UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 11, 2021
INARI MEDICAL, INC.
(Exact name of registrant as specified in its charter)
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001-39293 |
45-2902923 |
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( State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer |
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9 Parker, Suite 100 Irvine, California, 92618 |
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(Address of principal executive offices) |
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(877) 923-4747
(Registrant’s telephone number, include area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR |
Securities registered pursuant to Section 12(b) of the Act:
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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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Common stock, $0.001 par value per share |
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NARI |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
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. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 11, 2021, Inari Medical, Inc. (the “Company”) issued a press release announcing financial results for its first fiscal quarter ended March 31, 2021. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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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 hereunto duly authorized.
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INARI MEDICAL, INC. |
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Date: May 11, 2021 |
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By: |
/s/ William Hoffman |
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William Hoffman |
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President and Chief Executive Officer |
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Exhibit 99.1
Inari Medical Reports First Quarter 2021 Financial Results
IRVINE, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today reported financial results for its first quarter ended March 31, 2021.
First Quarter Revenue and Business Highlights:
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Treated a record number of patients, driving revenue of $57.4 million, which was up 18% sequentially and 113% over the prior year period. |
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Announced first patient enrolled in FLAME study, the largest clinical trial ever conducted on high risk PE patients. |
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Ended the quarter with $174.1 million in cash, cash equivalents, and short-term investments. |
“During Q1 we again made important progress in our mission to treat and transform the lives of our patients,” said Bill Hoffman, CEO of Inari Medical. “We treated a record number of patients and significantly expanded our commercial footprint. We further demonstrated our commitment to advancing the science and the VTE space more broadly by expanding our FLASH registry to 1,000 patients, adding longer term monitoring via a smart watch, and launching FLAME to study the sickest PE patient population. Increasingly, we see our future filled not just with opportunity, but with responsibility to serve ever more patients. We are grateful for this responsibility, and for the support of all of you who continue to believe and invest in our mission.”
First Quarter 2021 Financial Results
Revenue was $57.4 million for the first quarter of 2021, compared to $48.6 million for the prior quarter and $27.0 million for the first quarter of 2020. The increase over prior year was driven by continued US commercial expansion and increased production adoption.
Gross profit for the first quarter of 2021 was $52.7 million compared to $24.2 million for the first quarter of 2020. Gross margin increased slightly to 91.9% for the first quarter of 2021, compared with 90.0% in the same quarter last year, due primarily to greater operating leverage.
Operating expenses were $45.1 million for the first quarter of 2021, compared with $19.4 million in the same quarter last year. The increase was driven primarily by personnel-related expenses to fund expansion of the commercial, research and development, clinical and support organizations, as well as expenses related to being a public company.
Net income was $7.5 million for the first quarter of 2021 and net income per share was $0.15 on a weighted-average basic share count of 49.4 million and $0.13 on a diluted share count of 55.7 million,
compared to net income of $4.1 million and an income per share of $0.64 on a weighted-average basic share count of 64 million and $0.09 on a diluted share count of 45.0 million in the same period of the prior year.
Cash, cash equivalents and short-term investments were $174.1 million as of March 31, 2021.
COVID-19 and Guidance
Despite ongoing challenges and uncertainties in its operating environment due to the COVID-19 pandemic, Inari Medical is providing financial guidance as follows:
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For the full-year 2021, revenue of $240 to $250 million. |
Webcast and Conference Call Information
Inari Medical will host a conference call to discuss the first quarter financial results after market close on Tuesday, May 11, 2021 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 519-1265 for U.S. callers or (914) 800-3838 for international callers, using conference ID: 5787033. The live webinar can be accessed at https://ir.inarimedical.com.
About Inari Medical, Inc.
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by the FDA and CE Mark approved for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA and CE Mark approved for the treatment of pulmonary embolism and cleared by the FDA for clot in transit in the right atrium.
Forward Looking Statements
Statements in this press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “may,” “will,” “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. Forward-looking statements include financial guidance regarding first quarter and full year 2021 revenue and the potential impact of COVID-19 on the business, and are based on Inari’s current expectations, forecasts and assumptions, are subject to inherent uncertainties, risks and assumptions that are difficult to predict and actual outcomes and results could differ materially due to a number of factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the period ended December 31, 2020 and in its other reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are based on information available to Inari as of the date hereof and are made only as of the date of this release. Inari undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing Inari’s views as of any date subsequent to the date of this press release. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Inari.
Investor Contact:
Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
caroline.corner@westwicke.com
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 March 31, |
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2021 |
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2020 |
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Revenue |
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$ |
57,397 |
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$ |
26,953 |
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Cost of goods sold |
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4,623 |
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2,706 |
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Gross profit |
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52,774 |
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24,247 |
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Operating expenses |
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Research and development |
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8,163 |
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3,018 |
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Selling, general and administrative |
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36,898 |
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16,393 |
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Total operating expenses |
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45,061 |
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19,411 |
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Income from operations |
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7,713 |
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4,836 |
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Other income (expense) |
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Interest income |
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68 |
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55 |
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Interest expense |
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(73 |
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(346 |
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Change in fair value of warrant liabilities |
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— |
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(433 |
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Other expenses |
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(41 |
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— |
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Total other expenses |
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(46 |
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(724 |
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Income before income taxes |
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7,667 |
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4,112 |
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Provision for income taxes |
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198 |
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— |
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Net income |
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$ |
7,469 |
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$ |
4,112 |
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Other comprehensive income (loss) |
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Foreign currency translation adjustments |
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(180 |
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— |
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Unrealized gain on available-for-sale securities |
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18 |
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— |
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Total other comprehensive income (loss) |
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(162 |
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— |
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Comprehensive income |
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$ |
7,307 |
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$ |
4,112 |
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Net income per share |
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Basic |
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$ |
0.15 |
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$ |
0.64 |
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Diluted |
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$ |
0.13 |
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$ |
0.09 |
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Weighted average common shares used to compute net income per share |
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Basic |
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49,355,945 |
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6,398,897 |
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Diluted |
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55,722,293 |
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44,952,704 |
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Inari Medical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
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March 31, 2021 |
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December 31, 2020 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
102,903 |
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$ |
114,229 |
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Restricted cash |
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— |
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50 |
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Short-term investments |
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71,246 |
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49,981 |
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Accounts receivable, net |
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31,304 |
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28,008 |
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Inventories, net |
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13,665 |
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10,597 |
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Prepaid expenses and other current assets |
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2,159 |
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2,808 |
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Total current assets |
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221,277 |
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205,673 |
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Property and equipment, net |
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6,584 |
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7,498 |
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Restricted cash |
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— |
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338 |
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Operating lease right-of-use assets |
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1,047 |
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— |
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Deposits and other assets |
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5,669 |
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583 |
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Total assets |
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$ |
234,577 |
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$ |
214,092 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
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$ |
5,518 |
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$ |
3,047 |
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Payroll-related accruals |
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11,550 |
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8,198 |
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Accrued expenses and other current liabilities |
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2,758 |
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2,593 |
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Lease liabilities, current portion |
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789 |
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— |
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Total current liabilities |
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20,615 |
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13,838 |
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Lease liabilities, noncurrent portion |
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351 |
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— |
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Total liabilities |
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20,966 |
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13,838 |
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Commitments and contingencies (Note 7) |
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Stockholders' equity |
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Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of March 31, 2021 and December 31, 2020 |
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— |
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— |
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Common stock, $0.001 par value, 300,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 49,585,415 and 49,251,614 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively |
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50 |
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49 |
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Additional paid in capital |
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233,673 |
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227,624 |
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Accumulated other comprehensive income (loss) |
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(158 |
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4 |
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Accumulated deficit |
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(19,954 |
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(27,423 |
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Total stockholders' equity |
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213,611 |
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200,254 |
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Total liabilities and stockholders' equity |
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$ |
234,577 |
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$ |
214,092 |
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