UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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.
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).
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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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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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
As of October 28, 2022, the registrant had
Table of Contents
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Page |
PART I. |
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Item 1. |
3 |
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3 |
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Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) |
4 |
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5 |
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7 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
8 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
24 |
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Item 4. |
24 |
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PART II. |
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Item 1. |
26 |
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Item 1A. |
26 |
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Item 2. |
26 |
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Item 3. |
26 |
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Item 4. |
26 |
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Item 5. |
26 |
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Item 6. |
27 |
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28 |
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i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Quarterly Report, including without limitation statements regarding our business model and strategic plans for our products, technologies and business, including our implementation thereof, the impact on our business, financial condition and results of operations from macroeconomic conditions, the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide, the timing of and our ability to obtain and maintain regulatory approvals, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the commercial success and market acceptance of our products, the sufficiency of our cash, cash equivalents and short-term investments, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements.
The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties, and assumptions, including those described under the sections in this Quarterly Report entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the future events and trends discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon these forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance, or achievements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We intend the forward-looking statements contained in this Quarterly Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
ii
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited).
Inari Medical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data and par value)
(unaudited)
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September 30, |
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December 31, |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments in debt securities |
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Accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Deposits and other assets |
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Long-term investments in debt securities |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
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$ |
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$ |
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Payroll-related accruals |
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Accrued expenses and other current liabilities |
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Operating lease liabilities, current portion |
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Total current liabilities |
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Operating lease liabilities, noncurrent portion |
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Other long-term liability |
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Total liabilities |
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(Note 7) |
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Stockholders' equity |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid in capital |
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Accumulated other comprehensive loss |
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( |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders' equity |
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Total liabilities and stockholders' equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Inari Medical, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Cost of goods sold |
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Gross profit |
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Operating expenses |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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(Loss) income from operations |
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( |
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( |
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( |
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Other income (expense) |
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Interest income |
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Interest expense |
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( |
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( |
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( |
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( |
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Other income (expense) |
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( |
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( |
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Total other income (expenses) |
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( |
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( |
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(Loss) income before income taxes |
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( |
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( |
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( |
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Provision for income taxes |
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Net (loss) income |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Other comprehensive income (loss) |
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Foreign currency translation adjustments |
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( |
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( |
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( |
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( |
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Unrealized gain on available-for-sale debt securities |
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Total other comprehensive income (loss) |
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( |
) |
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( |
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( |
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Comprehensive (loss) income |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Net (loss) income per share |
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Basic |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Weighted average common shares used to compute net (loss) |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Inari Medical, Inc.
Condensed Consolidated Statements Stockholders’ Equity
(in thousands, except share data)
(unaudited)
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Common Stock |
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Additional Paid In |
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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 (Loss) |
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Deficit |
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Equity |
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Balance, December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Options exercised for |
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— |
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— |
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Shares issued under Employee |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
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— |
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— |
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( |
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Issuance of common stock in |
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— |
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— |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance, March 31, 2022 |
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( |
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( |
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Options exercised for |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance, June 30, 2022 |
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( |
) |
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( |
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Options exercised for common stock |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
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— |
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— |
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( |
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Shares issued under Employee |
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— |
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— |
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— |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance, September 30, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Inari Medical, Inc.
Condensed Consolidated Statements Stockholders’ Equity
(in thousands, except share data)
(unaudited)
|
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Common Stock |
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Additional Paid In |
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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 (Loss) |
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Deficit |
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Equity |
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Balance, December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Options exercised for |
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— |
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— |
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Shares issued under Employee |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Share-based compensation |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Net income |
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— |
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— |
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— |
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— |
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Balance, March 31, 2021 |
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( |
) |
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( |
) |
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Options exercised for common stock |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Share-based compensation expense |
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— |
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— |
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- |
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— |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Net income |
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— |
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— |
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— |
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— |
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Balance, June 30, 2021 |
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( |
) |
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( |
) |
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Options exercised for common stock |
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— |
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— |
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— |
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Shares issued under Employee |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Other comprehensive income (loss) |
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— |
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— |
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— |
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( |
) |
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— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, September 30, 2021 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Inari Medical, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net (loss) income |
|
$ |
( |
) |
|
$ |
|
|
Adjustments to reconcile net (loss) income to net cash (used in) provided by |
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Amortization of deferred financing costs |
|
|
|
|
|
|
||
Amortization of right-of-use assets |
|
|
|
|
|
|
||
Share-based compensation expense |
|
|
|
|
|
|
||
Allowance for credit losses, net |
|
|
|
|
|
( |
) |
|
Loss on disposal of fixed assets |
|
|
|
|
|
|
||
Changes in: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
( |
) |
Inventories |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses, deposits and other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
( |
) |
|
|
|
|
Payroll-related accruals, accrued expenses and other liabilities |
|
|
( |
) |
|
|
|
|
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
Lease prepayments for lessor's owned leasehold improvements |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by operating activities |
|
|
( |
) |
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Maturities of marketable securities |
|
|
|
|
|
|
||
Purchases of other investments |
|
|
( |
) |
|
|
|
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from issuance of common stock in public offering, net of |
|
|
|
|
|
|
||
Proceeds from issuance of common stock under employee stock purchase plan |
|
|
|
|
|
|
||
Proceeds from exercise of stock options |
|
|
|
|
|
|
||
Payment of taxes related to vested restricted stock units |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Effect of foreign exchange rate on cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Net decrease in cash |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
||
Cash paid for income taxes |
|
$ |
|
|
$ |
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Noncash investing and financing: |
|
|
|
|
|
|
||
Lease liabilities arising from obtaining new right-of-use assets |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Organization
Description of Business
Inari Medical, Inc. (the “Company”) was incorporated in Delaware in July 2011 and is headquartered in Irvine, California. The Company develops, manufactures, markets and sells devices for the interventional treatment of venous diseases.
2. Summary of Significant Accounting Policies
COVID-19
The global healthcare system continues to face an unprecedented challenge as a result of the novel coronavirus, or COVID-19, situation and its impact. COVID-19 may continue to have an adverse impact on significant aspects of the Company and the business, including the demand for products, business operations, and the ability to research and develop and bring to market new products and services. To the extent individuals and hospital systems de-prioritize, delay or cancel deferrable medical procedures as a result of COVID-19, staffing or resource issues, or otherwise, the Company’s business, cash flows, financial condition and results of operations may continue to be negatively affected.
The Company continues to focus its efforts on the health and safety of patients, healthcare providers and employees, while executing its mission of transforming lives of venous thromboembolism ("VTE") patients. However, the COVID-19 pandemic may continue to negatively impact the Company's 2022 performance.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
The interim condensed consolidated balance sheet as of September 30, 2022, the condensed consolidated statements of operations and comprehensive income (loss), stockholders’ equity, and cash flows for the three and nine months ended September 30, 2022 and 2021 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s consolidated financial position as of September 30, 2022 and its consolidated results of operations and cash flows for the three and nine months ended September 30, 2022 and 2021. The financial data and the other financial information disclosed in the notes to the condensed consolidated financial statements related to the three and nine months ended September 30, 2022 and 2021 are also unaudited. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2021 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with our audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed on February 23, 2022.
Principles of Consolidation
The condensed consolidated financial statements include the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Management Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements may include, but are not limited to, collectability of receivables, recoverability of long-lived assets, valuation of inventory, operating lease right-of-use ("ROU") assets and liabilities, other investments, fair value of stock options, recoverability of net deferred tax assets and related valuation allowance, and certain accruals. Estimates are based on historical experience and on various assumptions that the Company believes are reasonable under current circumstances. Actual results could differ materially from those estimates. Management periodically evaluates such estimates and assumptions, and they are adjusted prospectively based upon such periodic evaluation.
8
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
The Company sells its products primarily to hospitals in the United States utilizing the Company’s direct sales force. The Company recognizes revenue for arrangements where the Company has satisfied its performance obligation of shipping or delivering the product. For sales where the Company’s sales representative hand-deliver products directly to the hospitals, control of the products transfers to the customers upon such hand delivery. For sales where products are shipped, control of the products transfers either upon shipment or delivery of the products to the customer, depending on the shipping terms and conditions. Revenue from product sales is comprised of product revenue, net of product returns, administrative fees and sales rebates.
Performance Obligation—The Company has revenue arrangements that consist of a single performance obligation, the shipping or delivery of the Company’s products. The satisfaction of this performance obligation occurs with the transfer of control of the Company’s product to its customers, either upon shipment or delivery of the product.
Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring goods. The amount of revenue recognized is based on the transaction price, which represents the invoiced amount, net of administrative fees and sales rebates, where applicable. The Company provides a standard 30-day unconditional right of return period. The Company establishes estimated provisions for returns at the time of sale based on historical experience. Historically, the actual product returns have been immaterial to the Company’s consolidated financial statements.
As of September 30, 2022 and December 31, 2021, the Company recorded $
Revenue for ClotTriever and FlowTriever products as a percentage of total revenue was derived as follow:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
ClotTriever |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
FlowTriever |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
The Company offers payment terms to its customers of less than three months and these terms do not include a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price.
The Company offers its standard warranty to all customers. The Company does not sell any warranties on a standalone basis. The Company’s warranty provides that its products are free of material defects and conform to specifications, and includes an offer to repair, replace or refund the purchase price of defective products. This assurance does not constitute a service and is not considered a separate performance obligation. The Company estimates warranty liabilities at the time of revenue recognition and records it as a charge to cost of goods sold.
Costs associated with product sales include commissions and are recorded in selling, general and administrative ("SG&A") expenses. The Company applies the practical expedient and recognizes commissions as an expense when incurred because the amortization period is less than one year.
Other Investments
In March 2022, the Company made investments in certain privately held companies, with no readily determinable fair value. The Company measures these investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investments. The Company will monitor the information that becomes available from time to time and adjust the carrying values of these investments if there are identified events or changes in circumstances that have a significant adverse effect on the fair values. As of September 30, 2022, total other investments of $
9
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
3. Fair Value Measurements
The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2022 and December 31, 2021 (in thousands):
|
|
September 30, 2022 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Aggregate Fair Value |
|
||||
Financial Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market mutual funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total included in short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
December 31, 2021 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Aggregate Fair Value |
|
||||
Financial Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market mutual funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total included in short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities included in |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
There were
10
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
4. Cash Equivalents and Investments
The following is a summary of the Company’s cash equivalents and investments in debt securities as of September 30, 2022 and December 31, 2021 (in thousands):
|
|
September 30, 2022 |
|
|||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Fair Value |
|
||||
Financial Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market mutual funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
U.S. Government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total included in short-term investments |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
December 31, 2021 |
|
|||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Fair Value |
|
||||
Financial Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market mutual funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Corporate debt securities and commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total included in short-term investments |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
U.S. Treasury securities included in |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
5. Inventories, net
Inventories, net of reserves as of September 30, 2022 and December 31, 2021 totaling $
|
|
September 30, |
|
|
December 31, |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
11
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
6. Property and Equipment, net
Property and equipment consist of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Manufacturing equipment |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Assets in progress |
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Computer hardware |
|
|
|
|
|
|
||
Computer software |
|
|
|
|
|
|
||
Total property and equipment, gross |
|
|
|
|
|
|
||
Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation expense of $
7. Commitments and Contingencies
Operating Leases
The Company has operating leases for facilities and certain equipment. Leases with an initial term of
In March 2019, the Company executed a
In October 2020, the Company entered into a
The Company's wholly owned subsidiary, Inari Medical Europe GmbH, entered into a
12
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
As of September 30, 2022, the weighted average incremental borrowing rate used to measure operating lease liabilities was
Total lease cost for the three and nine months ended September 30, 2022, are as follows (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating lease cost |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Short-term lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Variable lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total lease costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Future minimum lease payments under operating leases liabilities as of September 30, 2022 are as follows (in thousands):
Year ending December 31: |
|
Amount |
|
|
Remainder of 2022 |
|
$ |
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments |
|
|
|
|
Less imputed interest |
|
|
( |
) |
Total lease liabilities |
|
|
|
|
Less: lease liabilities - current portion |
|
|
( |
) |
Lease liabilities - noncurrent portion |
|
$ |
|
|
The following are future minimum lease payments for the lease amendment discussed above, which has not yet commenced and is not included in ROU assets and operating lease liabilities as of September 30, 2022 (in thousands):
Year ending December 31: |
|
Amount |
|
|
Remainder of 2022 |
|
$ |
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
Total lease payments |
|
$ |
|
|
Indemnification
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and may provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not been subject to any claims or required to defend any action related to its indemnification obligations.
The Company’s amended and restated certificate of incorporation contains provisions limiting the liability of directors, and its amended and restated bylaws provide that the Company will indemnify each of its directors to the fullest extent permitted under Delaware law. The Company’s amended and restated certificate of incorporation and amended and restated bylaws also provide its board of directors with discretion to indemnify its officers and employees when determined appropriate by the board. In addition, the Company has entered and expects to continue to enter into agreements to indemnify its directors and executive officers.
13
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Legal Proceedings
From time to time, the Company may become involved in legal proceedings arising out of the ordinary course of its business. Management is currently not aware of any matters that will have a material adverse effect on the consolidated financial position, results of operations or cash flows of the Company.
Sublicense Agreement
In August 2019, the Company entered into a sublicense agreement of intellectual property rights related to the tubular braiding for the non-surgical removal of clots and treatment of embolism and thrombosis in human vasculature other than carotid arteries, coronary vasculature and cerebral vasculature. Under the sublicense agreement, the Company is required to pay an ongoing quarterly administration fee, which amounted to $
Licensed Technology
In December 2021, the Company entered into an exclusive, perpetual, royalty free, technology license agreement (the “Licensed Technology”) for use in a particular research and development project that requires total payments of approximately $
8. Concentrations
The Company’s revenue is derived primarily from the sale of catheter-based therapeutic devices in the United States. For the three and nine months ended September 30, 2022 and 2021, there were
9. Related Party
The Company utilizes MRI The Hoffman Group (“MRI”), a recruiting services company owned by the brother of the Chief Executive Officer and President and member of the board of directors of the Company. The Company paid for recruiting services provided by MRI amounting to $
10. Debt
Bank of America Credit Facility
In September 2020, the Company entered into a senior secured revolving credit facility with Bank of America (the “Credit Agreement”), as amended, under which the Company may borrow loans up to a maximum principal amount of $
Advances under the Credit Agreement will bear interest at a base rate per annum (the “Base Rate”) plus an applicable margin (the “Margin”). The Base Rate equals the greater of (i) the Prime Rate, (ii)
14
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
annum equal to the LIBOR rate plus the applicable Margin ranging from
The Credit Agreement also includes a Letter of Credit subline facility (the “LC Facility”) of up to $
11. Stockholder’s Equity
Common Stock
In March 2022, the Company completed an underwritten public offering (“Follow-On Offering”) of
12. Equity Incentive Plans
In 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”) to permit the grant of share-based awards, such as stock grants and incentives and non-qualified stock options to employees, directors, consultants and advisors. The Board has the authority to determine to whom awards will be granted, the number of shares, the term and the exercise price.
In March 2020, the Company adopted the 2020 Incentive Award Plan (the “2020 Plan”), which became effective in connection with the IPO. As a result, the Company may not grant any additional awards under the 2011 Plan. The 2011 Plan will continue to govern outstanding equity awards granted thereunder. The Company has initially reserved
2011 Equity Incentive Plan
Stock Options
A summary of stock option activities under the 2011 Plan for the nine months ended September 30, 2022 is as follows (intrinsic value in thousands):
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Weighted |
|
|
Intrinsic |
|
|||||
Outstanding, December 31, 2021 |
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|||||
Exercised |
|
|
( |
) |
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
||||
Cancelled |
|
|
( |
) |
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
||||
Outstanding, September 30, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|||||
Vested and exercisable at September 30, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|||||
Vested and expected to vest at September 30, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|||||
15
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
The aggregate intrinsic values of options outstanding, vested and exercisable, and vested and expected to vest were calculated as the difference between the exercise price of the options and the estimated fair value of the Company’s common stock.
Restricted Stock Units
In March 2019, the Company granted, under the 2011 Plan, restricted stock unit awards (“RSUs”) to certain employees that vest only upon the satisfaction of both a time-based service condition and a performance-based condition. The performance-based condition is a liquidity event requirement that was satisfied on the effective date of the IPO of the Company’s common stock. The RSUs are subject to a
There was
2020 Incentive Award Plan
Restricted Stock Units
RSUs are share awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon vesting. The RSUs cannot be transferred and the awards are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions.
RSU activities under the 2020 Plan is set forth below:
|
|
Number of |
|
|
Weighted |
|
||
Outstanding, December 31, 2021 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Cancelled |
|
|
( |
) |
|
|
|
|
Outstanding, September 30, 2022 |
|
|
|
|
$ |
|
||
The total fair value of RSUs vested under both the 2011 Plan and 2020 Plan was $
Stock-based Compensation Expense
Total compensation cost for all share-based payment arrangements recognized, including $
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Cost of goods sold |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
16
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Total compensation costs as of September 30, 2022 related to all non-vested awards to be recognized in future periods was $
Employee Stock Purchase Plan
In May 2020, the Company adopted the 2020 Employee Stock Purchase Plan (“ESPP”), which became effective on the date the ESPP was adopted by the Company’s board of directors. Each offering to the employees to purchase stock under the ESPP will begin on each August 1 and February 1 and will end on the following January 31 and July 31, respectively. The first offering period began on
The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model with the following assumptions:
|
|
Nine Months Ended September 30, |
||
|
|
2022 |
|
2021 |
Expected term (in years) |
|
|
||
Expected volatility |
|
|
||
Dividend yield |
|
|
||
Risk free interest rate |
|
|
||
As of September 30, 2022, a total of
13. Income Taxes
The following table reflects the Company’s provision for income taxes for the periods indicated (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
(Loss) income before income taxes |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Provision for income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) income |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Provision for income taxes as a percentage |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
The effective tax rate for all periods is driven by pre-tax income/(loss), business credits, equity compensation, state taxes, and the change in valuation allowance. The Company's income tax provision for interim reporting periods has historically been calculated by applying an estimate of the annual effective income tax rate for the full year to "ordinary" income (loss) for the interim reporting period, which is calculated as pre-tax income (loss) excluding unusual and infrequently occurring discrete items. For the nine months ended September 30, 2022, we calculated the income tax provision using a discrete effective income tax rate method as if the interim year to date period was an annual period. We determined that since normal changes in estimated "ordinary" income (loss) would result in disproportionate changes in the estimated annual effective income tax rate, the Company's historical method of calculating its income tax provision for interim reporting periods would not provide a reliable estimate for the nine months ended September 30, 2022.
For tax years beginning after December 31, 2021, certain research and development costs are required to be capitalized and amortized over a five year period under the Tax Cuts and Jobs Act, which was signed into law December 22, 2017. The Company has reviewed and incorporated this change, which will impact the expected U.S. federal and state tax expense and cash taxes to be paid for the tax year ending December 31, 2022.
Valuation Allowance
17
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
ASC 740 requires that the tax benefit of net operating losses, or NOLs, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryback or carryforward periods. As of December 31, 2021, the Company maintained a full valuation allowance of $
Uncertain Tax Positions
The Company has recorded uncertain tax positions related to its federal and California research and development credit carryforwards.
14. Retirement Plan
In December 2017, the Company adopted the Inari Medical, Inc. 401(k) Plan which allows employees after one month of service to contribute pre-tax and Roth contributions to the plan, as allowed by law. The plan assets are held by Vanguard and the plan administrator is Ascensus Trust Company. Beginning in January 2021, the Company contributes a $
18
Inari Medical, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
15. Net Income (Loss) Per Share
The components of net income per share are as follows:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) income (in thousands) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of common shares |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock equivalents from outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock equivalents from unvested RSUs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock equivalents from ESPP |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock equivalents from restricted stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of common shares |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
Diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2022 and the three months ended September 30, 2021 due to their anti-dilutive effect:
|
|
Three and Nine Months Ended September 30, 2022 |
|
|
Three Months Ended September 30, 2021 |
|
||
Common stock options |
|
|
|
|
|
|
||
RSUs |
|
|
|
|
|
|
||
Restricted stock subject to future vesting |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and related notes thereto for the year ended December 31, 2021, included in our Annual Report on Form 10-K for the year ended December 31, 2021. In addition to historical financial information, the following discussion contains forward-looking statements that are based upon current plans, expectations and beliefs that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021.
Overview
We are a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offerings consist of two minimally-invasive, novel catheter-based mechanical thrombectomy systems, which are purpose-built for the specific characteristic of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE - deep vein thrombosis, or DVT, and pulmonary embolism, or PE. Our ClotTriever product is FDA-cleared for the treatment of DVT. Our FlowTriever product is the first thrombectomy system FDA-cleared for the treatment of PE and is also FDA-cleared for clot in transit in the right atrium.
We believe the best way to treat VTE and improve the quality of life of patients suffering from this disease is to safely and effectively remove the blood clot. With that in mind, we designed and purpose-built our ClotTriever and FlowTriever systems. The ClotTriever is a mechanical thrombectomy system designed to core, capture and remove large clots from large vessels and is used to treat DVT. The FlowTriever is a large bore catheter-based aspiration and mechanical thrombectomy system designed to remove large clots from large vessels to treat PE. Both systems are designed to eliminate the need for thrombolytic drugs.
We believe our mission-focused and highly-trained commercial organization provides a significant competitive advantage. Our most important relationships are between our sales representatives and our treating physicians, which include interventional cardiologists, interventional radiologists and vascular surgeons. We recruit sales representatives who have substantial and applicable medical device and/or sales experience. Our front-line sales representatives typically attend procedures, which puts us at the intersection of the patients, products and physicians. We have developed systems and processes to harness the information gained from these relationships and we leverage this information to rapidly iterate products, introduce and execute physician education and training programs and scale our sales organization. We market and sell our products to hospitals, which are reimbursed by various third-party payors.
In March 2022, we completed an underwritten public offering, or the Follow-On Offering, of 2,300,000 shares of common stock, at a price of $81.00 per share. We received net proceeds of approximately $174.4 million, after deducting underwriters’ discounts and commissions and offering costs.
As of September 30, 2022, we had cash, cash equivalents, and short-term investments of $319.2 million, no long-term debt outstanding and an accumulated deficit of $41.1 million.
For the three months ended September 30, 2022, the Company generated $96.2 million in revenues with a gross margin of 88.5% and net loss of $10.2 million, as compared to revenues of $72.9 million with a gross margin of 90.3% and net loss of $2.8 million for the three months ended September 30, 2021.
For the nine months ended September 30, 2022, the Company generated $275.7 million in revenues with a gross margin of 88.6% and net loss of $23.5 million, as compared to revenues of $193.8 million with a gross margin of 91.5% and net income of $8.7 million for the nine months ended September 30, 2021.
COVID-19
The global healthcare system continues to face an unprecedented challenge as a result of the COVID-19 situation and its impact. COVID-19 may continue to have an adverse impact on aspects of our business, including the demand for our products, operations, and ability to research and develop and bring new products and services to market.
In response to the impact of COVID-19, we implemented a variety of measures to help manage through the impact and position us to keep operations running efficiently. However, with hospitals facing staff or other resource constraints, to the extent individuals and hospital systems de-prioritize, delay or cancel deferrable medical procedures, our business, cash flows, financial condition and results of operations may continue to be negatively affected.
The actual and perceived impact of COVID-19 is still evolving and cannot be predicted. As a result, we cannot assure you that our recent procedure volumes are indicative of future results or that we will not experience additional negative impacts associated with COVID-19 or staffing shortages, which could be significant. We continue to focus our efforts on the health and safety of patients, healthcare providers and employees, while executing our mission of transforming lives of patients. While the COVID-19 pandemic
20
may continue to negatively impact our 2022 performance, we believe the long-term fundamentals remain strong and we will continue to effectively manage through these challenges.
Revenue
We currently derive substantially all our revenue from the sale of our ClotTriever and FlowTriever systems directly to hospitals primarily in the United States. Our customers typically purchase an initial stocking order of our products and then reorder replenishment as procedures are performed. We expect our revenue to increase in absolute dollars as we expand our sales organization and sales territories, add customers, expand the base of physicians that are trained to use our products, expand awareness of our products with new and existing customers and as physicians perform more procedures using our products. Revenue for ClotTriever and FlowTriever systems as a percentage of total revenue is as follows:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
ClotTriever |
|
|
31 |
% |
|
|
30 |
% |
|
|
32 |
% |
|
|
33 |
% |
FlowTriever |
|
|
69 |
% |
|
|
70 |
% |
|
|
68 |
% |
|
|
67 |
% |
Critical Accounting Policies and Estimates
Other than the accounting policy changes discussed in "Note 2 - Summary of Significant Accounting Policies" to our condensed consolidated financial statements, which is included in "Part I, Item 1. Condensed Consolidated Financial Statements (Unaudited)", there have been no significant changes in our critical accounting policies during the nine months ended September 30, 2022, as compared to the critical accounting policies disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 23, 2022.
Results of Operations
Comparison of the three months ended September 30, 2022 and 2021
The following table sets forth the components of our unaudited condensed consolidated statements of operations in dollars and as percentage of revenue for the periods presented (dollars in thousands):
|
|
Three Months Ended September 30, |
|
|
|
|
||||||||||||||
|
|
2022 |
|
|
% |
|
|
2021 |
|
|
% |
|
|
Change $ |
|
|||||
Revenue |
|
$ |
96,204 |
|
|
|
100.0 |
% |
|
$ |
72,916 |
|
|
|
100.0 |
% |
|
$ |
23,288 |
|
Cost of goods sold |
|
|
11,064 |
|
|
|
11.5 |
% |
|
|
7,040 |
|
|
|
9.7 |
% |
|
|
4,024 |
|
Gross profit |
|
|
85,140 |
|
|
|
88.5 |
% |
|
|
65,876 |
|
|
|
90.3 |
% |
|
|
19,264 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Research and development |
|
|
19,105 |
|
|
|
19.9 |
% |
|
|
12,499 |
|
|
|
17.1 |
% |
|
|
6,606 |
|
Selling, general and administrative |
|
|
75,833 |
|
|
|
78.8 |
% |
|
|
56,104 |
|
|
|
76.9 |
% |
|
|
19,729 |
|
Total operating expenses |
|
|
94,938 |
|
|
|
98.7 |
% |
|
|
68,603 |
|
|
|
94.0 |
% |
|
|
26,335 |
|
Income (loss) from operations |
|
|
(9,798 |
) |
|
|
(10.2 |
%) |
|
|
(2,727 |
) |
|
|
(3.7 |
%) |
|
|
(7,071 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Interest income |
|
|
618 |
|
|
|
0.6 |
% |
|
|
27 |
|
|
|
0.0 |
% |
|
|
591 |
|
Interest expense |
|
|
(74 |
) |
|
|
(0.1 |
%) |
|
|
(73 |
) |
|
|
(0.1 |
%) |
|
|
(1 |
) |
Other income (expense) |
|
|
(59 |
) |
|
|
(0.1 |
%) |
|
|
30 |
|
|
|
0.0 |
% |
|
|
(89 |
) |
Total other expenses, net |
|
|
485 |
|
|
|
0.4 |
% |
|
|
(16 |
) |
|
|
(0.1 |
%) |
|
|
501 |
|
Income (loss) before income taxes |
|
$ |
(9,313 |
) |
|
|
(9.8 |
%) |
|
$ |
(2,743 |
) |
|
|
(3.8 |
%) |
|
$ |
(6,570 |
) |
Revenue. Revenue increased $23.3 million, or 31.9%, to $96.2 million during the three months ended September 30, 2022, compared to $72.9 million during the three months ended September 30, 2021. The increase in revenue was due primarily to an increase in the number of product offerings and the number of units sold as we expanded our sales territories, opened new accounts and achieved deeper penetration of our products into existing accounts.
Cost of Goods Sold. Cost of goods sold increased $4.0 million, or 57.2%, to $11.1 million during the three months ended September 30, 2022, compared to $7.0 million during the three months ended September 30, 2021. This increase was primarily due to the increase in the number of products sold and additional manufacturing overhead costs incurred as we invested significantly in our new facility and operational infrastructure to support our growth.
21
Gross Margin. Gross margin for the three months ended September 30, 2022 decreased to 88.5%, compared to 90.3% for the three months ended September 30, 2021, primarily due to the costs associated with the addition of new products to our FlowTriever per procedure pricing model.
Research and Development Expenses. R&D expenses increased $6.6 million, or 52.9%, to $19.1 million during the three months ended September 30, 2022, compared to $12.5 million during the three months ended September 30, 2021. The increase in R&D expenses was primarily due to increases of $5.1 million of personnel-related expenses, $0.9 million in materials and supplies, and $0.5 million of clinical and regulatory expenses, in support of our growth drivers to develop new products and build the clinical evidence base.
Selling, General and Administrative Expenses. SG&A expenses increased $19.7 million, or 35.2%, to $75.8 million during the three months ended September 30, 2022, compared to $56.1 million during the three months ended September 30, 2021. The increase in SG&A costs was primarily due to increases of $12.5 million in personnel-related expenses as a result of increased headcount across our organization and increased commissions due to higher revenue, $2.1 million in travel and related expenses, $1.5 million in marketing expenses, $1.5 million in professional fees, and $1.1 million in facility related expenses, particularly related to our new facility.
Interest Income. Interest income increased by $0.6 million during the three months ended September 30, 2022, compared to the three months ended September 30, 2021. The increase in interest income was primarily due to higher interest rate and higher average cash, cash equivalent and short-term investments balances during the three months ended September 30, 2022 compared to the three months ended September 30, 2021.
Interest Expense. Interest expense was consistent with $74,000 during the three months ended September 30, 2022, compared to $73,000 during the three months ended September 30, 2021.
Other Income (Expense). Other expense of $59,000 for the three months ended September 30, 2022 consisted primarily of foreign currency transaction losses.
Comparison of the nine months ended September 30, 2022 and 2021
The following table sets forth the components of our unaudited condensed consolidated statements of operations in dollars and as percentage of revenue for the periods presented (dollars in thousands):
|
|
Nine Months Ended September 30, |
|
|
|
|
||||||||||||||
|
|
2022 |
|
|
% |
|
|
2021 |
|
|
% |
|
|
Change $ |
|
|||||
Revenue |
|
$ |
275,700 |
|
|
|
100.0 |
% |
|
$ |
193,766 |
|
|
|
100.0 |
% |
|
$ |
81,934 |
|
Cost of goods sold |
|
|
31,378 |
|
|
|
11.4 |
% |
|
|
16,477 |
|
|
|
8.5 |
% |
|
|
14,901 |
|
Gross profit |
|
|
244,322 |
|
|
|
88.6 |
% |
|
|
177,289 |
|
|
|
91.5 |
% |
|
|
67,033 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Research and development |
|
|
53,809 |
|
|
|
19.5 |
% |
|
|
32,292 |
|
|
|
16.7 |
% |
|
|
21,517 |
|
Selling, general and administrative |
|
|
212,721 |
|
|
|
77.2 |
% |
|
|
135,899 |
|
|
|
70.1 |
% |
|
|
76,822 |
|
Total operating expenses |
|
|
266,530 |
|
|
|
96.7 |
% |
|
|
168,191 |
|
|
|
86.8 |
% |
|
|
98,339 |
|
Income from operations |
|
|
(22,208 |
) |
|
|
(8.1 |
%) |
|
|
9,098 |
|
|
|
4.7 |
% |
|
|
(31,306 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Interest income |
|
|
882 |
|
|
|
0.3 |
% |
|
|
130 |
|
|
|
0.1 |
% |
|
|
752 |
|
Interest expense |
|
|
(220 |
) |
|
|
(0.1 |
%) |
|
|
(220 |
) |
|
|
(0.1 |
%) |
|
|
— |
|
Other income (expense) |
|
|
169 |
|
|
|
0.1 |
% |
|
|
(4 |
) |
|
|
0.0 |
% |
|
|
173 |
|
Total other expenses, net |
|
|
831 |
|
|
|
0.3 |
% |
|
|
(94 |
) |
|
|
0.0 |
% |
|
|
925 |
|
Income (loss) before income taxes |
|
$ |
(21,377 |
) |
|
|
(7.8 |
%) |
|
$ |
9,004 |
|
|
|
4.7 |
% |
|
$ |
(30,381 |
) |
Revenue. Revenue increased $81.9 million, or 42.3%, to $275.7 million during the nine months ended September 30, 2022, compared to $193.8 million during the nine months ended September 30, 2021. The increase in revenue was due primarily to an increase in the number of product offerings and the number of units sold as we expanded our sales territories, opened new accounts and achieved deeper penetration of our products into existing accounts.
Cost of Goods Sold. Cost of goods sold increased $14.9 million, or 90.4%, to $31.4 million during the nine months ended September 30, 2022, compared to $16.5 million during the nine months ended September 30, 2021. This increase was primarily due to the increase in the number of products sold and additional manufacturing overhead costs incurred as we invested significantly in our new facility and operational infrastructure to support our growth.
Gross Margin. Gross margin for the nine months ended September 30, 2022 decreased to 88.6%, compared to 91.5% for the nine months ended September 30, 2021, primarily due to the costs associated with the addition of new products to our FlowTriever per procedure pricing model.
22
Research and Development Expenses. R&D expenses increased $21.5 million, or 66.6%, to $53.8 million during the nine months ended September 30, 2022, compared to $32.3 million during the nine months ended September 30, 2021. The increase in R&D expenses was primarily due to increases of $15.0 million of personnel-related expenses, $3.7 million in materials and supplies, $1.2 million of clinical and regulatory expenses, and $0.9 million in software costs and depreciation expenses, in support of our growth drivers to develop new products and build the clinical evidence base.
Selling, General and Administrative Expenses. SG&A expenses increased $76.8 million, or 56.5%, to $212.7 million during the nine months ended September 30, 2022, compared to $135.9 million during the nine months ended September 30, 2021. The increase in SG&A costs was primarily due to increases of $51.3 million in personnel-related expenses as a result of increased headcount across our organization and increased commissions due to higher revenue, $6.9 million in travel and related expenses, $6.3 million in marketing expenses, $5.4 million in professional fees, $3.4 million in facility related expenses, particularly related to our new facility, and $2.3 million in software costs and depreciation expenses.
Interest Income. Interest income increased by $0.8 million or 578.5% to $0.9 million during the nine months ended September 30, 2022, compared to $0.1 million during the nine months ended September 30, 2021. The increase in interest income was primarily due to higher interest rate and higher average cash, cash equivalent and short-term investments balances during the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021.
Interest Expense. Interest expense was consistent with $220,000 during the nine months ended September 30, 2022 and the nine months ended September 30, 2021.
Other income (Expenses) Other income of $169,000 for the nine months ended September 30, 2022 consisted primarily of foreign currency transaction gains.
Liquidity and Capital Resources
To date, our primary sources of capital have been the net proceeds we received through private placements of preferred stock, debt financing agreements, the sale of common stock in our IPO and Follow-On Offering, and revenue from the sale of our products. On May 27, 2020, we completed our IPO and sold 9,432,949 shares of our common stock at $19.00 per share. Upon completion of our IPO, we received net proceeds of approximately $163.0 million, after deducting underwriting discounts and commissions and offering expenses. In March 2022, we completed a Follow-On Offering and sold 2,300,000 shares of our common stock at $81.00 per share, for net proceeds of approximately $174.4 million, after deducting underwriting discounts and commissions and offering expenses. In September 2020, we entered into a revolving Credit Agreement with Bank of America which provides for loans up to a maximum of $30.0 million. As of September 30, 2022, we had cash and cash equivalents of $83.5 million, short-term investments of $235.7 million and an accumulated deficit of $41.1 million. As of September 30, 2022, we had no principal outstanding under the Credit Agreement and the amount available to borrow was approximately $28.0 million.
Based on our current planned operations, we expect that our cash and cash equivalents, short-term investments and available borrowings, along with cash flow from operations, will be adequate us to fund our operating expenses for at least the next 12 months.
If our available cash balances and cash flow from operations are insufficient to satisfy our liquidity requirements, we may seek to sell additional common or preferred equity or convertible debt securities, enter into an additional credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights or grant licenses on terms that are not favorable to us. Additional capital may not be available on reasonable terms, or at all.
Cash Flows
The following table summarizes our cash flows for each of the periods indicated (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Net cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(25,227 |
) |
|
$ |
10,479 |
|
Investing activities |
|
|
(161,969 |
) |
|
|
(48,365 |
) |
Financing activities |
|
|
178,827 |
|
|
|
4,693 |
|
Effect of foreign exchange rate on cash and cash equivalents |
|
|
(855 |
) |
|
|
(266 |
) |
Net decrease in cash and cash equivalents |
|
$ |
(9,224 |
) |
|
$ |
(33,459 |
) |
23
Net Cash (Used in) Provided by Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2022 was $25.2 million, consisting primarily of net loss of $23.5 million and a decrease in net operating assets of $28.5 million, offset by non-cash charges of $26.8 million. The decrease in net operating assets was primarily due to decreases in accounts payable and accrued liabilities of $1.0 million due to timing of payments and growth of our operations, lease prepayments for lessor's owned leasehold improvements of $4.5 million and a decrease in operating lease liabilities of $0.6 million, coupled with increases in accounts receivable of $12.2 million, inventories of $8.7 million, and prepaid and other assets of $1.5 million. The non-cash charges primarily consisted of $21.1 million in stock-based compensation expense, $3.4 million in depreciation, and $1.8 million in amortization of the right-of-use assets.
Net cash provided by operating activities for the nine months ended September 30, 2021 was $10.5 million, consisting primarily of net income of $8.7 million and non-cash charges of $23.7 million, offset by an increase in net operating assets of $21.9 million. The increase in net operating assets was primarily due to increases in accounts receivable of $10.9 million and inventories of $8.9 million to support the growth of our operations, an increase in prepaid and other assets of $4.5 million primarily from prepaid insurance, which were partially offset by increases in accounts payable of $2.0 million and accrued liabilities of $12.9 million due to timing of payments and growth of our operations, lease prepayments for lessor's owned leasehold improvements of $12.0 million and a decrease in operating lease liabilities of $0.6 million. The non-cash charges primarily consisted of $20.9 million in stock-based compensation expense, $2.1 million in depreciation, and $0.5 million in amortization of the right-of-use assets.
Net Cash Used in Investing Activities
Net cash used in investing activities for the nine months ended September 30, 2022 was $162.0 million, consisting of $332.1 million purchases of short-term investments, $5.7 million purchases of other investments, and $8.2 million purchases of property and equipment, offset by maturities of short-term investments of $184.0 million.
Net cash used in investing activities for the nine months ended September 30, 2021 was $48.4 million, consisting of $105.4 million purchases of marketable securities coupled with $10.9 million purchases of property and equipment, offset by maturities of short-term investments of $68.0 million.
Net Cash Provided by Financing Activities
Net cash provided by financing activities in the nine months ended September 30, 2022 was $178.8 million, consisting of $174.4 million net proceeds from the issuance of common stock in the Follow-On Offering, net of issuance costs of $11.9 million, $8.4 million proceeds from the issuance of common stock under our employee stock purchase plan and $0.6 million of proceeds from exercise of stock options, offset by $4.6 million of tax payments related to vested RSUs.
Net cash provided by financing activities in the nine months ended September 30, 2021 was $4.7 million, consisting of proceeds of $5.6 million in proceeds from the issuance of common stock under our employee stock purchase plan and $0.7 million of proceeds from exercise of stock options, offset by $1.6 million of tax payments related to vested RSUs.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined by applicable regulations of the U.S. Securities and Exchange Commission, that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.
Contractual Obligations and Commitments
There have been no material changes to our quantitative and qualitative disclosures about market risk from those disclosed in “Part II, Item 7. Quantitative and Qualitative Disclosures about Market Risk” included in our Annual Report on Form 10-K for the year ended December 31, 2021.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
There have been no material changes to our quantitative and qualitative disclosures about market risk as compared to the quantitative and qualitative disclosures about market risk described in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 23, 2022 under “Part II, Item 7. Quantitative and Qualitative Disclosures about Market Risk.
Item 4. Controls and Procedures.
Evaluation of disclosure controls and procedures
Our management, with the participation of our Principal Executive Officer and our Principal Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, or the Exchange Act), as of September 30, 2022. Based on such evaluation, our Principal Executive Office and Principal Financial Officer concluded that, as of September 30, 2022, these disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act, is
24
recorded, processed, summarized and reported, with the time period specified in the SEC rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Act is accumulated and communicated to our management.
Changes in internal control over financial reporting
During the three months ended September 30, 2022, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent limitations on effectiveness of controls and procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any control and procedure, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
25
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not subject to any material legal proceedings.
Item 1A. Risk Factors.
For a discussion of our potential risks and uncertainties, see the information in Part I, "Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021. As of the date of this Report, there have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
26
Item 6. Exhibits.
|
|
Incorporated by reference |
|||
Exhibit Number |
Description |
Form |
File Number |
Exhibit |
Filing Date |
3.1 |
8-K |
001-39293 |
3.1 |
5/28/2020 |
|
3.2 |
8-K |
001-39293 |
3.2 |
5/28/2020 |
|
31.1 |
|
|
|
|
|
31.2 |
|
|
|
|
|
32.1† |
|
|
|
|
|
32.2† |
|
|
|
|
|
101.INS |
Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its EBRL tags are embedded within the inline XBRL document. |
|
|
|
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
|
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
|
104 |
Cover Page with Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101). |
|
|
|
|
† The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the U.S. Securities and Exchange Commission and are not to be incorporated by reference into any filing of Inari Medical, 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, irrespective of any general incorporation language contained in such filing.
27
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.
|
|
Inari Medical, Inc. |
|
|
|
|
|
Date: November 2, 2022 |
|
By: |
/s/ William Hoffman |
|
|
|
William Hoffman |
|
|
|
Chief Executive Officer and President (Principal Executive Officer) |
|
|
|
|
Date: November 2, 2022 |
|
By: |
/s/ Mitchell Hill |
|
|
|
Mitchell Hill |
|
|
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
28
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, William Hoffman, certify that:
Date: November 2, 2022 |
|
By: |
/s/ William Hoffman |
|
|
|
William Hoffman |
|
|
|
Chief Executive Officer and President (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mitchell Hill, certify that:
Date: November 2, 2022 |
|
By: |
/s/ Mitchell Hill |
|
|
|
Mitchell Hill |
|
|
|
Chief Financial Officer (Principal Financial Officer and Principal 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
In connection with the Quarterly Report of Inari Medical, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: November 2, 2022 |
|
By: |
/s/ William Hoffman |
|
|
|
William Hoffman |
|
|
|
Chief Executive Officer and President (Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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
In connection with the Quarterly Report of Inari Medical, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: November 2, 2022 |
|
By: |
/s/ Mitchell Hill |
|
|
|
Mitchell Hill |
|
|
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.