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Exhibit 99.1
CareDx Reports Fourth Quarter and FY 2018 Results
AlloSure launch momentum drives 88% fourth quarter revenue growth
BRISBANE, Calif., March 6, 2019 (GLOBE NEWSWIRE) CareDx, Inc. (NASDAQ: CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today reported financial results for the fourth quarter and full year ended December 31, 2018.
Recent highlights:
| Continued the acceleration of AlloSure penetration |
- | In the fourth quarter of 2018, 100 U.S. transplant centers provided 4,575 AlloSure tests to approximately 3,400 patients |
- | Continued progress in AlloSure Registry (K-OAR) enrollment, with 47 centers initiated and 748 patients enrolled as of December 31, 2018 |
| Achieved total revenue of $23.5 million for the fourth quarter of 2018, increasing 88% year-over-year |
- | Testing services revenue of $18.9 million, with 4,575 AlloSure and 4,057 AlloMap patient results provided |
- | Product revenue of $4.6 million |
| Generated a net loss of $3.8 million, positive adjusted EBITDA of $0.8 million and positive net cash from operations of $2.0 million in the fourth quarter of 2018 |
| Strengthened balance sheet through public equity offering and repayment of all outstanding debt |
- | Cash and cash equivalents of $64.6 million at December 31, 2018 |
The CareDx team delivered another consecutive record quarter, including 88% year-over-year revenue growth. We achieved positive adjusted EBITDA and operating cash flow results for the second straight quarter. We strengthened our first mover advantage as the strong clinical value of AlloSure continues to resonate with the transplant community and, just over a year into the launch, we are 3% penetrated into this patient population, said Peter Maag, CareDx Chief Executive Officer. CareDx is making tremendous strides fortifying its position as the leading provider of genomics-based information in transplantation, with the goal to leverage these insights to improve long-term patient outcomes. I am very proud of CareDxs accomplishments in 2018, which sets the stage for another year of strong growth in 2019 and beyond.
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Continued the acceleration of AlloSure penetration - Continued progress in AlloSure Registry (K-OAR) enrollment, with 47 centers initiated and 748 patients enrolled as of December 31, 2018 Achieved total revenue of $23.5 million for the fourth quarter of 2018, increasing 88% year-over-year - Testing services revenue of $18.9 million, with 4,575 AlloSure and 4,057 AlloMap patient results provided - Product revenue of $4.6 million Generated a net loss of $3.8 million, positive adjusted EBITDA of $0.8 million and positive net cash from operations of $2.0 million in the fourth quarter of 2018 Strengthened balance sheet through public equity offering and repayment of all outstanding debt Revenue We derive our revenue from testing services, products sales and license and other revenues.
Comparison of the Years Ended December 31, 2017 and 2016 (In thousands) Testing Services Revenue Testing services revenue increased by $3.4 million, or 12%, in 2017 compared to the same period in 2016 mainly due to the increase in AlloMap test volume representing $1.8 million, as well as increased AlloMap cash collections of $1.1 million.
Cost of Testing Services Cost of testing services increased by approximately $1.5 million, or 13%, in 2017 compared to 2016 primarily due to higher headcount related expenses of $1.1 million and laboratory material costs of $0.6 million.
License and Other Revenue License and other revenue increased by $0.3 million in 2017, compared to 2016, reflecting additional royalty payments received under our services agreement with CardioDx, Inc.
AlloMap has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation (HCSC), Humana, Kaiser Foundation Health Plan, Inc., TRICARE and UnitedHealthcare.
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Financial Statements, Disclosures and Schedules
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Caredx, Inc. provided additional information to their SEC Filing as exhibits
Ticker: CDNA
CIK: 1217234
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-006533
Submitted to the SEC: Wed Mar 06 2019 12:22:47 PM EST
Accepted by the SEC: Wed Mar 06 2019
Period: Monday, December 31, 2018
Industry: Medical Laboratories