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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2023
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission File Number: 001-38943
Personalis, Inc.
(Exact Name of registrant as specified in its charter)
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Delaware |
27-5411038 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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6600 Dumbarton Circle Fremont, California |
94555 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 752-1300
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 |
Common Stock, par value $0.0001 |
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PSNL |
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The Nasdaq Global Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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☐ |
Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares of registrant’s Common Stock outstanding as of August 1, 2023 was 48,518,901.
PERSONALIS, INC.
Form 10-Q
For the Quarterly Period Ended June 30, 2023
TABLE OF CONTENTS
2
Table of Contents
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
•the evolution of cancer therapies and market adoption of our services and products;
•estimates of our total addressable market, future revenue and the timing thereof, expenses, use of cash and other resources, cost savings, capital requirements, and our needs for additional financing;
•future reimbursement and reimbursement rulings;
•our ability to enter into and compete in new markets;
•the impact our collaboration agreements and key opinion leaders may have on the broader use of our platform in the future;
•the potential impacts of inflation, macroeconomic conditions, and geopolitical conflicts on our business and operations;
•the benefits of our products and services, including their ability to increase the probability of clinical trial success;
•our ability to compete effectively with existing competitors and new market entrants;
•our business strategies, including our aim to focus on certain indications and the timing thereof;
•our planned closure of our operations in China and the timing thereof;
•our ability to benefit from the scaling of our infrastructure and new facility in Fremont;
•our ability to manage and grow our business by expanding our sales to existing customers or introducing our services and products to new customers;
•our ability to establish and maintain intellectual property protection for our services and products or avoid claims of infringement;
•our success in defending and enforcing our intellectual property rights, including patents;
•potential effects of extensive government regulation;
•our ability to hire and retain key personnel;
•our ability to obtain financing when needed;
•our belief that approval of personalized cancer therapies by the U.S. Food and Drug Administration may drive benefits to our business;
•our future business with the U.S. Department of Veterans Affairs' Million Veteran Program ("VA MVP"), Natera, Inc., and other collaboration partners and customers; and
•our ability to maintain proper and effective internal controls.
Actual events or results may differ from those expressed in forward-looking statements. As such, you should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, operating results, prospects, strategy, and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions, and other factors described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a highly competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that such information provides a reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information, actual results, revised expectations, or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.
Unless the context otherwise requires, references in this Quarterly Report on Form 10-Q to the “company,” “Personalis,” “we,” “us” and “our” refer to Personalis, Inc.
3
Table of Contents
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
PERSONALIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
97,195 |
|
|
$ |
89,128 |
|
Short-term investments |
|
|
40,012 |
|
|
|
78,530 |
|
Accounts receivable, net |
|
|
10,132 |
|
|
|
16,642 |
|
Inventory and other deferred costs |
|
|
8,140 |
|
|
|
8,591 |
|
Prepaid expenses and other current assets |
|
|
5,476 |
|
|
|
6,808 |
|
Total current assets |
|
|
160,955 |
|
|
|
199,699 |
|
Property and equipment, net |
|
|
59,486 |
|
|
|
61,935 |
|
Operating lease right-of-use assets |
|
|
24,660 |
|
|
|
26,480 |
|
Other long-term assets |
|
|
3,937 |
|
|
|
4,586 |
|
Total assets |
|
$ |
249,038 |
|
|
$ |
292,700 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
8,847 |
|
|
$ |
12,854 |
|
Accrued and other current liabilities |
|
|
16,408 |
|
|
|
19,013 |
|
Contract liabilities |
|
|
3,337 |
|
|
|
1,264 |
|
Total current liabilities |
|
|
28,592 |
|
|
|
33,131 |
|
Long-term operating lease liabilities |
|
|
40,326 |
|
|
|
41,041 |
|
Other long-term liabilities |
|
|
4,034 |
|
|
|
389 |
|
Total liabilities |
|
|
72,952 |
|
|
|
74,561 |
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued |
|
|
— |
|
|
|
— |
|
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 |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
589,418 |
|
|
|
579,456 |
|
Accumulated other comprehensive loss |
|
|
(313 |
) |
|
|
(912 |
) |
Accumulated deficit |
|
|
(413,024 |
) |
|
|
(360,410 |
) |
Total stockholders’ equity |
|
|
176,086 |
|
|
|
218,139 |
|
Total liabilities and stockholders’ equity |
|
$ |
249,038 |
|
|
$ |
292,700 |
|
See notes to condensed consolidated financial statements.
4
Table of Contents
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
16,699 |
|
|
$ |
18,240 |
|
|
$ |
35,559 |
|
|
$ |
33,467 |
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
11,907 |
|
|
|
13,959 |
|
|
|
26,037 |
|
|
|
24,908 |
|
Research and development |
|
|
17,852 |
|
|
|
16,288 |
|
|
|
34,425 |
|
|
|
33,386 |
|
Selling, general and administrative |
|
|
12,134 |
|
|
|
15,874 |
|
|
|
26,231 |
|
|
|
31,360 |
|
Restructuring and other charges |
|
|
152 |
|
|
|
— |
|
|
|
4,037 |
|
|
|
— |
|
Total costs and expenses |
|
|
42,045 |
|
|
|
46,121 |
|
|
|
90,730 |
|
|
|
89,654 |
|
Loss from operations |
|
|
(25,346 |
) |
|
|
(27,881 |
) |
|
|
(55,171 |
) |
|
|
(56,187 |
) |
Interest income |
|
|
1,465 |
|
|
|
349 |
|
|
|
2,718 |
|
|
|
493 |
|
Interest expense |
|
|
(39 |
) |
|
|
(50 |
) |
|
|
(86 |
) |
|
|
(109 |
) |
Other income (expense), net |
|
|
1 |
|
|
|
50 |
|
|
|
(25 |
) |
|
|
69 |
|
Loss before income taxes |
|
|
(23,919 |
) |
|
|
(27,532 |
) |
|
|
(52,564 |
) |
|
|
(55,734 |
) |
Provision for income taxes |
|
|
36 |
|
|
|
14 |
|
|
|
50 |
|
|
|
21 |
|
Net loss |
|
$ |
(23,955 |
) |
|
$ |
(27,546 |
) |
|
$ |
(52,614 |
) |
|
$ |
(55,755 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.11 |
) |
|
$ |
(1.23 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
47,669,513 |
|
|
|
45,637,838 |
|
|
|
47,204,891 |
|
|
|
45,316,795 |
|
See notes to condensed consolidated financial statements.
5
Table of Contents
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net loss |
|
$ |
(23,955 |
) |
|
$ |
(27,546 |
) |
|
$ |
(52,614 |
) |
|
$ |
(55,755 |
) |
Other comprehensive income (loss), net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(37 |
) |
|
|
(194 |
) |
|
|
(9 |
) |
|
|
(202 |
) |
Change in unrealized gain (loss) on available-for-sale debt securities |
|
|
179 |
|
|
|
(195 |
) |
|
|
608 |
|
|
|
(896 |
) |
Comprehensive loss |
|
$ |
(23,813 |
) |
|
$ |
(27,935 |
) |
|
$ |
(52,015 |
) |
|
$ |
(56,853 |
) |
See notes to condensed consolidated financial statements.
6
Table of Contents
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)
For the Three Months Ended June 30, 2023 and 2022
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders' |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
Balance—March 31, 2023 |
|
|
46,774,490 |
|
|
$ |
5 |
|
|
$ |
583,151 |
|
|
$ |
(455 |
) |
|
$ |
(389,069 |
) |
|
$ |
193,632 |
|
Proceeds from sales of common stock under ATM facility, net of commissions |
|
|
900,000 |
|
|
|
— |
|
|
|
1,873 |
|
|
|
— |
|
|
|
— |
|
|
|
1,873 |
|
Proceeds from exercise of stock options |
|
|
8 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Proceeds from ESPP |
|
|
468,643 |
|
|
|
— |
|
|
|
909 |
|
|
|
— |
|
|
|
— |
|
|
|
909 |
|
Restricted stock units vested |
|
|
363,960 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
3,485 |
|
|
|
— |
|
|
|
— |
|
|
|
3,485 |
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(37 |
) |
|
|
— |
|
|
|
(37 |
) |
Unrealized gain on available-for-sale debt securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
179 |
|
|
|
— |
|
|
|
179 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(23,955 |
) |
|
|
(23,955 |
) |
Balance—June 30, 2023 |
|
|
48,507,101 |
|
|
$ |
5 |
|
|
$ |
589,418 |
|
|
$ |
(313 |
) |
|
$ |
(413,024 |
) |
|
$ |
176,086 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—March 31, 2022 |
|
|
45,250,087 |
|
|
$ |
5 |
|
|
$ |
562,889 |
|
|
$ |
(875 |
) |
|
$ |
(275,304 |
) |
|
$ |
286,715 |
|
Proceeds from exercise of stock options |
|
|
195,839 |
|
|
|
— |
|
|
|
463 |
|
|
|
— |
|
|
|
— |
|
|
|
463 |
|
Proceeds from ESPP |
|
|
204,775 |
|
|
|
— |
|
|
|
974 |
|
|
|
— |
|
|
|
— |
|
|
|
974 |
|
Restricted stock units vested |
|
|
240,757 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
4,415 |
|
|
|
— |
|
|
|
— |
|
|
|
4,415 |
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(194 |
) |
|
|
— |
|
|
|
(194 |
) |
Unrealized loss on available-for-sale debt securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(195 |
) |
|
|
— |
|
|
|
(195 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(27,546 |
) |
|
|
(27,546 |
) |
Balance—June 30, 2022 |
|
|
45,891,458 |
|
|
$ |
5 |
|
|
$ |
568,741 |
|
|
$ |
(1,264 |
) |
|
$ |
(302,850 |
) |
|
$ |
264,632 |
|
See notes to condensed consolidated financial statements.
7
Table of Contents
PERSONALIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)
For the Six Months Ended June 30, 2023 and 2022
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders' |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
Balance—December 31, 2022 |
|
|
46,707,084 |
|
|
$ |
5 |
|
|
$ |
579,456 |
|
|
$ |
(912 |
) |
|
$ |
(360,410 |
) |
|
$ |
218,139 |
|
Proceeds from sales of common stock under ATM facility, net of commissions |
|
|
900,000 |
|
|
|
— |
|
|
|
1,873 |
|
|
|
— |
|
|
|
— |
|
|
|
1,873 |
|
Proceeds from exercise of stock options |
|
|
8 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Proceeds from ESPP |
|
|
468,643 |
|
|
|
— |
|
|
|
909 |
|
|
|
— |
|
|
|
— |
|
|
|
909 |
|
Restricted stock units vested |
|
|
431,366 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
7,180 |
|
|
|
— |
|
|
|
— |
|
|
|
7,180 |
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(9 |
) |
|
|
— |
|
|
|
(9 |
) |
Unrealized gain on available-for-sale debt securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
608 |
|
|
|
— |
|
|
|
608 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(52,614 |
) |
|
|
(52,614 |
) |
Balance—June 30, 2023 |
|
|
48,507,101 |
|
|
$ |
5 |
|
|
$ |
589,418 |
|
|
$ |
(313 |
) |
|
$ |
(413,024 |
) |
|
$ |
176,086 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance—December 31, 2021 |
|
|
44,904,512 |
|
|
$ |
4 |
|
|
$ |
557,558 |
|
|
$ |
(166 |
) |
|
$ |
(247,095 |
) |
|
$ |
310,301 |
|
Proceeds from exercise of stock options |
|
|
475,044 |
|
|
|
1 |
|
|
|
978 |
|
|
|
— |
|
|
|
— |
|
|
|
979 |
|
Proceeds from ESPP |
|
|
204,775 |
|
|
|
— |
|
|