)

 

 

(9,937

)

Investing activities:

 

 

 

 

 

 

 

 

Acquisition of intangible assets through Illumina Licensing Agreement

 

 

(5,202

)

 

 

 

Acquisition of Allenex AB minority interest

 

 

(692

)

 

 

 

Purchase of property and equipment

 

 

(461

)

 

 

(94

)

Net cash used in investing activities

 

 

(6,355

)

 

 

(94

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from debt, net of issuance costs

 

 

14,282

 

 

 

24,002

 

Proceeds from issuance of common stock under employee stock purchase plan

 

 

32

 

 

 

44

 

Principal payments on debt and capital lease obligations

 

 

(11,349

)

 

 

(12,871

)

Acquisition of Conexio Genomics Pty Ltd.

 

 

(91

)

 

 

 

Change in short term credit facility

 

 

(677

)

 

 

176

 

Proceeds from exercise of warrants

 

 

524

 

 

 

 

Repurchases of common stock under employee incentive plans

 

 

(142

)

 

 

 

Proceeds from exercise of stock options

 

 

179

 

 

 

 

Net cash provided by financing activities

 

 

2,758

 

 

 

11,351

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(50

)

 

 

(64

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

(10,051

)

 

 

1,256

 

Cash, cash equivalents, and restricted cash at beginning of period

 

 

26,474

 

 

 

17,401

 

Cash, cash equivalents, and restricted cash at end of period

 

$

16,423

 

 

$

18,657

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Deferred purchase consideration

 

$

 

 

$

1,064

 

Contingent consideration shares issued

 

 

2,689

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash, Cash Equivalents and Restricted Cash as of:

 

June 30, 2018

 

 

December 31, 2017

 

Cash and cash equivalents

 

$

16,246

 

 

$

16,895

 

Restricted cash

 

 

177

 

 

 

9,579

 

Total cash, cash equivalents and restricted cash at the end of period

 

$

16,423

 

 

$

26,474

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6


 

CareDx, Inc.

Notes to Unaudited Condensed 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 surveillance 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.

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, the Company has sought to expand the adoption and utilization of its 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 its 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.  The Company believes 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, the Company believes 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 (the “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.  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.

On October 9, 2017, the Company commercially launched AlloSure, its proprietary next-generation sequencing-based test to measure dd-cfDNA after transplantation. The Company believes 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, the Company believes AlloSure can improve patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate dosage levels of immunosuppressants.

The Company also develops, manufactures, markets and sells 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 (“HLA”) alleles, based on the sequence specific primer (“SSP”) technology.  Olerup SBTTM is a complete product range for sequence-based typing of HLA alleles. Olerup 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.  

On May 4, 2018, the Company entered into a License and Commercialization 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.

The Company’s headquarters are in Brisbane, California; primary operations are in Brisbane, U.S. and Stockholm, Sweden; and the Company operates in two reportable segments.

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 $288.1 million at June 30, 2018. As of June 30, 2018, the Company had cash and cash equivalents of $16.2 million, and $13.3 million of debt outstanding, net of debt discount, under its debt obligations, of which none is current.

On April 17, 2018, the Company entered into a credit agreement with Perceptive Credit Holdings II, LP (“Perceptive”) for an initial term loan of $15.0 million (“the Perceptive Credit Agreement”) and repaid the outstanding indebtedness of the promissory notes previously issued to FastPartner AB and Mohammed Al Amoudi and the term loan and credit facility with Danske Bank A/S (“Danske”).  A second tranche of $10.0 million will be available at the Company’s option subject to the satisfaction of customary conditions. Refer to Note 10 for additional details.

7


 

The Company may require additional financing in the future to fund working capital and pay its 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 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 at least the next 12 months.

 

 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2017, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 are reflected below.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting.  As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted.  These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information.  The condensed consolidated balance sheet as of December 31, 2017 has been derived from audited financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements.  Operating results for the three and six months ended June 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated.  The Company acquired CareDx International AB, formerly Allenex AB “Allenex”, on April 14, 2016.  Since the acquisition of Allenex through March 15, 2018, the Company owned less than 100% of the shares of Allenex and recorded a net loss attributable to noncontrolling interest in its condensed consolidated statements of operations equal to the percentage of the economic or ownership interest retained by the respective noncontrolling parties in such entities.  On March 15, 2018, the Company acquired the remaining noncontrolling interest in Allenex and has not reported any noncontrolling interest balances since this date.

Use of Estimates

The preparation of unaudited condensed 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 unaudited condensed consolidated financial statements and accompanying notes.  On an ongoing basis, management evaluates its estimates, including those related to (i) variable transaction price consideration related to contracts with customers, (ii) the determination of the accruals for clinical studies, (iii) the fair value of assets and liabilities acquired in business combinations, including contingent consideration, (iv) inventory valuation, (v) the valuation of common stock warrant liability, (vi) the fair value of embedded derivatives, (vii) measurement of stock-based compensation expense, (viii) the determination of the valuation allowance and estimated tax benefit associated with deferred tax assets and net deferred tax liability, (ix) any impairment of long-lived assets, including in-process technology and goodwill, and (x) legal contingencies.  Actual results could differ from those estimates.

Concentrations of Credit Risk and Other Risks and Uncertainties

For the six months ended June 30, 2018 and 2017, approximately 45% and 28%, respectively, of total revenue was derived from Medicare. No other payers or customers represented more than 10% of total revenue for these periods.

At June 30, 2018 and December 31, 2017, approximately 24% and 16%, respectively, of accounts receivable was due from Medicare.  No other payer or customer represented more than 10% of accounts receivable on either June 30, 2018 or December 31, 2017.

Restricted Cash

A restricted cash balance of $9.4 million was released upon the full conversion of the debt obligation to JGB Collateral LLC and certain of its affiliates (“JGB”) (refer to Note 10) during the three months ended March 31, 2018 and is no longer classified as 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

8


 

used to support these arrangements is classified as long-term restricted cash on the accompanying condensed consolidated balance sheets.

Common Stock Warrant Liability and Derivative Liability

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). The warrant issued to Perceptive (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.

Derivative Liability

The convertible debt financing with JGB (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 liability in the condensed 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 liability in the condensed 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 provision. This embedded derivative fair value of $0.2 million was recorded as debt issuance discount. Refer to Note 10 for additional details.  The derivative is remeasured at the end of each reporting period if debt remains outstanding with changes recorded in change in estimated fair value of common stock warrant liability and derivative liability in the condensed consolidated statements of operations.

Revenue

The Company recognizes 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

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 Accounting Standards Codifications (“ASC”) Topic 606, 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.

The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates.

9


 

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 three or six months ended June 30, 2018 or 2017.

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 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 for tests performed are recognized in the same period. Royalties for licensed technology, calculated as a percentage of test revenues, are recorded as license fees in cost of testing services at the time the test revenues are recognized.

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 retained earnings 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. 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 June 30, 2018 (in thousands):

 

 

Balance as Reported

 

 

Balance without the adoption of ASC 606

 

 

Impact of Adoption of ASC 606

 

Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

Accounts Receivable

 

$

8,072

 

 

$

4,564

 

 

$

3,508

 

The following table summarizes the impact to the statement of operations in accordance with the new revenue standard requirements for the three and six months ended June 30, 2018 (in thousands):

10


 

 

 

Three Months Ended June 30, 2018

 

 

 

Balance As Reported

 

 

Balance without the adoption of ASC 606

 

 

Revenue Impact of adoption of ASC 606

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Testing revenue

 

$

13,997

 

 

$

13,484

 

 

$

513

 

Product revenue

 

 

3,550

 

 

 

3,550

 

 

 

 

License and other revenue

 

 

276

 

 

 

276

 

 

 

 

 

 

$

17,823

 

 

$

17,310

 

 

$

513

 

 

 

 

Six Months Ended June 30, 2018

 

 

 

Balance As Reported

 

 

Balance without the adoption of ASC 606

 

 

Revenue Impact of adoption of ASC 606

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Testing revenue

 

$

24,601

 

 

$

24,076

 

 

$

525

 

Product revenue

 

 

6,857

 

 

 

6,857

 

 

 

 

License and other revenue

 

 

418

 

 

 

418

 

 

 

 

 

 

$

31,876

 

 

$

31,351

 

 

$

525

 

In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (Topic 842), which, for operating leases, requires the lessee to recognize a right-of-use 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 the practical expedient and recognize a cumulative-effect adjustment to the opening balance of the retained earnings.  The Company has created an implementation plan and is in the early stages of assessing the impact of the guidance on its consolidated financial statements.  

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 condensed 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 condensed 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 condensed 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).  

11


 

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”).  The Company is still reviewing the Tax Act and its impact to the condensed consolidated financial statements. 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.

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 and does not expect the adoption to have a material impact to the condensed consolidated financial statements.      

 

 

3. NET LOSS PER SHARE

Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive.

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):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to CareDx, Inc. used to compute basic

  and diluted net loss per share

 

$

(14,062

)

 

$

(3,968

)

 

$

(23,031

)

 

$

(9,530

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used to compute basic and diluted

   net loss per share attributable to CareDx, Inc.

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

Net loss per share attributable to CareDx, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

The following potentially dilutive securities have been excluded from diluted net loss per share, because their effect would be antidilutive:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Shares of common stock subject to outstanding options

 

 

2,561,458

 

 

 

1,898,389

 

 

 

2,561,458

 

 

 

1,898,389

 

Shares of common stock subject to outstanding common

   stock warrants

 

 

3,328,089

 

 

 

4,509,926

 

 

 

3,328,089

 

 

 

4,509,926

 

Shares of common stock subject to convertible notes

 

 

 

 

 

6,092,105

 

 

 

 

 

 

6,092,105

 

Shares of common stock subject to contingent consideration

 

 

 

 

 

227,845

 

 

 

 

 

 

227,845

 

Restricted stock units

 

 

896,904

 

 

 

353,807

 

 

 

896,904

 

 

 

353,807

 

Total common stock equivalents

 

 

6,786,451

 

 

 

13,082,072

 

 

 

6,786,451

 

 

 

13,082,072

 

 

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 subject to convertible notes 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; therefore, the Company issued 227,845 shares of common stock to the former owners of ImmuMetrix, Inc. (“IMX”) that was previously considered contingent consideration.  

The Perceptive Credit Agreement includes a Tranche B loan of $10.0 million available at the Company’s option at any time from April 17, 2018 to April 17, 2019 (the “Tranche B Term Loan”). If the Tranche B Term Loan is funded, the Company will issue to Perceptive an additional warrant to purchase up to 93,333 shares of common stock.

 

 

 

12


 

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 which include quoted prices in active markets for identical assets and liabilities.

 

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table sets forth the Company’s financial assets and liabilities measured at fair value on a recurring basis, as of June 30, 2018 and December 31, 2017 (in thousands):

 

 

 

June 30, 2018

 

 

 

Fair Value Measured Using

 

 

 

 

 

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

 

Total

Balance

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,958

 

 

$

 

 

$

 

 

$

12,958

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock warrant liability

 

 

 

 

 

 

 

 

16,800

 

 

 

16,800

 

Perceptive derivative liability

 

 

 

 

 

 

 

 

235

 

 

 

235

 

Total liabilities

 

$

 

 

$

 

 

$

17,035

 

 

$

17,035

 

 

 

 

December 31, 2017

 

 

 

Fair Value Measured Using

 

 

 

 

 

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

 

Total

Balance

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

13,097

 

 

$

 

 

$

 

 

$

13,097

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

 

 

$

 

 

$

1,672

 

 

$

1,672

 

Common stock warrant liability

 

 

 

 

 

 

 

 

18,712

 

 

 

18,712

 

JGB derivative liability

 

 

 

 

 

 

 

 

14,600

 

 

 

14,600

 

Total liabilities

 

$

 

 

$

 

 

$

34,984

 

 

$

34,984

 

The following table presents the issuances, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):

 

 

 

(Level 3)

 

 

 

Contingent

Consideration

Liability

 

 

Common Stock Warrant Liability

 

 

JGB Derivative

Liability

 

 

Perceptive Derivative Liability

 

 

Total

 

Balance as of December 31, 2017

 

$

1,672

 

 

$

18,712

 

 

$

14,600

 

 

 

 

 

$

34,984

 

Exercise of warrants

 

 

 

 

 

(127

)

 

 

 

 

 

 

 

 

(127

)

Conversion of JGB debt to common stock (Note 10)

 

 

 

 

 

 

 

 

(12,066

)

 

 

 

 

 

(12,066

)

Reclassification to equity (Note 2)

 

 

 

 

 

(6,550

)

 

 

 

 

 

 

 

 

(6,550

)

Issuance of Perceptive derivative liability

 

 

 

 

 

 

 

 

 

 

 

235

 

 

 

235

 

Change in estimated fair value

 

 

(1,672

)

 

 

4,765

 

 

 

(2,534

)

 

 

 

 

 

559

 

Balance as of June 30, 2018

 

$

-

 

 

$

16,800

 

 

$

 

 

$

235

 

 

$

17,035

 

 

13


 

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 June 30, 2018 and December 31, 2017, money market funds were included on the balance sheets in cash and cash equivalents.

 

Perceptive Credit Agreement - The Company has recorded its debt with Perceptive at carrying value.  The fair value is consistent with its carry value of $13.3 million as of June 30, 2018.