SOUTH SAN FRANCISCO, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today reported financial results for the quarter ended June 30, 2020.
Second Quarter 2020 and Recent Highlights:
- Achieved total revenue of $41.8 million for the three months ended June 30, 2020, increasing 33% year-over-year
- Provided over 17,100 AlloSure Kidney and AlloMap Heart patient results, with over 40% originating from RemoTraC and mobile phlebotomy
- Recorded first-ever AlloCell revenue from a cell therapy partnership
- Completed successful public offering raising $134.6 million in net proceeds, increasing cash and cash equivalents to $211.4 million
“Throughout this challenging time, our team at CareDx successfully executed across our initiatives and never wavered from our commitment to improving the lives of transplant patients. Our performance in the second quarter, highlighted by strong growth and robust results from RemoTraC, is a testament to our patient-focus and dedication,” said Peter Maag, CareDx Chairman and Chief Executive Officer. “As we look to the second half of this year, while uncertainty continues, what remains clear is the dedication of our team, our ability to navigate through this time and our confidence to be able to continue to deliver durable long-term operational growth.”
Second Quarter 2020 Financial Results
Revenue for the three months ended June 30, 2020 was $41.8 million, compared with $31.5 million in the second quarter of 2019. Testing services revenue for the second quarter was $36.3 million, compared with $25.7 million in the same period of 2019. Product revenue in the three months ended June 30, 2020 was $3.3 million, compared to $4.6 million in the same period of 2019. Digital and other revenue for the second quarter 2020 was $2.2 million, compared to $1.2 million in the same period of 2019.
For the second quarter of 2020, the net loss was $6.6 million compared to a net loss of $7.8 million in the same period of 2019. Diluted net loss per share was $0.15 in the second quarter of 2020, compared to a diluted net loss per share of $0.19 in the second quarter of 2019.
Non-GAAP net income was $1.7 million in the second quarter of 2020 compared to $0.1 million non-GAAP net loss in the second quarter of 2019. Diluted non-GAAP net income per share was $0.04 in the second quarter of 2020, compared to a diluted non-GAAP net loss per share of $0.00 in the second quarter of 2019.
Adjusted EBITDA for the second quarter of 2020 was a loss of $2.8 million, compared to an adjusted EBITDA gain of $0.1 million in the second quarter of 2019.
Cash and cash equivalents were $211.4 million as of June 30, 2020.
For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Financial Measures,” and “Reconciliation of GAAP to Non-GAAP Adjusted EBITDA Financial Measures” below.
2020 Guidance
While CareDx experienced improved trends in the second quarter, due to the continued uncertainties with respect to the COVID-19 pandemic, CareDx will not be providing guidance at this time.
About CareDx
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
Forward-Looking Statements
This press release includes forward-looking statements, including expectations regarding the achievement of our financial and operational goals and our prospects. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including general economic and market factors, among others discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed by CareDx with the SEC on February 28, 2020, and the periodic reports that CareDx has subsequently filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Use of Non-GAAP Financial Measures
CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP net income, non-GAAP basic and diluted net income per share and adjusted EBITDA. We define non-GAAP net income and per share results as the GAAP net income and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of warrants, derivative liabilities and contingent consideration; acquisition related impairment charges and amortization of intangible assets, purchase accounting adjustments and related tax effects; costs involved with completing an acquisition; amortization of debt discount; and certain other financing charges. We define adjusted EBITDA as non-GAAP net income/(loss) before net interest expense, income tax expense, depreciation and amortization, and other income and expense. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx's operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly-titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables.
Investor Relations Contact
Greg Chodaczek
347-620-7010
investor@caredx.com
| 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, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Testing services revenue | $ | 36,293 | $ | 25,677 | $ | 67,735 | $ | 47,195 | ||||||||
| Product revenue | 3,291 | 4,593 | 7,986 | 9,026 | ||||||||||||
| Digital and other revenue | 2,217 | 1,184 | 4,460 | 1,215 | ||||||||||||
| Total revenue | 41,801 | 31,454 | 80,181 | 57,436 | ||||||||||||
| Cost of revenue | 15,025 | 11,512 | 27,417 | 21,245 | ||||||||||||
| Gross profit | 26,776 | 19,942 | 52,764 | 36,191 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 13,129 | 7,630 | 23,142 | 13,244 | ||||||||||||
| Sales and marketing | 12,134 | 10,644 | 23,857 | 17,569 | ||||||||||||
| General and administrative | 12,316 | 8,512 | 22,319 | 17,618 | ||||||||||||
| Total operating expenses | 37,579 | 26,786 | 69,318 | 48,431 | ||||||||||||
| Loss from operations | (10,803 | ) | (6,844 | ) | (16,554 | ) | (12,240 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 21 | 300 | 117 | 642 | ||||||||||||
| Change in estimated fair value of common stock warrant liability | (664 | ) | (1,351 | ) | (1,069 | ) | (4,360 | ) | ||||||||
| CARES Act Provider Relief Fund | 4,813 | — | 4,813 | — | ||||||||||||
| Other expense, net | (255 | ) | (172 | ) | (318 | ) | (246 | ) | ||||||||
| Total other income (expense) | 3,915 | (1,223 | ) | 3,543 | (3,964 | ) | ||||||||||
| Loss before income taxes | (6,888 | ) | (8,067 | ) | (13,011 | ) | (16,204 | ) | ||||||||
| Income tax benefit | 330 | 220 | 630 | 826 | ||||||||||||
| Net loss | $ | (6,558 | ) | $ | (7,847 | ) | $ | (12,381 | ) | $ | (15,378 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.15 | ) | $ | (0.19 | ) | $ | (0.28 | ) | $ | (0.37 | ) | ||||
| Diluted | $ | (0.15 | ) | $ | (0.19 | ) | $ | (0.28 | ) | $ | (0.37 | ) | ||||
| Weighted-average shares used to compute net loss per share: | ||||||||||||||||
| Basic | 44,708,037 | 42,132,396 | 43,765,732 | 41,873,337 | ||||||||||||
| Diluted | 44,708,037 | 42,132,396 | 43,765,732 | 41,873,337 | ||||||||||||
| CareDx, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) | |||||||
| June 30, 2020 | December 31, 2019 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 211,409 | $ | 38,223 | |||
| Accounts receivable | 27,111 | 24,057 | |||||
| Inventory | 8,741 | 6,014 | |||||
| Prepaid and other current assets | 4,286 | 3,628 | |||||
| Total current assets | 251,547 | 71,922 | |||||
| Property and equipment, net | 7,313 | 4,430 | |||||
| Operating leases right-of-use assets | 16,416 | 4,730 | |||||
| Intangible assets, net | 44,356 | 45,541 | |||||
| Goodwill | 23,857 | 23,857 | |||||
| Restricted cash | 253 | 256 | |||||
| Other assets | 1,000 | 1,000 | |||||
| Total assets | $ | 344,742 | $ | 151,736 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 8,675 | $ | 5,506 | |||
| Accrued compensation | 11,089 | 12,484 | |||||
| Accrued and other liabilities | 16,682 | 16,838 | |||||
| Deferred revenue - CMS advance payment | 20,496 | — | |||||
| Total current liabilities | 56,942 | 34,828 | |||||
| Deferred tax liability | 1,313 | 1,973 | |||||
| Common stock warrant liability | 1,681 | 6,607 | |||||
| Deferred payments for intangible assets | 5,400 | 5,207 | |||||
| Operating lease liability, less current portion | 17,025 | 2,370 | |||||
| Other liabilities | 1,614 | 1,751 | |||||
| Total liabilities | 83,975 | 52,736 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock | 47 | 42 | |||||
| Additional paid-in capital | 612,228 | 437,976 | |||||
| Accumulated other comprehensive loss | (5,314 | ) | (5,205 | ) | |||
| Accumulated deficit | (346,194 | ) | (333,813 | ) | |||
| Total stockholders’ equity | 260,767 | 99,000 | |||||
| Total liabilities and stockholders’ equity | $ | 344,742 | $ | 151,736 | |||
| 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, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Net loss per share | $ | (6,558 | ) | $ | (7,847 | ) | $ | (12,381 | ) | $ | (15,378 | ) | |||
| Stock-based compensation expense | 6,417 | 4,992 | 10,676 | 11,045 | |||||||||||
| Acquisition related-amortization of purchased intangibles | 1,160 | 822 | 2,309 | 1,576 | |||||||||||
| Acquisition related fees and expenses | — | 568 | — | 568 | |||||||||||
| Change in estimated fair value of contingent consideration | 76 | — | 266 | — | |||||||||||
| Change in estimated fair value of common stock warrant liability | 664 | 1,351 | 1,069 | 4,360 | |||||||||||
| Accretion of liability | 88 | — | 192 | — | |||||||||||
| Tax effect related to amortization of purchased intangibles | (119 | ) | (122 | ) | (239 | ) | (245 | ) | |||||||
| Impairment | — | 150 | — | 150 | |||||||||||
| Non-GAAP net income (loss) | $ | 1,728 | $ | (86 | ) | $ | 1,892 | $ | 2,076 | ||||||
| GAAP basic and diluted net loss per share | $ | (0.15 | ) | $ | (0.19 | ) | $ | (0.28 | ) | $ | (0.37 | ) | |||
| Non-GAAP basic net income (loss) per share | $ | 0.04 | $ | (0.00 | ) | $ | 0.04 | $ | 0.05 | ||||||
| Non-GAAP diluted net income (loss) per share | $ | 0.04 | $ | (0.00 | ) | $ | 0.04 | $ | 0.05 | ||||||
| Shares used in computing non-GAAP basic net income (loss) per share | 44,708,037 | 42,132,396 | 43,765,732 | 41,873,337 | |||||||||||
| Shares used in computing non-GAAP diluted net income (loss) per share | 45,882,569 | 42,132,396 | 44,604,886 | 44,897,442 | |||||||||||
| CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures (Unaudited) (In thousands) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Non-GAAP net income (loss) | $ | 1,728 | $ | (86 | ) | $ | 1,892 | $ | 2,076 | ||||||
| Interest expense | (21 | ) | (300 | ) | (117 | ) | (642 | ) | |||||||
| Income tax benefit | (211 | ) | (98 | ) | (391 | ) | (581 | ) | |||||||
| Depreciation expense | 381 | 397 | 748 | 804 | |||||||||||
| CARES Act Provider Relief Fund | (4,813 | ) | — | (4,813 | ) | — | |||||||||
| Other expense, net | 167 | 172 | 126 | 246 | |||||||||||
| Adjusted EBITDA | $ | (2,769 | ) | $ | 85 | $ | (2,555 | ) | $ | 1,903 | |||||
| CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) | ||||||||||||||||||||||||||||||||
| Three Months Ended June 30, 2020 | ||||||||||||||||||||||||||||||||
| Total revenue | Cost of revenue | Research and development | Sales and marketing | General and administrative | Total other income | Income tax benefit (expense) | Net income (loss) | |||||||||||||||||||||||||
| GAAP | $ | 41,801 | $ | 15,025 | $ | 13,129 | $ | 12,134 | $ | 12,316 | $ | 3,915 | $ | 330 | $ | (6,558 | ) | |||||||||||||||
| Non-GAAP adjustments: | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | (711 | ) | (1,456 | ) | (1,581 | ) | (2,669 | ) | 6,417 | |||||||||||||||||||||||
| Acquisition related-amortization of purchased intangibles | (804 | ) | (356 | ) | 1,160 | |||||||||||||||||||||||||||
| Change in estimated fair value of contingent consideration | (76 | ) | 76 | |||||||||||||||||||||||||||||
| Change in estimated fair value of common stock warrant liability | 664 | 664 | ||||||||||||||||||||||||||||||
| Accretion of liability | 88 | 88 | ||||||||||||||||||||||||||||||
| Tax effect related to amortization of purchased intangibles | (119 | ) | (119 | ) | ||||||||||||||||||||||||||||
| Non-GAAP | $ | 41,801 | $ | 13,510 | $ | 11,673 | $ | 10,197 | $ | 9,571 | $ | 4,667 | $ | 211 | $ | 1,728 | ||||||||||||||||
| Six Months Ended June 30, 2020 | ||||||||||||||||||||||||||||||||
| Total revenue | Cost of revenue | Research and development | Sales and marketing | General and administrative | Total other income | Income tax benefit (expense) | Net income (loss) | |||||||||||||||||||||||||
| GAAP | $ | 80,181 | $ | 27,417 | $ | 23,142 | $ | 23,857 | $ | 22,319 | $ | 3,543 | $ | 630 | $ | (12,381 | ) | |||||||||||||||
| Non-GAAP adjustments: | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | (1,076 | ) | (2,267 | ) | (2,550 | ) | (4,783 | ) | 10,676 | |||||||||||||||||||||||
| Acquisition related-amortization of purchased intangibles | (1,596 | ) | (713 | ) | 2,309 | |||||||||||||||||||||||||||
| Change in estimated fair value of contingent consideration | (266 | ) | 266 | |||||||||||||||||||||||||||||
| Change in estimated fair value of common stock warrant liability | 1,069 | 1,069 | ||||||||||||||||||||||||||||||
| Accretion of liability | 192 | 192 | ||||||||||||||||||||||||||||||
| Tax effect related to amortization of purchased intangibles | (239 | ) | (239 | ) | ||||||||||||||||||||||||||||
| Non-GAAP | $ | 80,181 | $ | 24,745 | $ | 20,875 | $ | 20,594 | $ | 17,270 | $ | 4,804 | $ | 391 | $ | 1,892 | ||||||||||||||||
| CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) | ||||||||||||||||||||||||||||||||
| Three Months Ended June 30, 2019 | ||||||||||||||||||||||||||||||||
| Total revenue | Cost of revenue | Research and development | Sales and marketing | General and administrative | Total other income (expense) | Income tax benefit (expense) | Net income (loss) | |||||||||||||||||||||||||
| GAAP | $ | 31,454 | $ | 11,512 | $ | 7,630 | $ | 10,644 | $ | 8,512 | $ | (1,223 | ) | $ | 220 | $ | (7,847 | ) | ||||||||||||||
| Non-GAAP adjustments: | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | (508 | ) | (1,441 | ) | (940 | ) | (2,103 | ) | 4,992 | |||||||||||||||||||||||
| Acquisition related-amortization of purchased intangibles | (539 | ) | (283 | ) | 822 | |||||||||||||||||||||||||||
| Acquisition related fees and expenses | (568 | ) | 568 | |||||||||||||||||||||||||||||
| Change in estimated fair value of common stock warrant liability | 1,351 | 1,351 | ||||||||||||||||||||||||||||||
| Tax effect related to amortization of purchased intangibles | (122 | ) | (122 | ) | ||||||||||||||||||||||||||||
| Impairment | (150 | ) | 150 | |||||||||||||||||||||||||||||
| Non-GAAP | $ | 31,454 | $ | 10,465 | $ | 6,189 | $ | 9,271 | $ | 5,841 | $ | 128 | $ | 98 | $ | (86 | ) | |||||||||||||||
| Six Months Ended June 30, 2019 | ||||||||||||||||||||||||||||||||
| Total revenue | Cost of revenue | Research and development | Sales and marketing | General and administrative | Total other income (expense) | Income tax benefit (expense) | Net income (loss) | |||||||||||||||||||||||||
| GAAP | $ | 57,436 | $ | 21,245 | $ | 13,244 | $ | 17,569 | $ | 17,618 | $ | (3,964 | ) | $ | 826 | $ | (15,378 | ) | ||||||||||||||
| Non-GAAP adjustments: | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | (1,284 | ) | (2,273 | ) | (1,667 | ) | (5,821 | ) | 11,045 | |||||||||||||||||||||||
| Acquisition related-amortization of purchased intangibles | (1,030 | ) | (546 | ) | 1,576 | |||||||||||||||||||||||||||
| Acquisition related fees and expenses | (568 | ) | 568 | |||||||||||||||||||||||||||||
| Change in estimated fair value of common stock warrant liability | 4,360 | 4,360 | ||||||||||||||||||||||||||||||
| Tax effect related to amortization of purchased intangibles | (245 | ) | (245 | ) | ||||||||||||||||||||||||||||
| Impairment | (150 | ) | 150 | |||||||||||||||||||||||||||||
| Non-GAAP | $ | 57,436 | $ | 18,931 | $ | 10,971 | $ | 15,206 | $ | 11,229 | $ | 396 | $ | 581 | $ | 2,076 | ||||||||||||||||