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 ...

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. ...

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, 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 ...

[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

| --- | --- | |----------------------------|-------| | | | | 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 ...

Financial Data and Key Metrics Changes - In Q2 2020, CareDx reported revenue of $41.8 million, a 33% increase compared to Q2 2019, primarily driven by testing services revenue of $36.3 million, which grew by 41% year-over-year [11][28] - The net loss for Q2 2020 was $6.6 million, an improvement from a net loss of $7.8 million in Q2 2019, with a net loss per share of $0.15 compared to $0.19 in the prior year [31][32] - Non-GAAP net income was $1.7 million in Q2 2020, compared to a non-GAAP net loss of $0.1 million in Q2 2019 [32] Business Line Data and Key Metrics Changes - Testing services revenue increased to $36.3 million, while product revenue decreased to $3.3 million due to COVID-related restrictions [28][29] - Digital revenue contributed $2.2 million to the total revenue [12][28] - The RemoTraC service accounted for over 40% of patient results, indicating significant growth in remote testing capabilities [14][15] Market Data and Key Metrics Changes - Transplant volume was reported to be down approximately 7% year-to-date, but many transplant centers are returning to normal operations [49][70] - The company noted a significant increase in organ availability due to various factors, including cardiovascular deaths and overdoses, which could drive transplantation rates higher [70] Company Strategy and Development Direction - CareDx is focusing on expanding its direct-to-patient capabilities and enhancing its digital solutions to improve patient care in transplantation [12][41] - The company is committed to building a strong presence in community nephrology settings, expanding its reach beyond transplant centers [65][66] - The launch of the AlloCare app is aimed at improving patient compliance and monitoring, set to launch in September [46][47] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the remainder of 2020, highlighting the successful pivot to remote services during the COVID-19 pandemic [41][70] - The company anticipates continued growth in transplantation volumes as centers adapt to new protocols and patient needs [70] - There is a recognition of the shift from traditional biopsies to non-invasive testing methods, which positions CareDx favorably in the market [53][70] Other Important Information - The company closed Q2 2020 with a cash position of $211 million, bolstered by a successful public offering [26][38] - Adjusted EBITDA for Q2 2020 was negative $2.8 million, impacted by increased costs associated with RemoTraC and R&D spending [34][36] Q&A Session Summary Question: What are the future prospects for the RemoTraC program? - Management indicated that RemoTraC is well-received by patients and is expected to continue growing, although variability exists based on transplant centers' approaches to telehealth [44][45] Question: Can you provide an update on the transplant pipeline and the impact of the pandemic? - Transplant volume is recovering, with many centers returning to normal operations, and the company expects continued growth in the coming months [49][70] Question: What is the status of heart care reimbursement? - Heart care reimbursement is expected to progress towards a final coverage decision by the end of the year [58][59] Question: How are operating expenses affected by COVID-19 investments? - Operating expenses increased due to investments in RemoTraC and other initiatives, with expectations for continued investment in patient care management [71][72]

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 __ ...

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 ...

The Transplant Company Focused on better outcomes through personalized transplant surveillance. April 2020 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 regarding future financial position of CareDx, Inc. (together with its subsidiaries, "CareDx" or the "Company"), including financial targets, business strategy, and plans and objectives ...