Natera, Inc. engages in the discovery, development, and commercialization of genetic testing services. It offers Panorama Non-Invasive Prenatal Test, Horizon Carrier Screening, Spectrum Pre-implantation Genetic Screening and Spectrum Pre-implantation Genetic Diagnosis, Anora Products of Conception and Non-Invasive Paternity Testing. The company was founded by Matthew Rabinowitz and Jonathan Sheena in November 2003 and is headquartered in San Carlos, CA.
We derive most of our revenues from Panorama, and if our efforts to further increase the use and adoption of Panorama or to develop new products and services in the future do not succeed, our business will be harmed.
Uncertainty in the development and commercialization of our enhanced or new tests or services could materially adversely affect our business, financial condition and results of operations.
Our quarterly results may fluctuate significantly, which could adversely impact the value of our common stock.
If we are unable to compete successfully with respect to our current or future products or services, we may be unable to increase or sustain our revenues or achieve profitability.
We may not be successful in commercializing our cloud‑based distribution model.
We may be subject to increased compliance risks as a result of our rapid growth, including our dependence on our sales, marketing and billing efforts.
We rely on internal and third‑party data centers and platforms to host our laboratory and cloud‑based software, and any interruptions of service or failures may impair our laboratory operations or the delivery of our cloud‑based services and harm our business.
If we are unable to successfully grow revenues for our products or services in addition to Panorama, our business and results of operations may be adversely affected.
If our primary CLIA‑certified laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed.
We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers.
We rely on commercial courier delivery services to transport samples to our facilities in a timely and cost‑efficient manner and if these delivery services are disrupted, our business will be harmed.
Security breaches, loss of data and other disruptions, including with respect to cybersecurity, could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and reputation.
The marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources.
If we are unable to successfully scale our operations, our business could suffer.
If we lose the services of our founder and Executive Chairman or other members of our senior management team, we may not be able to execute our business strategy.
We may engage in acquisitions, dispositions or other strategic transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
Our outstanding debt may impair our financial and operating flexibility.
Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar rates.
If we are unable to expand, maintain or obtain third‑party payer coverage and reimbursement for Panorama and our other tests, or if we are required to refund any reimbursements already received, our revenues and results of operations would be adversely affected.
Our revenues may be adversely affected if we are unable to successfully obtain reimbursement from the Medicare program and state Medicaid programs.
Our revenues may be adversely impacted if third‑party payers withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors.
Failure to obtain necessary regulatory approvals may adversely affect our ability to expand our operations internationally, including our ability to continue commercializing our cloud‑based distribution model.
Changes in laws and regulations, or in their application, may adversely affect our business, financial condition and results of operations.
If we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business.
Changes in government healthcare policy could increase our costs and negatively impact coverage and reimbursement for our tests by governmental and other third‑party payers.
If we or our laboratory distribution partners, consultants or commercial partners act in a manner that violates healthcare fraud and abuse laws or otherwise engage in misconduct, we may be subject to civil or criminal penalties.
Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business.
Changes in the way the FDA regulates the reagents, other consumables, and testing equipment we use when developing, validating, and performing our tests could result in delay or additional expense in bringing our tests to market or performing such tests for our customers.
Our use of hazardous materials in the development of our tests exposes us to risks related to accidental contamination or injury and requires us to comply with regulations governing hazardous waste materials.
If the validity of an informed consent from a patient intake for Panorama or our other tests is challenged, we could be precluded from billing for such testing, forced to stop performing such tests, or required to repay amounts previously received, which would adversely affect our business and financial results.
Third‑party claims of intellectual property infringement could result in litigation or other proceedings, which would be costly and time‑consuming, and could limit our ability to commercialize our products or services.
Any inability to effectively protect our proprietary technologies could harm our competitive position.
If we are not able to adequately protect our trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
The market price of our common stock has been and may be volatile, which could subject us to litigation.
As a public company, we will continue to incur significantly increased costs and devote substantial management time.
We will be an emerging growth company through December 31, 2019 and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.
Commencing December 31, 2019, we will no longer be an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies will no longer apply to us.
If we are unable to implement and maintain effective internal controls over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be adversely affected.
We do not intend to pay dividends on our capital stock so any returns will be limited to changes in the value of our common stock.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans or in connection with acquisitions or strategic or commercial transactions, could result in additional dilution of the percentage ownership of our stockholders and could cause the price of our common stock to decline.
Sales of a substantial number of shares of our common stock in the public markets could cause the price of our common stock to decline.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
Insiders have substantial control over us and will be able to influence corporate matters.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part I, Item 1 of this report.
We are a growing diagnostics company with proprietary molecular and bioinformatics technology that we are deploying to change the management of genetic disease worldwide. Our goal is to develop and commercialize non- or minimally-invasive tests to evaluate risk for a wide range of genetic conditions, such as Down syndrome, the results of which can enable early detection, diagnosis and treatment. Our technology has been proven clinically and commercially in the prenatal testing space. We have begun translating this success into the liquid biopsy space, where we are leveraging our core expertise to develop products for oncology diagnostic applications, and are also working to develop a transplant rejection test. We seek to enable even wider adoption of our technology through our global cloud-based distribution model. In addition to our direct sales force in the United States, we have a global network of over 100 laboratory distribution partners, including many of the largest international laboratories.