CareDx Reports Fourth Quarter and FY2017 Financial Results
47 Transplantation Centers Offering AlloSure
9 Centers Enrolled in K-OAR
Recent highlights:
- AlloSure commercially launched on
October 9, 2017
-- As ofFebruary 28, 2018 , 47 U.S. transplant centers providing AlloSure testing to patients
-- Continued progress in Kidney Allograft Outcomes AlloSure Registry (K-OAR) enrollment, with 9 centers initiated as clinical trial sites as ofFebruary 28, 2018 - Achieved total revenue for the fourth quarter 2017 of
$12.5 million
-- AlloSure® testing revenue of$0.5 million , representing 282 test results provided to kidney transplant patients
-- AlloMap® testing revenue of$8.1 million , with fourth quarter US test volume increasing 8% year-over-year to 3,840 tests
-- Product revenue of$3.7 million - Revenue for the full year ended
December 31, 2017 was$48.3 million , an increase of 19% year-over-year - Announced refinancing of debt with
Perceptive Advisors , to be completed inApril 2018
“The initial AlloSure interest and traction we experienced in the fourth quarter of 2017 continues in 2018,” said
Maag added, “We believe our new and simplified capital structure positions
Fourth Quarter 2017 Financial Results
Revenue for the three months ended
For the fourth quarter of 2017, the net loss was
Non-GAAP net loss was
Cash and cash equivalents were
Full Year 2017 Financial Results
Revenue for the full year ended
Net loss for the full year ended
Non-GAAP net loss was
For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP financial Measures” and “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
2018 Guidance
For the full year 2018,
About
For more information, please visit: www.CareDx.com.
Forward Looking Statements
This press release includes forward-looking statements, including expectations regarding the Company’s fiscal 2018 revenue, timing for profitability, achievement of our financial and operational goals and prospects. These forward-looking statements are based upon information that is currently available to
Use of Non-GAAP Financial Measures
CONTACTS:
Chief Commercial Officer
415-287-2393
sking@caredx.com
Investor Relations
Integrated Corporate Relations, Inc.
646-277-1266
david.clair@icrinc.com
CareDx, Inc. | ||||||||||||||||
Consolidated Statements of Operations | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2017 | 2016 | 2017 (1) | 2016 (1) | |||||||||||||
Revenue: | ||||||||||||||||
Testing revenue | $ | 8,621 | $ | 7,363 | $ | 33,106 | $ | 29,680 | ||||||||
Product revenue | 3,718 | 3,487 | 14,634 | 10,715 | ||||||||||||
Collaboration and license revenue | 164 | 10 | 584 | 236 | ||||||||||||
Total revenue | 12,503 | 10,860 | 48,324 | 40,631 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of testing | 3,121 | 2,654 | 12,345 | 10,882 | ||||||||||||
Cost of product | 2,468 | 3,829 | 9,026 | 10,240 | ||||||||||||
Research and development | 3,028 | 3,154 | 12,388 | 12,385 | ||||||||||||
Sales and marketing | 3,061 | 2,622 | 12,808 | 11,166 | ||||||||||||
General and administrative | 4,241 | 4,475 | 18,913 | 20,725 | ||||||||||||
Goodwill impairment | - | 13,021 | 1,958 | 13,021 | ||||||||||||
Change in estimated fair value of contingent consideration | 871 | (34 | ) | 1,180 | (456 | ) | ||||||||||
Total operating expenses | 16,790 | 29,721 | 68,618 | 77,963 | ||||||||||||
Loss from operations | (4,287 | ) | (18,861 | ) | (20,294 | ) | (37,332 | ) | ||||||||
Interest expense | (1,697 | ) | (509 | ) | (5,863 | ) | (1,860 | ) | ||||||||
Other (expense) income, net | (299 | ) | 1,414 | (1,490 | ) | (1,920 | ) | |||||||||
Change in estimated fair value of common stock warrant liability and derivative liability | (26,218 | ) | 1,529 | (29,622 | ) | (250 | ) | |||||||||
Loss before income taxes | (32,501 | ) | (16,427 | ) | (57,269 | ) | (41,362 | ) | ||||||||
Income tax benefit | 872 | 718 | 1,709 | 1,606 | ||||||||||||
Net loss | (31,629 | ) | (15,709 | ) | (55,560 | ) | (39,756 | ) | ||||||||
Net loss attributable to noncontrolling interest | 42 | (229 | ) | (91 | ) | (287 | ) | |||||||||
Net loss attributable to CareDx, Inc. | $ | (31,671 | ) | $ | (15,480 | ) | $ | (55,469 | ) | $ | (39,469 | ) | ||||
Net loss per share attributable to CareDx, Inc.: | ||||||||||||||||
Basic | $ | (1.13 | ) | $ | (0.73 | ) | $ | (2.38 | ) | $ | (2.39 | ) | ||||
Diluted | $ | (1.13 | ) | $ | (0.73 | ) | $ | (2.38 | ) | $ | (2.39 | ) | ||||
Weighted average shares used to compute net loss per share attributable to CareDx, Inc.: |
||||||||||||||||
Basic | 27,983,033 | 21,270,151 | 23,332,503 | 16,496,911 | ||||||||||||
Diluted | 27,983,033 | 21,270,151 | 23,332,503 | 16,496,911 | ||||||||||||
(1) The Consolidated Statements of Operations for the twelve months ended December 31, 2017 and December 31, 2016 have been derived from audited financial statements. | ||||||||||||||||
CareDx, Inc. | ||||||||||
Condensed Consolidated Balance Sheets | ||||||||||
(In thousands) | ||||||||||
December 31, 2017 (1) | December 31, 2016 (1) | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 16,895 | $ | 17,258 | ||||||
Accounts receivable | 2,991 | 2,768 | ||||||||
Inventory | 5,529 | 5,461 | ||||||||
Prepaid and other assets | 1,352 | 1,186 | ||||||||
Total current assets | 26,767 | 26,673 | ||||||||
Property and equipment, net | 2,075 | 2,931 | ||||||||
Intangible assets, net | 33,139 | 33,124 | ||||||||
Goodwill | 12,005 | 13,839 | ||||||||
Restricted cash | 9,579 | 143 | ||||||||
Other assets | - | 20 | ||||||||
Total assets | $ | 83,565 | $ | 76,730 | ||||||
Liabilities and stockholders’ (deficit) equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 3,391 | $ | 3,065 | ||||||
Accrued payroll liabilities | 5,013 | 3,851 | ||||||||
Accrued and other liabilities | 3,735 | 5,320 | ||||||||
Accrued royalties | - | 263 | ||||||||
Deferred revenue | 39 | 42 | ||||||||
Deferred purchase consideration | 407 | 5,445 | ||||||||
Derivative liability | 14,600 | - | ||||||||
Current debt | 15,721 | 22,846 | ||||||||
Total current liabilities | 42,906 | 40,832 | ||||||||
Deferred rent, net of current portion | 913 | 1,301 | ||||||||
Deferred revenue, net of current portion | 730 | 759 | ||||||||
Deferred tax liability | 4,933 | 6,057 | ||||||||
Long-term debt, net of current portion | 18,338 | 1,098 | ||||||||
Contingent consideration | 1,672 | 492 | ||||||||
Common stock warrant liability | 18,712 | 5,208 | ||||||||
Other liabilities | 1,315 | 1,222 | ||||||||
Total liabilities | 89,519 | 56,969 | ||||||||
Stockholders’ equity: | ||||||||||
Common stock | 29 | 21 | ||||||||
Additional paid-in capital | 264,204 | 235,673 | ||||||||
Accumulated other comprehensive loss | (2,345 | ) | (3,659 | ) | ||||||
Accumulated deficit | (268,022 | ) | (212,553 | ) | ||||||
Total CareDx, Inc. stockholders' (deficit) equity | (6,134 | ) | 19,482 | |||||||
Noncontrolling interest | 180 | 279 | ||||||||
Total stockholders' (deficit) equity | (5,954 | ) | 19,761 | |||||||
Total liabilities and stockholders’ (deficit) equity | $ | 83,565 | $ | 76,730 | ||||||
(1) The condensed balance sheets at December 31, 2017 and December 31, 2016 have been derived from audited financial statements. | ||||||||||
CareDx, Inc. | ||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||||||||
(Unaudited) | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Cost of testing reconciliation: | ||||||||||||||||
GAAP cost of testing | $ | 3,121 | $ | 2,654 | $ | 12,345 | $ | 10,882 | ||||||||
Stock-based compensation expense | (31 | ) | (40 | ) | (188 | ) | (144 | ) | ||||||||
Non-GAAP cost of testing | $ | 3,090 | $ | 2,614 | $ | 12,157 | $ | 10,738 | ||||||||
Cost of product reconciliation: | ||||||||||||||||
GAAP cost of product | $ | 2,468 | $ | 3,829 | $ | 9,026 | $ | 10,240 | ||||||||
Acquisition related-amortization of purchased intangibles | (373 | ) | (393 | ) | (1,466 | ) | (1,040 | ) | ||||||||
Acquisition related-amortization of inventory valuation adjustment | (89 | ) | (1,427 | ) | (509 | ) | (3,926 | ) | ||||||||
Non-GAAP cost of product | $ | 2,006 | $ | 2,009 | $ | 7,051 | $ | 5,274 | ||||||||
Research and development expenses reconciliation: | ||||||||||||||||
GAAP research and development expenses | $ | 3,028 | $ | 3,154 | $ | 12,388 | $ | 12,385 | ||||||||
Stock-based compensation expense | (126 | ) | (115 | ) | (405 | ) | (437 | ) | ||||||||
Non-GAAP research and development expenses | $ | 2,902 | $ | 3,039 | $ | 11,983 | $ | 11,948 | ||||||||
Sales and marketing expenses reconciliation: | ||||||||||||||||
GAAP sales and marketing expenses | $ | 3,061 | $ | 2,622 | $ | 12,808 | $ | 11,166 | ||||||||
Acquisition related-amortization of purchased intangibles | (248 | ) | (228 | ) | (967 | ) | (681 | ) | ||||||||
Stock-based compensation expense | (30 | ) | (33 | ) | (157 | ) | (151 | ) | ||||||||
Non-GAAP sales and marketing expenses | $ | 2,783 | $ | 2,361 | $ | 11,684 | $ | 10,334 | ||||||||
General and administrative expenses reconciliation: | ||||||||||||||||
GAAP general and administrative expenses | $ | 4,241 | $ | 4,475 | $ | 18,913 | $ | 20,725 | ||||||||
Acquisition related fees and expenses | — | (135 | ) | — | (4,433 | ) | ||||||||||
Stock-based compensation expense | (241 | ) | (277 | ) | (994 | ) | (1,213 | ) | ||||||||
Non-GAAP general and administrative expenses | $ | 4,000 | $ | 4,063 | $ | 17,919 | $ | 15,079 | ||||||||
Goodwill impairment reconciliation: | ||||||||||||||||
GAAP goodwill impairment | $ | — | $ | 13,021 | $ | 1,958 | $ | 13,021 | ||||||||
Goodwill impairment | — | (13,021 | ) | (1,958 | ) | (13,021 | ) | |||||||||
Non-GAAP goodwill impairment | $ | — | $ | — | $ | — | $ | — | ||||||||
Change in estimated fair value of contingent consideration reconciliation: | ||||||||||||||||
GAAP change in estimated fair value of contingent consideration | $ | 871 | $ | (34 | ) | $ | 1,180 | $ | (456 | ) | ||||||
Change in estimated fair value of contingent consideration | (871 | ) | 34 | (1,180 | ) | 456 | ||||||||||
Non-GAAP change in estimated fair value of contingent consideration | $ | — | $ | — | $ | — | $ | — | ||||||||
Interest expense reconciliation: | ||||||||||||||||
GAAP interest expense | $ | (1,697 | ) | $ | (509 | ) | $ | (5,863 | ) | $ | (1,860 | ) | ||||
Amortization of debt discount | 731 | 40 | 2,098 | 167 | ||||||||||||
Non-GAAP interest expense | $ | (966 | ) | $ | (469 | ) | $ | (3,765 | ) | $ | (1,693 | ) | ||||
Other expense, net reconciliation: | ||||||||||||||||
GAAP other expense, net | $ | (299 | ) | $ | 1,414 | $ | (1,490 | ) | $ | (1,920 | ) | |||||
Debt financing related fees and expenses | — | (785 | ) | 309 | 2,154 | |||||||||||
Loss on conversion from debt to equity | 278 | — | 278 | — | ||||||||||||
Non-GAAP other expense, net | $ | (21 | ) | $ | 629 | $ | (903 | ) | $ | 234 | ||||||
Change in estimated fair value of common stock warrant and derivative liabilities reconciliation: | ||||||||||||||||
GAAP change in estimated fair value of common stock warrant and derivative liabilities | $ | (26,218 | ) | $ | 1,529 | $ | (29,622 | ) | $ | (250 | ) | |||||
Change in estimated fair value of common stock warrant and derivative liabilities reconciliation: | 26,218 | (1,529 | ) | 29,622 | 250 | |||||||||||
Non-GAAP change in estimated fair value of common stock warrant and derivative liabilities | $ | — | $ | — | $ | — | $ | — | ||||||||
Income tax benefit reconciliation: | ||||||||||||||||
GAAP income tax benefit | $ | 872 | $ | 718 | $ | 1,709 | $ | 1,606 | ||||||||
Tax effect related to amortization of purchased intangibles | (200 | ) | (551 | ) | (735 | ) | (1,442 | ) | ||||||||
Non-GAAP income tax benefit | $ | 672 | $ | 167 | $ | 974 | $ | 164 | ||||||||
Net loss reconciliation: | ||||||||||||||||
GAAP net loss attributable to CareDx, Inc. | $ | (31,671 | ) | $ | (15,480 | ) | $ | (55,469 | ) | $ | (39,469 | ) | ||||
Acquisition related-amortization of purchased intangibles | 621 | 621 | 2,433 | 1,721 | ||||||||||||
Acquisition related-amortization of inventory valuation adjustment | 89 | 1,427 | 509 | 3,926 | ||||||||||||
Tax effect related to amortization of purchased intangibles | (200 | ) | (551 | ) | (735 | ) | (1,442 | ) | ||||||||
Acquisition related fees and expenses | — | 135 | — | 4,433 | ||||||||||||
Debt financing related fees and expenses | — | (785 | ) | 309 | 2,154 | |||||||||||
Amortization of debt discount | 731 | 40 | 2,098 | 167 | ||||||||||||
Loss on conversion from debt to equity | 278 | — | 278 | — | ||||||||||||
Stock-based compensation expenses | 428 | 465 | 1,744 | 1,945 | ||||||||||||
Goodwill impairment | — | 13,021 | 1,958 | 13,021 | ||||||||||||
Change in estimated fair value of contingent consideration | 871 | (34 | ) | 1,180 | (456 | ) | ||||||||||
Change in estimated fair value of common stock warrant liability and derivative liability | 26,218 | (1,529 | ) | 29,622 | 250 | |||||||||||
Non-GAAP net loss | $ | (2,635 | ) | $ | (2,670 | ) | $ | (16,073 | ) | $ | (13,750 | ) | ||||
Basic and diluted net loss per share reconciliation: | ||||||||||||||||
GAAP basic and diluted net loss per share attributable to CareDx | $ | (1.13 | ) | $ | (0.73 | ) | $ | (2.38 | ) | $ | (2.39 | ) | ||||
Acquisition related-amortization of purchased intangibles | 0.02 | 0.03 | 0.10 | 0.10 | ||||||||||||
Acquisition related-amortization of inventory valuation adjustment | 0.00 | 0.07 | 0.02 | 0.24 | ||||||||||||
Tax effect related to amortization purchased intangibles | (0.01 | ) | (0.03 | ) | (0.03 | ) | (0.09 | ) | ||||||||
Acquisition related fees and expenses | - | 0.01 | - | 0.27 | ||||||||||||
Debt financing related fees and expenses | - | (0.04 | ) | 0.01 | 0.13 | |||||||||||
Amortization of debt discount | 0.03 | 0.00 | 0.09 | 0.01 | ||||||||||||
Loss on conversion from debt to equity | 0.01 | - | 0.01 | - | ||||||||||||
Stock-based compensation expenses | 0.02 | 0.02 | 0.07 | 0.12 | ||||||||||||
Goodwill impairment | - | 0.61 | 0.08 | 0.79 | ||||||||||||
Change in estimated fair value of contingent consideration | 0.03 | (0.00 | ) | 0.05 | (0.03 | ) | ||||||||||
Change in estimated fair value of common stock warrant and derivative liabilities | 0.94 | (0.07 | ) | 1.27 | 0.02 | |||||||||||
Non-GAAP basic net loss per share attributable to CareDx | $ | (0.09 | ) | $ | (0.13 | ) | $ | (0.69 | ) | $ | (0.83 | ) | ||||
Non-GAAP diluted net loss per share attributable to CareDx | $ | (0.09 | ) | $ | (0.13 | ) | $ | (0.69 | ) | $ | (0.83 | ) | ||||
Non-GAAP adjustment summary: | ||||||||||||||||
Cost of testing | $ | 31 | $ | 40 | $ | 188 | $ | 144 | ||||||||
Cost of product | 462 | 1,820 | 1,975 | 4,966 | ||||||||||||
Research and development | 126 | 115 | 405 | 437 | ||||||||||||
Sales and marketing | 278 | 261 | 1,124 | 832 | ||||||||||||
General and administrative | 241 | 412 | 994 | 5,646 | ||||||||||||
Goodwill impairment | — | 13,021 | 1,958 | 13,021 | ||||||||||||
Change in estimated fair value of contingent consideration | 871 | (34 | ) | 1,180 | (456 | ) | ||||||||||
Interest expense, net | 731 | 40 | 2,098 | 167 | ||||||||||||
Other (expense) income, net | 278 | (785 | ) | 587 | 2,154 | |||||||||||
Change in estimated fair value of common stock warrant and derivative liabilities | 26,218 | (1,529 | ) | 29,622 | 250 | |||||||||||
Tax effect related to amortization of purchased intangibles | (200 | ) | (551 | ) | (735 | ) | (1,442 | ) | ||||||||
Total Non-GAAP adjustment summary: | $ | 29,036 | $ | 12,810 | $ | 39,396 | $ | 25,719 | ||||||||
Source: CareDx, Inc.