CareDx Reports Second Quarter Results
AlloSure launch momentum drives 48% revenue growth
Recent highlights:
- Accelerated AlloSure penetration in key kidney transplant centers
- Less than 9 months into AlloSure launch,
CareDx supports approximately 1% of the U.S. living kidney transplant patient population - As of
June 30, 2018 , 76 U.S. transplant centers have provided AlloSure testing - Continued progress in AlloSure Registry (K-OAR) enrollment, with 27 centers initiated as of
June 30, 2018 and 237 K-OAR patients enrolled - Notable presence at the 2018
American Transplant Congress including a standing room only symposium on clinical experiences with AlloSure
- Less than 9 months into AlloSure launch,
- Achieved total revenue of
$17.8 million for the second quarter of 2018, increasing 48% year-over-year- Testing services revenue of
$14.0 million , with 2,300 AlloSure and 4,132 AlloMap patient results provided - Product revenue of
$3.6 million .
- Testing services revenue of
- Broadened testing services and product offerings
- Entered into partnership with
Illumina to develop and sell Next Generation Sequencing transplant products - Launched HeartCare, a comprehensive diagnostic solution for surveillance of heart transplant patients, combining AlloMap with AlloSure-Heart
- Validated Olerup QTYPE on multiple platforms and received CE mark certification
- Entered into partnership with
- Announced the addition of
Amy Abernethy , MD, PhD, Flatiron Health’s Chief Medical Officer and Chief Science Officer, to our Board of Directors.
“The CareDx team delivered a record quarter, including 48% year-over-year revenue growth. The rapid clinical adoption of AlloSure demonstrates the medical need and the potential for better surveillance in this patient population. We are executing well on our strategy to focus on peer-reviewed published clinical and analytical validation data and
Second Quarter 2018 Financial Results
Revenue for the three months ended
For the second quarter of 2018, the net loss was
Non-GAAP net loss was
Adjusted EBITDA for the second quarter of 2018 was a loss of
Net cash used in operating activities in the second quarter of 2018 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 adjusted EBITDA profitability and 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 | ||||||||||||||||
(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 | ||||||||||||
Collaboration and license 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.: | ||||||||||||||||
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 | ||||||||||||
CareDx, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(In thousands) | ||||||||
June 30, 2018 | December 31, 2017 (1) | |||||||
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’ (deficit) 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 | ||||||
Stockholders’ equity: | ||||||||
Common stock | 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 | ||||
(1) The condensed balance sheets at December 31, 2017 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 June 30, | Six Months Ended June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net loss | $ | (14,062 | ) | $ | (3,968 | ) | $ | (23,031 | ) | $ | (9,530 | ) | ||||
Stock-based compensation expense | 2,512 | 495 | 3,217 | 886 | ||||||||||||
Acquisition related-amortization of purchased intangibles | 734 | 587 | 1,498 | 1,175 | ||||||||||||
Change in estimated fair value of contingent consideration | 873 | (64 | ) | 1,017 | (285 | ) | ||||||||||
Amortization of debt discount | 55 | 606 | 1,978 | 717 | ||||||||||||
Debt financing related fees and expenses | - | (125 | ) | - | 309 | |||||||||||
Loss on conversion from debt to equity | - | - | 2,806 | - | ||||||||||||
Change in estimated fair value of common stock warrant and derivative liabilities | 8,768 | (1,067 | ) | 7,447 | (5,195 | ) | ||||||||||
Tax effect related to amortization of purchased intangibles | (190 | ) | (181 | ) | (422 | ) | (336 | ) | ||||||||
Acquisition related-amortization of inventory valuation adjustment | 25 | 138 | 189 | 170 | ||||||||||||
Goodwill impairment | - | - | - | 1,958 | ||||||||||||
Non-GAAP net loss | $ | (1,285 | ) | $ | (3,579 | ) | $ | (5,301 | ) | $ | (10,131 | ) | ||||
GAAP basic and diluted net loss per share attributable to CareDx | $ | (0.40 | ) | $ | (0.19 | ) | $ | (0.71 | ) | $ | (0.45 | ) | ||||
Non-GAAP basic and diluted net loss per share attributable to CareDx | $ | (0.04 | ) | $ | (0.17 | ) | $ | (0.16 | ) | $ | (0.47 | ) | ||||
Shares used in computing basic and diluted not losses per share | 35,549,837 | 21,412,480 | 32,599,032 | 21,378,321 | ||||||||||||
CareDx, Inc. | ||||||||||||||||
Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures | ||||||||||||||||
(Unaudited) | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Non-GAAP net loss | $ | (1,285 | ) | $ | (3,579 | ) | $ | (5,301 | ) | $ | (10,131 | ) | ||||
Interest expense | 369 | 1,085 | 1,141 | 1,764 | ||||||||||||
Income tax benefit | (191 | ) | (195 | ) | (383 | ) | (323 | ) | ||||||||
Depreciation expense | 248 | 300 | 526 | 646 | ||||||||||||
Other expense | 42 | 313 | 45 | 565 | ||||||||||||
Net loss attributable to noncontrolling interest | - | (67 | ) | (25 | ) | (114 | ) | |||||||||
Adjusted EBITDA | $ | (817 | ) | $ | (2,143 | ) | $ | (3,997 | ) | $ | (7,593 | ) | ||||
Source: CareDx, Inc.