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CareDx(CDNA) - 2021 Q1 - Quarterly Report
2021-05-04 16:00
Table of Contents 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 March 31, 2021 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(CDNA) - 2020 Q4 - Earnings Call Presentation
2021-02-26 19:37
The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance February 2021 Allo-transplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient from a genetically non-identical donor of the same species Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements ...
CareDx(CDNA) - 2020 Q4 - Earnings Call Transcript
2021-02-25 03:38
Start Time: 16:30 January 1, 0000 5:13 PM ET CareDx, Inc. (NASDAQ:CDNA) Q4 2020 Earnings Conference Call February 24, 2021, 16:30 PM ET Company Participants Reginald Seeto - President and CEO Marcel Konrad - CFO Sham Dholakia - SVP, Medical Affairs and Clinical Operations Greg Chodaczek - Managing Director Conference Call Participants Matthew Andrews - Jefferies Rachel Vatnsdal - Piper Sandler Alex Nowak - Craig-Hallum Capital Group Andrew Cooper - Raymond James Sung-Ji Nam - BTIG Boobalan Pachaiyappan - H. ...
CareDx(CDNA) - 2020 Q4 - Annual Report
2021-02-23 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________________________________________________________________ Form 10-K ________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF TH ...
CareDx(CDNA) - 2020 Q3 - Earnings Call Transcript
2020-11-01 17:07
CareDx, Inc. (NASDAQ:CDNA) Q3 2020 Earnings Conference Call October 29, 2020 5:00 PM ET Company Participants Greg Chodaczek - Managing Director Peter Maag - Chairman and Chief Executive Officer Reginald Seeto - President and Chief Business Officer Michael Bell - Chief Financial Officer Conference Call Participants Brandon Couillard - Jefferies Steven Mah - Paper Sandler Alex Nowak - Craig-Hallum Capital Group Andrew Cooper - Raymond James Sung Ji Nam - BTIG Yi Chen - H.C. Wainwright Operator Greetings and w ...
CareDx(CDNA) - 2020 Q3 - Quarterly Report
2020-10-29 21:11
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q3 2020 reflect significant asset growth, increased revenue primarily from testing services, and improved cash flow from operations despite a net loss [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2020, total assets significantly increased to **$353.6 million**, primarily driven by a substantial rise in cash and cash equivalents, alongside growth in liabilities and stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $213,798 | $38,223 | | Accounts receivable | $30,610 | $24,057 | | Total current assets | $258,659 | $71,922 | | Total assets | $353,552 | $151,736 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $62,423 | $34,828 | | Deferred revenue - CMS advance payment | $20,496 | $0 | | Total liabilities | $84,908 | $52,736 | | Total stockholders' equity | $268,644 | $99,000 | | Total liabilities and stockholders' equity | $353,552 | $151,736 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2020, total revenue increased **58%** to **$53.4 million**, primarily from testing services, though operating expenses also rose, resulting in a net loss of **$2.8 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2020 | Q3 2019 | Nine Months 2020 | Nine Months 2019 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | **$53,369** | **$33,811** | **$133,550** | **$91,247** | | Testing services revenue | $45,529 | $28,226 | $113,264 | $75,421 | | Product revenue | $5,383 | $4,200 | $13,369 | $13,226 | | Total operating expenses | $56,276 | $40,558 | $153,011 | $110,234 | | Loss from operations | ($2,907) | ($6,747) | ($19,461) | ($18,987) | | **Net Loss** | **($2,818)** | **($1,813)** | **($15,199)** | **($17,191)** | | Net loss per share (basic & diluted) | ($0.06) | ($0.04) | ($0.33) | ($0.41) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, net cash from operations significantly improved to **$26.3 million**, primarily due to a CMS advance payment and equity offerings, leading to a substantial increase in cash and cash equivalents Cash Flow Summary for the Nine Months Ended September 30 (in thousands) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $26,250 | ($1,686) | | Net cash used in investing activities | ($9,920) | ($21,237) | | Net cash provided by (used in) financing activities | $159,185 | ($214) | | **Net increase (decrease) in cash** | **$175,579** | **($23,630)** | | Cash, cash equivalents, and restricted cash at end of period | $214,058 | $41,178 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on the company's precision medicine business, the impact of COVID-19 and mitigation efforts, significant financing activities, and ongoing litigation - **CareDx** is a precision medicine company focused on diagnostic solutions for transplant patients, with commercial services including **AlloSure Kidney** and **AlloMap Heart**[31](index=31&type=chunk) - The **COVID-19 pandemic** caused an initial slowdown in testing volumes, but the company launched **RemoTraC**, a remote home-based blood draw solution, which helped volumes recover and exceed pre-pandemic levels from May 2020 onwards[37](index=37&type=chunk) - In April 2020, the company received a **$20.5 million** advance payment from **CMS** under the **CARES Act**, recorded as deferred revenue; repayment is set to begin one year after issuance through recoupment of future Medicare payments[40](index=40&type=chunk)[78](index=78&type=chunk) - The company is involved in litigation with **Natera Inc.**, which includes a **false advertising suit** and a **patent infringement suit**; CareDx intends to defend these matters vigorously[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong Q3 2020 revenue growth driven by testing services and the impact of COVID-19 mitigation, alongside significant improvements in liquidity from various financing activities despite a net loss - Q3 2020 total revenue was **$53.4 million**, a **58%** increase YoY, with over **21,800** AlloSure Kidney and AlloMap Heart patient results provided[112](index=112&type=chunk) - The company launched **RemoTraC**, a remote home-based blood draw solution, in response to the **COVID-19 pandemic**, which helped testing volumes recover to pre-pandemic levels by May 2020[126](index=126&type=chunk) Q3 2020 vs Q3 2019 Results of Operations (in thousands) | Item | Q3 2020 | Q3 2019 | Change | | :--- | :--- | :--- | :--- | | Total revenue | $53,369 | $33,811 | $19,558 | | Testing services revenue | $45,529 | $28,226 | $17,303 | | Total operating expenses | $56,276 | $40,558 | $15,718 | | Loss from operations | ($2,907) | ($6,747) | $3,840 | | Net loss | ($2,818) | ($1,813) | ($1,005) | - The company's cash position was significantly enhanced through multiple financing activities in 2020, including a **$134.6 million** public offering, a **$23.5 million** at-the-market offering, and **$25.3 million** in funds from the **CARES Act**[164](index=164&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces minimal interest rate risk and manages foreign currency exchange risk from international operations, with a 10% adverse change impacting financial results by less than **$0.1 million** - Interest rate risk is considered **low**; a **50 basis point** change in interest rates would have an approximate impact of **$0.8 million** on the financial statements[186](index=186&type=chunk) - The company is subject to **foreign currency exchange risk** due to operations in Sweden, Austria, and Australia; an unfavorable **10%** change in exchange rates would have negatively impacted financial results by **less than $0.1 million** and product revenue by **$0.7 million** for the nine months ended September 30, 2020[187](index=187&type=chunk)[189](index=189&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting during Q3 2020 - Management concluded that as of September 30, 2020, the company's disclosure controls and procedures were **effective** at a reasonable assurance level[190](index=190&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the third quarter of 2020[191](index=191&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in ongoing litigation with Natera Inc., involving counterclaims of false advertising and patent infringement allegations related to AlloSure - **CareDx** is engaged in legal disputes with **Natera Inc.**, which include counterclaims of **false advertising** by Natera and a separate lawsuit from Natera alleging **patent infringement** by **AlloSure**[87](index=87&type=chunk)[193](index=193&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company identifies key business risks, including the impact of the COVID-19 pandemic, reliance on a single laboratory, cybersecurity threats, and stock price volatility - The **COVID-19 pandemic** poses a **material risk**, potentially affecting financial condition, liquidity, supply chain, and clinical trial operations[195](index=195&type=chunk) - The company relies on a **single laboratory** in Brisbane, California, which is located near earthquake fault lines and **lacks redundancy**, making it vulnerable to natural disasters or other disruptions[199](index=199&type=chunk) - The business is highly dependent on information technology and faces **cybersecurity risks**, including **data breaches** and unauthorized disclosure of confidential information, which are heightened by remote work arrangements[203](index=203&type=chunk) - The company's stock price has been and is expected to remain **volatile** due to factors such as fluctuating operating results, reimbursement decisions, and general market conditions[206](index=206&type=chunk)[207](index=207&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q3 2020, the company repurchased **16,146** shares of common stock to cover employee tax withholding obligations from restricted stock unit vesting Issuer Purchases of Equity Securities (Q3 2020) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | July 1 - July 31, 2020 | 1,309 | $6.19 | | August 1 - August 31, 2020 | 11,429 | $7.10 | | September 1 - September 30, 2020 | 3,408 | $6.66 | | **Total** | **16,146** | **—** | [Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported [Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) No other material information is reported in this section [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications
CareDx(CDNA) - 2020 Q2 - Earnings Call Presentation
2020-08-07 20:00
| --- | --- | |----------------------------|-------| | | | | The Allo-Transplantation | | | | | | Company | | | Focused on better outcomes | | | through personalized | | | transplant surveillance | | August 2020 Allotransplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient from a genetically non-identical donor of the same species el Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements. All statements ...
CareDx(CDNA) - 2020 Q2 - Earnings Call Transcript
2020-08-05 02:44
CareDx, Inc (NASDAQ:CDNA) Q2 2020 Earnings Conference Call August 4, 2020 4:30 PM ET Company Participants Greg Chodaczek - Head of Investor Relations Peter Maag - Chief Executive Officer Michael Bell - Chief Financial Officer Reginald Seeto - Chief Business Officer Conference Call Participants Brandon Couillard - Jefferies & Company, Inc. Rachel Vatnsdal - Piper Sandler Alexander Nowak - Craig-Hallum Capital Group LLC Andrew Cooper - Raymond James & Associates, Inc. Yi Chen - HC Wainwright Operator Greeting ...
CareDx(CDNA) - 2020 Q2 - Quarterly Report
2020-08-04 21:07
Table of Contents 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, 2020 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 (CDNA) Investor Presentation - Slideshow
2020-05-30 15:18
The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance. May 2020 Allotransplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient from a genetically non-identical donor of the same species Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regar ...