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Natera(NTRA) - 2022 Q4 - Annual Report
2023-02-28 16:00
PART I [Business](index=6&type=section&id=Item%201.%20Business) Natera is a diagnostics company specializing in cell-free DNA technology, primarily focusing on women's health, oncology, and organ health, generating revenue from its core diagnostic tests Financial and Operational Highlights (2020-2022) | Metric | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | **Total Revenues** | $820.2 million | $625.5 million | $391.0 million | | **Product Revenues** | $797.3 million | $580.1 million | $377.9 million | | **Net Losses** | ($547.8 million) | ($471.7 million) | ($229.7 million) | | **Tests Processed** | ~2.1 million | ~1.6 million | ~1.0 million | - Natera's core cfDNA technology combines novel molecular assays with statistical algorithms to identify genetic variations with **high accuracy** from small samples, applicable across women's health, oncology, and organ health[25](index=25&type=chunk)[29](index=29&type=chunk) - The company operates **CLIA-certified laboratories** in Austin, Texas, and San Carlos, California[28](index=28&type=chunk) [Overview](index=6&type=section&id=Item%201.%20Business-Overview) Natera is a diagnostics company leveraging cfDNA technology across women's health, oncology, and organ health, with 2022 revenues of $820.2 million and approximately 2.1 million tests processed [Our Solution](index=6&type=section&id=Item%201.%20Business-Our%20Solution) Natera's solution uses proprietary mmPCR and computational algorithms to detect genomic variations with high sensitivity and specificity across various diagnostic applications, distributed globally via Constellation - The company's technology combines mmPCR to measure thousands of SNPs with advanced algorithms to analyze the data, achieving **high signal-to-noise ratio** for detecting DNA fragments at very low frequencies[32](index=32&type=chunk) - Natera's technology has demonstrated **high performance** across its three main business areas: women's health (Panorama), oncology (Signatera), and organ health (Prospera)[33](index=33&type=chunk) [Women's Health](index=7&type=section&id=Item%201.%20Business-Women's%20Health) Natera's Women's Health division offers family planning, prenatal screening, and hereditary cancer risk tests, with Panorama NIPT and Horizon carrier screening as flagship products generating most revenue - The Panorama NIPT screens for fetal chromosomal abnormalities like Down syndrome as early as nine weeks into pregnancy, using a unique SNP-based method that provides **high accuracy**[36](index=36&type=chunk)[38](index=38&type=chunk) - The SMART study demonstrated Panorama's high performance for 22q11.2 deletion syndrome, with **83% sensitivity** and a **53% positive predictive value (PPV)** using an updated AI algorithm[42](index=42&type=chunk) - The Horizon carrier screening test screens for **over 200 inherited conditions**, including Cystic Fibrosis and Spinal Muscular Atrophy, and can be performed from the same blood sample as Panorama[45](index=45&type=chunk)[46](index=46&type=chunk) [Oncology](index=10&type=section&id=Item%201.%20Business-Oncology) Natera's oncology division focuses on molecular residual disease (MRD) detection and recurrence monitoring in solid tumors, with Signatera as its personalized ctDNA test, targeting a U.S. market over $15 billion - Signatera is a personalized ctDNA test for MRD assessment that is custom-designed for each patient by tracking 16 tumor-specific clonal mutations, allowing for **high accuracy** at very low variant allele frequencies[54](index=54&type=chunk) - Clinical studies across multiple tumor types have shown that a positive Signatera test result predicted relapse with an overall positive predictive value (PPV) of **over 98%** without further treatment[58](index=58&type=chunk) - The total addressable market in the U.S. for recurrence and treatment monitoring for solid tumor cancers is estimated to be **over $15 billion**[53](index=53&type=chunk) [Organ Health](index=11&type=section&id=Item%201.%20Business-Organ%20Health) Natera's organ health division offers tests like Prospera for organ transplant rejection assessment, targeting an estimated U.S. market of approximately $3.0 billion, and Renasight for chronic kidney disease - The Prospera test assesses organ transplant rejection by measuring dd-cfDNA in the recipient's blood, offering a **non-invasive alternative** to biopsies for kidney, heart, and lung transplants[61](index=61&type=chunk)[62](index=62&type=chunk) Prospera Clinical Validation Performance | Organ | Metric | Performance | Source Chunk | | :--- | :--- | :--- | :--- | | Kidney | Sensitivity | 89% | 63 | | Kidney | Specificity | 73% | 63 | | Heart | AUC | 0.86 | 63 | | Lung | AUC (Rejection vs. Stable) | 0.91 | 63 | [Constellation](index=12&type=section&id=Item%201.%20Business-Constellation) Constellation is Natera's cloud-based platform enabling global partners to perform molecular workflows locally and access Natera's bioinformatics algorithms for analysis, expanding technology access - The Constellation platform enables **international and U.S. laboratories** to license Natera's technology, run molecular assays locally, and access Natera's bioinformatics algorithms through the cloud[67](index=67&type=chunk) [Commercial Capabilities](index=13&type=section&id=Item%201.%20Business-Commercial%20Capabilities) Natera's commercial strategy combines a direct U.S. sales force with a global partner network, focusing on physician education and test bundling to maximize sales and market penetration - In FY2022, approximately **75%** of customers ordering the basic Panorama panel also ordered screening for 22q11.2 deletion syndrome, and about **33%** also ordered Horizon carrier screening[72](index=72&type=chunk) [Competition](index=14&type=section&id=Item%201.%20Business-Competition) Natera operates in highly competitive molecular diagnostics markets, facing rivals like LabCorp, Illumina, Roche, Guardant Health, and CareDx across its women's health, oncology, and organ health segments - Key competitors in NIPT include **LabCorp, Illumina, Myriad, and Quest**[81](index=81&type=chunk) - Key competitors in MRD assessment include **Roche, Guardant Health, and Adaptive Biotechnologies**[82](index=82&type=chunk) - Key competitors in organ health include **CareDx and Eurofins Viracor**[83](index=83&type=chunk) [Intellectual Property](index=15&type=section&id=Item%201.%20Business-Intellectual%20Property) Natera protects its intellectual property through over 150 issued patents and 220 pending applications as of December 31, 2022, and is actively involved in IP litigation - As of December 31, 2022, Natera held **over 150 issued U.S. and foreign patents** and had **over 220 pending patent applications**[86](index=86&type=chunk) [Reimbursement](index=15&type=section&id=Item%201.%20Business-Reimbursement) Natera receives reimbursement from commercial and government payers, with NIPT widely covered, but microdeletions testing reimbursement remains low, covering over 231 million lives in the U.S. as of December 31, 2022 - As of December 31, 2022, Natera and its laboratory partners had in-network contracts with health plans covering **over 231 million lives** in the United States[95](index=95&type=chunk) - Reimbursement for NIPT in average-risk pregnancies has **improved**, with most commercial insurers and an increasing number of state Medicaid programs providing positive coverage[94](index=94&type=chunk) - The company has experienced **low average reimbursement rates** for microdeletions testing and for its broader Horizon panel due to the implementation of specific CPT codes[92](index=92&type=chunk) [Government Regulations](index=17&type=section&id=Item%201.%20Business-Government%20Regulations) Natera's business is subject to extensive federal, state, and international regulations, including FDA oversight of LDTs, CLIA certification, HIPAA, GDPR, and healthcare fraud and abuse laws - Natera's tests are currently offered as Laboratory Developed Tests (LDTs), which have historically been subject to FDA enforcement discretion, but the regulatory landscape remains **uncertain**[107](index=107&type=chunk)[108](index=108&type=chunk) - The company's laboratories in Austin, TX, and San Carlos, CA, are **CLIA certified** and **accredited by the College of American Pathologists (CAP)**. They also hold licenses in states with stringent requirements, such as California and New York[114](index=114&type=chunk)[115](index=115&type=chunk)[117](index=117&type=chunk)[119](index=119&type=chunk) - The company is subject to healthcare fraud and abuse laws, including the federal Anti-Kickback Statute, the Stark Law, and the False Claims Act, which carry **significant civil and criminal penalties** for violations[134](index=134&type=chunk)[145](index=145&type=chunk)[148](index=148&type=chunk) [Human Capital Management](index=26&type=section&id=Item%201.%20Business-Human%20Capital%20Management) As of December 31, 2022, Natera had a global workforce of 3,018 employees, a 10.7% increase, emphasizing diversity with 62.7% women and over 40% minorities in the U.S. workforce - As of December 31, 2022, the global workforce comprised **3,018 employees**, representing a **10.7% increase** during 2022[157](index=157&type=chunk) - In 2022, women made up approximately **62.7%** of the global workforce, and minorities comprised **over 40%** of the U.S. workforce[158](index=158&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including revenue concentration, reimbursement uncertainty, a history of net losses, intense competition, potential FDA regulation, supply chain dependence, and intellectual property litigation - A **majority of the company's revenues** are derived from sales of its Panorama NIPT and Horizon carrier screening tests, and the business would be harmed if it cannot grow revenues for these products[199](index=199&type=chunk) - The company has incurred net losses since inception, with a net loss of **$547.8 million** in 2022 and an accumulated deficit of **$1.9 billion** as of December 31, 2022[205](index=205&type=chunk) - The company faces **intense competition** from established and emerging companies in women's health, oncology, and organ health, some of which have greater financial and technological resources[218](index=218&type=chunk)[219](index=219&type=chunk) - Natera relies on Illumina as the **sole supplier** for its sequencing platform and related reagents for key tests like Panorama, Horizon, and Signatera, creating significant supply chain risk[232](index=232&type=chunk)[233](index=233&type=chunk) [Unresolved Staff Comments](index=66&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) None [Properties](index=66&type=section&id=Item%202.%20Properties) Natera leases its primary laboratory and office facilities, including approximately 136,000 square feet in San Carlos, CA, and 191,722 square feet in Austin, TX, with leases extending to 2027 and 2033 respectively Key Leased Facilities | Location | Size (sq. ft.) | Lease Expiration | | :--- | :--- | :--- | | San Carlos, CA | ~136,000 | October 2027 | | Austin, TX | ~191,722 | March 2033 | | South San Francisco, CA | 11,395 | November 2026 | [Legal Proceedings](index=67&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in various legal proceedings, including intellectual property, billing, marketing, and employment matters, with details referenced from the Consolidated Financial Statements - The company is involved in legal proceedings from time to time, the results of which are **uncertain** and could have an **adverse impact** due to defense costs and potential settlements[395](index=395&type=chunk) [Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=68&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Natera's common stock (NTRA) trades on Nasdaq, with no cash dividends paid or anticipated, as the company intends to retain earnings for business growth - The company's common stock is listed on the **Nasdaq Global Select Market** under the symbol **"NTRA"**[400](index=400&type=chunk) - **No cash dividends** have ever been paid, and the company intends to retain all future earnings for business operations and expansion[402](index=402&type=chunk) [Selected Financial Data](index=70&type=section&id=Item%206.%20Selected%20Financial%20Data) Information required by this item is omitted as per SEC amendments to Regulation S-K effective February 10, 2021 [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=71&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Natera's 2022 revenues grew 31.1% to $820.2 million, driven by product revenue, though net loss widened to $547.8 million due to increased costs, with management affirming sufficient liquidity for at least 12 months Results of Operations (2021 vs. 2022) | Metric (in millions) | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $820.2 | $625.5 | 31.1% | | Product Revenues | $797.3 | $580.1 | 37.4% | | Licensing & Other Revenues | $22.9 | $45.4 | (49.5)% | | **Total Cost & Expenses** | $1,361.3 | $1,093.7 | 24.5% | | Cost of Product Revenues | $453.6 | $315.2 | 43.9% | | R&D | $316.4 | $264.2 | 19.8% | | SG&A | $588.6 | $511.0 | 15.2% | | **Net Loss** | ($547.8) | ($471.7) | 16.1% | - The increase in product revenues was driven by higher test volumes, which grew from approximately **1.57 million tests** processed in 2021 to **2.07 million** in 2022[419](index=419&type=chunk)[461](index=461&type=chunk) - The decrease in licensing revenue was primarily due to the recognition of **$28.6 million** in deferred revenue from a settlement with Qiagen in 2021 that did not recur in 2022[462](index=462&type=chunk) - As of December 31, 2022, the company had **$466.1 million** in cash and cash equivalents and **$432.3 million** in marketable securities. Management believes this is sufficient to meet cash requirements for **at least 12 months** from March 1, 2023[470](index=470&type=chunk)[473](index=473&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=82&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Natera is primarily exposed to interest rate risk, where a 100 basis point increase could raise annual interest expense by $0.8 million and increase investment income by $4.3 million - The company's primary market risk is **interest rate volatility** affecting its variable-rate Credit Line and its investment portfolio[494](index=494&type=chunk) [Financial Statements and Supplementary Data](index=83&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains Natera's audited consolidated financial statements for the fiscal years ended December 31, 2022, 2021, and 2020, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes and an unqualified auditor's opinion from Ernst & Young LLP Consolidated Balance Sheet Summary (As of Dec 31, 2022) | Account (in thousands) | Amount | | :--- | :--- | | **Total Assets** | **$1,394,474** | | Cash, Cash Equivalents & Short-term Investments | $898,306 | | Accounts Receivable, net | $244,385 | | **Total Liabilities** | **$688,730** | | Debt Financing (Short & Long-term) | $362,003 | | **Total Stockholders' Equity** | **$705,744** | Consolidated Statement of Operations Summary (Year Ended Dec 31, 2022) | Account (in thousands) | Amount | | :--- | :--- | | **Total Revenues** | **$820,222** | | Total Cost and Expenses | $1,361,262 | | Loss from Operations | ($541,040) | | **Net Loss** | **($547,799)** | | Net Loss Per Share (Basic & Diluted) | ($5.57) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=125&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None [Controls and Procedures](index=125&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, a conclusion affirmed by Ernst & Young LLP, following ERP system modifications - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[738](index=738&type=chunk) - Management concluded that the company maintained **effective** internal control over financial reporting as of December 31, 2022, a conclusion audited and affirmed by Ernst & Young LLP[740](index=740&type=chunk)[741](index=741&type=chunk) [Other Information](index=128&type=section&id=Item%209B.%20Other%20Information) Chief Operating Officer Robert Schueren transitioned to a part-time role effective February 24, 2023, and is no longer considered a Section 16 officer of the company - Effective February 24, 2023, Chief Operating Officer Robert Schueren transitioned to a **part-time role** and is **no longer a Section 16 officer**[755](index=755&type=chunk)[756](index=756&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=128&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) None PART III [Directors, Executive Officers and Corporate Governance](index=128&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2023 annual meeting of stockholders [Executive Compensation](index=128&type=section&id=Item%2011.%20Executive%20Compensation) The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2023 annual meeting of stockholders [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=128&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2023 annual meeting of stockholders [Certain Relationships and Related Transactions, and Director Independence](index=128&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2023 annual meeting of stockholders [Principal Accounting Fees and Services](index=128&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The information required by this item is incorporated by reference from the company's definitive proxy statement for its 2023 annual meeting of stockholders PART IV [Exhibits and Financial Statement Schedules](index=129&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K, including corporate governance documents, material contracts, and Sarbanes-Oxley Act certifications [Form 10-K Summary](index=133&type=section&id=Item%2016.%20Form%2010-K%20Summary) None
Natera(NTRA) - 2022 Q3 - Earnings Call Transcript
2022-11-09 01:13
Natera, Inc. (NASDAQ:NTRA) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Michael Brophy - Chief Financial Officer Steve Chapman - Chief Executive Officer Solomon Moshkevich - General Manager, Oncology Conference Call Participants Puneet Souda - SVB Securities Tejas Savant - Morgan Stanley Max Masucci - Cowen Julia Qin - JPMorgan Catherine Schulte - Baird Operator Welcome to Natera's 2022 Third Quarter Financial Results Conference Call. At this time, all participants are i ...
Natera(NTRA) - 2022 Q3 - Earnings Call Presentation
2022-11-08 21:31
× × × × × × × × x 8 natera × × × Ⅹ X X X X X × × × × × × X X × × × Ⅹ X X X X X × × × × X X x × x × × × X X × × × × × × × x × × × × × × × × × × × × × × × × × Natera, Inc. Investor presentation × × × × × × × × × Third Quarter 2022 Earnings Call November 8, 2022 × × × × × X X × × × × × Safe harbor statement × × × × X X × × This presentation contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts cont ...
Natera(NTRA) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
PART I — FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) This section presents Natera, Inc.'s unaudited condensed consolidated financial statements for the quarter ended September 30, 2022, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes on business description, significant accounting policies, revenue recognition, fair value measurements, financial instruments, balance sheet components, leases, commitments and contingencies, stock-based compensation, debt, income taxes, net loss per share, and subsequent events [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Natera's financial position, detailing assets, liabilities, and stockholders' equity at specific points in time | Metric | September 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | **Assets** | | | | Cash and cash equivalents | $57,042 | $84,386 | | Short-term investments | $464,112 | $829,896 | | Accounts receivable, net | $236,362 | $122,074 | | Total current assets | $829,629 | $1,093,138 | | Total assets | $1,009,112 | $1,236,487 | | **Liabilities** | | | | Total current liabilities | $267,281 | $218,956 | | Long-term debt financing | $281,336 | $280,394 | | Total liabilities | $647,491 | $583,183 | | **Stockholders' Equity** | | | | Accumulated deficit | $(1,800,062) | $(1,394,836) | | Total stockholders' equity | $361,621 | $653,304 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines Natera's financial performance over specific periods, detailing revenues, expenses, and net loss | Metric | Three months ended Sep 30, 2022 (in thousands) | Three months ended Sep 30, 2021 (in thousands) | Nine months ended Sep 30, 2022 (in thousands) | Nine months ended Sep 30, 2021 (in thousands) | | :----------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Product revenues | $199,831 | $153,940 | $584,415 | $413,971 | | Licensing and other revenues | $10,806 | $4,176 | $18,555 | $38,487 | | Total revenues | $210,637 | $158,116 | $602,970 | $452,458 | | Cost of product revenues | $115,436 | $80,511 | $326,862 | $221,870 | | Research and development | $65,510 | $98,457 | $228,504 | $192,397 | | Selling, general and administrative | $147,667 | $128,485 | $444,769 | $364,273 | | Loss from operations | $(119,052) | $(150,197) | $(399,267) | $(328,508) | | Net loss | $(121,480) | $(151,273) | $(405,226) | $(331,152) | | Basic and diluted net loss per share | $(1.25) | $(1.63) | $(4.20) | $(3.72) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section details changes in Natera's stockholders' equity, reflecting the impact of net losses, unrealized gains/losses, and equity transactions - Total stockholders' equity decreased from **$653.3 million** at **December 31, 2021**, to **$361.6 million** at **September 30, 2022**, primarily due to a net loss of **$405.2 million** and unrealized losses on available-for-sale securities of **$17.3 million**, partially offset by increases from stock-based compensation and common stock issuances[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes Natera's cash inflows and outflows from operating, investing, and financing activities over specific periods | Cash Flow Activity | Nine Months Ended Sep 30, 2022 (in thousands) | Nine Months Ended Sep 30, 2021 (in thousands) | | :----------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Cash used in operating activities | $(350,374) | $(236,500) | | Cash provided by (used in) investing activities | $308,421 | $(284,697) | | Cash provided by financing activities | $14,467 | $567,673 | | Net increase in cash, cash equivalents and restricted cash | $(27,486) | $46,476 | | Cash, cash equivalents and restricted cash, end of period | $57,128 | $95,331 | [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the unaudited interim condensed consolidated financial statements [1. Description of Business](index=10&type=section&id=1.%20Description%20of%20Business) This note describes Natera, Inc.'s core business as a diagnostics company leveraging cell-free DNA technology across women's health, oncology, and organ health markets - Natera, Inc. is a diagnostics company utilizing proprietary cell-free DNA (cfDNA) technology and bioinformatics for disease management[29](index=29&type=chunk)[30](index=30&type=chunk) - Initially focused on women's health (e.g., Panorama NIPT, Horizon Carrier Screening), the company has expanded into oncology (Signatera) and organ health (Prospera) markets[29](index=29&type=chunk)[30](index=30&type=chunk) - It operates CLIA-certified laboratories and offers a cloud-based distribution model, Constellation, for laboratory partners[29](index=29&type=chunk)[30](index=30&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and estimates used in preparing Natera's financial statements, including going concern considerations - The company's financial statements are prepared in conformity with U.S. GAAP for interim financial information, with no material changes to significant accounting policies during the nine months ended **September 30, 2022**[31](index=31&type=chunk)[32](index=32&type=chunk)[45](index=45&type=chunk) - Key estimates include allowance for doubtful accounts, average selling price from insurance payors, operating lease assets/liabilities, deferred revenues, stock-based compensation, and income tax uncertainties[31](index=31&type=chunk)[32](index=32&type=chunk)[45](index=45&type=chunk) - Natera has incurred net losses since inception, with a **$405.2 million** net loss for the nine months ended **September 30, 2022**, and an accumulated deficit of **$1.8 billion**[36](index=36&type=chunk)[38](index=38&type=chunk) - The company anticipates continued losses and negative operating cash flows, requiring additional equity or debt financing to fund operations and growth[36](index=36&type=chunk)[38](index=38&type=chunk) - The company believes its existing cash and marketable securities (**$57.1 million** cash, **$464.1 million** investments as of **September 30, 2022**) will be sufficient for at least **12 months** after **November 8, 2022**[36](index=36&type=chunk)[43](index=43&type=chunk) [3. Revenue Recognition](index=18&type=section&id=3.%20Revenue%20Recognition) This note details Natera's policies for recognizing revenue from product sales and licensing agreements, including variable consideration and disaggregation by payer and geography - Product revenues are primarily from prenatal genetic tests, oncology testing, and are recognized when test results are delivered[85](index=85&type=chunk)[87](index=87&type=chunk)[93](index=93&type=chunk)[95](index=95&type=chunk) - Licensing and other revenues come from the Constellation cloud-based platform and strategic
Natera(NTRA) - 2022 Q2 - Earnings Call Transcript
2022-08-06 22:40
Natera, Inc. (NASDAQ:NTRA) Q2 2022 Results Conference Call August 4, 2022 4:30 PM ET Company Participants Michael Brophy - Chief Financial Officer Steve Chapman - Chief Executive Officer Solomon Moshkevich - General Manager, Oncology Conference Call Participants Tejas Savant - Morgan Stanley Dave Delahunt - Goldman Sachs Catherine Schulte - Baird Max Masucci - Cowen Puneet Souda - Leerink Julia Qin - JPMorgan Vidyun Bais - BTIG Connor Stevenson - Craig-Hallum Mason Carrico - Stephens Operator Welcome to Nat ...
Natera(NTRA) - 2022 Q2 - Earnings Call Presentation
2022-08-05 21:44
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |--------------|-------|-------|-------|-------|---------|-------|-------|-------|-------|-------------|-------| | | | | | | | | | | | | | | | | | | | × × | | × | | × × | × | × | | natera | | | | | × × | | × | | xxxxx | × | | | | | | | | × × | | × | | × × | × | | | | | | | | × × | | × | × | × | X X X | | | | | | | | × × × × | | × × | × × | × × | × × × x x x | | | | | | | | × × | | × | × | × | x | | | | | | | | × × | | × | × | × | x X ...
Natera(NTRA) - 2022 Q2 - Quarterly Report
2022-08-04 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 June 30, 2022 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: 001-37478 NATERA, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 01-0894487 (State or Other ...
Natera(NTRA) - 2022 Q1 - Earnings Call Presentation
2022-05-08 07:20
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Natera(NTRA) - 2022 Q1 - Earnings Call Transcript
2022-05-08 07:06
Natera, Inc. (NASDAQ:NTRA) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Michael Brophy - Chief Financial Officer Steve Chapman - Chief Executive Officer Solomon Moshkevich - General Manager, Oncology Conference Call Participants Tejas Savant - Morgan Stanley Stephanie Yan - Cowen Catherine Schulte - Baird Matt Sykes - Goldman Sachs Puneet Souda - SVB Securities Operator Welcome to Natera???s 2022 First Quarter Financial Results Conference Call. At this time, all participants ...
Natera(NTRA) - 2022 Q1 - Quarterly Report
2022-05-05 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, 2022 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: 001-37478 NATERA, INC. (Exact Name of Registrant as Specified in Its Charter) 13011 McCallen Pass Building A Suit ...