UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 August 8, 2023, Personalis, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2023. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
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.
Date: August 8, 2023 |
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Personalis, Inc. |
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By: |
/s/ Aaron Tachibana |
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Aaron Tachibana |
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Chief Financial Officer and Chief Operating Officer |
Exhibit 99.1
Personalis Reports Second Quarter 2023 Financial Results
FREMONT, Calif. – August 8, 2023 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the second quarter ended June 30, 2023 and provided recent business highlights.
Recent Business Updates
“We continue expanding our biopharma funnel of opportunities for NeXT Personal® and expect revenue growth to begin ramping later this year, which allowed us to tighten the revenue guidance range,” said Chris Hall, President and CEO of Personalis. “We continue to crisply execute and plan to launch our highly sensitive MRD test later this year for oncologists. As we and our partners build a base of supportive evidence, we are paving the way for our successful entry into the clinical diagnostics market.”
Second Quarter Financial Highlights
1
Third Quarter and Full Year 2023 Outlook
Personalis expects the following for the third quarter of 2023:
Personalis expects the following for the full year of 2023:
Webcast and Conference Call Information
Personalis will host a conference call to discuss the second quarter financial results after market close on Tuesday, August 8, 2023 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at https://investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and Twitter.
2
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “aim,” “continue to,” “expect,” “future,” “goal,” or “will” or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding NeXT Personal’s ability to predict responses to immunotherapy, the company entering into the clinical diagnostics market with NeXT Personal in 2023 and becoming a critical partner in cancer recurrence monitoring and detection, effective defense and enforcement of the company’s patents, the company’s third quarter and full year financial guidance, expected revenue growth, cash runway, the company’s business outlook, and the company’s goals and aims. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Personalis’ actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from Natera, which accounted for 44% of the company’s total revenue in the second quarter, and the VA MVP; the launch and market adoption of new products and new product features, such as NeXT Personal; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter-over-quarter and year-over-year; whether orders for the NeXT Platform and revenue from biopharmaceutical customers and Natera increase or decrease in future periods; ability to demonstrate attributes or advantages of NeXT Personal or the Personalis NeXT Platform; the evolution of cancer therapies and market adoption of the company’s services; risks associated with health epidemics or pandemics; unstable market, economic and geo-political conditions, which may significantly impact the company’s business and operations and the business and operations of Personalis’ customers and suppliers; and the outcome of legal proceedings to enforce patents, and the presumed validity or enforceability of the company’s patents or other intellectual property rights. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (SEC) on February 23, 2023, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 3, 2023, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, being filed with the SEC later today. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
Contacts:
Investor Relations Contact:
Caroline Corner
investors@personalis.com
415-202-5678
Media:
pr@personalis.com
3
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue |
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$ |
16,699 |
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$ |
18,240 |
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$ |
35,559 |
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$ |
33,467 |
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Costs and expenses |
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Cost of revenue |
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11,907 |
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13,959 |
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26,037 |
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24,908 |
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Research and development |
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17,852 |
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16,288 |
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34,425 |
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33,386 |
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Selling, general and administrative |
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12,134 |
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15,874 |
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26,231 |
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31,360 |
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Restructuring and other charges |
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152 |
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— |
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4,037 |
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— |
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Total costs and expenses |
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42,045 |
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46,121 |
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90,730 |
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89,654 |
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Loss from operations |
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(25,346 |
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(27,881 |
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(55,171 |
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(56,187 |
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Interest income |
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1,465 |
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349 |
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2,718 |
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493 |
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Interest expense |
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(39 |
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(50 |
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(86 |
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(109 |
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Other income (expense), net |
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1 |
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50 |
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(25 |
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69 |
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Loss before income taxes |
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(23,919 |
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(27,532 |
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(52,564 |
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(55,734 |
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Provision for income taxes |
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36 |
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14 |
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50 |
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21 |
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Net loss |
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$ |
(23,955 |
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$ |
(27,546 |
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$ |
(52,614 |
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$ |
(55,755 |
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Net loss per share, basic and diluted |
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$ |
(0.50 |
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$ |
(0.60 |
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$ |
(1.11 |
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$ |
(1.23 |
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Weighted-average shares outstanding, basic and diluted |
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47,669,513 |
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45,637,838 |
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47,204,891 |
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45,316,795 |
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4
PERSONALIS, INC.
SUPPLEMENTAL REVENUE INFORMATION (unaudited)
(in thousands)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Pharma tests and services |
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$ |
6,083 |
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$ |
7,257 |
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$ |
12,416 |
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$ |
14,819 |
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Enterprise sales |
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7,386 |
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6,891 |
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16,844 |
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11,007 |
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Population sequencing |
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3,000 |
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4,055 |
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6,005 |
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7,556 |
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Other |
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230 |
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37 |
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294 |
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85 |
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Total revenue |
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$ |
16,699 |
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$ |
18,240 |
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$ |
35,559 |
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$ |
33,467 |
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5
PERSONALIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands, except share and per share data)
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June 30, 2023 |
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December 31, 2022 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
97,195 |
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$ |
89,128 |
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Short-term investments |
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40,012 |
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78,530 |
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Accounts receivable, net |
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10,132 |
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16,642 |
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Inventory and other deferred costs |
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8,140 |
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8,591 |
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Prepaid expenses and other current assets |
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5,476 |
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6,808 |
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Total current assets |
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160,955 |
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199,699 |
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Property and equipment, net |
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59,486 |
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61,935 |
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Operating lease right-of-use assets |
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24,660 |
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26,480 |
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Other long-term assets |
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3,937 |
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4,586 |
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Total assets |
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$ |
249,038 |
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$ |
292,700 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
8,847 |
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$ |
12,854 |
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Accrued and other current liabilities |
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16,408 |
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19,013 |
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Contract liabilities |
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3,337 |
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1,264 |
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Total current liabilities |
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28,592 |
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33,131 |
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Long-term operating lease liabilities |
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40,326 |
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41,041 |
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Other long-term liabilities |
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4,034 |
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389 |
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Total liabilities |
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72,952 |
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74,561 |
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Commitments and contingencies |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued |
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— |
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— |
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Common stock, $0.0001 par value — 200,000,000 shares authorized; 48,507,101 and 46,707,084 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively |
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5 |
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5 |
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Additional paid-in capital |
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589,418 |
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579,456 |
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Accumulated other comprehensive loss |
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(313 |
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(912 |
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Accumulated deficit |
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(413,024 |
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(360,410 |
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Total stockholders’ equity |
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176,086 |
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218,139 |
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Total liabilities and stockholders’ equity |
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$ |
249,038 |
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$ |
292,700 |
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6