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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 September 30, 2021

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission File Number: 001-38943

 

Personalis, Inc.

(Exact Name of registrant as specified in its charter)

 

 

Delaware

27-5411038

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

1330 O’Brien Drive

Menlo Park, California 94025

94025

(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:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001

 

PSNL

 

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.

 

Large accelerated filer

 

         ☐

  

Accelerated filer

 

Non-accelerated filer

 

         ☒

  

Smaller reporting company

 

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. 

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 October 29, 2021 was 44,783,861.

 


 

PERSONALIS, INC.

 

Form 10-Q

For the Quarterly Period Ended September 30, 2021

 

TABLE OF CONTENTS

 

 

 

 

 

Page

 

Special Note Regarding Forward-Looking Statements

3

 

 

 

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements

4

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations

5

 

Condensed Consolidated Statements of Comprehensive Loss

6

 

Condensed Consolidated Statements of Stockholders’ Equity

7

 

Condensed Consolidated Statements of Cash Flows

9

 

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

30

 

 

 

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

69

Item 3.

Defaults Upon Senior Securities

69

Item 4.

Mine Safety Disclosures

69

Item 5.

Other Information

69

Item 6.

Exhibits

70

 

Signatures

71

 

2


 

SPECIAL 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,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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;

 

estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing;

 

our ability to enter into and compete in new markets;

 

the impact of the COVID-19 pandemic on our business, our customers’ and suppliers’ businesses and the general economy;

 

our ability to compete effectively with existing competitors and new market entrants;

 

our ability to scale our infrastructure;

 

our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers;

 

expectations regarding our relationship with the U.S. Department of Veterans Affairs’ Million Veteran Program;

 

our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement;

 

potential effects of extensive government regulation;

 

our ability to hire and retain key personnel;

 

our ability to obtain financing in future offerings;

 

the volatility of the trading price of our common stock;

 

our belief that approval of personalized cancer therapies by the Food and Drug Administration may drive benefits to our business; 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


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

PERSONALIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(in thousands, except share and per share data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

79,572

 

 

$

68,525

 

Short-term investments

 

 

225,658

 

 

 

134,765

 

Accounts receivable, net

 

 

10,534

 

 

 

6,349

 

Inventory and other deferred costs

 

 

5,523

 

 

 

5,639

 

Prepaid expenses and other current assets

 

 

7,728

 

 

 

5,441

 

Total current assets

 

 

329,015

 

 

 

220,719

 

Property and equipment, net

 

 

17,689

 

 

 

11,834

 

Operating lease right-of-use assets

 

 

54,923

 

 

 

10,271

 

Other long-term assets

 

 

5,067

 

 

 

2,018

 

Total assets

 

$

406,694

 

 

$

244,842

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

7,288

 

 

$

8,301

 

Accrued and other current liabilities

 

 

16,261

 

 

 

11,301

 

Contract liabilities

 

 

2,967

 

 

 

21,034

 

Total current liabilities

 

 

26,516

 

 

 

40,636

 

Long-term operating lease liabilities

 

 

52,866

 

 

 

8,541

 

Other long-term liabilities

 

 

2,016

 

 

 

720

 

Total liabilities

 

 

81,398

 

 

 

49,897

 

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; 44,706,263 and 39,105,548 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

552,176

 

 

 

376,788

 

Accumulated other comprehensive income

 

 

12

 

 

 

22

 

Accumulated deficit

 

 

(226,896

)

 

 

(181,869

)

Total stockholders’ equity

 

 

325,296

 

 

 

194,945

 

Total liabilities and stockholders’ equity

 

$

406,694

 

 

$

244,842

 

 

 

See notes to condensed consolidated financial statements.

 

4


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

 

$

22,261

 

 

$

19,816

 

 

$

64,812

 

 

$

58,472

 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,195

 

 

 

14,483

 

 

 

41,151

 

 

 

44,428

 

Research and development

 

 

13,617

 

 

 

7,193

 

 

 

34,800

 

 

 

20,048

 

Selling, general and administrative

 

 

12,140

 

 

 

7,793

 

 

 

33,989

 

 

 

22,772

 

Total costs and expenses

 

 

39,952

 

 

 

29,469

 

 

 

109,940

 

 

 

87,248

 

Loss from operations

 

 

(17,691

)

 

 

(9,653

)

 

 

(45,128

)

 

 

(28,776

)

Interest income

 

 

88

 

 

 

117

 

 

 

286

 

 

 

873

 

Interest expense

 

 

(60

)

 

 

 

 

 

(125

)

 

 

(2

)

Other income (expense), net

 

 

5

 

 

 

(4

)

 

 

(43

)

 

 

5

 

Loss before income taxes

 

 

(17,658

)

 

 

(9,540

)

 

 

(45,010

)

 

 

(27,900

)

Provision for income taxes

 

 

12

 

 

 

5

 

 

 

17

 

 

 

39

 

Net loss

 

$

(17,670

)

 

$

(9,545

)

 

$

(45,027

)

 

$

(27,939

)

Net loss per share, basic and diluted

 

$

(0.40

)

 

$

(0.27

)

 

$

(1.03

)

 

$

(0.85

)

Weighted-average shares outstanding, basic and diluted

 

 

44,511,534

 

 

 

35,460,092

 

 

 

43,579,308

 

 

 

32,845,583

 

 

 

See notes to condensed consolidated financial statements.

5


PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)

(in thousands)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(17,670

)

 

$

(9,545

)

 

$

(45,027

)

 

$

(27,939

)

Other comprehensive income (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

(9

)

 

 

6

 

 

 

12

 

 

 

(2

)

Change in unrealized gain (loss) on available-for-sale debt securities

 

 

3

 

 

 

(75

)

 

 

(22

)

 

 

45

 

Comprehensive loss

 

$

(17,676

)

 

$

(9,614

)

 

$

(45,037

)

 

$

(27,896

)

 

 

See notes to condensed consolidated financial statements.

 

6


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)

For the Three Months Ended September 30, 2021 and 2020

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance—June 30, 2021

 

 

44,209,968

 

 

$

4

 

 

$

547,951

 

 

$

18

 

 

$

(209,226

)

 

$

338,747

 

Proceeds from exercise of stock options

 

 

448,738

 

 

 

 

 

 

536

 

 

 

 

 

 

 

 

 

536

 

Restricted stock units vested

 

 

47,557

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,689

 

 

 

 

 

 

 

 

 

3,689

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(9

)

 

 

 

 

 

(9

)

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,670

)

 

 

(17,670

)

Balance—September 30, 2021

 

 

44,706,263

 

 

$

4

 

 

$

552,176

 

 

$

12

 

 

$

(226,896

)

 

$

325,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance—June 30, 2020

 

 

31,872,122

 

 

$

3

 

 

$

251,997

 

 

$

106

 

 

$

(158,983

)

 

$

93,123

 

Proceeds from follow-on equity offering, net of offering costs

 

 

6,578,947

 

 

 

1

 

 

 

117,064

 

 

 

 

 

 

 

 

 

117,065

 

Exercise of common stock warrants

 

 

79,772

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

226,637

 

 

 

 

 

 

1,276

 

 

 

 

 

 

 

 

 

1,276

 

Restricted stock units vested

 

 

32,711

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,690

 

 

 

 

 

 

 

 

 

1,690

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

6

 

Unrealized loss on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

(75

)

 

 

 

 

 

(75

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,545

)

 

 

(9,545

)

Balance—September 30, 2020

 

 

38,790,189

 

 

$

4

 

 

$

372,027

 

 

$

37

 

 

$

(168,528

)

 

$

203,540

 

 

 

See notes to condensed consolidated financial statements.


7


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)

For the Nine Months Ended September 30, 2021 and 2020

(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, 2020

 

 

39,105,548

 

 

$

4

 

 

$

376,788

 

 

$

22

 

 

$

(181,869

)

 

$

194,945

 

Proceeds from follow-on equity offering, net of offering costs

 

 

4,542,500

 

 

 

 

 

 

161,916

 

 

 

 

 

 

 

 

 

161,916

 

Proceeds from exercise of stock options

 

 

833,676

 

 

 

 

 

 

1,935

 

 

 

 

 

 

 

 

 

1,935

 

Proceeds from Employee Stock Purchase Plan purchases

 

 

57,001

 

 

 

 

 

 

1,191

 

 

 

 

 

 

 

 

 

1,191

 

Restricted stock units vested

 

 

167,538

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,346

 

 

 

 

 

 

 

 

 

10,346

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

12

 

 

 

 

 

 

12

 

Unrealized loss on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

(22

)

 

 

 

 

 

(22

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(45,027

)

 

 

(45,027

)

Balance—September 30, 2021

 

 

44,706,263

 

 

$

4

 

 

$

552,176

 

 

$

12

 

 

$

(226,896

)

 

$

325,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance—December 31, 2019

 

 

31,243,029

 

 

$

3

 

 

$

247,282

 

 

$

(6

)

 

$

(140,589

)

 

$

106,690

 

Proceeds from follow-on equity offering, net of offering costs

 

 

6,578,947

 

 

 

1

 

 

 

117,064

 

 

 

 

 

 

 

 

 

117,065

 

Exercise of common stock warrants

 

 

79,772

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

740,630

 

 

 

 

 

 

2,289

 

 

 

 

 

 

 

 

 

2,289

 

Proceeds from Employee Stock Purchase Plan purchases

 

 

71,480

 

 

 

 

 

 

631

 

 

 

 

 

 

 

 

 

631

 

Restricted stock units vested

 

 

76,331

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,761

 

 

 

 

 

 

 

 

 

4,761

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

(2

)

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

45

 

 

 

 

 

 

45

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,939

)

 

 

(27,939

)

Balance—September 30, 2020

 

 

38,790,189

 

 

$

4

 

 

$

372,027

 

 

$

37

 

 

$

(168,528

)

 

$

203,540

 

 

See notes to condensed consolidated financial statements.

 

 

 

 

 

.

 

8


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2021