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 September 30, 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: 001-37478
NATERA, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware |
01-0894487 |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
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13011 McCallen Pass
Building A Suite 100
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78753 |
(Address of Principal Executive Offices) |
(Zip Code) |
(650) 249-9090
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, par value $0.0001 per share |
NTRA |
The Nasdaq Stock Market LLC (Nasdaq Global Select Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ◻
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ◻
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
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Large accelerated filer |
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Accelerated filer |
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◻ |
Non-accelerated filer |
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Smaller reporting company |
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◻ |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ◻ No ⌧
As of November 1, 2021, the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was 94,594,816.
Natera, Inc.
FORM 10-Q FOR THE QUARTER ENDED September 30, 2021
TABLE OF CONTENTS
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5 |
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Condensed Consolidated Balance Sheets at September 30, 2021 and December 31, 2020 |
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5 |
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6 |
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7 |
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9 |
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Notes to Unaudited Interim Condensed Consolidated Financial Statements |
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10 |
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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39 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
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50 |
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50 |
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51 |
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52 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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52 |
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52 |
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52 |
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52 |
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53 |
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54 |
2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements, including in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Forward-looking statements include information concerning our future results of operations and financial position, strategy and plans, and our expectations for future operations. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as "anticipate," "believe," "continue," "could," "design," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "seek," "should," "will," "would" or the negative version of these words and similar expressions.
These forward-looking statements include, but are not limited to, statements concerning the following:
● | our expectation that, for the foreseeable future, a significant portion of our revenues will be derived from sales of Panorama and Horizon; |
● | our ability to increase demand for Panorama and Horizon, including our expectation that Panorama will be adopted for broader use in average-risk pregnancies and for the screening of microdeletions; |
● | our expectation that Panorama will be adopted for broader use in average-risk pregnancies and for the screening of microdeletions and that third-party payer reimbursement will be available for these applications, including our expectations regarding the results of our SNP based Microdeletion and Aneuploidy RegisTry, or SMART, Study and our expectations that the results from such study may support broader use and reimbursement for the use of Panorama in average risk pregnancies and for microdeletions; |
● | the extent and duration of the impact of the COVID-19 pandemic on our business, results of operations, stock price, or overall financial condition; |
● | our expectations of the reliability, accuracy, and performance of our tests, as well as expectations of the benefits of our tests to patients, providers, and payers; |
● | our ability to successfully develop additional revenue opportunities and expand our product offerings to include new tests; |
● | our efforts to successfully develop and commercialize our oncology and organ health products; |
● | the effect of improvements in our cost of goods sold; |
● | our estimates of the total addressable markets for our current and potential product offerings; |
● | our ability and expectations regarding obtaining, maintaining and expanding third-party payer coverage of, and reimbursement for, our tests; |
● | the effect of changes in the way we account for our revenue; |
● | the scope of protection we establish and maintain for, and developments or disputes concerning, our intellectual property or other proprietary rights; |
● | our ability to successfully compete in the markets we serve; |
● | our reliance on collaborators such as medical institutions, contract laboratories, laboratory partners, and other third parties; |
● | our ability to operate our laboratory facility and meet expected demand, and to successfully scale our operations; |
● | our reliance on a limited number of suppliers, including sole source suppliers, which may impact our ability to maintain a continued supply of laboratory instruments and materials and to run our tests; |
● | our expectations of the rate of adoption of Panorama, Horizon and of any of our other current or future tests by laboratories, clinics, clinicians, payers, and patients; |
● | our ability to complete clinical studies and publish compelling clinical data in peer-reviewed medical publications regarding Panorama and any of our future tests, including our SMART study and our ongoing and planned trials in oncology and transplant rejection; |
● | our reliance on our partners to market and offer our tests in the United States and in international markets; |
● | our expectations regarding acquisitions, dispositions and other strategic transactions; |
● | our expectations regarding the conversion of our outstanding 2.25% convertible senior notes due 2027 in the aggregate principal amount of $287.5 million and our ability to make debt service payments under the Convertible Notes if such Convertible Notes are not converted; |
● | our ability to fund our working capital requirements; |
● | the factors that may impact our financial results; |
3
● | anticipated trends and challenges in our business and the markets in which we operate; |
● | whether we will elect to exercise the option we have to acquire certain assets of a third party and, if exercised, whether that acquisition will be consummated and meet our expectations; and |
● | our compliance with federal, state, and foreign regulatory requirements. |
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including those discussed in Part II, Item 1A, “Risk Factors” in in this report and Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on February 26, 2021. Given these uncertainties, you should not place undue reliance on these forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. You should read this report completely and with the understanding that our actual future results may be materially different from what we expect.
Also, forward-looking statements represent our beliefs and assumptions only as of the date of this report. Any forward-looking statement made by us in this report speaks only as of the date on which it is made. Except as required by law, we disclaim any obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
As used in this quarterly report on Form 10-Q, the terms “Natera,” “Registrant,” “Company,” “we,” “us,” and “our” mean Natera, Inc. and its subsidiaries unless the context indicates otherwise.
4
PART I – FINANCIAL INFORMATION
ITEM 1. |
FINANCIAL STATEMENTS |
Natera, Inc.
Condensed Consolidated Balance Sheets
(in thousands except par value and per share amounts)
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September 30, |
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December 31, |
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2021 |
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2020 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
95,103 |
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$ |
48,668 |
Restricted cash |
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228 |
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187 |
Short-term investments |
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928,596 |
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688,606 |
Accounts receivable, net of allowance of $2,965 in 2021 and $3,080 in 2020 |
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110,416 |
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78,565 |
Inventory |
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28,022 |
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20,031 |
Prepaid expenses and other current assets, net |
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28,858 |
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26,606 |
Total current assets |
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1,191,223 |
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862,663 |
Property and equipment, net |
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59,293 |
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33,348 |
Operating lease right-of-use assets |
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47,656 |
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21,399 |
Other assets |
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13,202 |
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14,743 |
Total assets |
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$ |
1,311,374 |
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$ |
932,153 |
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
8,181 |
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$ |
8,096 |
Accrued compensation |
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35,331 |
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30,371 |
Other accrued liabilities |
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96,486 |
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60,407 |
Deferred revenue, current portion |
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9,667 |
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50,125 |
Short-term debt financing |
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50,049 |
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50,054 |
Total current liabilities |
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199,714 |
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199,053 |
Long-term debt financing |
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280,085 |
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202,493 |
Deferred revenue, long-term portion |
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22,706 |
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22,805 |
Operating lease liabilities, long-term portion |
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48,388 |
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21,246 |
Other long-term liabilities |
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1,464 |
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320 |
Total liabilities |
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552,357 |
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445,917 |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity: |
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Common stock, $0.0001 par value: 750,000 shares authorized at both September 30, 2021 and December 31, 2020, respectively; 94,538 and 86,223 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively |
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10 |
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9 |
Additional paid in capital |
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2,011,788 |
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1,411,286 |
Accumulated deficit |
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(1,254,272) |
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(929,318) |
Accumulated other comprehensive gain |
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1,491 |
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4,259 |
Total stockholders’ equity |
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759,017 |
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486,236 |
Total liabilities and stockholders’ equity |
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$ |
1,311,374 |
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$ |
932,153 |
See accompanying notes to the unaudited interim condensed consolidated financial statements.
5
Natera, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share data)
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Three months ended |
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Nine months ended |
||||||||
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September 30, |
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September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenues |
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Product revenues |
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$ |
150,651 |
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$ |
93,286 |
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$ |
406,265 |
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$ |
260,746 |
Licensing and other revenues |
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7,465 |
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4,857 |
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46,193 |
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17,881 |
Total revenues |
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158,116 |
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98,143 |
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452,458 |
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278,627 |
Cost and expenses |
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Cost of product revenues |
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76,838 |
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46,873 |
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211,387 |
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131,124 |
Cost of licensing and other revenues |
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4,533 |
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4,948 |
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12,909 |
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12,614 |
Research and development |
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98,457 |
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26,421 |
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192,397 |
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67,651 |
Selling, general and administrative |
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128,485 |
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75,678 |
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364,273 |
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209,547 |
Total cost and expenses |
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308,313 |
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153,920 |
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780,966 |
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420,936 |
Loss from operations |
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(150,197) |
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(55,777) |
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(328,508) |
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(142,309) |
Interest expense |
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(2,078) |
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(4,270) |
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(6,226) |
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(10,772) |
Interest and other income, net |
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1,274 |
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1,749 |
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4,230 |
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5,661 |
Loss on debt extinguishment |
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— |
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— |
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— |
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(5,848) |
Loss before income taxes |
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(151,001) |
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(58,298) |
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(330,504) |
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(153,268) |
Income tax expense |
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(272) |
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(25) |
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(648) |
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(63) |
Net loss |
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$ |
(151,273) |
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$ |
(58,323) |
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$ |
(331,152) |
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$ |
(153,331) |
Unrealized gain (loss) on available-for-sale securities, net of tax |
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(950) |
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(600) |
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(2,768) |
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|
4,251 |
Comprehensive loss |
|
$ |
(152,223) |
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$ |
(58,923) |
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$ |
(333,920) |
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$ |
(149,080) |
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Net loss per share (Note 12): |
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Basic and diluted |
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$ |
(1.63) |
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$ |
(0.72) |
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$ |
(3.72) |
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$ |
(1.93) |
Weighted-average number of shares used in computing basic and diluted net loss per share: |
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Basic and diluted |
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92,558 |
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80,908 |
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89,130 |
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|
79,430 |
See accompanying notes to the unaudited interim condensed consolidated financial statements.
6
Natera, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(in thousands)
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Three months ended September 30, 2020 |
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Common Stock |
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Additional
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Accumulated Other Comprehensive |
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Accumulated |
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Total
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Shares |
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Amount |
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Capital |
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Income |
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Deficit |
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Equity |
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Balance as of June 30, 2020 |
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79,717 |
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$ |
8 |
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$ |
1,093,072 |
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$ |
5,770 |
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$ |
(794,583) |
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$ |
304,267 |
Issuance of common stock upon exercise of stock options |
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498 |
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— |
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4,974 |
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— |
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— |
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4,974 |
Issuance of common stock for public offering, net |
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4,792 |
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1 |
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270,649 |
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— |
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— |
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270,650 |
Vesting of restricted stock |
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274 |
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— |
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— |
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— |
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— |
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— |
Stock-based compensation |
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— |
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— |
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15,032 |
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— |
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— |
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15,032 |
Unrealized gain on available-for sale securities |
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— |
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— |
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— |
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(600) |
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— |
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(600) |
Net loss |
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— |
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— |
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— |
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— |
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(58,323) |
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|
(58,323) |
Balance as of September 30, 2020 |
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85,281 |
|
$ |
9 |
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$ |
1,383,727 |
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$ |
5,170 |
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$ |
(852,906) |
|
$ |
536,000 |
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7
See accompanying notes to the unaudited interim condensed consolidated financial statements.
8
Natera, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Nine Months Ended |
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September 30, |
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2021 |
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2020 |
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(in thousands) |
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Operating activities |
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Net loss |
|
$ |
(331,152) |
|
$ |
(153,331) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
|
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8,259 |
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|
6,215 |
Expensed in-process research and development |
|
|
35,604 |
|
|
— |
Premium amortization and discount accretion on investment securities |
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5,707 |
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3,333 |
(Gain) loss on investments |
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(58) |
|
|
— |
Stock-based compensation |
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|
84,797 |
|
|
34,406 |
Non-cash lease expense |
|
|
8,106 |
|
|
5,819 |
Amortization of debt discount and issuance cost |
|
|
917 |
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|
149 |
Inventory reserve adjustments |
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|
726 |
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|
(180) |
Other non-cash benefits (charges) |
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|
133 |
|
|
(135) |
Provision for credit losses |
|
|
380 |
|
|
1,445 |
Loss on Debt Extinguishment |
|
|
— |
|
|
5,848 |
Accretion of Convertible Note |
|
|
— |
|
|
4,514 |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
(32,232) |
|
|
(17,940) |
Inventory |
|
|
(8,717) |
|
|
(7,803) |
Prepaid expenses and other current assets |
|
|
(7,851) |
|
|
(7,288) |
Other assets |
|
|
(550) |
|
|
97 |
Accounts payable |
|
|
183 |
|
|
(1,613) |
Accrued compensation |
|
|
4,960 |
|
|
6,362 |
Other accrued liabilities |
|
|
34,845 |
|
|
16,362 |
Deferred revenue |
|
|
(40,557) |
|
|
(5,470) |
Cash used in operating activities |
|
|
(236,500) |
|
|
(109,210) |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Purchases of investments |
|
|
(674,372) |
|
|
(479,037) |
Proceeds from sale of investments |
|
|
77,563 |
|
|
11,500 |
Proceeds from maturity of investments |
|
|
348,410 |
|
|
247,315 |
Purchases of property and equipment, net |
|
|
(32,027) |
|
|
(12,073) |
Cash paid for acquisition of an asset |
|
|
(4,271) |
|
|
— |
Cash used in investing activities |
|
|
(284,697) |
|
|
(232,295) |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
10,774 |
|
|
15,782 |
Proceeds from issuance of common stock under employee stock purchase plan |
|
|
6,085 |
|
|
3,062 |
Proceeds from Convertible Note, net of issuance costs |
|
|
— |
|
|
278,316 |
Loan payment |
|
|
— |
|
|
(78,757) |
Proceeds from public offering, net of issuance cost |
|
|
550,814 |
|
|
270,650 |
Cash provided by financing activities |
|
|
567,673 |
|
|
489,053 |
|
|
|
|
|
|
|
Net increase in cash, cash equivalents and restricted cash |
|
|
46,476 |
|
|
147,548 |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
48,855 |
|
|
61,981 |
Cash, cash equivalents and restricted cash, end of period |
|
$ |
95,331 |
|
$ |
209,529 |
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
3,690 |
|
$ |
3,137 |
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
Purchases of property and equipment in accounts payable and accruals |
|
$ |
4,957 |
|
$ |
2,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited interim condensed consolidated financial statements.
9
Natera, Inc.
Notes to Unaudited Interim Condensed Consolidated Financial Statements
1. Description of Business
Natera, Inc. (the "Company") was formed in the state of California as Gene Security Network, LLC in November 2003 and incorporated in the state of Delaware in January 2007. The Company is a diagnostics company with proprietary molecular and bioinformatics technology that it is applying to change the management of disease worldwide. The Company’s cell-free DNA (“cfDNA”) technology combines its novel molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell, with its statistical algorithms which incorporate data available from the broader scientific community to identify genetic variations covering a wide range of serious conditions with best-in-class accuracy and coverage. The Company’s technology has been proven clinically and commercially in the women’s health space, in which it develops and commercializes non- or minimally-invasive tests to evaluate risk for, and thereby enable early detection of, a wide range of genetic conditions, such as Down syndrome. The Company is now translating its success in women’s health and applying its core technology to the oncology market, in which it is commercializing a personalized blood-based DNA test to detect molecular residual disease and monitor disease recurrence, as well as to the organ health market, initially with a test to assess kidney transplants for rejection. The Company operates laboratories certified under the Clinical Laboratory Improvement Amendments ("CLIA") providing a host of cell-free DNA-based molecular testing services. The Company determines its operating segments based on the way it organizes its business to make operating decisions and assess performance. The Company operates one segment, the development and commercialization of molecular testing services, applying its proprietary technology in the fields of women’s health, oncology and organ health. The Company also has two subsidiaries, one of which operates in the state of Texas and the other in Canada.
The Company's product offerings include its Panorama Non-Invasive Prenatal Test ("NIPT") that screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother; Vistara, a single-gene mutations screening test performed to identify single-gene disorders; Horizon Carrier Screening ("HCS") to determine carrier status for a large number of severe genetic diseases that could be passed on to the carrier’s children; Spectrum Pre-implantation Genetics (“Spectrum”) to evaluate embryos to identify chromosomal anomalies or inherited genetic conditions to improve the chances of a healthy pregnancy during an in vitro fertilization ("IVF") cycle; Anora Miscarriage Test (“Anora”) to rapidly and extensively analyze fetal chromosomes to understand the cause of miscarriage; Non-Invasive Paternity Testing ("PAT"), which is exclusively marketed and sold by a licensee from whom the Company receives a royalty; Signatera, which detects circulating tumor DNA in patients previously diagnosed with cancer to assess molecular residual disease and monitor for recurrence; and Prospera, to assess organ transplant rejection. All testing is available principally in the United States. The Company also offers its Panorama test to customers outside of the United States, primarily in Europe. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Company’s algorithms and bioinformatics in order to validate and launch tests based on the Company’s technology. Through the third quarter of 2019, the Company offered Evercord for the collection and storage of newborn cord blood and cord tissue units, which was sold in the third quarter of 2019 to a third-party buyer.
2. Summary of Significant Accounting Policies
During the nine months ended September 30, 2021, there were no material changes to the Company’s significant accounting policies as disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (filed on February 26, 2021), except as described in Recently Adopted Accounting Pronouncements below.
10
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. The unaudited interim condensed consolidated financial information includes only adjustments of a normal recurring nature necessary for a fair presentation of the results of operations, financial position, changes in stockholders’ equity, and cash flows. The results of operations for the three and nine months ended September 30, 2021, are not necessarily indicative of the results for the full year or the results for any future periods. The condensed consolidated balance sheet as of December 31, 2020 has been derived from audited financial statements at that date, these financial statements should be read in conjunction with the audited financial statements, and related notes for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 26, 2021.
Liquidity Matters
The Company has incurred net losses since its inception and anticipates net losses and negative operating cash flows for the near future. The Company had a net loss of $331.2 million for the nine months ended September 30, 2021 and an accumulated deficit of $1.3 billion as of September 30, 2021. As of September 30, 2021, the Company had $95.3 million in cash, cash equivalents, and restricted cash, $928.6 million in marketable securities, $50.0 million of outstanding balance of the Credit Line (as defined in Note 10, Debt) including accrued interest, and $287.5 million outstanding principal balance of its 2.25% Convertible Senior Notes (the “Convertible Notes”). In April 2020, the Company used a portion of the net proceeds from the offering of the Convertible Notes to repay its obligations under its 2017 Term Loan with OrbiMed.
While the Company has introduced multiple products that are generating revenues, these revenues have not been sufficient to fund all operations. Accordingly, the Company has funded the portion of operating costs that exceeds revenues through a combination of equity issuances, debt issuances, and other financings.
The Company continues to develop and commercialize future products and, consequently, it will need to generate additional revenues to achieve future profitability and may need to raise additional equity or debt financing. If the Company raises additional funds by issuing equity securities, its stockholders will experience dilution. Additional debt financing, if available, may involve covenants restricting its operations or its ability to incur additional debt. Any additional debt financing or additional equity that the Company raises may contain terms that are not favorable to it or its stockholders and requires significant debt service payments, which diverts resources from other activities. Additional financing may not be available at all, or in amounts or on terms acceptable to the Company. If the Company is unable to obtain additional financing, it may be required to delay the development and commercialization of its products and significantly scale back its business and operations.
In May 2021, the Company entered into a development and option agreement with a third party that requires the third party to use its best efforts to perform an agreed upon development plan and provides the Company with an exclusive option to purchase the third party’s assets. The Company paid the third party $10 million in the second quarter of 2021 for conducting the development work and for entering into the agreement, and if the Company elects to exercise its option, the Company has agreed to pay the third party an additional $290.0 million for the designated assets. There is no assurance that the development plan will be successful, or that the Company will elect to exercise its option to purchase the third party’s assets or, if the Company exercises this option, that it will derive the anticipated benefit from the acquisition of these assets.
On September 10, 2021, the Company entered into an agreement with a third party for an asset acquisition where the acquired asset was in-process research and development (“IPR&D”) in exchange for an equity consideration payment. The third party was a biotechnology company focused on oncology. The total acquisition consideration amounts to $35.6 million composed of the issuance of 276,346 shares of the Company's common stock with a fair value of $30.9 million, approximately $3.9 million of cash consideration, assumed net liabilities of $0.2 million, as well as $0.6 million of acquisition related legal and accounting costs directly attributable to the acquisition of the asset. Further, there are an estimated 269,547 of additional shares, consistent with the registration statement filed with the SEC on September 10,
11
2021, that are potentially issuable to legacy shareholders of this third party upon the achievement of defined milestones which will be revalued at each reporting date. These milestones are assessed as probable as of September 30, 2021. As a result, this was accounted as contingent compensation expense recognized over the performance period at fair market value. The Company concluded the acquired IPR&D has no alternative-future use and accordingly expensed on the day of the transaction close as research and development expense which is reflected in our condensed consolidated statement of operations.
In April 2019, the Company completed an underwritten equity offering and sold 6,052,631 shares of its common stock at a price of $19 per share to the public. Before offering expenses of $0.6 million, the Company received proceeds of $108.1 million net of the underwriting discount. In October 2019, the Company completed another underwritten equity offering and sold 6,571,428 shares of its common stock at a price of $35 per share to the public. Before offering expenses of $0.4 million, the Company received proceeds of $216.2 million net of the underwriting discount. In September 2020, the Company completed an additional underwritten equity offering and sold 4,791,665 shares of its common stock at a price of $60.00 per share to the public. Before offering expenses of $0.3 million, the Company received proceeds of $271.0 million net of the underwriting discount. In July 2021, the Company completed an underwritten equity offering and sold 5,175,000 shares of its common stock at a price of $113 per share to the public. Before offering expenses of $0.4 million, the Company received proceeds of $551.2 million net of the underwriting discount.
Based on the Company’s current business plan, the Company believes that its existing cash and marketable securities will be sufficient to meet its anticipated cash requirements for at least 12 months after November 4, 2021.
Principles of Consolidation
The accompanying condensed consolidated financial statements include all the accounts of the Company and its subsidiaries. The Company established a subsidiary that operates in the state of Texas to support the Company’s laboratory and operational functions. The Company established a subsidiary that operates in Canada following the acquisition of the IPR&D asset, which includes a lease for the laboratory space located in Canada. All intercompany balances and transactions have been eliminated.
Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles (GAAP) in the United States requires management to make estimates and assumptions about future events that affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenues and expenses. Significant items subject to such estimates include the allowance for doubtful accounts calculated based on the average selling price expected to be received from insurance payors, the operating right-of-use assets and the associated lease liabilities, deferred revenues associated with unsatisfied performance obligations, accrued liability for potential refund requests, the valuation of the Convertible Notes, stock-based compensation, the fair value of options, income tax uncertainties, and the expected consideration to be received from contracts with customers. These estimates and assumptions are based on management's best estimates and judgment. Management regularly evaluates its estimates and assumptions using historical experience and other factors, including contractual terms and statutory limits; however, actual results could differ from these estimates and could have an adverse effect on the Company's financial statements.
Credit Losses
Trade accounts receivable and other receivables. The allowance for doubtful accounts is based on the Company’s assessment of the collectability of customer accounts. The Company regularly reviews the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay.
12
The following is a roll-forward of the allowances for credit losses related to trade accounts receivable and other receivables for the nine months ended September 30, 2021:
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2021 |
|
|
|
|
(in thousands) |
Beginning balance |
|
$ |
4,220 |
Provision for credit losses |
|
|
380 |
Write-offs |
|
|
(495) |
Total |
|
$ |
4,105 |
|
|
|
|
Available-for-sale debt securities. The amended guidance from ASU 2016-13 requires the measurement of expected credit losses for available-for-sale debt securities held at the reporting date over the remaining life based on historical experience, current conditions, and reasonable and supportable forecasts. The Company evaluated its investment portfolio under the available-for-sale debt securities impairment model guidance and determined the Company’s investment portfolio is composed of low-risk, investment grade securities.
Investments
Investments consist primarily of debt securities such as U.S. Treasuries, U.S. agency and municipal bonds. Management determines the appropriate classification of securities at the time of purchase and re-evaluates such determination at each balance sheet date. The Company generally classifies its entire investment portfolio as available-for-sale. The Company views its available-for-sale portfolio as available for use in current operations. Accordingly, the Company classifies all investments as short-term, irrespective of maturity date. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity.
Risk and Uncertainties
The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company's business is highly uncertain and difficult to predict, and the full extent and duration of the impact of the COVID-19 pandemic on its business, its operations, and the global economy as a whole is not yet known. While the Company’s test volumes and overall average selling prices for its tests increased during the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020, the Company cannot predict the potential nature, magnitude and duration of the effects of the COVID-19 pandemic on the macroeconomic environment or its business.
Financial instruments that potentially subject the Company to credit risk consist of cash, accounts receivable and investments. The Company limits its exposure to credit loss by placing its cash in financial institutions with high credit ratings. The Company's cash may consist of deposits held with banks that may at times exceed federally insured limits. The Company performs evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any one institution.
The Company performs evaluations of financial conditions for insurance carriers, patients, clinics and laboratory partners and generally does not require collateral to support credit sales. For the nine months ended September 30, 2021, and 2020, there were no customers exceeding 10% of total revenues on an individual basis. As of September 30, 2021 and December 31, 2020, there were no customers with an outstanding balance exceeding 10% of net accounts receivable.
13
Accumulated Other Comprehensive Income (Loss)
Comprehensive loss and its components encompass all changes in equity other than those with stockholders, and include net loss, unrealized gains and losses on available-for-sale marketable securities.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
||||||||
|
September 30, |
|
September 30, |
||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||
|
(in thousands) |
|
(in thousands) |
||||||||
Beginning balance |
$ |
2,441 |
|
$ |
5,770 |
|
$ |
4,259 |
|
$ |
919 |
Net unrealized gain (loss) on available-for-sale securities, net of tax |
|
(950) |
|
|
(600) |
|
|
(2,768) |
|
|
4,251 |
Ending balance |
$ |
1,491 |
|
$ |
5,170 |
|
$ |
1,491 |
|
$ |
5,170 |
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) under its accounting standard codifications or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed below, the Company believes that the impact of accounting standards updates recently issued that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
Recently Adopted Accounting Pronouncements
Fair Value Measurement
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 proposes new disclosure requirements for unrealized gains or losses recognized in other comprehensive income that are attributable to fair value changes in assets and liabilities categorized within Level III of the fair value hierarchy, as well as quantitative information about significant unobservable inputs used to value such assets and liabilities. It eliminates the requirement to disclose the reasons for the transfers of assets and liabilities measured in fair value on a recurring basis between Level I and Level II. The Company has adopted this ASU as of January 1, 2020, which did not have a material impact on its consolidated financial statements.
Goodwill - Internal-Use Software
In August 2018, the FASB issued ASU 2018‑15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350‑40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The accounting for the service element of a hosting arrangement that is a service contract is not affected by the amendments in this update. The Company adopted ASU 2018-15 as of January 1, 2020 using the prospective approach, which did not have a material impact on its condensed consolidated financial statements upon the adoption.
Credit Losses
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments and also issued subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, and ASU 2019-05. The standard requires measurement and recognition of expected credit losses for financial assets by requiring an allowance to be recorded as an offset to the amortized cost of such assets. For available-for-sale debt securities, expected credit losses should be estimated when the fair value of the debt securities is below their associated
14
amortized costs. The Company adopted ASU 2016-13, as amended, effective January 1, 2020 using the modified retrospective method and recorded a cumulative-effect adjustment of $0.4 million in retained earnings as of January 1, 2020.
Collaborative Arrangements
In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, Topic 808 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. This guidance will be effective for the Company beginning January 1, 2020. The Company has adopted this standard as of January 1, 2020, which did not have a material impact on its condensed consolidated financial statements upon the adoption.
Income Taxes
In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (Topic 740), which simplifies the accounting for income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and clarifies certain aspects of the current guidance to promote consistency among reporting entities. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020. An entity that elects early adoption must adopt all the amendments in the same period. Most amendments within this ASU are required to be applied on a prospective basis, while certain amendments must be applied on a retrospective or modified retrospective basis. The Company has adopted this standard as of September 30, 2020, which did not have a material impact on its condensed consolidated financial statements upon the adoption.
In October 2020, ASU 2020-10, Codification Improvements, was issued, which simplifies the existing codification. The guidance includes presentation disclosures for the amount of income tax expense or benefit related to other comprehensive income. ASU 2010-10 is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Early application of the amendments is permitted for public business entities for any annual or interim period for which financial statements have not been issued. The Company has adopted this standard as of January 1, 2021, which did not have a material impact on its condensed consolidated financial statements upon the adoption.
Debt
In August 2020, ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) was issued which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition is permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted no earlier than the fiscal year beginning after December 15, 2020. The Company has adopted this standard as of January 1, 2021 using the modified retrospective approach. As a result of the adoption of ASU 2020-06, the Convertible Notes due May 2027 are no longer bifurcated into separate liability and equity components in the March 31, 2021 condensed consolidated balance sheet. Rather, the $287.5 million principal amount of the Company’s Convertible Notes was classified only as a liability in the March 31, 2021 condensed consolidated balance sheet. Upon adoption of ASU 2020-06, an adjustment was recorded to the Convertible Notes liability component, equity component (additional paid-in-capital) and retained earnings. The cumulative effect of the change was recognized as an adjustment to the opening balance of retained earnings at the date of adoption. The comparative information has not been restated and continues to be presented according to accounting standards in effect for those periods. This adjustment was calculated based on the carrying amount of the Convertible Notes as if it had always been treated only as a liability. Further, an adjustment was recorded to the debt discount and issuance costs as if these had always been treated as a contra liability only. Interest expense related to the accretion of the Convertible Notes is no longer recognized. Interest expense for the Convertible Notes for the three and nine months ended September 30, 2021 would have been $2.4 million and $7.0 million higher without the adoption of ASU 2020-06,
15
respectively. As such, net loss from continuing operations attributable to the Company per common share for the three and nine months ended September 30, 2021 was $0.03 and $0.08 lower due to the effect of adoption of ASU 2020-06, respectively.
New Accounting Pronouncements Not Yet Adopted
In March 2020, ASU 2020-04, Reference Rate Reform (Topic 848) was issued which provides temporary optional guidance to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients and exceptions for applying generally accepted accounting principles to transactions affected by reference rate reform if certain criteria are met. These transactions include contract modifications, hedging relationship, and sale or transfer of debt securities classified as held-to-maturity. Early adoption of this ASU is permitted, and the Company may elect to apply the amendments prospectively through December 31, 2022. The Company’s financial instruments that are in the scope of ASU 2020-04 include but are not limited to the UBS credit line agreement. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.
3. Revenue Recognition
The Company recognizes revenues when, or as, performance obligations in the contracts are satisfied, in the amount reflecting the expected consideration to be received from the goods or services transferred to the customers.
Product Revenues
Product revenues are derived from contracts with insurance carriers, laboratory partners and patients in connection with sales primarily related to prenatal genetic tests. The Company enters into contracts with insurance carriers with primarily payment terms related to tests provided to the patients who have health insurance coverage. Insurance carriers are considered as third-party payers on behalf of the patients, and the patients are considered as the customers who receive genetic test services. Tests may be billed to insurance carriers, patients, or a combination of insurance carriers and patients. Further, the Company sells tests to a number of domestic and international laboratory partners and identifies the laboratory partners as customers provided that there is a test services agreement between the two parties.
A performance obligation represents a promise in a contract to transfer a distinct good or service to a customer, which represents a unit of accounting in accordance with ASC 606. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once the Company has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. A portion of the consideration should be allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The Company evaluates its contracts with insurance carriers, laboratory partners and patients and identifies the performance obligations in those contracts, which are the delivery of the test results.
16
The total consideration which the Company expects to collect in exchange for the Company’s products is an estimate and may be fixed or variable. Consideration includes reimbursement from both patients and insurance carriers, adjusted for variable consideration related to disallowed cases, discounts, refunds and doubtful accounts, and is estimated using the expected value approach. For insurance carriers with similar reimbursement characteristics, the Company uses a portfolio of relevant historical data to estimate variable consideration and total collections for the Company’s products. The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future periods. The consideration expected from laboratory partners usually includes a fixed amount, but it can be variable depending on the volume of tests performed, and the Company determines the variable consideration using the expected value approach. For insurance carriers, laboratory partners and patients, the Company allocates the total consideration to a single performance obligation, which is the delivery of the test results to the customers.
When assessing the total consideration for insurance carriers and patients, a certain percentage of revenues is further constrained for estimated refunds.
The Company generally bills an insurance carrier, a laboratory partner or a patient upon delivery of test results. The Company also bills patients directly for out-of-pocket costs involving co-pays and deductibles that they are responsible for. Tests billed to insurance carriers and directly to patients usually take an average of nine to twelve months to collect payment, and for tests billed to laboratory distribution partners, the average collection cycle takes approximately two to three months. At times, the Company may or may not get reimbursed for the full amount billed. Further, the Company may not get reimbursed at all for tests performed if such tests are not covered under the insurance carrier’s reimbursement policies or the Company is not a qualified provider to the insurance carrier, or if the tests were not previously authorized.
Product revenue is recognized in an amount equal to the total consideration (as described above) at a point in time when the test results are delivered. The Company reserves certain amounts in other accrued liabilities on the balance sheet in anticipation of requests for refunds of payments previously made by insurance carriers, which are accounted for as reductions in product revenues in the statement of operations and comprehensive loss. During the three months ended September 30, 2021 and 2020, $1.6 million and $1.1 million, respectively, were released from amounts previously held in reserves in other accrued liabilities, and recognized as product revenue. During the nine months ended September 30, 2021 and 2020, $4.6 million and $2.7 million, respectively, were released from amounts previously held in reserves in other accrued liabilities, and recognized as product revenue. The release of amounts reserved were recognized as product revenue within that period.
Licensing and Other Revenues
The Company recognizes licensing revenues from its cloud-based distribution service offering, Constellation, by granting licenses to its licensees to use certain of the Company’s proprietary intellectual properties and cloud-based software and IVD kits. The Company also recognizes revenues from the Signatera research use only (“RUO”) offering and from its agreements with Qiagen LLC, (“Qiagen”), BGI Genomics Co., Ltd. (“BGI Genomics”), and Foundation Medicine, Inc. (“Foundation Medicine”).
17
Constellation
The laboratory partners with whom the Company enters into a licensing arrangement represent the licensees and are identified as customers. The licensees do not have the right to possess the Company’s software, but rather receive services through the cloud software. These arrangements often include: (i) the delivery of the services through the cloud software, (ii) the necessary support and training, and (iii) the IVD kits to be consumed as tests are processed. The Company does not consider the software as a service, the support or the training as being distinct in the context of such arrangements, and therefore they are combined as a single performance obligation. The software, support and training are delivered simultaneously to the licensees over the term of the arrangement.
The Company bills the majority of licensees, who process the tests in their laboratories, a fixed price for each test processed. Licensing revenues are recognized as the performance obligations are satisfied (i.e., upon the delivery of each test) and reported in licensing and other revenues in the Company’s statements of operations and comprehensive loss.
Signatera
The Company enters into agreements with pharmaceutical companies to utilize the Company’s Signatera tests typically to study new cancer treatments or to validate the outcomes of clinical trials for which the pharmaceutical companies are identified as customers. Such arrangements generally involve performing whole exome sequencing (“WES”) services and the testing of patient samples to detect cancer mutations using its Signatera test. Each test is billable to customers and the personalized cancer profile also makes each test distinct within the context of the contract as customers can exercise control over the test results upon delivery. The Company allocates the contract price to each test using the stand-alone selling price for each service and recognizes the test processing revenue as individual test results are delivered to customers.
Qiagen
In March 2018, the Company entered into a License, Development and Distribution Agreement (the “Qiagen Agreement”) with Qiagen under which the Company granted Qiagen a license to develop, manufacture, distribute and commercialize NGS-based genetic testing assays and sequencing systems utilizing such assays, which incorporate the Company’s proprietary technology. According to the terms of the Qiagen Agreement, the Company is initially entitled to receive an upfront license fee and prepaid royalties totaling $40.0 million, which was fully collected in 2018. All or a portion of the prepaid royalties are refundable in limited circumstances. In addition, the Company was entitled to potential milestone payments from Qiagen upon the successful achievement of certain volume, regulatory and commercial milestones, and tiered royalties of $10.0 million, of which the Company received $5.0 million due December 31, 2018. The Qiagen Agreement has a term of 10 years and expires in March 2028, and it may be terminated earlier in certain circumstances. Upon termination of the Qiagen Agreement, the license granted to Qiagen will also terminate, except in certain limited circumstances. The Company provided to Qiagen standard indemnification protections, which is part of an assurance that the license meets the contract’s specifications and is not an obligation to provide goods or services.
Effective in March 2020, the Company terminated the Qiagen Agreement. Subsequently, in March 2021, the Company and Qiagen signed a Termination and Settlement Agreement where the Company agreed to refund a net $10 million as a result of the termination. The remaining $28.6 million of deferred revenue was recognized as other licensing and other revenue in the first quarter of 2021.
BGI Genomics
In February 2019, the Company entered into a License Agreement (the “BGI Genomics Agreement”) with BGI Genomics to develop, manufacture, and commercialize NGS-based genetic testing assays for clinical and commercial use. The BGI Genomics Agreement has a term of ten years and expires in February 2029. According to the BGI Genomics Agreement, the Company is entitled to a total of $50 million, comprised of upfront technology license fees, prepaid royalties relating to future sales of licensed products and performance of assay interpretation services, and milestone payments. During the three months ended June 30, 2019, the Company received $35.6 million, net of withholding taxes, of these amounts. The Company recorded a receivable of $2.5 million upon achieving the first milestone as of June 30,
18
2019, which was received in January 2021. Also, as required by the BGI Genomics Agreement, in June 2019 the Company prepaid $6.0 million to BGI Genomics for future sequencing services and $4.0 million for future sequencing equipment. These advance payments for equipment and services to be received in future periods aggregating to $10.0 million were recorded in long-term advances on the Company’s Condensed Consolidated Balance Sheet.
Pursuant to the BGI Genomics Agreement, the Company licensed its intellectual property and will provide development services. Following completion of development services, the Company will provide assay interpretation services over the term of the BGI Genomics Agreement. The Company concluded that the license is not a distinct performance obligation as it does not have a stand-alone value to BGI Genomics apart from the related development services. Therefore, license and related development services, for each NIPT and Oncology product, represents a single performance obligation.
The Company is responsible for granting a license to specified intellectual property and performing certain development activities to customize its genetic testing assays for oncology and NIPT for use with BGI Genomics’ sequencing instruments and proprietary technology platform. Revenue associated with these performance obligations is recognized over time using the input method, based on costs incurred to perform the development services, since the level of costs incurred over time best reflect the transfer of development services. Revenue associated with the assay interpretation services will be recognized upon delivery of these services. Funds received in advance are recorded as deferred revenue and will be recognized as the related services are delivered.
The initial transaction price was primarily comprised of license and milestone fees. The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future periods. Certain milestone and license fees were constrained and not included in the transaction price due to the uncertainties of research and development. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The allocation of the transaction price was performed based on standalone selling prices, which are based on estimated amounts that the Company would charge for a performance obligation if it were sold separately.
In accordance with ASC 340-40, any incremental costs incurred to obtain a contract with a customer are required to be capitalized and amortized over the period in which the goods and services are transferred to the customer. The Company has elected to apply a practical expedient under ASC 340-40 to recognize the incremental costs of obtaining a contract as an expense when incurred provided that the amortization period of such costs, if capitalized, is one year or less. The incremental costs incurred in connection with the BGI Genomics arrangement is not material on an accumulated basis and therefore will not be capitalized on the balance sheet but will be expensed as incurred.
Foundation Medicine, Inc.
In August 2019, the Company entered into a License and Collaboration Agreement (the “Foundation Medicine Agreement”) with Foundation Medicine to develop and commercialize personalized circulating tumor DNA monitoring assays, for use by biopharmaceutical and clinical customers who order Foundation Medicine’s FoundationOne CDx. The Foundation Medicine Agreement has an initial term of five years, expiring in August 2024, with automatic renewals thereafter for successive one-year terms, unless the Foundation Medicine Agreement is earlier terminated in accordance with its terms. Natera and Foundation Medicine will share the revenues generated from both biopharmaceutical and clinical customers in accordance with the terms of the Foundation Medicine Agreement. The Foundation Medicine Agreement provides for approximately $13.3 million in upfront licensing fees and prepaid revenues payable to the Company, and up to approximately $32.0 million in minimum annual payments and payments tied to the Company’s achievement of certain developmental, regulatory, and commercial milestones. As of December 31, 2019, the Company received $16.3 million of these amounts, of which $3.0 million was for achieving certain milestones, and $13.3 million was for licensing fees and prepaid revenue. There was an additional milestone met in May 2021. The Company accrued a $1.0 million milestone payment against accounts receivable and short-term deferred revenue. This milestone was paid in early July 2021. No other payments have been received in the nine months ending September 30, 2021.
Pursuant to the Foundation Medicine Agreement, the Company will provide development services in conjunction with granting the use of the Company’s intellectual property. Following completion of those development services, the
19
Company is currently providing RUO assay testing services over the term of the agreement. The Company has concluded that the license is not a distinct performance obligation as it is highly interrelated and interdependent with the related development services. Therefore, license and related development services represent a single performance obligation.
The Company is responsible for providing the technology license and certain development services that are required to customize its proprietary Signatera test to work with Foundation Medicine’s FoundationOne CDx. The intellectual property has been licensed to Foundation Medicine for the customized test. In addition, the Company is responsible for delivering clinical study plans in order to demonstrate efficacy of the customized test which has commenced in the second quarter of 2021. Revenues associated with each of the performance obligations are recognized over time using the input method, based on costs incurred to perform the development services, since the level of costs incurred over time best reflect the transfer of development services. Revenue associated with the assay testing services will be recognized upon delivery of these services. Funds received in advance are recorded as deferred revenue and will be recognized as the related services are delivered.
The initial transaction price was primarily comprised of license and milestone fees. The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future periods. Certain milestone fees were constrained and not included in the transaction price due to the uncertainties of research and development. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. The allocation of the transaction price was performed based on standalone selling prices, which are based on estimated amounts that the Company would charge for a performance obligation if it were sold separately.
In accordance with ASC 340-40, any incremental costs incurred to obtain a contract with a customer are required to be capitalized and amortized over the period in which the goods and services are transferred to the customer. The Company has elected to apply a practical expedient under ASC 340-40 to recognize the incremental costs of obtaining a contract as an expense when incurred provided that the amortization period of such costs, if capitalized, is one year or less.
Disaggregation of Revenues
The Company measures its performance results primarily based on revenues recognized from the three categories described below. The following table shows disaggregation of revenues by payer types:
20
The following table presents total revenues by geographic area based on the location of the Company’s payers:
The following table summarizes the Company’s beginning and ending balances of accounts receivable and deferred revenues:
The following table shows the changes in the balance of deferred revenues during the period:
During the nine months ended September 30, 2021, revenue recognized that was included in the deferred revenue balance at the beginning of the period totaled $32.9 million, with approximately a net $4.0 million related to BGI Genomics and Foundation Medicine, and $28.6 million related to Qiagen, with the remaining $0.3 million related to genetic testing services. The current portion of deferred revenue includes $3.5 million from the BGI Genomics Agreement and $3.7 million from the Foundation Medicine Agreement.
4. Fair Value Measurements
The Company's financial assets and liabilities carried at fair value are comprised of investment assets that include money market and investments.
21
The fair value accounting guidance requires that assets and liabilities be carried at fair value and classified in one of the following three categories:
Level I: Quoted prices in active markets for identical assets and liabilities that the Company has the ability to access.
Level II: Observable market-based inputs or unobservable inputs that are corroborated by market data, such as quoted prices, interest rates, and yield curves.
Level III: Inputs that are unobservable data points that are not corroborated by market data.
This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value.
Assets and Liabilities That Are Measured at Fair Value on a Recurring Basis
The following table represents the fair value hierarchy for the Company’s financial assets and financial liabilities measured at fair value on a recurring basis:
Fair Value of Long-Term Debt:
As of September 30, 2021, the estimated fair value of the Convertible Notes, which are not presented at fair value on the Condensed Consolidated Balance Sheets as of September 30, 2021, was $863.3 million and was based upon observable, Level 2 inputs, including pricing information from recent trades of the Convertible Notes (see Note 10, Debt).
22
5. Financial Instruments
The Company elected to invest a portion of its cash assets in conservative, income earning, and liquid investments. Cash equivalents and investments, all of which are classified as available-for-sale securities, consisted of the following:
(1) | Per the Company’s investment policy, all debt securities are classified as short-term investments irrespective of holding period. |
(2) | Cash equivalents includes cash sweep accounts and U.S. Treasury money market mutual funds. |
The Company invests in U.S. Treasuries, U.S. agency and high quality municipal bonds which mature at par value and are all paying their coupons on schedule. The Company has therefore concluded there is currently no other than temporary impairment of its investments and will continue to recognize unrealized gains and losses in other comprehensive income (loss). During the nine months ended September 30, 2021 and 2020, the Company sold $77.6 million and $11.5 million of investments, respectively. During the nine months ended September 30, 2021, the amount of gross realized gains and realized losses upon sales of investments were insignificant. The Company uses the specific investment identification method to calculate realized gains and losses and amounts reclassified out of other comprehensive income to net income. As of September 30, 2021, the Company had 43 investments in an unrealized loss position in its portfolio. An allowance for credit losses was not necessary for the third quarter of 2021 since the investments are low risk, investment grade securities. The Company has assessed the unrealized loss position for available-for-sale debt securities for which an allowance for credit losses has not been recorded. The fair value for investment securities at an unrealized loss position as of September 30, 2021 was $522.0 million. The aggregate amount of unrealized losses of these securities was $0.7 million, and the impact of the securities in a continuous loss position to the condensed consolidated statements of operations and comprehensive loss were not material as of September 30, 2021.
The following table summarizes the Company’s portfolio of available-for-sale securities by contractual maturity as of September 30, 2021:
23
6. Balance Sheet Components
Property and Equipment, net
The Company’s property and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
||
|
Useful Life |
2021 |
|
2020 |
||
|
|
(in thousands) |
||||
Machinery and equipment |
3-5 years |
$ |
64,583 |
|
$ |
51,001 |
Furniture and fixtures |
3 years |
|
1,393 |
|
|
1,376 |
Computer equipment |
3 years |
|
2,772 |
|
|
2,428 |
Capitalized software held for internal use |
3 years |
|
8,776 |
|
|
7,417 |
Leasehold improvements |
Lesser of useful life or lease term |
|
15,351 |
|
|
14,810 |
Construction-in-process |
|
|
24,732 |
|
|
6,370 |
|
|
|
117,607 |
|
|
83,402 |
Less: Accumulated depreciation and amortization |
|
|
(58,314) |
|
|
(50,054) |
Total Property and Equipment, net |
|
$ |
59,293 |
|
$ |
33,348 |
All of the Company’s long-lived assets are located in the United States.
During the nine months ended September 30, 2021, the increase in net property and equipment was due to purchases of new equipment for the Company’s laboratories located in Texas and California to expand testing capabilities, offset by depreciation expense of $8.3 million recorded in the nine months ended September 30, 2021. The Company did not incur an impairment charge during the nine months ended September 30, 2021.
Accrued Compensation
The Company’s accrued compensation consisted of the following:
|
|
|
|
|
|
|
September 30, |
|
December 31, |
||
|
2021 |
|
2020 |
||
|
(in thousands) |
||||
Accrued paid time off |
$ |
2,472 |
|
$ |
2,260 |
Accrued commissions |
|
10,950 |
|
|
12,686 |
Accrued bonuses |
|
12,275 |
|
|
9,635 |
Other accrued compensation |
|
9,634 |
|
|
5,790 |
Total accrued compensation |
$ |
35,331 |
|
$ |
30,371 |
24
Other Accrued Liabilities
The Company’s other accrued liabilities consisted of the following:
|
|
|
|
|
|
|
September 30, |
|
December 31, |
||
|
2021 |
|
2020 |
||
|
(in thousands) |
||||
Reserves for refunds to insurance carriers |
$ |
15,879 |
|
$ |
17,366 |
Accrued charges for third-party testing |
|
17,690 |
|
|
5,141 |
Testing and laboratory materials from suppliers |
|
6,513 |
|
|
2,720 |
Marketing and corporate affairs |
|
6,152 |
|
|
3,325 |
Legal, audit and consulting fees |
|
15,215 |
|
|
4,189 |
Accrued shipping charges |
|
399 |
|
|
1,604 |
Sales tax payable |
|
1,758 |
|
|
1,723 |
Accrued third-party service fees |
|
3,363 |
|
|
2,355 |
Clinical trials and studies |
|
6,282 |
|
|
2,353 |
Operating lease liabilities, current portion |
|
6,922 |
|
|
7,300 |
Fixed asset purchases |
|
4,957 |
|
|
1,691 |
Other accrued interest |
|
2,695 |
|
|
1,078 |
Other accrued expenses |
|
8,661 |
|
|
9,562 |
Total other accrued liabilities |
$ |
96,486 |
|
$ |
60,407 |
Reserves for refunds to insurance carriers include overpayments from and amounts to be refunded to insurance carriers, and additional amounts that the Company estimates for potential refund requests during the period. When the Company releases these previously accrued amounts, they are recognized as product revenues in the statements of operations and comprehensive loss.
The following table summarizes the reserve balance and activities for refunds to insurance carriers for the nine months ended September 30, 2021:
7. Leases
Operating Leases
In September 2015, the Company’s subsidiary entered into a long-term lease agreement for laboratory and office space totaling approximately 94,000 square feet in Austin, Texas. The lease term is 132 months beginning in December 2015 and expiring in November 2026 with monthly payments beginning in December 2016.
In October 2016, the Company entered into a lease directly with its landlord for laboratory and office spaces at its facilities located in San Carlos, California. The Company currently occupies approximately 113,000 square feet comprised of two office spaces (the “First Space” and the “Second Space”). The First Space covers approximately 88,000 square feet, and the Second Space totals approximately 25,000 square feet. The term of this lease is approximately 84 months and expires in October 2023. This lease contains an option to renew the lease term for five years, but the fair market rent amount upon renewal is not available from the landlord. In January 2021, the Company entered into an
25
amendment of the lease to extend the term for 48 months to October 2027. The combined annual rent for the First Space and Second Space will be $9.3 million commencing in October 2023.
The Company entered into a lease agreement commencing June 2018 for its cord blood tissue storage facility in Tukwila, Washington that covers approximately 10,000 square feet. The lease term is 62 months expiring in July 2023. The Company has the option to extend this lease for five years, and the fair market rent upon renewal is not determinable. However, since the Company sold its business related to cord blood and tissue storage in September 2019, the Company has subleased the facility and does not intend to exercise its option to renew the facility upon expiration.
In addition, the Company entered into a sublease agreement in June 2019 with a third party to sublease 25,879 square feet of space located on the third floor of the San Carlos, California building while maintaining its primary obligation as the intermediate lessor. The term of this lease is approximately 48 months commencing in October 2019 and expiring in September 2023. The annual lease payment starts at $1.9 million and will escalate annually commencing in October 2020. In February 2021, the Company entered into an amendment of the San Carlos sublease agreement whereas the third party will surrender 25,879 rentable square feet by the end of the year. For the nine months ended September 30, 2021, the Company had noncash investing activities of $31.3 million primarily related to additional right-of-use assets of which $29.7 million was a result of the San Carlos lease extension which was accounted for as a modification under ASC 842.
The Company entered into a lease agreement in November 2020 to lease 11,395 square feet of space located in South San Francisco, California over a 36-month term. The premises will be used for general office, laboratory and research use. The annual lease payment starts at $0.9 million and will escalate annually commencing in December 2021.
As part of the IPR&D asset acquisition in September 2021, the Company inherited a lease for 7,107 square feet of laboratory space in Canada over a 24-month period. The annual lease payment starts at $0.2 million.
The Company has also historically entered into leases of individual workspaces at various locations on both a month-to-month basis without an established lease term, and more recently for certain locations, have committed to terms approximating three to five years. For the facilities without a committed lease term, the Company has elected to not recognize them as the right-of-use assets on the balance sheet as they are all considered short-term leases. For individual workspaces where the committed lease term exceeds one year, the Company has recorded a right-of-use asset.
The operating lease right-of-use assets are classified as noncurrent assets in the balance sheet. The corresponding lease liabilities are separated into current and long-term portions as follows:
The initial recognition of the operating lease liabilities was measured as the present value of the future minimum lease payments using a discount rate determined as of January 1, 2019. The operating right-of-use assets was calculated as the operating lease liabilities discounted at the present value, less the amount of unamortized tenant improvement allowance and deferred rent. The discount rate used was the Company’s incremental borrowing rate given that the implicit rate to each lease was not readily determinable. In accordance with ASC 842, the incremental borrowing rate was estimated as the annual percentage yield resulting from a corporate debt financing over a loan term approximating the remaining term of each lease, with the effect of certain credit risk rating. As of September 30, 2021, the weighted-average remaining lease term was 3.66 years and the weighted-average discount rate was 7.48%.
26
The Company continues to recognize lease expense on a straight-line basis. The lease expense includes the amortization of the right-of-assets with the associated interest component estimated by applying the effective interest method. For the three months ended September 30, 2021 and 2020, total lease expense of $2.8 million and $1.9 million was recognized in the condensed statements of operations and comprehensive loss, respectively. For the nine months ended September 30, 2021 and 2020, total lease expense of $8.1 million and $5.8 million was recognized in the condensed statements of operations and comprehensive loss, respectively. Cash paid for amounts in the measurement of operating lease liabilities totaled $2.6 million and $2.2 million for the three months ended September 30, 2021 and 2020, respectively. Cash paid for amounts in the measurement of operating lease liabilities totaled $7.6 million and $6.6 million for the nine months ended September 30, 2021, respectively.
The present value of the future annual minimum lease payments under all non-cancellable operating leases as of September 30, 2021 are as follows:
27
8. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is involved in disputes, litigation, and other regulatory or administrative actions, including those with respect to intellectual property, employment, testing, billing, reimbursement and other matters. Such actions may include allegations of negligence, products/professional liability or other legal claims, and could involve claims for substantial compensatory and/or punitive damages or claims for indeterminate amounts of damages. The Company is aggressively defending and/or prosecuting its current litigation matters, but cannot provide any assurance as to the ultimate outcome or that an adverse resolution would not have a material adverse effect on its financial condition and results of operations. There are many uncertainties associated with any litigation and these actions or other third party claims against the Company, including by governmental entities, or by the Company against third parties, may cause the Company to incur costly litigation and/or substantial settlement charges. In addition, the resolution of any intellectual property litigation may require the Company to make royalty payments, which could adversely affect gross margins in future periods. If this were to occur, the Company's business, financial condition, results of operations, and cash flows could be adversely affected.
The Company assesses legal contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements. When evaluating legal contingencies, the Company may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition, damage amounts claimed in litigation or other matters may be unsupported, exaggerated or unrelated to possible outcomes, and as such are not meaningful indicators of its potential liability. During the periods presented, the Company has not recorded any accrual for loss contingencies associated with such legal proceedings or other matters, determined that an unfavorable outcome is probable or reasonably possible, or determined that the amount or range of any possible loss is reasonably estimable.
Intellectual Property Litigation Matters.
The Company has been involved in two patent litigations against CareDx, Inc. (“CareDx”) in the United States District Court for the District of Delaware (“CareDx Patent Cases”). In the first suit, CareDx alleged, in a complaint filed jointly with the Board of Trustees of the Leland Stanford Junior University (“Stanford”) in March 2019 and amended in March 2020, that the Company infringed three patents. The complaint sought unspecified damages and injunctive relief. On September 28, 2021, the Court granted the Company’s motion for summary judgment, finding all three patents invalid. CareDx and Stanford have filed a notice of appeal to the United States Court of Appeals for the Federal Circuit. In the second suit, filed by the Company in January 2020, the Company alleged infringement by CareDx of two of the Company’s patents, seeking unspecified damages and injunctive relief. The case is currently pending.
The Company has filed suit against ArcherDX, Inc. (“ArcherDX”) in the United States District Court for the District of Delaware, alleging, in complaints filed in January, April, and August of 2020, which cases were consolidated in September 2020, that certain ArcherDX DNA oncology products infringe five of the Company’s patents. In June 2020, ArcherDX filed a motion to dismiss aspects of the Company’s case, including to invalidate several of the Company’s asserted patents. That motion was denied in its entirety in October 2020. In January 2021, the Company filed a second amended complaint naming an additional Archer DX entity, ArcherDx LLC, and Invitae Corp. as defendants. The Company is seeking unspecified monetary damages and injunctive relief. A jury trial is set for May 16, 2022.
The Company is the subject of a lawsuit filed against it by Ravgen, Inc. (“Ravgen”) in June 2020 in the United States District Court for the Western District of Texas, alleging infringement of two Ravgen patents. The complaint seeks monetary damages and injunctive relief. Trial is set for December 13, 2021.
The Company filed suit against Progenity, Inc. (“Progenity”) in June 2020 in the United States District Court for the Western District of Texas and in the United States District Court for the Northern District of Texas, in each case alleging that Progenity’s NIPT test infringes six of the Company’s patents. The complaints sought treble damages and
28
injunctive relief. In July 2020, Progenity filed suit against the Company in the United States District Court for the Southern District of California, seeking declaratory judgment of non-infringement of the Company’s asserted patents. Progenity also petitioned the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office for inter partes review of all of the Company’s asserted patents. The PTAB instituted review of three of the petitions and set trial for March 7, 2022, and denied institution of the other three petitions. On August 3, 2021, the parties entered into a settlement agreement to settle the matters described above.
In October 2020, the Company filed suit against Genosity Inc. (“Genosity”), in the United States District Court for the District of Delaware, alleging that various Genosity oncology products infringe one of the Company’s patents and seeking unspecified monetary damages and injunctive relief. In March 2021, the Company filed a motion to dismiss certain of Genosity’s affirmative defenses and a counterclaim.
In January 2021, the Company filed suit against Inivata, Inc. and Inivata Ltd. (collectively “Inivata”) in the United States District Court for the District of Delaware. The complaint, amended by the Company in May 2021, alleges that various Inivata oncology products infringe two of the Company’s patents and seeks unspecified monetary damages and injunctive relief. In June 2021, Inivata filed a motion to dismiss the Company’s amended complaint.
In May 2021, Invitae Corp. (“Invitae”) filed a complaint against the Company alleging infringement of one patent and seeking monetary damages and injunctive relief. In June 2021, the Company filed a motion to dismiss Invitae’s complaint in its entirety.
Other Litigation Matters.
In August 2019, a suit was filed against the Company in the Circuit Court of Cook County, Illinois by a patient alleging claims relating to a discordant test result and seeking monetary damages. The suit was dismissed in June 2021.
The Company is also the subject of a lawsuit filed by CareDx against the Company in April 2019 in the United States District Court for the District of Delaware, alleging false advertising, trademark disparagement, unfair competition, and unfair or deceptive trade practices based on statements describing studies that concern the Company’s technology and CareDx’s technology (“CareDx’s Advertising Case”). The complaint seeks unspecified damages and injunctive relief. In May 2019, the Company filed a motion to dismiss the entirety of CareDx’s Advertising Case for failure to state a claim, following which in February 2020, CareDx filed an amended complaint withdrawing its trademark disparagement claim. Also in February 2020, the Company filed a counterclaim against CareDx in the United States District Court for the District of Delaware, alleging false advertising, unfair competition and deceptive trade practices and seeking unspecified damages and injunctive relief. The parties cross-moved for partial summary judgment, which was denied in April 2021.
The Company is involved in litigation against Guardant, Inc. (“Guardant”). On or about May 27, 2021, Guardant filed suit against the Company in the United States District Court of the Northern District of California alleging false advertising and related claims and seeking unspecified damages and injunctive relief. On or about May 28, 2021, the Company filed suit against Guardant in the Western District of Texas, alleging false advertising and related claims. The Company has voluntarily dismissed its Texas suit against Guardant. In the California action, the Company has answered Guardant’s complaint and has asserted its claims as counterclaims, seeking unspecified damages and injunctive relief. On August 3, 2021, Guardant moved to dismiss the Company’s counterclaims.
29
Director and Officer Indemnifications
As permitted under Delaware law, and as set forth in the Company’s Amended and Restated Certificate of Incorporation and its Amended and Restated Bylaws, the Company indemnifies its directors, executive officers, other officers, employees and other agents for certain events or occurrences that may arise while in such capacity. The maximum potential amount of future payments the Company could be required to make under this indemnification is unlimited; however, the Company has insurance policies that may limit its exposure and may enable it to recover a portion of any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, the Company believes any obligations under this indemnification would not be material, other than standard retention amounts for securities related claims. However, no assurances can be given that the covering insurers will not attempt to dispute the validity, applicability, or amount of coverage without expensive litigation against these insurers, in which case the Company may incur substantial liabilities as a result of these indemnification obligations.
Third-Party Payer Reimbursement Audits
From time to time, the Company receives recoupment requests from third-party payers for alleged overpayments. The Company disagrees with the contentions of pending requests and/or has recorded an estimated reserve for the alleged overpayments.
Contractual Commitments
The following table sets forth the material contractual commitments as of September 30, 2021 with a remaining term of at least one year:
|
|
|
|
|
Party |
Commitments |
|
Expiry Date |
|
|
|
(in thousands) |
|
|
Material suppliers |
$ |
14,717 |
|
June 2026 |
Application service providers |
|
30,331 |
|
March 2026 |
Earnouts for asset development with third party* |
|
35,000 |
|
September 2023 |
Other material suppliers |
|
10,581 |
|
Various |
Total |
$ |
90,630 |
|
|
* The earnouts for asset development with the third party consists of three milestones which are upon the satisfaction of certain contractual conditions.
9. Stock-Based Compensation
2015 Equity Incentive Plan
General. The Company’s board of directors adopted its 2015 Equity Incentive Plan (the “2015 Plan”) in June 2015. The 2015 Plan replaced all of its prior stock plans.
Share Reserve. The initial number of shares of the Company’s common stock available for issuance under the 2015 Plan was 3,451,495 shares. The number of shares reserved for issuance under the 2015 Plan will be increased automatically on the first business day of each fiscal year, commencing in 2016, by a number equal to the smallest of:
● | 3,500,000 shares; |
● | 4% of the shares of common stock outstanding on the last business day of the prior fiscal year; or |
● | the number of shares determined by the Company’s board of directors. |
30
Stock options vest as determined by the compensation committee. In general, they will vest over a four-year period following the date of grant. Stock options expire at the time determined by the compensation committee but in no event more than ten years after they are granted. These awards generally expire earlier if the participant's service terminates earlier.
Restricted Shares and Stock Units. Restricted shares and stock units may be awarded under the 2015 Plan in return for any lawful consideration, and participants who receive restricted shares or stock units generally are not required to pay cash for their awards. In general, these awards will be subject to vesting. Vesting may be based on length of service, the attainment of performance-based milestones or a combination of both, as determined by the compensation committee.
Performance-based Awards
The Company grants certain senior-level executives performance stock options and units which vest based on either market and time-based service conditions or performance and time-based service conditions, which are referred to herein as performance-based awards. The Company assessed the performance-based awards with the appropriate valuation method and has recognized the applicable stock-based compensation expense. The following table summarizes the performance-based awards as of September 30, 2021:
________________________________
(1) The awards will vest based on the achievement of certain values of the Company’s common stock at multiple thresholds within certain periods and are contingent upon the completion of requisite service through the date of such vesting.
(2) The vesting of the awards will be triggered after the end of the achievement milestone, as measured by the Company.
(3) The awards will vest based on achievement of a revenue target and are contingent upon the completion of requisite service through the date of such vesting.
(4) The awards vest based on achievement of a reimbursement target.
|
The Company has recognized $9.6 million and $39.5 million in stock-based compensation for performance-based awards for the three and nine months ended September 30, 2021, respectively. The Company has recognized $6.6 million and $11.8 million in stock-based compensation for performance-based awards for the three and nine months ended September 30, 2020, respectively.
31
The Company estimated the fair value of performance-based awards with market conditions using a Monte-Carlo simulation model with the following inputs for the period ended September 30, 2021:
|
|
|
|
|
|
|
|
September 30, |
|||||
|
2021 |
|||||
Risk-free interest rate |
|
0.80 |
% |
— |
1.42 |
% |
Expected dividend yield |
|
|
|
|
0.00 |
% |
Expected volatility |
|
|
|
|
60 |
% |
Expected term (years) |
|
7.25 |
|
— |
10.00 |
|
Employee Stock Purchase Plan
During the period ended September 30, 2021, there have not been any changes to the Company’s 2015 Natera, Inc. Employee Stock Purchase Plan (the “ESPP”) as disclosed in Form 10-K for the fiscal year ended December 31, 2020. The Company has made 2,940,084 shares available for issuance under the Plan as of September 30, 2021, a number that is automatically increased by the least of (i) 1% of the total number of shares of common stock actually issued and outstanding on the last business day of the prior fiscal year, (ii) 880,000 shares of common stock (subject to certain adjustments pursuant to Subsection (c) below), or (iii) a number of shares of common stock determined by the Company’s board of directors.
The first offering period of 2021 started on November 1, 2020 and ended on April 30, 2021, and 106,435 shares were purchased for proceeds of $6.1 million. The second offering period of 2021 began on May 1, 2021 and will end on October 31, 2021. As of September 30, 2021, no shares have been purchased in the second offering period.
32
Stock Options and Restricted Stock Units
The following table summarizes option activity for the nine months ended September 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
||||||||||
|
|
|
|
|
|
|
|
Weighted- |
|
|
||
|
|
|
|
|
|
Weighted- |
|
Average |
|
|
||
|
|
Shares |
|
|
|
Average |
|
Remaining |
|
Aggregate |
||
|
|
Available for |
|
Number of |
|
Exercise |
|
Contractual |
|
Intrinsic |
||
(in thousands, except for contractual life and exercise price) |
|
Grant |
|
Shares |
|
Price |
|
Life |
|
Value |
||
|
|
|
|
|
|
|
|
|
(in years) |
|
|
|
Balance at December 31, 2020 |
|
3,197 |
|
6,707 |
|
$ |
11.19 |
|
6.04 |
|
$ |
592,468 |
Additional shares authorized |
|
3,446 |
|
— |
|
|
|
|
|
|
|
|
Options granted |
|
(391) |
|
391 |
|
$ |
104.02 |
|
|
|
|
|
Options exercised |
|
— |
|
(1,051) |
|
$ |
10.26 |
|
|
|
|
|
Options forfeited/cancelled |
|
35 |
|
(35) |
|
$ |
13.78 |
|
|
|
|
|
RSUs granted |
|
(1,528) |
|
— |
|
|
|
|
|
|
|
|
RSUs forfeited/cancelled |
|
227 |
|
— |
|
|
|
|
|
|
|
|
Balance at September 30, 2021 |
|
4,986 |
|
6,012 |
|
$ |
17.37 |
|
5.63 |
|
$ |
566,871 |
Exercisable at September 30, 2021 |
|
|
|
4,785 |
|
$ |
9.99 |
|
4.98 |
|
$ |
485,498 |
Vested and expected to vest at September 30, 2021 |
|
|
|
5,936 |
|
$ |
17.00 |
|
5.60 |
|
$ |
561,788 |
The following table summarizes RSU activity for the nine months ended September 30, 2021:
Stock-Based Compensation Expense
Stock based compensation is related to stock options and RSUs granted to the Company’s employees and is measured at the grant date based on the fair value of the award. The fair value is recognized as expense over the requisite service period, which is generally the vesting period of the respective awards on a straight-line basis. No compensation cost is recognized when the requisite service has not been met and the awards are therefore forfeited.
Employee stock-based compensation expense was calculated based on awards ultimately expected to vest and has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Non-employee stock-based compensation expense was not adjusted for estimated forfeitures up until the occurrence of the actual forfeiture of the associated awards.
33
The following tables present the effect of employee and non-employee stock-based compensation expense on selected statements of operations line items for the three and nine months ended September 30, 2021 and 2020.
As of September 30, 2021, approximately $195.3 million of unrecognized compensation expense, adjusted for estimated forfeitures, related to unvested option awards and RSUs will be recognized over a weighted-average period of approximately 2.8 years.
Valuation of Stock Option Grants to Employees and Non-employees
The Company utilizes the Black-Scholes option pricing model when estimating the fair value of stock options. For the three nine months ended September 30, 2021, the following valuation assumptions were applied on both the employee and non-employee options. In the same period of the prior year, the valuation assumptions as follows were only used for stock options granted to employees.
As of September 30, 2021, total options outstanding include 32,053 shares of option awards that were granted to non-employees, of which 1,459 shares are unvested. Stock-based compensation expense related to stock options granted to non-employees is recognized as the stock option is earned and the services are rendered. The Company believes that the estimated fair value of the stock options is more readily measurable than the fair value of the services rendered.
34
10. Debt
Credit Line Agreement
In September 2015, the Company entered into a credit line with UBS (the “Credit Line”) providing for a $50.0 million revolving line of credit which was fully drawn down in 2016. The Credit Line was amended in July 2017 and bears interest at 30-day LIBOR plus 1.10%. The Credit Line is secured by a first priority lien and security interest in the Company’s money market and marketable securities held in its managed investment account with UBS. UBS has the right to demand full or partial payment of the Credit Line Obligations and terminate the Credit Line, in its discretion and without cause, at any time.
For the three months ended September 30, 2021 and 2020, the Company recorded interest expense on the Credit Line of $0.2 million for both periods. For the nine months ended September 30, 2021 and 2020, the Company recorded interest expense on the Credit Line of $0.5 million and $0.7 million, respectively. Interest payments on the Credit Line were made within the same periods. As of September 30, 2021, the total principal amount outstanding with accrued interest was $50.0 million.
Convertible Notes
In April 2020, the Company issued $287.5 million aggregate principal amount of Convertible Notes due 2027 in a private placement offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The Convertible Notes are senior, unsecured obligations of the Company and bear interest at a rate of 2.25% per year, payable in cash semi-annually. The Convertible Notes mature in May 2027, unless earlier converted, repurchased or redeemed in accordance with their terms. Upon conversion, the Convertible Notes are convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election.
The Company received net proceeds from the Convertible Notes of $278.3 million, after deducting the initial purchasers’ discounts and debt issuance costs. The Company used approximately $79.2 million of the net proceeds from the Convertible Notes offering to repay its obligations under the 2017 Term Loan with OrbiMed.
The holders of the Convertible Notes may convert all or a portion of their Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding February 1, 2027 in multiples of $1,000 principal amount, under any the following circumstances:
● | During any fiscal quarter commencing after March 31, 2020 (and only during such fiscal quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding fiscal quarter is greater than or equal to 130% of the conversion price on each applicable trading day. |
● | During the five business day period after any five consecutive trading day period in which the trading price per $1,000 principal amount of Convertible Notes for each trading day of that five-day consecutive trading period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day. |
● | If the Company calls any or all of the Convertible Notes for redemption at any time prior to the close of business on the second business day prior to the redemption date. |
● | Upon the occurrence of certain distributions. |
● | Upon the occurrence of specified corporate transactions. |
The Convertible Notes are convertible into shares of the Company’s common stock, par value $0.0001 per share, at an initial conversion rate of 25.7785 shares of common stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $38.79 per share of common stock, convertible to 7,411,704 shares of common stock. The conversion rate and corresponding conversion price are subject to adjustment
35
upon the occurrence of certain events but will not be adjusted for any accrued or unpaid interest. The holders of the Convertible Notes who redeem their Convertible Notes in connection with a make-whole fundamental change are, under certain circumstances, entitled to an increase in the conversion rate. Additionally, in the event of a fundamental change, the holders of the Convertible Notes may require the Company to repurchase for cash all or a portion of their Convertible Notes at a price equal to 100% of the principal amount, plus any accrued and unpaid interest.
The Company may not redeem the Convertible Notes prior to May 2024, and no sinking fund is provided for the Convertible Notes. The Company may redeem for cash all or any portion of the Convertible Notes, at the Company’s option, on or after May 2024, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on the trading day immediately preceding the date on which the Company provides notice of redemption. The redemption price will be equal to 100% of the principal amount of the Convertible Notes to be redeemed plus accrued and unpaid interest.
Upon adoption of ASU 2020-06, the Company allocated all of the debt discount to long-term debt. The debt discount is amortized to interest expense using the effective interest method, computed to be 2.72%, over the life of the Convertible Notes or approximately its seven-year term. The outstanding Convertible Notes balances as of September 30, 2021 are summarized in the following table:
The following table presents total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2021:
11. Income Taxes
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was signed into law in March 2020. The CARES Act includes modifications for net operating loss carryovers and carrybacks, limitations of business interest expense, immediate refund of alternative minimum tax (“AMT”) credit carryovers as well as a technical correction to the Tax Cuts and Jobs Act of 2017, for qualified improvement property. As of September 30, 2021, the Company expects that these provisions will not have a material impact as the Company has no net operating losses or AMT credits that would fall under these provisions and does not expect interest expense to be deductible due to current and historical losses.
During the three months ended September 30, 2021 and 2020, the Company recorded total income tax expense of approximately $272,000 and $25,000, respectively. During the nine months ended September 30, 2021 and 2020, the Company recorded total income tax expense of approximately $648,000 and $63,000, respectively. For the three and nine months ended September 30, 2021, the income tax expense is primarily attributable to state income tax and foreign income
36
tax expenses resulting from testing to clinics and licenses of cloud-based software and intellectual property that are based in a foreign country. There was no state income tax expense recorded for the three and nine months ended September 30, 2020. Due to the Company’s history of cumulative operating losses, the Company concluded that, after considering all the available objective evidence, it is not more likely than not that all of the Company’s net deferred tax assets will be realized. Accordingly, all of the Company’s deferred tax assets, which includes net operating loss or NOL carryforwards and tax credits related primarily to research and development, continue to be subjected to a valuation allowance as of September 30, 2021. The Company will continue to maintain a full valuation allowance until there is sufficient evidence to support recoverability of its deferred tax assets.
As described in Note 10, Debt, the Company accounted for the issuance of the Convertible Notes by separating the Convertible Notes into separate liability and equity components. The portion of the proceeds allocated to equity created a basis difference at issuance and resulted in a deferred tax liability. The debt issuance costs attributable to the equity component are deductible for tax and represent a deferred tax asset as of the issuance date. However, since the Company has a full valuation allowance, both the deferred tax liability related to the equity component and the deferred tax asset related to the debt issuance costs had no impact to income tax expense in the three and nine months ended September 30, 2021. The Company adopted ASU 2020-06 as of January 1, 2021 which recombined the liability and equity components of the Convertible Notes. Recombining the debt and equity components of the Convertible Notes impacted the difference between the book and tax base of the Convertible Notes. The deferred tax asset and deferred tax liability balances recorded in 2020 have been reversed as of January 1, 2021. Upon reversal of the deferred tax asset and liability the Company recognized an increase in the valuation allowance as of January 1, 2021.
The Company had $13.6 million and $11.5 million in unrecognized tax benefits as of September 30, 2021 and December 31, 2020, respectively. The reversal of the uncertain tax benefits would not affect the effective tax rate to the extent that the Company continues to maintain a full valuation allowance against its deferred tax assets. Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business.
Interest and/or penalties related to income tax matters are recognized as a component of income tax expense. As of September 30, 2021, there were no accrued interest and penalties related to uncertain tax positions.
As part of the IPR&D acquisition, the Company acquired $5.8 million of deferred tax assets which have been fully offset by a valuation allowance as it is not more likely that these assets will be realized as of September 30, 2021. Included in the deferred tax assets is $12.1 million of NOL carryforwards which begin to expire in 2031. Because the IPR&D was expensed immediately after acquisition, the Company treated this asset as IPR&D expense. For tax purposes the write-off of amounts assigned to IPR&D occurs prior to the measurement of deferred taxes. Therefore a deferred tax liability has not been recorded as of the acquisition date and the value of the IPR&D is expected to be treated as a permanent tax difference.
12. Net Loss per Share
Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, excluding shares subject to repurchase and without consideration of potentially dilutive securities. Diluted net loss per share is computed by giving effect to all potentially dilutive common shares outstanding for the period. For purposes of this computation, outstanding common stock options, and restricted stock units are considered to be common share equivalents. Common share equivalents are excluded from the computation in periods in which they have an anti-dilutive effect, unless the consideration of any one of them gives a dilutive effect.
The Convertible Notes are convertible as of September 30, 2021. Upon conversion, the Company has the option to pay cash, issue shares of common stock, or any combination thereof for the aggregate amount due upon conversion. If converted, the value of the Convertible Notes based on contractual settlement provisions would exceed its principal amount by $564.6 million as of September 30, 2021. Since the Company is in a net loss position in the periods presented, the shares which would be issued upon conversion of the Convertible Notes are excluded from the net loss per share calculation as it would have an antidilutive effect. As such, the 7.4 million shares underlying the conversion option of the Convertible
37
Notes will not have an impact on the Company’s diluted earnings per share. If converted, the Company does not intend to settle the obligation in cash.
The following table provides the basic and diluted net loss per share computations for the nine months ended September 30, 2021 and 2020.
The following table shows total outstanding potentially dilutive shares excluded from the computation of diluted loss per share as their effect would be anti-dilutive, as of September 30, 2021 and 2020:
13. Subsequent Events
None.
38
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. Our actual results could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020.
Overview
We are a diagnostics company with proprietary molecular and bioinformatics technology that we deploy to change the management of disease worldwide. Our technology has been proven clinically and commercially in women’s health, in which we develop and commercialize non- or minimally- invasive tests to evaluate risk for, and thereby enable early detection of, a wide range of genetic conditions, such as Down syndrome. We are now translating our success in women’s health and applying our core technology in oncology, for which we are commercializing a personalized blood-based DNA test to detect molecular residual disease and help guide treatment decisions, as well as in organ health, with tests to assess the health of organ transplant patients. We seek to enable even wider adoption of our technology through Constellation, 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 and distribution partners, including many of the largest international laboratories.
We currently provide a comprehensive suite of women’s health products, as well as our offerings in oncology and organ health, and our Constellation cloud-based platform. We generate a majority of our revenues from the sale of Panorama, our non-invasive prenatal test (“NIPT”), as well as Horizon, our Carrier Screening (“HCS”) test. In addition to Panorama and Horizon, our women’s health product offerings include Spectrum Preimplantation Genetics, our Anora miscarriage test, and our Vistara single-gene NIPT. Our oncology product is our Signatera molecular residual disease test, which we commercialize as a test run in our CLIA laboratory and offer on a research use only (“RUO”) basis to research laboratories and pharmaceutical companies; and our primary organ health offering is our Prospera transplant assessment test.
We process tests in our laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) in Austin, Texas and San Carlos, California. A portion of our testing is performed by third-party laboratories. Our customers include independent laboratories, national and regional reference laboratories, medical centers and physician practices for our screening tests, and research laboratories and pharmaceutical companies. We market and sell our prenatal, oncology, and organ health, screening tests both through our direct sales force and through our laboratory distribution partners. We bill clinics, laboratory distribution partners, patients, pharmaceutical companies and insurance payers for the tests we perform. In cases where we bill laboratory distribution partners, our partners in turn bill clinics, patients and insurers. The majority of our revenue comes from insurers with whom we have in-network contracts. Such insurers reimburse us for NIPT procedures pursuant to our in-network contracts with them, based on positive coverage determinations, which means that the insurer has determined that NIPT in general is medically necessary for this category of patient. In the United States, the majority of insurance providers provide positive NIPT coverage.
In addition to offering tests to be performed at our laboratories, either directly or through our laboratory distribution partners, we also establish licensing arrangements with laboratories under Constellation, our cloud-based distribution model, whereby our laboratory licensees run the molecular workflows themselves and then access our bioinformatics algorithms through our cloud-based software. This cloud-based distribution model results in lower revenues and gross profit per test compared to cases we process. However, because we do not incur the costs of processing the tests, our costs per test under this model are also lower. We began entering into these licensing arrangements starting in the fourth quarter of 2015.
39
The principal focus of our commercial operations is to offer our tests through both our direct sales force and laboratory distribution partners, and our Constellation licensees under our cloud-based distribution model. The number of tests that we accession is a key indicator that we use to assess our business. A test is accessioned when we receive the test at our laboratory, the relevant information about the test is entered into our computer system, and the test sample is routed into the appropriate workflow. This number is a subset of the number of tests that we process, which includes tests distributed through our Constellation licensees. The number of tests that we process is a key metric as it tracks overall volume growth, particularly as our laboratory partners may transition from sending samples to our laboratory to our cloud-based distribution model, as a result of which our tests accessioned would decrease but our tests processed would remain unchanged. During the nine months ended September 30, 2021, we processed 1,131,200 tests, comprised of approximately 1,089,200 tests accessioned in our laboratory, compared to approximately 731,500 tests processed, comprised of approximately 693,300 tests accessioned in our laboratory, during the nine months ended September 30, 2020. This increase in volume primarily represents continued commercial growth of Panorama and HCS, both as tests performed in our laboratory as well as through our Constellation software platform.
The percent of our revenues attributable to our U.S. direct sales force for the nine months ended September 30, 2021 was 90%, an increase from 87% for the nine months ended September 30, 2020. The percent of our revenues attributable to U.S. laboratory distribution partners for the nine months ended September 30, 2021 was 5%, a decrease from 7% in the same period in the prior year. Our ability to increase our revenues and gross profit will depend on our ability to further penetrate the U.S. market with our direct sales force. The percent of our revenues attributable to international laboratory distribution partners and other international sales for the nine months ended September 30, 2021 was 5%, down from 6% for the nine months ended September 30, 2020, due primarily to the increase in US direct sales as a percentage of revenue.
For the nine months ended September 30, 2021, total revenues were $452.5 million, compared to $278.6 million in the nine months ended September 30, 2020. Revenues generated from testing accounted for $406.3 million, representing 90% of total revenues for the nine months ended September 30, 2021; compared to $260.7 million representing 94% of total revenues for the nine months ended September 30, 2020. For the nine months ended September 30, 2021 and 2020, no customers exceeded 10% of the total revenues on an individual basis. Revenues from customers outside the United States were $24.7 million, representing approximately 5% of total revenues, for the nine months ended September 30, 2021. For the nine months ended September 30, 2020, revenues from customers outside the United States were $17.6 million, representing approximately 6% total revenues. Most of our revenues have been denominated in U.S. dollars, though we generate some revenue in foreign currency, primarily denominated in Euros and Singapore Dollars.
Our net loss for the nine months ended September 30, 2021 and 2020 were $331.2 million and $153.3 million, respectively. This included non-cash stock compensation expense of $84.8 million and $34.4 million for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, we had an accumulated deficit of $1.3 billion.
COVID-19 Impact
The COVID-19 pandemic has continued to present a global public health and economic challenge that has affected our business operations and the U.S. and other major economies and financial markets. We have modified our business practices in response to the spread of COVID-19 (including temporary closures of our offices, implementing remote work policies and practices, and other measures as we have deemed necessary or appropriate from time to time), and incur additional operating costs, and we may take further actions from time to time as may be required by government authorities or that we determine are in the best interests of our employees, customers and business partners. Such actions could also impact our ability to fully integrate businesses we may acquire in the future. There is no certainty that such actions will be sufficient to mitigate the risks posed by the virus or otherwise be satisfactory to government authorities. If significant portions of our workforce, and particularly our laboratory staff, are unable to work effectively, including due to illness, quarantines, social distancing, government actions or other restrictions in connection with the COVID-19 pandemic, our operations and financial results will be impacted.
The extent to which the COVID-19 pandemic impacts our business, results of operations and financial condition will depend on future developments, which continue to remain highly uncertain and cannot be predicted, including, but
40
not limited to, the continued duration and spread of the pandemic, its severity, the actions to contain the virus or address its impact, and whether, when and to what extent pre-pandemic economic and operating activities can resume. The COVID-19 pandemic could limit the ability of our customers, suppliers and business partners to perform under their contracts with us, including third-party payers’ ability to make timely payments to us during and following the pandemic. We may also experience a shortage of laboratory supplies and reagents or a suspension of services from other laboratories or third parties. We also increased our dependence on growing and maintaining a network of mobile phlebotomy specialists who can provide testing capabilities, as many consumers are unable to visit clinics, hospitals or other testing facilities as a result of the COVID-19 pandemic. Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business because of its global economic impact, including any recession that has occurred or may occur in the future.
Specifically, difficult macroeconomic conditions as a result of COVID-19, such as decreases in per capita income and level of disposable income, increased and prolonged unemployment, a decline in consumer confidence, as well as limited or significantly reduced points of access of our products, could have a material adverse effect on the demand for some of our products, such as our products targeted for the IVF market. Decreased demand for our tests, particularly in the United States, could negatively affect our overall financial performance. A significant portion of our revenue is concentrated in the United States, where the impact of COVID-19 has been significant, and the potential decrease in demand for our tests could have a disproportionately negative impact on our business and financial results.
In particular, while our test volumes in 2021 have increased compared to the previous year, and the average selling price of our tests in the nine months ended September 30, 2021 increased compared to the nine months ended September 30, 2020, we cannot predict volatility of the volumes and selling prices of our tests that may result from the continued impact of the COVID-19 pandemic, and either or both of these metrics may fluctuate from period to period. Further, we cannot predict the potential nature, magnitude and duration of the effects of the COVID-19 pandemic on our business.
In response to the COVID-19 pandemic, we have implemented measures to protect the health of our employees and to support the functionality of our laboratories. We will continue to support and incur expenditures towards COVID-19 prevention and employee safety.
Components of the Results of Operations
Revenues
We generate revenues from the sale of our tests, primarily from the sale of our Panorama and HCS tests. Our two primary distribution channels are our direct sales force and our laboratory partners. In cases where we promote our tests through our direct sales force, we generally bill directly to a patient, clinic or insurance carrier, or a combination of the insurance carrier and patient, for the fees.
Sales of our clinical tests are recorded as product revenues. Revenues recognized from tests processed through our Constellation model, from the Qiagen, BGI Genomics, and Foundation Medicine agreements (collectively the “Strategic Partnership Agreements”), and from our Signatera research use only offering are reported in licensing and other revenues.
In cases where we sell our tests through our laboratory partners, the majority of our laboratory partners bill the patient, clinic or insurance carrier for the performance of our tests, and we are entitled to either a fixed price per test or a percentage of their collections.
Our ability to increase our revenues will depend on our ability to further penetrate the domestic and international markets and, in particular, generate sales through our direct sales force, develop and commercialize additional tests, obtain reimbursement from additional third-party payers and increase our reimbursement rate for tests performed. In particular, our financial performance depends on reimbursement for Panorama in the average risk population and for microdeletions. There has been a significant increase in the number of commercial third-party payers that cover the use of Panorama in
41
the average risk population, representing approximately 95% of commercial covered lives in the United States, as well as an increasing number of state Medicaid payers expanding coverage to average risk pregnancies. Many third-party payers do not currently reimburse for microdeletions screening in part because there is currently limited published data on the performance of microdeletions screening tests. A new current procedure terminology (“CPT”) code for microdeletions went into effect beginning January 1, 2017. We have experienced low average reimbursement rates thus far for microdeletions testing under this new code, and we expect that this new code will cause, at least in the near term, our microdeletions reimbursement to remain low, due to third-party payers declining to reimburse and through reduced reimbursement under the new code. This has had, and we expect it will continue to have, an adverse impact on our revenues. In addition, a new CPT code for expanded carrier screening went into effect beginning January 1, 2019, and has had, and may continue to have, an adverse effect on our reimbursement rates for our broader Horizon carrier screening panel for which we previously primarily received reimbursement on a per-condition basis, as those tests may be reimbursed as a combined single panel instead of as multiple individual tests. Because our revenues from Horizon continue to represent an increasing proportion of our overall revenues, a decline in our reimbursement rates for, and therefore our average selling price of, Horizon, could result in a decline in our overall revenue.
Our financial performance has also been impacted by the increase in in-network coverage of our tests by third-party payers, which we believe is crucial to our growth and long-term success. However, because the negotiated fees under our contracts with third-party payers are typically lower than the list price of our tests, as we enter into additional in-network contracts with insurance providers, our average reimbursement per test may decrease as compared to out-of-network contracts. While we expect the reduction in average reimbursement per test from in-network pricing to reduce our revenues and gross margins in the near term, in-network pricing is more predictable than out-of-network pricing, and we intend to continue to mitigate the impact by driving more business from our most profitable accounts.
Cost of Product Revenues
The components of our cost of product revenues are material and service costs, impairment charges associated with testing equipment, personnel costs, including stock-based compensation expense, equipment and infrastructure expenses associated with testing samples, electronic medical records, order and delivery systems, shipping charges to transport samples, costs incurred from third party test processing fees, and allocated overhead such as rent, information technology costs, equipment depreciation and utilities. Costs associated with Whole Exome Sequencing (“WES”) are also included, as well as labor costs, relating to our Signatera CLIA offering. Costs associated with performing tests are recorded when the test is accessioned. We expect cost of product revenues in absolute dollars to increase as the number of tests we perform increases.
As we continue to achieve scale, we have increased our focus on more efficient use of labor, automation, and DNA sequencing. For example, we updated the molecular and bioinformatics process for Panorama to further reduce the sequencing reagents, test steps and associated labor costs required to obtain a test result, while increasing the accuracy of the test to allow it to run with lower fetal fraction input. These improvements also reduced the frequency of the need to require blood redraws from the patient.
Cost of Licensing and Other Revenues
The components of our cost of licensing and other revenues are material costs associated with test kits sold to Constellation clients, development and support services relating to our Strategic Partnership Agreements, and costs associated with specimens and WES, as well as labor costs, relating to our Signatera research use only offering.
We currently have 15 revenue generating licensing and service agreements with laboratories under our Constellation distribution model. We consider our cost of licensing and other revenues for the Constellation software platform to be relatively low, and therefore we expect its associated gross margin is higher. We expect our cost of licensing will increase in relation to volume growth.
42
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated, and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting policies and estimates to be revenue recognition, leases, inventory, fair value measurements, and stock-based compensation.
Recent Accounting Pronouncements
We have adopted ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) which simplifies the accounting for convertible instruments. See Note 2, Summary of Significant Accounting Policies, of Item 1, Financial Statement, for recently adopted accounting pronouncements. There have been no material changes to our other critical accounting policies and estimates as compared to the disclosures in our annual report on Form 10-K for the year ended December 31, 2020.
Results of Operations
Comparison of the three months ended September 30, 2021 and 2020
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|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
||||||||
|
September 30, |
|
Change |
|
|||||||
|
2021 |
|
2020 |
|
Amount |
|
Percent |
|
|||
(in thousands except percentage) |
|
|
|
|
|
|
|
|
|
||
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
$ |
150,651 |
|
$ |
93,286 |
|
$ |
57,365 |
|
61.5 |
% |
Licensing and other revenues |
|
7,465 |
|
|
4,857 |
|
|
2,608 |
|
53.7 |
|
Total revenues |
|
158,116 |
|
|
98,143 |
|
|
59,973 |
|
61.1 |
|
Cost and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
76,838 |
|
|
46,873 |
|
|
29,965 |
|
63.9 |
|
Cost of licensing and other revenues |
|
4,533 |
|
|
4,948 |
|
|
(415) |
|
(8.4) |
|
Research and development |
|
98,457 |
|
|
26,421 |
|
|
72,036 |
|
272.6 |
|
Selling, general and administrative |
|
128,485 |
|
|
75,678 |
|
|
52,807 |
|
69.8 |
|
Total cost and expenses |
|
308,313 |
|
|
153,920 |
|
|
154,393 |
|
100.3 |
|
Loss from operations |
|
(150,197) |
|
|
(55,777) |
|
|
(94,420) |
|
169.3 |
|
Interest expense |
|
(2,078) |
|
|
(4,270) |
|
|
2,192 |
|
(51.3) |
|
Interest and other income, net |
|
1,274 |
|
|
1,749 |
|
|
(475) |
|
(27.2) |
|
Loss before income taxes |
|
(151,001) |
|
|
(58,298) |
|
|
(92,703) |
|
159.0 |
|
Income tax expense |
|
(272) |
|
|
(25) |
|
|
(247) |
|
988.0 |
|
Net loss |
$ |
(151,273) |
|
$ |
(58,323) |
|
$ |
(92,950) |
|
159.4 |
% |
Revenues
Total revenues are comprised of product revenues, which are primarily driven by sales of our Panorama and HCS tests, and licensing and other revenues, which primarily includes development licensing revenue, licensing of our Constellation software to our licensees, and revenues from our Signatera research use only offering. Total revenues increased by $60.0 million, or 61.1%, when compared to the three months ended September 30, 2020.
43
We derive our revenues from tests based on units reported to customers—tests delivered with a result. All reported units are either accessioned in our laboratory or processed outside of our laboratory. As noted in the section titled “Overview” above, the number of tests that we process is a key metric as it tracks overall volume growth. During the three months ended September 30, 2021, total reported units were approximately 373,100, comprised of approximately 360,700 tests reported in our laboratory. Comparatively, during the three months ended September 30, 2020, total reported units were approximately 238,600, comprising of approximately 226,700 tests reported in our laboratory.
Product Revenues
During the three months ended September 30, 2021, product revenues increased by $57.4 million, or 61.5% compared to the three months ended September 30, 2020, as a result of the continued revenue growth from test volumes.
Licensing and Other Revenues
Licensing and other revenues increased by $2.6 million, or 53.7%, during the three months ended September 30, 2021 when compared to the three months ended September 30, 2020. The increase in revenue was primarily due to an increase in revenues recognized from our collaborative agreements.
Cost of Product Revenues
During the three months ended September 30, 2021, cost of product revenues increased compared to the three months ended September 30, 2020 by approximately $30.0 million, or 63.9%, due to a $10.0 million increase in third-party fees, higher costs related to inventory consumption of $2.8 million driven by an increase in accessioned tests, a $1.8 million increase in shipping related charges, and a $15.4 million increase in labor and overhead costs driven by headcount growth and product support.
Cost of Licensing and Other Revenues
Cost of licensing and other revenues for the three months ended September 30, 2021, when compared to the three months ended September 30, 2020, decreased by $0.4 million, or 8.4%, due to a decrease in labor and overhead costs related to license and development support.
Research and Development
Research and development expenses during the three months ended September 30, 2021, increased by $72.0 million, or 272.6%, when compared to the three months ended September 30, 2020. The increase was driven by a $15.5 million increase in salary and related expenditures primarily due to headcount growth, which includes a $3.6 million increase in stock-based compensation expense, an increase of $8.4 million of consulting costs, a $7.9 million increase of costs related to clinical studies to support our new product offerings, a $35.6 million write-off of the acquired in-process research and development asset, $1.2 million of expenses related to acquisition-related milestones and a $3.4 million increase in facilities, office and other costs.
Selling, General and Administrative
Selling, general and administrative expenses increased by $52.8 million, or 69.8%, during the three months ended September 30, 2021 compared to the three months ended September 30, 2020. The increase was attributable to an increase of $29.7 million in salary and related expenditures primarily due to headcount growth, which includes a $7.0 million increase in stock-based compensation expense, a $5.1 million increased in marketing expenses, a $4.1 million increase in travel related costs, a $8.1 million increase in consulting and legal fees, a $1.6 million increase in hardware and software licenses, and a $4.2 million increase from business insurance and other administrative costs.
44
Interest Expense
Interest expense decreased by $2.2 million, or 51.3%, in the three months ended September 30, 2021 compared to the same period in the prior year. The interest expense from the Convertible Notes issued in April 2020 was lower in the current period due to the adoption of ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) in January 2021.
Interest and Other Income
Interest and other income for the three months ended September 30, 2021 decreased $0.5 million compared to the same period in the prior year, primarily due to less interest income as a result of lower yields from our investments.
Comparison of the nine months ended September 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
||||
|
September 30, |
|
Change |
|
|||||||
|
2021 |
|
2020 |
|
Amount |
|
Percent |
|
|||
(in thousands except percentage) |
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
$ |
406,265 |
|
$ |
260,746 |
|
$ |
145,519 |
|
55.8 |
% |
Licensing and other revenues |
|
46,193 |
|
|
17,881 |
|
|
28,312 |
|
158.3 |
|
Total revenues |
|
452,458 |
|
|
278,627 |
|
|
173,831 |
|
62.4 |
|
Cost and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
211,387 |
|
|
131,124 |
|
|
80,263 |
|
61.2 |
|
Cost of licensing and other revenues |
|
12,909 |
|
|
12,614 |
|
|
295 |
|
2.3 |
|
Research and development |
|
192,397 |
|
|
67,651 |
|
|
124,746 |
|
184.4 |
|
Selling, general and administrative |
|
364,273 |
|
|
209,547 |
|
|
154,726 |
|
73.8 |
|
Total cost and expenses |
|
780,966 |
|
|
420,936 |
|
|
360,030 |
|
85.5 |
|
Loss from operations |
|
(328,508) |
|
|
(142,309) |
|
|
(186,199) |
|
130.8 |
|
Interest expense |
|
(6,226) |
|
|
(10,772) |
|
|
4,546 |
|
(42.2) |
|
Interest and other income, net |
|
4,230 |
|
|
5,661 |
|
|
(1,431) |
|
(25.3) |
|
Loss on debt extinguishment |
|
— |
|
|
(5,848) |
|
|
5,848 |
|
(100.0) |
|
Loss before income taxes |
|
(330,504) |
|
|
(153,268) |
|
|
(177,236) |
|
115.6 |
|
Income tax expense |
|
(648) |
|
|
(63) |
|
|
(585) |
|
928.6 |
|
Net loss |
$ |
(331,152) |
|
$ |
(153,331) |
|
$ |
(177,821) |
|
116.0 |
% |
Revenues
Total revenues are comprised of product revenues, which are primarily driven by sales of our Panorama and HCS tests, and licensing and other revenues, which primarily includes development licensing revenue, licensing of our Constellation software to our licensees and revenues from our Signatera (RUO) offering. Total revenues increased by $173.8 million, or 62.4%, when compared to the nine months ended September 30, 2020.
We derive our revenues from tests based on units reported to customers—tests delivered with a result. All reported units are either accessioned in our laboratory or processed outside of our laboratory. As noted in “Overview,” the number of tests that we process is a key metric as it tracks overall volume growth. During the nine months ended September 30, 2021, total reported units were approximately 1,042,600, comprised of approximately 1,003,100 tests reported in our laboratory. Comparatively, during the nine months ended September 30, 2020, total reported units were approximately 680,100, comprised of approximately 644,300 tests reported in our laboratory.
45
Product Revenues
During the nine months ended September 30, 2021, product revenues increased by $145.5 million, or 55.8% compared to the nine months ended September 30, 2020, as a result of the continued revenue growth from test volumes.
Licensing and Other Revenues
Licensing and other revenues increased by $28.3 million, or 158.3%, during the nine months ended September 30, 2021 when compared to the nine months ended September 30, 2020 due to $28.6 million of revenue recognized from Qiagen which was previously recorded in deferred revenue and a $0.3 million decrease in revenues from our collaborative agreements.
Cost of Product Revenues
During the nine months ended September 30, 2021, cost of product revenues increased by $80.3 million, or 61.2% when compared to the nine months ended September 30, 2020, due to higher costs related to inventory consumption of $17.3 million, a $22.0 million increase in third-party fees, and a $5.3 million increase in shipping related charges due to volume, and a $35.7 million increase in labor and overhead costs driven by headcount growth and product support.
Cost of Licensing and Other Revenues
Cost of licensing and other revenues for the nine months ended September 30, 2021, when compared to the nine months ended September 30, 2020, increased by $0.3 million, or 2.3% primarily due to an increase in labor and overhead costs and third-party service fees related to increased volumes for Signatera RUO.
Research and Development
Research and development expenses during the nine months ended September 30, 2021 increased by $124.7 million, or 184.4%, when compared to the nine months ended September 30, 2020. The increase was driven by a $42.6 million increase in salary and related expenditures primarily due to headcount growth, which includes a $9.3 million increase in stock-based compensation expense, an increase of $19.1 million of consulting costs, a $17.3 million increase of costs related to clinical studies to support our new product offerings, a $35.6 million write-off of the acquired in-process research and development asset, $1.2 million of expenses related to acquisition-related milestones, a $5.7 million increase related to software licenses, and a $3.2 million increase in facilities and other costs.
Selling, General and Administrative
Selling, general and administrative expenses increased by $154.7 million, or 73.8%, in the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020. The increase was attributable to an increase of $107.6 million in salary and related expenditures primarily due to headcount growth, which includes a $39.0 million increase in stock-based compensation expense, a $12.2 million increase in marketing expenses, a $7.7 million increase in travel related costs, a $14.6 million increase in consulting and legal fees, a $4.2 million increase related to computer hardware and software licenses, and a $8.4 million increase from business insurance, bank fees, office supplies and other costs.
Interest Expense
Interest expense decreased by $4.5 million, or 42.2%, in the nine months ended September 30, 2021 compared to the same period in the prior year. The interest expense from the Convertible Notes issued in April 2020, was lower in the
46
current period due to the adoption of ASU 2020-06. In addition, the 2017 Term Loan with Orbimed was extinguished in April 2020.
Interest and Other Income
Interest and other income decreased by $1.4 million, or 25.3%, in the nine months ended September 30, 2021, compared to the same period in the prior year, primarily due to less interest income as a result of lower yields from our investments.
Loss on Debt Extinguishment
The loss on debt extinguishment of $5.8 million was a result of the repayment of the outstanding principal and interest under the 2017 Term Loan with OrbiMed in the second quarter of 2020.
Liquidity and Capital Resources
We have incurred net losses each year since our inception. For the nine months ended September 30, 2021, we had a net loss of $331.2 million, and we expect to continue to incur losses in future periods as we continue to devote a substantial portion of our resources to our research and development and commercialization efforts for our existing and new products. As of September 30, 2021, we had an accumulated deficit of $1.3 billion. We had $95.3 million in cash and cash equivalents and restricted cash, $928.6 million in marketable securities, $50.0 million of outstanding balance of the Credit Line including accrued interest, and $287.5 million outstanding principal balance on the Convertible Notes. We used a portion of the net proceeds from the offering of the Convertible Notes to repay our obligations under our 2017 Term Loan with OrbiMed.
While we have introduced multiple products that are generating revenues, these revenues have not been sufficient to fund all operations. Accordingly, we have funded the portion of operating costs that exceeds revenues through a combination of equity issuances and debt and other financings. We expect to develop and commercialize future products and, consequently, we will need to generate additional revenues to achieve future profitability and may need to raise additional equity or incur additional debt. If we raise additional funds by issuing equity securities, our stockholders would experience dilution. Additional debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any additional debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders and requires significant debt service payments, which diverts resources from other activities. Additional financing may not be available at all, or in amounts or on terms acceptable to us. If we are unable to obtain additional financing, we may be required to delay the development and commercialization of our products and significantly scale back our business and operations.
In May 2021, we entered into a development and option agreement with a third party that requires the third party to use its best efforts to perform an agreed upon development plan and provides an exclusive option to purchase the third party’s assets. We paid the third party $10 million in the second quarter of 2021 for conducting the development work and for entering into the agreement, and if we elect to exercise the option, we have agreed to pay the third party an additional $290 million for the designated assets. There is no assurance that the development plan will be successful, or that we will elect to exercise the option to purchase the third party’s assets or, if we exercise the option, that it will derive the anticipated benefit from the acquisition of these assets.
On September 10, 2021, we entered into an agreement with a third party for an asset acquisition where the acquired asset was in-process research and development (“IPR&D”) in exchange for an equity consideration payment. The third party was a biotechnology company focused on oncology. The total acquisition consideration amounts to $35.6 million composed of the issuance of 276,346 shares of our common stock with a fair value of $30.9 million, approximately $3.9 million of cash consideration, assumed net liabilities of $0.2 million, as well as $0.6 million of acquisition related legal and accounting costs directly attributable to the acquisition of the asset. Further, there are an estimated 269,547 of additional shares, consistent with the registration statement filed with the SEC on September 10, 2021, that are potentially issuable to legacy shareholders of this third-party upon the achievement of defined milestones which will be revalued at each reporting date. These milestones are assessed as probable as of September 30, 2021. As a result, this was accounted
47
as contingent compensation expense recognized over the performance period at fair market value. We concluded the acquired IPR&D has no alternative-future use and accordingly expensed on the day of the transaction close as research and development expense which is reflected in our condensed consolidated statement of operations.
In April 2019, we completed an underwritten equity offering and sold 6,052,631 shares of common stock at a price of $19 per share to the public. Before offering expenses of $0.6 million, we received proceeds of $108.1 million net of the underwriting discount. In October 2019, we completed another underwritten equity offering and sold 6,571,428 shares of our common stock at a price of $35 per share to the public. Before offering expenses of $0.4 million, we received proceeds of $216.2 million net of the underwriting discount. In September 2020, the Company completed an additional underwritten equity offering and sold 4,791,665 shares of our common stock at a price of $60.00 per share to the public. Before offering expenses of $16.5 million, we received proceeds of $271.0 million net of the underwriting discount. In July 2021, the Company completed an underwritten equity offering and sold 5,175,000 shares of its common stock at a price of $113 per share to the public. Before offering expenses of $0.4 million, the Company received proceeds of $551.2 million net of the underwriting discount.
Based on our current business plan, we believe that our existing cash and marketable securities will be sufficient to meet our anticipated cash requirements for at least 12 months after November 4, 2021.
Credit Line Agreement
In September 2015, we entered into the Credit Line with UBS providing for a $50.0 million revolving line of credit which was fully drawn down in 2016. The Credit Line was amended in July 2017 and bears interest at 30-day LIBOR plus 1.10%, and it is secured by a first priority lien and security interest in our money market and marketable securities held in our managed investment account with UBS. UBS has the right to demand full or partial payment of the Credit Line obligations and terminate it, in its discretion and without cause, at any time. As of September 30, 2021, the total principal amount outstanding with accrued interest was $50.0 million.
Convertible Notes
In April 2020, we issued $287.5 million aggregate principal amount of Convertible Notes in a private placement offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.
The Convertible Notes are senior, unsecured obligations of the Company and bear interest at a rate of 2.25% per year, payable in cash semi-annually in arrears in May and November of each year, beginning in November 2020. The Convertible Notes mature in May 2027, unless earlier converted, repurchased or redeemed in accordance with their terms. Upon conversion, the Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election.
We received net proceeds from the Convertible Notes of $278.3 million, after deducting the initial purchasers’ discounts and debt issuance costs. We used approximately $79.2 million of the net proceeds from the Convertible Notes offering to repay our obligations under the 2017 Term Loan with OrbiMed.
48
Cash Flows
The following table summarizes our condensed consolidated cash flows for the periods indicated:
|
|
|
|
|
|
|
|
|
Nine Months Ended |
||||
|
|
September 30, |
||||
|
|
2021 |
|
2020 |
||
(in thousands) |
|
|
|
|
|
|
Cash used in operating activities |
|
$ |
(236,500) |
|
$ |
(109,210) |
Cash used in investing activities |
|
|
(284,697) |
|
|
(232,295) |
Cash provided by financing activities |
|
|
567,673 |
|
|
489,053 |
Net increase in cash, cash equivalents and restricted cash |
|
|
46,476 |
|
|
147,548 |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
48,855 |
|
|
61,981 |
Cash, cash equivalents and restricted cash, end of period |
|
$ |
95,331 |
|
$ |
209,529 |
Cash Used in Operating Activities
Cash used in operating activities during the nine months ended September 30, 2021 was $236.5 million. The net loss of $331.2 million includes $144.6 million in non-cash charges resulting from $8.3 million of depreciation and amortization, $35.6 million expense of in-process research and development, $5.7 million premium amortization and discount accretion on investment securities, $84.8 million of stock-based compensation expense, $8.1 million of non-cash lease expense, $0.9 million for amortization of debt discount and issuance cost, $0.7 million of inventory reserve adjustments, $0.4 million of provision for credit losses, and $0.1 million of other non-cash charges. Operating assets had cash outflows of $49.3 million resulting from $32.2 million in increases in accounts receivable, $8.7 million in increases in inventory, and $8.4 million in increases in prepaid expenses and other current assets. Operating liabilities resulted in cash outflows of $0.6 million resulting from a $40.6 million decrease in deferred revenue offset by a $34.8 million increase in other accrued liabilities, $5.0 million increase in accrued compensation, and a $0.2 million increase in accounts payable.
Cash used in operating activities during the nine months ended September 30, 2020 was $109.2 million. The net loss of $153.3 million includes $61.4 million in non-cash charges resulting from $6.2 million of depreciation and amortization, $3.4 million premium amortization and discount accretion on investment securities, $34.4 million of stock-based compensation expense, $5.8 million non-cash lease expense, $1.4 million provision for credit losses, and $5.8 million loss on debt extinguishment, $4.5 million for accretion of the convertible note, and $0.2 million of amortization of debt discount, these non-cash charges were offset by $0.2 million of inventory reserve adjustments, and $0.1 million of non-cash benefits. Operating assets had cash outflows of $32.9 million resulting from $17.9 million increases in accounts receivable, $7.8 million increases in inventory, and $7.3 million decreases in prepaid assets, offset by $0.1 million increases in other assets. Operating liabilities generated cash inflows of $15.6 million resulting from a $16.3 million increase in other accrued liabilities, a $6.4 million increase in accrued compensation, offset by a $5.5 million decrease in deferred revenue and a $1.6 million decrease in accounts payable.
Cash Used in Investing Activities
Cash used in investing activities for the nine months ended September 30, 2021 totaled $284.7 million, which was comprised of $674.4 million in purchasing of new investments, $32.0 million in acquisitions of property, plant and equipment, and $4.3 million in cash paid for the acquisition of an asset, offset by $77.6 million from proceeds from sale of investments and $348.4 million from proceeds of investments maturities.
Cash used in investing activities for the nine months ended September 30, 2020 totaled $232.3 million, which was comprised of purchasing new investments of $479.0 million and $12.1 million in acquisitions of property, plant and equipment, offset by $247.3 million from proceeds of investments maturities and $11.5 million proceeds from sale of investments.
49
Cash Provided by Financing Activities
Cash provided by financing activities for the nine months ended September 30, 2021 totaled $567.7 million which was comprised of $550.8 million net proceeds from our equity offering completed in the third quarter of 2021, $10.8 million of proceeds from the exercise of stock options and $6.1 million from issuance of common stock under the employee stock purchase plan.
Cash provided by financing activities for the nine months ended September 30, 2020 totaled $489.1 million comprised of $15.8 million cash proceeds from the exercise of stock options, $3.1 million in issuance of common stock under the employee stock purchase plan, $278.3 million net proceeds from the issuance of the Convertible Notes, and $270.7 million in net proceeds from our equity offering completed in the third quarter of 2020. This was offset by a $78.8 million repayment of the 2017 Term Loan with OrbiMed.
Contractual Obligations and Other Commitments
See Note 8 – Commitments and Contingencies for details.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Interest Rate Risk
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rates. Our Credit Line has an interest rate of one-month LIBOR plus 1.10%. The LIBOR rate is variable. An incremental change in the borrowing rate of 100 basis points would increase our annual interest expense by $0.5 million based on our $50.0 million gross debt outstanding on our Credit Line, including principal and accrued interest as of September 30, 2021. The interest rate for our Convertible Notes is fixed at 2.25% and not exposed market risk related to interest rates. Our investment portfolio is exposed to market risk from changes in interest rates. This risk is mitigated as we have maintained a relatively short average maturity for our investment portfolio. An incremental change in the investment yield of 100 basis points would increase our annual interest income by approximately $9.3 million annually in relation to amounts we would expect to earn, based on our short-term investments as of September 30, 2021.
Foreign Currency Exchange Rate Fluctuations
Our operations are currently conducted primarily in the United States. As we expand internationally, our results of operations and cash flows may become subject to fluctuations due to changes in foreign currency exchange rates. In periods when the U.S. dollar declines in value as compared to the foreign currencies in which we incur expenses, our foreign currency based expenses will increase when translated into U.S. dollars. In addition, future fluctuations in the value of the U.S. dollar may affect the price at which we sell our tests outside the United States. To date, our foreign currency risk has been minimal and we have not historically hedged our foreign currency risk; however, we may consider doing so in the future.
ITEM 4. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2021. The term “disclosure controls and procedures,” as defined in Rule 13a-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the
50
Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Based on the evaluation of our disclosure controls and procedures as of September 30, 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no material changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting despite a large group of our employees who are working remotely due to the COVID-19 pandemic.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, do not expect that our disclosure controls or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II – OTHER INFORMATION
ITEM 1.LEGAL PROCEEDINGS
From time to time, we are involved in legal proceedings. The results of such legal proceedings and claims cannot be predicted with certainty, and regardless of the outcome, legal proceedings could have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors.
For information regarding certain current legal proceedings, see “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to Unaudited Interim Condensed Consolidated Financial Statements, which is incorporated herein by reference.
51
ITEM 1A.RISK FACTORS
Investing in our common stock involves a high degree of risk. In addition to the information set forth in this Quarterly Report on Form 10-Q, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes, you should consider carefully the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on February 26, 2021. The occurrence of any of the risks and uncertainties described in such Annual Report could materially and adversely affect our business, financial condition, results of operations and prospects. In that event, the price of our common stock could decline and you could lose part or all of your investment. Furthermore, such risks are not the only ones we face; additional risks and uncertainties not currently known or that we currently deem to be immaterial may also materially adversely affect our business, financial condition or results of operations.
ITEM 2 UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) Recent Sales of Unregistered Securities
None.
(b) Use of Proceeds
Not applicable.
(c) Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
ITEM 3 DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4 MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5 OTHER INFORMATION
On November 3, 2021, the Company’s Board of Directors amended and restated the Company’s Amended and Restated Bylaws (as amended and restated, the “Bylaws”), effective as of such date, to (i) update certain indemnification provisions provided therein to provide consistency and clarity as between the indemnification provisions in the Bylaws and the indemnification provisions in the indemnification agreements the Company has previously entered into with its directors and officers, and (ii) include a forum selection provision for the adjudication of certain disputes.
The Bylaws include the following amendments:
52
The foregoing description of the Bylaws is qualified in its entirety by reference to the full text of the Bylaws, a copy of which is attached hereto as Exhibit 3.1 and incorporated herein by reference.
ITEM 6 EXHIBITS
INDEX TO EXHIBITS
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Incorporated by Reference |
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Exhibit No. |
Description |
Form |
File No. |
Exhibit |
Filing Date |
Filed Herewith |
3.1 |
Amended and Restated Bylaws of the Registrant, effective as of November 3, 2021. |
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X |
10.1* |
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X |
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31.1 |
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X |
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31.2 |
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X |
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32.1† |
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X |
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32.2† |
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X |
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101.INS |
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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X |
53
*Portions of this exhibit (indicated by asterisks) have been omitted and are subject to confidential treatment.
†The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the SEC and are not to be incorporated by reference into any filing of Natera, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, regardless of any general incorporation language contained in any filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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NATERA, INC. |
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Date: November 4, 2021 |
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By: |
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/ s / Steve Chapman |
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Name: |
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Steve Chapman |
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Title: |
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Chief Executive Officer, President, and Director |
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(Principal Executive Officer) |
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By: |
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/ s / Michael Brophy |
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Name: |
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Michael Brophy |
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Title: |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
54
Exhibit 3.1
Amended and Restated Bylaws
Natera, Inc.
(as of November 3, 2021)
GDSVF&H\7706247.2
Table of Contents
Page
Article I Stockholders1
1.1Place of Meetings1
1.2Annual Meeting1
1.3Special Meetings1
1.4Notice of Meetings1
1.5Voting List1
1.6Quorum1
1.7Adjournments2
1.8Voting and Proxies2
1.9Action at Meeting2
1.10Nomination of Directors2
1.11Notice of Business at Annual Meetings5
1.12Conduct of Meetings6
Article II Directors7
2.1General Powers7
2.2Number, Election and Qualification7
2.3Chairman of the Board; Vice Chairman of the Board7
2.4Classes of Directors7
2.5Terms of Office7
2.6Quorum8
2.7Action at Meeting8
2.8Removal8
2.9Vacancies8
2.10Resignation8
2.11Regular Meetings8
2.12Special Meetings8
2.13Notice of Special Meetings8
2.14Meetings by Conference Communications Equipment8
2.15Action by Consent8
2.16Committees8
2.17Compensation of Directors9
Article III Officers9
3.1Titles9
3.2Appointment9
3.3Qualification9
3.4Tenure9
3.5Removal; Resignation9
3.6Vacancies9
3.7President; Chief Executive Officer9
3.8Chief Financial Officer10
3.9Vice Presidents10
3.10Secretary and Assistant Secretaries10
3.11Salaries10
3.12Delegation of Authority10
3.13Execution of Contracts10
Article IV Capital Stock10
4.1Issuance of Stock10
4.2Stock Certificates; Uncertificated Shares10
4.3Transfers11
4.4Lost, Stolen or Destroyed Certificates11
4.5Record Date11
i
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4.6Regulations11
4.7Dividends12
Article V General Provisions12
5.1Fiscal Year12
5.2Corporate Seal12
5.3Waiver of Notice12
5.4Voting of Securities12
5.5Evidence of Authority12
5.6Certificate of Incorporation12
5.7Severability12
5.8Pronouns12
5.9Electronic Transmission12
Article VI Amendments12
Article VII Indemnification and Advancement12
7.1Power to Indemnify in Actions, Suits or Proceedings other than Those by or in the Right of the Corporation12
7.2Power to Indemnify in Actions, Suits or Proceedings by or in the Right of the Corporation13
7.3Authorization of Indemnification13
7.4Good Faith Defined13
7.5Right of Claimant to Bring Suit13
7.6Expenses Payable in Advance14
7.7Nonexclusivity of Indemnification and Advancement of Expenses14
7.8Insurance14
7.9Certain Definitions14
7.10Survival of Indemnification and Advancement of Expenses14
7.11Limitation on Indemnification14
7.12Contract Rights15
Article VIII Exclusive Forum15
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GDSVF&H\7706247.2
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GDSVF&H\7706247.2
Board in its sole discretion, or represented by proxy, shall constitute a quorum for the transaction of business; provided, however, that where a separate vote by a class or classes or series of capital stock is required by law or the Certificate of Incorporation, the holders of a majority in voting power of the shares of such class or classes or series of the capital stock of the Corporation issued and outstanding and entitled to vote on such matter, present in person, present by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy, shall constitute a quorum entitled to take action with respect to the vote on such matter. A quorum, once established at a meeting, shall not be broken by the withdrawal of enough votes to leave less than a quorum.
If, however, such quorum is not present or represented at any meeting of the stockholders, then either (i) the chairperson of the meeting, or (ii) the stockholders entitled to vote at the meeting, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present or represented.
2
GDSVF&H\7706247.2
The stockholder’s notice to the Secretary shall set forth: (A) as to each proposed nominee (1) such person’s name, age, business address and, if known, residence address, (2) such person’s principal occupation or employment, (3) the class and series and number of shares of stock of the Corporation that are, directly or indirectly, owned, beneficially or of record, by such person, (4) a description of all direct and indirect compensation and other material monetary agreements, arrangements and understandings during the past three years, and any other material relationships, between or among (x) the stockholder, the beneficial owner, if any, on whose behalf the nomination is being made and the respective affiliates and associates of, or others acting in concert with, such stockholder and such beneficial owner, on the one hand, and (y) each proposed nominee, and his or her respective affiliates and associates, or others acting in concert with such nominee(s), on the other hand, including all information that would be required to be disclosed pursuant to Item 404 of Regulation S-K if the stockholder making the nomination and any beneficial owner on whose behalf the nomination is made or any affiliate or associate thereof or person acting in concert therewith were the “registrant” for purposes of such Item and the proposed nominee were a director or executive officer of such registrant, (5) a description of any agreement, arrangement or understanding (including any derivative or short positions, swaps, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into by, or on behalf of, such proposed nominee, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such proposed nominee with respect to shares of stock of the Corporation, and (6) any other information concerning such person that must be disclosed as to nominees in proxy solicitations pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended (the “Exchange Act”); and (B) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination is being made (1) the name and address of such stockholder, as they appear on the Corporation’s books, of such beneficial owner, and any Stockholder Associated Person (as defined below), (2) the class and series and number of shares of stock of the Corporation that are, directly or indirectly, owned, beneficially or of record, by such stockholder, such beneficial owner and any Stockholder Associated Person, (3) a description of any agreement, arrangement or understanding between or among such stockholder, such beneficial owner and/or any Stockholder Associated Person and each proposed nominee and any other person or persons (including their names) pursuant to which the nomination(s) are being made or who may participate in the solicitation of proxies in favor of electing such nominee(s), (4) a description of any agreement, arrangement or understanding (including any derivative or short positions, swaps, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into by, or on behalf of, such stockholder, such beneficial owner or any Stockholder Associated Person, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such stockholder, such beneficial owner or any Stockholder Associated Person with respect to shares of stock of the Corporation, (5) any other information relating to such stockholder, such beneficial owner and any Stockholder Associated Person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in a contested election pursuant to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder, (6) a representation that such stockholder intends to appear in person or by proxy at the meeting to nominate the person(s) named in its notice and (7) a representation whether such stockholder, such beneficial owner and/or such Stockholder Associated Person intends or is part of a group which intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock reasonably believed by such
3
GDSVF&H\7706247.2
stockholder, such beneficial owner or such Stockholder Associated Person to be sufficient to elect the nominee and/or (y) otherwise to solicit proxies or votes from stockholders in support of such nomination. Such information provided and statements made as required by clauses (A) and (B) above or otherwise by this Section 1.10 are hereinafter referred to as a “Nominee Solicitation Statement.” Not later than ten (10) days after the record date for determining stockholders entitled to notice of the meeting, the information required by Items (A)(1)-(5) and (B)(1)-(5) of the prior sentence shall be supplemented by the stockholder giving the notice to provide updated information as of such record date. In addition, to be effective, the stockholder’s notice must be accompanied by the written consent of the proposed nominee to serve as a director if elected and a written statement executed by the proposed nominee acknowledging that as a director of the Corporation, the nominee will owe a fiduciary duty under Delaware law with respect to the Corporation and its stockholders. The Corporation may require any proposed nominee to furnish such other information as the Corporation may reasonably require to determine the eligibility of such proposed nominee to serve as a director of the Corporation or whether such nominee would be independent under applicable Securities and Exchange Commission and stock exchange rules and the Corporation’s publicly disclosed corporate governance guidelines. A stockholder shall not have complied with this Section 1.10(b) if the stockholder (or beneficial owner, if any, on whose behalf the nomination is made) solicits or does not solicit, as the case may be, proxies or votes in support of such stockholder’s nominee in contravention of the representations with respect thereto required by this Section 1.10. For purposes of these Bylaws, a “Stockholder Associated Person” of any stockholder shall mean (i) any person controlling, directly or indirectly, or acting in concert with, such stockholder, (ii) any beneficial owner of shares of stock of the corporation owned of record or beneficially by such stockholder and on whose behalf the proposal or nomination, as the case may be, is being made, or (iii) any person controlling, controlled by or under common control with such person referred to in the preceding clauses (i) and (ii).
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GDSVF&H\7706247.2
The stockholder’s notice to the Secretary shall set forth: (A) as to each matter the stockholder proposes to bring before the annual meeting (1) a brief description of the business desired to be brought before the annual meeting, (2) the text of the proposal (including the exact text of any resolutions proposed for consideration and, in the event that such business includes a proposal to amend the Bylaws, the exact text of the proposed amendment), and (3) the reasons for conducting such business at the annual meeting, and (B) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the proposal is being made (1) the name and address of such stockholder, as they appear on the Corporation’s books, of such beneficial owner and of any Stockholder Associated Person, (2) the class and series and number of shares of stock of the Corporation that are, directly or indirectly, owned, beneficially or of record, by such stockholder, such beneficial owner and any Stockholder Associated Person, (3) a description of any material interest of such stockholder, such beneficial owner or any Stockholder Associated Person and the respective affiliates and associates of, or others acting in concert with, such stockholder, such beneficial owner or any Stockholder Associated Person in such business, (4) a description of any agreement, arrangement or understanding between or among such stockholder, such beneficial owner and/or any Stockholder Associated Person and any other person or persons (including their names) in connection with the proposal of such business or who may participate in the solicitation of proxies in favor of such proposal, (5) a description of any agreement, arrangement or understanding (including any derivative or short positions, swaps, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into by, or on behalf of, such stockholder, such beneficial owner or any Stockholder Associated Person, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such stockholder, such beneficial owner or any Stockholder Associated Person with respect to shares of stock of the Corporation, (6) any other information relating to such stockholder, such beneficial owner and any Stockholder Associated Person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the business proposed pursuant to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder, (7) a representation that such stockholder intends to appear in person or by proxy at the annual meeting to bring such business before the meeting and (8) a representation whether such stockholder, such beneficial owner and/or any Stockholder Associated Person intends or is part of a group which intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve or adopt the proposal and/or (y) otherwise to solicit proxies or votes from stockholders in support of such proposal. Such information provided and statements made as required by clauses (A) and (B) above or otherwise by this Section 1.11 are hereinafter referred to as a “Business Solicitation Statement.” Not later than ten (10) days after the record date for determining stockholders entitled to notice of the meeting, the information required by Items (A)(3) and (B)(1)-(6) of the prior sentence shall be supplemented by the stockholder giving the notice to provide updated information as of such record date. Notwithstanding anything in these Bylaws to the contrary, no business shall be conducted at any annual meeting of
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GDSVF&H\7706247.2
stockholders except in accordance with the procedures in this Section 1.11; provided that any stockholder proposal which complies with Rule 14a-8 of the proxy rules (or any successor provision) promulgated under the Exchange Act and is to be included in the Corporation’s proxy statement for an annual meeting of stockholders shall be deemed to comply with the notice requirements of this Section 1.11. A stockholder shall not have complied with this Section 1.11(b) if the stockholder (or beneficial owner, if any, on whose behalf the proposal is made) solicits or does not solicit, as the case may be, proxies or votes in support of such stockholder’s proposal in contravention of the representations with respect thereto required by this Section 1.11.
6
GDSVF&H\7706247.2
7
GDSVF&H\7706247.2
8
GDSVF&H\7706247.2
of a committee, the member or members of the committee present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board and subject to the provisions of law, shall have and may exercise all the powers and authority of the Board in the management of the business and affairs of the Corporation and may authorize the seal of the Corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority to (i) approve or adopt, or recommend to the stockholders,any action or matter (other than the election or removal of directors) expressly required by the DGCL to be submitted to stockholders for approval, or (ii) adopt, amend or repeal any bylaw of the Corporation. Each such committee shall keep minutes and make such reports as the Board may from time to time request. Except as the Board may otherwise determine, any committee may make rules for the conduct of its business, but unless otherwise provided by the directors or in such rules, its business shall be conducted as nearly as possible in the same manner as is provided in these Bylaws for the Board. Except as otherwise provided in the Certificate of Incorporation, these Bylaws, or the resolution of the Board designating the committee, a committee may create one or more subcommittees, each subcommittee to consist of one or more members of the committee, and delegate to a subcommittee any or all of the powers and authority of the committee.
9
GDSVF&H\7706247.2
Any Assistant Secretary shall perform such duties and possess such powers as the Board, the Chief Executive Officer or the Secretary may from time to time prescribe.
In the absence of the Secretary or any Assistant Secretary at any meeting of stockholders or directors, the chairman of the meeting shall designate a temporary secretary to keep a record of the meeting.
Each certificate for shares of stock which are subject to any restriction on transfer pursuant to the Certificate of Incorporation, these Bylaws, applicable securities laws or any agreement among any number of stockholders or among such holders and the Corporation shall have conspicuously noted on the face or back of the certificate either the full text of the restriction or a statement of the existence of such restriction.
10
GDSVF&H\7706247.2
If the Corporation shall be authorized to issue more than one class of stock or more than one series of any class, the powers, designations, preferences and relative participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights shall be set forth in full or summarized on the face or back of each certificate representing shares of such class or series of stock, provided that in lieu of the foregoing requirements there may be set forth on the face or back of each certificate representing shares of such class or series of stock a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
Within a reasonable time after the issuance or transfer of uncertificated shares, the Corporation shall send to the registered owner thereof a written notice containing the information required to be set forth or stated on certificates pursuant to Sections 151, 156, 202(a) or 218(a) of the DGCL or, with respect to Section 151 of DGCL, a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.
In order that the Corporation may determine the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board may fix a record date, which shall not be more than sixty (60) days prior to such action. If no such record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto.
11
GDSVF&H\7706247.2
These Bylaws may be altered, amended or repealed, in whole or in part, or new Bylaws may be adopted by the Whole Board or by the stockholders as expressly provided in the Certificate of Incorporation.
12
GDSVF&H\7706247.2
director or officer of the Corporation, or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe such person’s conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea or nolo contendere or its equivalent, shall not, of itself, create a presumption that the person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that such person’s conduct was unlawful.
13
GDSVF&H\7706247.2
by the Corporation, the claimant may at any time thereafter (but not before) bring suit against the Corporation in the Court of Chancery in the State of Delaware to recover the unpaid amount of the claim, together with interest thereon, or to obtain advancement of expenses, as applicable. It shall be a defense to any such action brought to enforce a right to indemnification (but not in an action brought to enforce a right to an advancement of expenses) that the claimant has not met the standards of conduct which make it permissible under the DGCL (or other applicable law) for the Corporation to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the Corporation. Neither a contrary determination in the specific case under Section 7.3 nor the absence of any determination thereunder shall be a defense to such application or create a presumption that the claimant has not met any applicable standard of conduct. If successful, in whole or in part, the claimant shall also be entitled to be paid the expense of prosecuting such claim, including reasonable attorneys’ fees incurred in connection therewith, to the fullest extent permitted by applicable law.
14
GDSVF&H\7706247.2
Unless the Corporation consents in writing to the selection of an alternative forum, the federal district courts of the United States of America shall be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
Any person or entity purchasing or otherwise acquiring any interest in any security of the Corporation shall be deemed to have notice of and consented to the provisions of this Article VIII. For the avoidance of doubt, nothing contained in this section Article VIII shall apply to any action brought to enforce a duty or liability created by the 1934 Act or any successor thereto.
15
GDSVF&H\7706247.2
THE SYMBOL “[*]” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
Confidential Exhibit 10.1
SEVENTH AMENDMENT TO SUPPLY AGREEMENT
This Seventh Amendment to Supply Agreement (the “Seventh Amendment”) is effective as of the date last signed below (the “Seventh Amendment Date”) between Illumina, Inc., a Delaware corporation having a place of business at 5200 Illumina Way, San Diego, CA 92122 ("Illumina") and Natera, Inc., having a place of business at 201 Industrial Road, Suite 410, San Carlos, CA 94070 (“Customer”). Customer and Illumina may be referred to herein as “Party” or “Parties.”
WHEREAS, Illumina and Customer are Parties to a Supply Agreement having an Effective Date of August 16, 2013, and amended on September 18, 2014, September 23, 2015, June 8, 2016, January 3, 2019, December 18, 2019, and May 8, 2020 (“Agreement”);
WHEREAS, on August 18, 2021 GRAIL, Inc. (now GRAIL, LLC”) became a wholly owned subsidiary of Illumina;
WHEREAS, the Parties have agreed upon certain amendments to (i) add products available for purchase and any applicable discounts under the Agreement, (ii) incorporate, effective as of the Seventh Amendment Date, [*], and (iii) address specific points relating to Customer’s IVD development rights under the Agreement;
NOW, THEREFORE, in consideration of the mutual promises and covenants hereinafter set forth, the Parties hereto agree to amend the Agreement as follows:
1. | Section 1 of the Agreement is amended as follows: |
i. | The definition of “Consumables” is amended to add the following sentence at the end: |
For clarity purposes only, Consumables include any Certain Sequencing Consumables.
ii. | The definition of “Product” is amended to add the following sentence at the end: |
For clarity purposes only, Products include any Supplied Products.
2. | The following new definitions are incorporated into Section 1 of the Agreement: |
“Certain Sequencing Consumables” means those Consumables intended by Illumina to be used to perform a sequencing process on Illumina’s [*] instruments and any future sequencing hardware launched by Illumina or its Affiliates, and includes core consumables that are (i) commercialized or otherwise made available by Illumina to customers or Affiliates of Illumina and (ii) intended by Illumina to be used to perform a sequencing process on any such system. Certain Sequencing Consumables do not include products that were at the “end of life” or “end of sales” or were announced (before [*]) to customers as a planned “end of life” or “end of sale”. The Certain Sequencing Consumables are limited to Products that are shipped to and used in [*]. The Certain Sequencing Consumables purchasable under this Agreement as of the Seventh Amendment Date are contained within Exhibit B.
Confidential
“Equivalent” means, with respect to the comparison of Customer to another customer, that (a) the aggregate volume of all Supplied Products purchased by such other customer from Illumina in the immediately preceding year (measured in U.S. dollars) is not more than [*]% greater than the volume purchased by Customer in prior year, and (b) such other customer is a For-Profit Entity.
“For-Profit Entity” means a for-profit company in the United States that purchases Supplied Products for performing sequencing for liquid biopsy cancer screening or diagnostic tests for clinical oncology purposes, on human samples received from, and delivered to, unaffiliated health care professionals, health care organizations or other laboratories for clinical oncology purposes. A For-Profit Entity excludes governments, government agencies, hospitals, research institutes, academic institutions, non-profits and Illumina Affiliates (including GRAIL).
“GRAIL” means GRAIL, LLC for so long as it is an Affiliate of Illumina, or any successor to GRAIL, LLC or any substantial part of the business of GRAIL, LLC that in either case is Illumina or an Affiliate of Illumina.
“Grandfathered Pricing” means any pricing (either under a quote of duration longer than 30 days or a supply agreement) that is operative for the Customer for use of the Supplied Products on [*], provided that this pricing is for ongoing, ordinary course purchases of Supplied Products.
“Pre-Release Sequencing Product” means Illumina sequencing hardware or Certain Sequencing Consumables that are not available for purchase in Illumina’s product catalogue. Such sequencing hardware or Certain Sequencing Consumables shall include any re-designed or modified products made available to any For-Profit Entity or to GRAIL that optimize, in any material respect, a product’s interoperability, capabilities, or performance.
“Short Term Project” means a project or circumstance giving rise to a discrete purchase of Certain Sequencing Consumables outside of ongoing ordinary course of purchases made by a For-Profit Entity. The duration of a Short Term Project is no more than two years.
“Supplied Product(s)” means the following Products: Illumina’s [*]instruments, and any future sequencing instruments launched by Illumina or its Affiliates, or Certain Sequencing Consumables, that are purchased by Customer for any Customer Use pursuant to the Agreement. Supplied Products do not include products that were at the “end of life” or “end of sale” or were announced (before [*]) to customers as a planned “end of life” or “end of sale”. Supplied Products are limited to products that are shipped to and used in [*]. The Supplied Products purchasable under this Agreement as of the Seventh Amendment Date are contained within Exhibit B.
“Volume-Based Net Price” means the actual list price of a Supplied Product less the applicable discount for Customer’s volume under a volume-based discount schedule.
3. | Section 2.d. of the Agreement is amended by adding the following sentence: |
“Customer will have access to the same product and support services that a For-Profit Entity or GRAIL has access to, or that Customer has access to as of the Seventh Amendment Date. For such services, Customer shall have access to the same volume-based pricing that GRAIL has access to for the equivalent level of service, or to which Customer had access to as of the Seventh Amendment Date, at Customer’s option.”
Page 2 of 17
Confidential
4. | Subsection (d) of Section 4 of the Agreement is deleted in its entirety and replaced with the following: “In no event will Illumina have the right to cease shipping of the Supplied Products solely on the basis of any alleged claim of infringement of any intellectual property rights of Illumina.” |
5. | Section 7.c. of the Agreement is amended by adding the following sentence: |
“Purchase Orders submitted in accordance with this Agreement may be rejected by Illumina only if Illumina does not have sufficient supply of the applicable Supplied Product to fulfill the order or if the Purchase Order is not in accordance with standard lead times for the applicable Supplied Product. In the event Illumina is experiencing a supply shortage of the applicable Supplied Product (or components therein), Illumina will allocate the existing supply in an equitable manner among its customers (including Affiliates) based on expiring lots, and which shall not favor Affiliates over other customers.”
6. | The following is hereby added to the Agreement as Section 7.f.: |
“Access to Supplied Products. Customer shall have access to the Supplied Products for purchase that GRAIL or any For-Profit Entity has access, within [*]of when GRAIL or such For-Profit Entity, as applicable, is offered such access (if not earlier) for purchase.”
7. | The following is added to the Agreement as Section 7.g.: |
“Access to Pre-Release Sequencing Products. Customer shall have access for purchase to any Pre-Release Sequencing Product to which GRAIL or any For-Profit Entity is offered access within [*] of when GRAIL or such For-Profit Entity, as applicable, is offered such access (if not earlier), and for the same categories of uses, specifically: (i) feedback to Illumina for development of NGS products, including through alpha or beta testing; (ii) for clinical trials; (iii) for clinical validation; (iv) for pre- commercial test development not relating to clinical trials; or (v) for a commercialized product developed by Customer. Customer’s purchase of any Pre-Release Sequencing Product is subject to the pricing terms in this Agreement. This provision does not apply to Pre-Release Sequencing Products that are developed by Illumina for a specific For-Profit Entity pursuant to a development agreement under Section 7.h with such For-Profit Entity. “
8. | The following is added to the Agreement as Section 7.h.: |
“Development Agreement. Illumina shall enter into, upon Customer request, a separate development agreement with Customer on commercially reasonable terms, relating to the design or modification of any Supplied Product, in a manner that optimizes interoperability with Customer’s tests, including, without limitation, capabilities, performance, speed, efficiency, cost, convenience, accuracy, specificity, precision, ease of use and user experience.“
9. | The following is added to the Agreement as Section 7.i.: |
“No Obsolescence. Illumina shall not discontinue (i) any Supplied Product so long as Customer continues to purchase that Supplied Product, or (ii) any [*] that Customer has purchased (for on-going development or commercial testing purposes) at least [*]. Illumina shall also make the
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following extensions to previously announced obsolescence dates: (a) Consumables bearing the Illumina catalogue numbers [*] and [*] shall continue to be available for purchase by Customer so long as any such purchase is made using a binding purchase order with a [*] lead time for shipment and with a last possible shipment date for such Consumables of [*]; and (b) Illumina will continue to provide technical support for Customer’s [*] sequencing systems in Customer’s possession as of the Seventh Amendment Date until [*] at the same service level owed as of the Seventh Amendment Date to Customer for such systems (provided, however, Customer acknowledges that Microsoft Windows 10 will no longer be supported by Microsoft after 2022, and certain spare parts for such sequencing systems may not be available for support that is requested after [*], which could affect Illumina’s ability to provide such technical support).”
10. | The following is added to the Agreement as Section 7.j.: |
“Quality of Supplied Products. Supplied Products provided pursuant to the “No Obsolescence” provision in Section 7.i. above shall be manufactured to at least the quality standards and provided with at least the level of product support in effect upon Customer’s initial purchase of such Supplied Products.“
11. | The following is added to the Agreement as Section 7.k.: |
“No Price Increases. The inflation-adjusted (based on the Bureau of Labor Statistics’ Analytical Laboratory Instrument Manufacturing Index in the Producer Price Index (“PPI”)) Volume-Based Net Price (under Tables 2, 5, or 6(a) (subject to Table 6(b)) of Exhibit B, as applicable) that Customer has access to for each Supplied Product purchased under this Agreement (under Tables 2, 5, or 6(a) (subject to Table 6(b)) of Exhibit B, as applicable) following the Seventh Amendment Date shall not increase. To the extent Illumina’s costs of goods sold for a Supplied Product materially increase due to factors beyond Illumina’s control, then such Volume-Based Net Price (under Tables 2, 5, or 6(a) (subject to Table 6(b)) of Exhibit B, as applicable) may increase solely to reflect that cost increase and solely for the duration of that cost increase.“
12. | The following is added to the Agreement as Section 7.l.: |
“New Product Pricing. To the extent that Illumina launches a new version of any Supplied Product (e.g., a sequencing instrument of similar throughput, or a Certain Sequencing Consumable of the same sequencing read length and similar number of sequencing reads per flow cell), the new version of the Supplied Product shall be automatically added to Exhibit B of this Agreement with pricing and the inflation-adjusted (based on the PPI) Volume-Based Net Price per gigabase of sequencing shall not be higher as compared to the Volume-Based Net Price of the prior version of the Supplied Product, provided that the new version of the Supplied Product does not result in any material improvements in performance or capability. In addition, Illumina commits that by 2025, under this Agreement, the Volume-Based Net Price to Customer per gigabase of sequencing using the highest throughput Illumina instrument then available, with the highest throughput, best-performance flow cell and kit then available, at full capacity, will be at least 43% lower than the inflation-adjusted (based on the PPI) Volume-Based Net Price (under Table 2 of Exhibit B as applicable as of the Seventh Amendment Date), per gigabase of sequencing using the NovaSeq instrument, with an S4 300 flow cell, at full capacity. For the avoidance of doubt, in accordance with the previous sentence, holding volume constant, every customer (regardless of their application, or whether they are in
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oncology screening) using the highest throughput instrument and best-performance flow cell would observe by 2025 a reduction in price, under the Universal Pricing option, per gigabase of sequencing, of 43%. By way of example, for a customer at the highest volume discount tier today, the per gigabase sequencing price is $4, using a NovaSeq instrument with an S4 300 flow cell. Under this commitment, the per gigabase of sequencing price for that customer at the same volume discount tier in 2025 would be no greater than $2.26 (inflation-adjusted based on the PPI) using the highest throughput Illumina instrument then available, with the highest-throughput, best-performance flow cell and kit then available. To the extent Illumina’s costs of goods sold for a Supplied Product materially increase due to factors beyond Illumina’s control, then the Volume-Based Net Price as referenced in this Section 7.l. may increase solely to reflect that cost increase and solely for the duration of that cost increase. The price for a new Product or a new version of a materially improved Product must be commercially reasonable.“
13. | The following is added to the Agreement as Section 7.m.: |
“Most-Favored Pricing. If Customer is not receiving Grandfathered Pricing for Supplied Product, Customer shall have access to Volume-Based Net Prices for that Supplied Product that are no less favorable than the Volume-Based Net Prices provided to an Equivalent customer or to GRAIL (inclusive of transfer pricing, portability fees, and royalties) for that Supplied Product. “
14. | The following is added to the Agreement as Section 7.n.: |
“Notification and Refund. In the event that Section 7.m is triggered, Illumina will notify Customer promptly, and no later than 45 days after the end of the applicable Illumina fiscal quarter, and the pricing made available to Customer for the applicable Supplied Products will be reduced in accordance with Section 7.m., effective as of the date on which GRAIL or the Equivalent customer received the triggering pricing, and the Customer will receive such reduced pricing for the period of time that the triggering pricing is available to GRAIL or the Equivalent customer. With respect to units of Supplied Product ordered and invoiced pursuant to a Purchase Order accepted after the date the triggering purchase was made, and for which Customer has paid the applicable invoice, Illumina will refund to Customer the difference between the pricing made available to Customer and the triggering pricing, multiplied by the number of affected units of Supplied Product.“
15. | The following is added to the Agreement as Section 7.o.: |
“Short Term Projects. Customer shall have access to Short Term Project pricing that is no less favorable than pricing extended to Equivalent customer or GRAIL for a Short Term Project of substantially similar size (i.e., using between [*]% and [*]% of the volume of Certain Sequencing Consumables) and duration (i.e., for a period of not more than [*] longer than the other Short Term Project), provided that Customer has requested such pricing. If Illumina offers GRAIL pricing for a Short Term Project under this section, Illumina shall make Customer aware of such pricing promptly, but in no event later than 45 days after the end of the applicable Illumina fiscal quarter. No customer, including GRAIL, may receive Short Term Project pricing for more than two consecutive years. No customer, including GRAIL, may use Short Term Project pricing for ongoing ordinary course purchases, including for its standard commercial testing. Pricing for Short Term Projects will not be considered as triggering with respect to the obligations in Section 7.m.“
16. | The following is added to the Agreement as Section 7.p.: |
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“Access to Information. Customer shall have access to the same information about final product specifications of any new Supplied Product, any new version of a Supplied Product or any Pre-Release Sequencing Product within [*] of when GRAIL is provided such information.“
17. | The following is added to the Agreement as Section 7.q.: |
“GRAIL Purchases and Services. Illumina shall publish, on the “Oncology Contract Terms” website, (i) the Supplied Products, by SKU, that GRAIL is purchasing; (ii) the service plans, by SKU, that GRAIL is purchasing; and (iii) the pricing grid for both products and services under which GRAIL is purchasing Supplied Products and services. To the extent necessary, Illumina shall update this website within [*] of entry of any purchase order for Supplied Products or any service contract relating to the Supplied Products by GRAIL.“
18. | The following is added to the Agreement as Section 14.g: |
“Confidential Information. To the extent that Illumina may have access to Confidential Information of Customer in connection with this Agreement or the provision of supplied Products by Illumina to Customer, Illumina shall in no event share such Confidential Information of Customer with GRAIL or any subsidiary of GRAIL, or any employees who work within GRAIL. Any Confidential Information received shall be used by Illumina only (i) to perform Illumina’s product supply obligations, service or obligations under any agreement to Customer, or (ii) for performance of general business practices by non-technical functions (e.g., accounting, customer service) within Illumina, which functions shall have access to such information only on a need-to-know basis, and Illumina shall not use such Confidential Information for any other purpose, expressly including without limitation, for any of its own or Affiliates’ internal purposes. All employees who may receive Confidential Information will be advised of these confidentiality obligations and use restrictions. Illumina shall continue its practice of maintaining all Confidential Information of Customer confidential as to any other entity. Illumina shall establish a firewall designed to prevent any GRAIL personnel (and any Illumina personnel carrying out activities with respect to the GRAIL business or products) from accessing any Confidential Information obtained by or made available to Illumina relating to Customer or its business or products, whether pursuant to this Agreement or otherwise.”
19. | Section 17.a. The first sentence of Section 17.a. of the Agreement is deleted in its entirety and replaced with the following: |
“This Agreement shall commence on the Effective Date and shall terminate on August 18, 2033, unless otherwise terminated as provided hereunder or extended by mutual written agreement of the Parties.”
20. | Section 17.c.i. Section 17.c.i. of the Agreement is deleted in its entirety and replaced with the following: |
“Breach of Provision. If either party materially breaches this Agreement and fails to cure such breach within 60 days after receiving written notice of the breach, the non-breaching party shall have the right to terminate this Agreement by providing written notice to the other party; provided, however, that if such breach is curable, but not reasonably curable within such 60-day period, and
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the breaching Party is using commercially reasonable efforts to cure the breach, then such cure period will be extended to not longer than 180 days.”
21. | Section 17.c.v. of the Agreement is deleted in its entirety and replaced with the following: |
“Termination by Customer for Convenience. Customer has a unilateral right to terminate its supply relationship with Illumina at any time and for any reason without termination liability upon [*] prior written notice to Illumina, provided, however, that Customer shall honor all invoices, which invoices shall be issued upon shipment, for supplied Products ordered under a Purchase Order that was accepted by Illumina prior to the termination date. Illumina cannot terminate this Agreement for convenience during the Term.”
22. | The following is added to the Agreement as Section 20.p.: |
“Illumina agrees to a [*] audit by a Big 4 accounting firm to assess Illumina’s compliance with the terms contained in Sections 2.d., 7.c., 7.f., 7.g., 7.i., 7.k.-7.q., and 14.a. of this Agreement. Illumina will provide Customer with a written report (with reasonable redactions) confirming compliance with the commitments set forth herein. Illumna shall provide cooperation, including access to necessary books and records, in support of any [*] audit conducted. To the extent Customer has a good faith basis for alleging that Illumina is in breach of a commitment contained in this Agreement, Illumina shall engage an auditor to assess Customer’s allegation separate from and in addition to Illumina’s audit. In addition to providing the written report, in the event of any finding of potential noncompliance with Illumina’s performance under the Agreement, Customer shall be notified within [*] days of identifying such a finding of potential noncompliance.”
23. | Exhibit A. Exhibit A, Part 1, Section 3.a. is hereby deleted in its entirety and replaced with the following: 'a. Exclusivity. Reserved.'" |
24. | The following shall be added as Section 5.vi. to Exhibit A, Part 4: |
“Illumina will use commercially reasonable efforts to provide Customer the same level of timely access to Illumina’s device design history file(s) and/or any other filing or documentation that is customarily provided to other IVD partners as useful or required in connection with any submission by Customer to any regulatory authority for a Natera IVD Kit. Such access will be provided without further payment by Customer.”
25. | The following shall be added as Section 8.a.iii. to Exhibit A, Part 4: |
“iii. The [*] set forth in Exhibit A, Part 4, Section 8.a.i and ii shall be the only [*] due to Illumina upon execution of each Development Plan for a Natera IVD Kit and/or approval by the U.S. FDA of a PMA for each Natera IVD Kit so approved.”
26. | Exhibit A, Part 4, Section 9 shall be amended by replacing references to “[*]” with “[*]”. |
27. | The following shall be added as Section 10 to Exhibit A, Part 4: |
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“Customer may enter into, at any time from today until [*], an additional agreement with Illumina under which Customer may develop and commercialize additional in-vitro diagnostic (“IVD”) test kits on Illumina’s diagnostic (“Dx”) sequencing platforms. Illumina will provide standard terms for Customer to enter into a stand-alone agreement to enable Customer to develop and commercialize additional IVD test kits on one or all of Illumina’s Dx sequencing platforms. Illumina will provide any documentation or information reasonably required for Customer to seek FDA approval or FDA marketing authorization to sell a for-profit, clinical test using the Supplied Products.”
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IN WITNESS WHEREOF, the Parties hereto acknowledge and agree to the terms and conditions of this Seventh Amendment and have caused this Agreement to be executed by their respective duly authorized representatives to be effective as of the Seventh Amendment Date.
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Natera, Inc.: |
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Illumina, Inc.: |
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By: |
/s/ John Fesko |
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By: |
/s/ Nicole Berry |
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Name: |
John Fesko |
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Name: |
Nicole Berry |
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Title: |
Chief Business Officer |
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Title: |
SVP & GM, AMR Commercial Operations |
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Date: |
10/7/21 |
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Date: |
10/5/21 |
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ATTACHMENT 1
EXHIBIT B
Only the Products listed in Table 1 of this Exhibit B are subject to purchase under this Agreement.
The following pricing schedule replaces and supersedes all conflicting pricing terms in this Agreement. Notwithstanding anything to the contrary, no additional discounts shall apply unless otherwise specified by Illumina in writing at a later date.
Exhibit B Definitions
“Annual Sequencing Consumable Spend” equals the total of all amounts invoiced (excluding amounts paid for taxes and shipping, insurance, customs, and other transportation costs) by Illumina to Customer for the purchase of Certain Sequencing Consumables shipped to a particular country under this Agreement during the immediately precedingContract Year during the Term.
“Contract Year” means the period from February 15th of a given calendar year during the Term through and including February 14th of the immediately following calendar year during the Term.
The following are set forth for example purposes only:
Example 1: If the Seventh Amendment Date is October 1, 2021, then the applicable Annual Sequencing Consumable Spend for purposes of determining discounts applicable to the purchase of Certain Sequencing Consumables by Customer shipped to the applicable country during the period from October 1, 2021 – February 14, 2022, would equal the total of all amounts invoiced (excluding amounts paid for taxes and shipping, insurance, customs, and other transportation costs) by Illumina to Customer for the purchase of Certain Sequencing Consumables shipped to a particular country during the period from February 15, 2020 to February 14, 2021.
Example 2: If the Seventh Amendment Date is October 1, 2021, then the applicable Annual Sequencing Consumable Spend for purposes of determining discounts applicable to the purchase of Certain Sequencing Consumables by Customer shipped to the applicable country during the period from February 15, 2022 – February 14, 2023, would equal the total of all amounts invoiced (excluding amounts paid for taxes and shipping, insurance, customs, and other transportation costs) by Illumina to Customer for the purchase of Certain Sequencing Consumables shipped to a particular country during the period from February 15, 2021 to February 14, 2022.
Example 3: If the Seventh Amendment Date is October 1, 2021, then the applicable Annual Sequencing Consumable Spend for purposes of determining discounts applicable to the purchase of Certain Sequencing Consumables by Customer shipped to the applicable country, during the period from February 15, 2023 – February 14, 2024, would equal the total of all amounts invoiced (excluding amounts paid for taxes and shipping, insurance, customs, and other transportation costs) by Illumina to Customer for the purchase of Certain Sequencing Consumables shipped to a particular country during the period from February 15, 2022 to February 14, 2023.
The tables that follow list the Consumables subject to purchase under this Agreement and any applicable discounts off the then-current list price (or in the case of [*] Consumables set
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forth in Table 3, the Base Price)) in the country to which the applicable Products will be shipped by Illumina. Discounts for Consumables shall be determined on a country-specific basis (i.e., shipments to multiple countries may not be aggregated for purposes of Consumables discounting).
Table 1 below and on the following page contains a list of the Consumables subject to this Agreement together with applicable part numbers and the applicable list price as of the Seventh Amendment Date.
TABLE 1
Product Name |
Part Number |
2021 US
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Discounts for new versions of Supplied Products (e.g., future consumables for [*], or future platforms) shall be added to this Exhibit B in compliance with the terms and conditions of this Exhibit B and the Agreement, including without limitation Sections 7.k, 7.l, 7.m, 7.n, and 7.o.
Quotations: Solely with respect to the pricing (including applicable discounts) of Consumables as set forth in this Exhibit B:
First Quote. Illumina will provide Customer a quotation referencing this Agreement and specifying the price consistent with this Exhibit B which will apply for each Consumable the Customer may purchase until February 14 immediately following the Seventh Amendment Date (“First Quote”). The First Quote and pricing shall commence on the Seventh Amendment Date and expires on February 14 immediately following the Seventh Amendment Date (“First Quote Period”). All purchase orders placed during the First Quote Period must reference this Agreement to be valid. Any purchase orders which reference the First Quote, but are not received by Illumina until after the expiry of the First Quote Period will be invalid and may not be accepted by Illumina; however, if Illumina does accept such purchase order, it will fill the same in accordance with this Agreement.
Annual Quotes and Purchase Orders for Consumables. No later than February 15 of each calendar year of this Agreement, Illumina will issue a quotation referencing this Agreement and specifying the price consistent with this Exhibit B for each Consumable (the “Annual Quote”) for the Contract Year beginning on that February 15. Each Annual Quote and pricing found therein expires on February 14 of the next consecutive calendar year and sets forth the pricing that will be used on all Purchase Orders that are
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provided by Customer prior to the end of such Contract Year. The Purchase Orders placed against each Annual Quote must reference this Agreement to be valid. Any Purchase Orders which reference an Annual Quote, but are not received by Illumina until after the expiry of the relevant Annual Quote Period will be invalid and may not be accepted by Illumina; however, if Illumina does accept such purchase order, it will fill the same in accordance with this Agreement. For clarity, if Illumina fails to timely issue any Annual Quote, then the prior Annual Quote shall remain in effect until such subsequent Annual Quote is so issued.
Consumables Discounting
The following tables set forth the discounts for the applicable Consumables, as specified in such tables.
Discounting for [*] Consumables. Discounts off then-current list price of [*] Consumables listed in Table 1 are set forth in Table 2 below. Discounts for new catalogue versions of Consumables (e.g., future Consumables for [*], or future platforms) shall be added to this Exhibit B at the time such Consumables are added to this Agreement. Illumina shall make such Consumables available to Customer upon commercial launch of such Consumables. The discounts applicable to the purchase of the applicable Consumables set forth in Table 2, during a given period during the Term, are determined by the applicable Annual Sequencing Consumable Spend.
TABLE 2
[*] |
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Discounting for [*] Consumables:
Solely with respect to discounting for the [*] Consumables described in Table 3 below, “Total Spend” is determined quarterly at the first day of each calendar quarter (i.e., January 1, April 1, July 1, October 1), and equals (1) the total amount (minus freight, taxes, and any product credits or offsets) Illumina has invoiced Customer for shipments of all Products delivered to Customer during the 12 calendar month period that immediately precedes such first day of a calendar quarter under this Agreement, which includes Products purchased under this Agreement and Products purchased from Illumina outside of this Agreement, (2) the total amount Illumina has invoiced customer for Services during the 12 calendar month period that immediately precedes such first day of a calendar quarter under this Agreement, which includes Services purchased under this Agreement and Services purchased from Illumina outside of this Agreement; and (3) the total amount of NIPT Test Fees paid by Customer to Illumina during the 12 calendar month period that immediately precedes such first day of a calendar quarter under this Agreement.
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Natera’s price (1) with respect to the [*] Consumables described in Table 3 below bearing the Illumina catalogue numbers [*], until [*], (2) with respect to the [*] Consumables described in Table 3 below bearing the Illumina catalogue numbers [*], during availability as set forth in Section 7.i. of the Agreement, and (3) with respect to the [*] Consumables described in Table 3 below, will be the base price listed in Table 3 without any discount; provided that, beginning [*], if Customer achieves Total Spend above $[*], an additional [*] discount will apply corresponding to the Total Spend amount specified in Table 3 below. After [*], Customer’s prices for the [*] Consumables described in Table 3 will be Illumina’s then-current list price for each such product less the volume-based discount listed in Table 4 below (in the column designated as “[*]”).
Product Name |
Part # |
Base Price |
Total Spend [*] |
Total Spend [*] |
Total Spend [*] |
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Table 4: Discounting for [*] Consumables
Solely with respect to [*] Consumables, “Overall Sequencing Consumable Spend” is determined quarterly at the first day of each calendar quarter (i.e., January 1, April 1, July 1, October 1), and equals the total amount (minus freight, taxes, and any product credits or offsets) Illumina has
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invoiced Customer for shipments of all Sequencing Consumables delivered to Customer during the 12 calendar month period that immediately precedes such first day of a calendar quarter under this Agreement, which includes Sequencing Consumables purchased under this Agreement and Sequencing Consumables purchased from Illumina outside of this Agreement. Overall Sequencing Consumable Spend does not include, by way of example, amounts invoiced for array products, Test Fees, Services, or Illumina Hardware.
As used in the definition of “Overall Sequencing Consumable Spend”, “Sequencing Consumables” means a Consumable directed for use on an Illumina sequencing instrument.
Customer’s prices for the [*] Consumable Products specified in Table 1 will be the then-current list price for each such Product less the discount listed in Table 4 above corresponding to the applicable Overall Sequencing Consumable Spend and the aggregate number of [*] sequencing systems purchased by Customer from Illumina.
Table 5. Universal Consumables Discount Schedule:
In the event Customer elects to switch from pricing under Table 3 (with respect to the listed [*] skus) or Table 4 (with respect to certain [*] (including [*] as applicable) skus after [*]), as applicable, to universal grid pricing, as set forth under paragraph 28 in the Seventh Amendment, the following discounts shall apply:
Annual Sequencing Consumable Spend (in USD) |
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Universal Hardware Discount Schedule:
In the event Customer elects to switch from existing Illumina Hardware discounting to universal grid pricing, as set forth under paragraph 28 of the Seventh Amendment, the following discounts shall apply:
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Table 6(a): Universal Hardware Discount Schedule:
The table below lists any applicable discounts off the then-current list price in the country to which the applicable Supplied Products will be shipped by Illumina. Instrument credits shall be determined on a country-specific basis and applied solely to instrument purchases within that country (i.e., Installed Instruments in multiple countries may not be aggregated for purposes of instrument discounting).
Tier |
Instrument Credits |
Discount off [*]Instrument |
Discount off [*] Instrument |
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[*] |
[*] |
Table 6(b): Allocation of Instrument Credits:
Installed Instrument |
Instrument Credits |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
For each Installed Instrument, Customer shall be entitled to a specific number of Instrument Credits as set forth in Table 6(b).
“Installed Instrument” means a Supplied Product that is a sequencing instrument covered under an active service contract with Illumina, and is installed in Customer’s or its Affiliates’ facility in a particular country.
[*] and Other Products:
Customer’s price for the following Products will be the price specified in Table 7 below without any additional discount:
Table 7:
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
Page 16 of 17
Confidential
Page 17 of 17
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Steve Chapman, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Natera, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
3 |
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Date: November 4, 2021 |
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By: |
/s/ Steve Chapman |
|
|
Name: |
Steve Chapman |
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Title: |
Chief Executive Officer and President |
|
|
|
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER
PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael Brophy, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Natera, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
3 |
|
|
|
Date: November 4, 2021 |
|
By: |
/ s / Michael Brophy |
|
|
Name: |
Michael Brophy |
|
|
Title: |
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Steve Chapman, Chief Executive Officer and President of Natera, Inc. (the “Company”), certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) The quarterly report on Form 10-Q for the Company for the quarter ended September 30, 2021 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
3 |
|
|
|
Date: November 4, 2021 |
|
By: |
/ s / Steve Chapman |
|
|
Name: |
Steve Chapman |
|
|
Title: |
Chief Executive Officer and President |
|
|
|
(Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael Brophy, Chief Financial Officer of Natera, Inc. (the “Company”), certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) The quarterly report on Form 10-Q for the Company for the quarter ended September 30, 2021 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
3 |
|
|
|
Date: November 4, 2021 |
|
By: |
/ s / Michael Brophy |
|
|
Name: |
Michael Brophy |
|
|
Title: |
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |