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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, 2024

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

 

img80987439_0.jpg 

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.)

 

 

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:

 

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 August 1, 2024 was 53,074,698.

 

 


 

PERSONALIS, INC.

 

Form 10-Q

For the Quarterly Period Ended June 30, 2024

 

TABLE OF CONTENTS

 

Page

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

Index to Notes

10

Notes to Condensed Consolidated Financial Statements

11

Item 2.

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

22

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

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

72

Item 3.

Defaults Upon Senior Securities

72

Item 4.

Mine Safety Disclosures

72

Item 5.

Other Information

72

Item 6.

Exhibits

73

Signatures

74

 

2


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 products in the future;
the expected benefits of and activities to be performed under our Commercialization and Reference Laboratory Agreement with Tempus AI, Inc. (formerly known as Tempus Labs, Inc.);
our ability to obtain financing when needed;
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 sales, marketing and commercialization plans and strategies;
our business strategies, including our aim to focus on certain indications and the timing thereof;
our ability to benefit from the scaling of our infrastructure and 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 government regulation;
our ability to hire and retain key personnel;
the impact of our reductions in force on our operations and operating results;
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., Moderna, 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. and our subsidiary, Personalis (UK) Ltd.

3


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, 2024

 

 

December 31, 2023

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

47,747

 

 

$

56,984

 

Short-term investments

 

 

39,225

 

 

 

57,195

 

Accounts receivable, net

 

 

12,921

 

 

 

17,730

 

Inventory and other deferred costs

 

 

9,164

 

 

 

10,474

 

Prepaid expenses and other current assets

 

 

4,046

 

 

 

4,361

 

Total current assets

 

 

113,103

 

 

 

146,744

 

Property and equipment, net

 

 

52,662

 

 

 

57,366

 

Operating lease right-of-use assets

 

 

17,166

 

 

 

17,852

 

Other long-term assets

 

 

2,571

 

 

 

3,137

 

Total assets

 

$

185,502

 

 

$

225,099

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

9,936

 

 

$

14,920

 

Accrued and other current liabilities

 

 

19,248

 

 

 

23,941

 

Contract liabilities

 

 

4,174

 

 

 

3,288

 

Short-term warrant liability

 

 

775

 

 

 

5,085

 

Total current liabilities

 

 

34,133

 

 

 

47,234

 

Long-term operating lease liabilities

 

 

36,524

 

 

 

38,321

 

Long-term warrant liability

 

 

1,513

 

 

 

4,942

 

Other long-term liabilities

 

 

1,060

 

 

 

5,161

 

Total liabilities

 

 

73,230

 

 

 

95,658

 

Commitments and contingencies

 

 

 

 

 

 

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; 53,052,847 and 50,480,694 shares issued and outstanding, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

606,863

 

 

 

598,364

 

Accumulated other comprehensive loss

 

 

(120

)

 

 

(222

)

Accumulated deficit

 

 

(494,476

)

 

 

(468,706

)

Total stockholders’ equity

 

 

112,272

 

 

 

129,441

 

Total liabilities and stockholders’ equity

 

$

185,502

 

 

$

225,099

 

 

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

22,580

 

 

$

16,699

 

 

$

42,105

 

 

$

35,559

 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,543

 

 

 

11,907

 

 

 

28,575

 

 

 

26,037

 

Research and development

 

 

12,957

 

 

 

17,852

 

 

 

25,728

 

 

 

34,425

 

Selling, general and administrative

 

 

11,973

 

 

 

12,134

 

 

 

23,575

 

 

 

26,231

 

Restructuring and other charges

 

 

 

 

 

152

 

 

 

 

 

 

4,037

 

Total costs and expenses

 

 

39,473

 

 

 

42,045

 

 

 

77,878

 

 

 

90,730

 

Loss from operations

 

 

(16,893

)

 

 

(25,346

)

 

 

(35,773

)

 

 

(55,171

)

Interest income

 

 

1,136

 

 

 

1,465

 

 

 

2,495

 

 

 

2,718

 

Interest expense

 

 

(9

)

 

 

(39

)

 

 

(18

)

 

 

(86

)

Other income (expense), net

 

 

2,968

 

 

 

1

 

 

 

7,537

 

 

 

(25

)

Loss before income taxes

 

 

(12,798

)

 

 

(23,919

)

 

 

(25,759

)

 

 

(52,564

)

Provision for income taxes

 

 

4

 

 

 

36

 

 

 

11

 

 

 

50

 

Net loss

 

$

(12,802

)

 

$

(23,955

)

 

$

(25,770

)

 

$

(52,614

)

Net loss per share, basic and diluted

 

$

(0.24

)

 

$

(0.50

)

 

$

(0.50

)

 

$

(1.11

)

Weighted-average shares outstanding, basic and diluted

 

 

52,394,678

 

 

 

47,669,513

 

 

 

51,536,632

 

 

 

47,204,891

 

 

See notes to condensed consolidated financial statements.

5


PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)

(in thousands)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss

 

$

(12,802

)

 

$

(23,955

)

 

$

(25,770

)

 

$

(52,614

)

Other comprehensive income (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

 

Changes in foreign currency translation adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Change during period

 

 

2

 

 

 

(37

)

 

 

(27

)

 

 

(9

)

Reclassification of adjustments to net loss due to dissolution of Personalis (Shanghai) Ltd

 

 

 

 

 

 

 

 

199

 

 

 

 

Net changes in foreign currency translation adjustments

 

 

2

 

 

 

(37

)

 

 

172

 

 

 

(9

)

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

 

 

3

 

 

 

179

 

 

 

(70

)

 

 

608

 

Comprehensive loss

 

$

(12,797

)

 

$

(23,813

)

 

$

(25,668

)

 

$

(52,015

)

 

See notes to condensed consolidated financial statements.

6


PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)

For the Three Months Ended June 30, 2024 and 2023

(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, 2024

 

 

51,394,199

 

 

$

5

 

 

$

602,488

 

 

$

(125

)

 

$

(481,674

)

 

$

120,694

 

Proceeds from sales of common stock under ATM facility, net of commissions

 

 

1,020,143

 

 

 

 

 

 

1,405

 

 

 

 

 

 

 

 

 

1,405

 

Proceeds from ESPP

 

 

391,415

 

 

 

 

 

 

317

 

 

 

 

 

 

 

 

 

317

 

Restricted stock units vested

 

 

247,090

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,653

 

 

 

 

 

 

 

 

 

2,653

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

2

 

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,802

)

 

 

(12,802

)

Balance—June 30, 2024

 

 

53,052,847

 

 

$

5

 

 

$

606,863

 

 

$

(120

)

 

$

(494,476

)

 

$

112,272

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

See notes to condensed consolidated financial statements.

7


PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (unaudited)

For the Six Months Ended June 30, 2024 and 2023

(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, 2023

 

 

50,480,694

 

 

$

5

 

 

$

598,364

 

 

$

(222

)

 

$

(468,706

)

 

$

129,441

 

Proceeds from sales of common stock under ATM facility, net of commissions

 

 

1,900,143

 

 

 

 

 

 

2,842

 

 

 

 

 

 

 

 

 

2,842

 

Proceeds from ESPP

 

 

391,415

 

 

 

 

 

 

317

 

 

 

 

 

 

 

 

 

317

 

Restricted stock units vested

 

 

280,595

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,340

 

 

 

 

 

 

 

 

 

5,340

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

172

 

 

 

 

 

 

172

 

Unrealized loss on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

(70

)

 

 

 

 

 

(70

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,770

)

 

 

(25,770

)

Balance—June 30, 2024

 

 

53,052,847

 

 

$

5

 

 

$

606,863

 

 

$

(120

)

 

$

(494,476

)

 

$

112,272

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

See notes to condensed consolidated financial statements.

8


PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(25,770

)

 

$

(52,614

)

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

 

 

Stock-based compensation expense

 

 

5,340

 

 

 

7,180

 

Depreciation and amortization

 

 

5,640

 

 

 

5,630

 

Noncash operating lease cost

 

 

686

 

 

 

1,120

 

Noncash gain related to liability classified Tempus Warrants

 

 

(7,739

)

 

 

 

Amortization of premium (discount) on short-term investments

 

 

(1,264

)

 

 

(740

)

Noncash restructuring and other charges

 

 

 

 

 

476

 

Other

 

 

8

 

 

 

234

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Accounts receivable

 

 

4,809

 

 

 

6,510

 

Inventory and other deferred costs

 

 

1,271

 

 

 

295

 

Prepaid expenses and other assets

 

 

879

 

 

 

1,538

 

Accounts payable

 

 

(5,101

)

 

 

(1,353

)

Accrued and other current liabilities

 

 

(5,513

)

 

 

(2,357

)

Contract liabilities

 

 

(2,701

)

 

 

5,703

 

Operating lease liabilities

 

 

(1,701

)

 

 

2,219

 

Net cash used in operating activities

 

 

(31,156

)

 

 

(26,159

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of available-for-sale debt securities

 

 

(37,836

)

 

 

(23,894

)

Proceeds from maturities of available-for-sale debt securities

 

 

57,000

 

 

 

63,755

 

Purchases of property and equipment

 

 

(110

)

 

 

(6,519

)

Proceeds from sales of property and equipment

 

 

240

 

 

 

 

Net cash provided by investing activities

 

 

19,294

 

 

 

33,342

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from sales of common stock under ATM facility, net of commissions

 

 

2,842

 

 

 

1,873

 

Repayments of loans

 

 

(514

)

 

 

(1,857

)

Proceeds from exercise of equity awards

 

 

317

 

 

 

909

 

Net cash provided by financing activities

 

 

2,645

 

 

 

925

 

Effect of exchange rates on cash, cash equivalents and restricted cash

 

 

(20

)

 

 

(41

)

Net change in cash, cash equivalents and restricted cash

 

 

(9,237

)

 

 

8,067

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

58,774

 

 

 

90,918

 

Cash, cash equivalents and restricted cash, end of period

 

$

49,537

 

 

$

98,985

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:

 

Cash and cash equivalents

 

$

47,747

 

 

$

97,195

 

Restricted cash, included in other long-term assets

 

 

1,790

 

 

 

1,790

 

Total cash, cash equivalents and restricted cash

 

$

49,537

 

 

$

98,985

 

See notes to condensed consolidated financial statements.

9


PERSONALIS, INC.

INDEX FOR NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)

 

 

 

 

 

Page

Note 1.

Company and Nature of Business

11

Note 2.

Summary of Significant Accounting Policies

11

Note 3.

Revenue

12

Note 4.

Balance Sheet Details

13

Note 5.

Fair Value Measurements

14

Note 6.

Loans

15

Note 7.

Leases

16

Note 8.

Tempus Agreement

16

Note 9.

Restructuring and Other Charges

18

Note 10.

Stock-Based Compensation

18

Note 11.

Contingencies

20

Note 12.

Basic and Diluted Net Loss Per Common Share

21

 

10


PERSONALIS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)

Note 1. Company and Nature of Business

Personalis, Inc. (the "Company" or "Personalis") develops and markets advanced cancer genomic tests and analytics for precision oncology and personalized testing. The Company also provides sequencing and data analysis services to support population sequencing initiatives. Genomic tests are sold primarily to pharmaceutical companies, biopharmaceutical companies, diagnostics companies, universities, non-profits, and government entities, while services for population sequencing initiatives are sold primarily to government entities. The principal markets for the Company’s services are in the United States and Europe.

The Company is expanding its business model to offer genomic tests directly to cancer patients in a clinical setting. However, revenue generated from clinical customers was not significant for any periods presented.

The Company was incorporated in Delaware in February 2011 and began operations in September 2011. The Company formed a wholly owned subsidiary, Personalis (UK) Ltd., in August 2013 and a wholly owned subsidiary, Shanghai Personalis Biotechnology Co., Ltd., which is referred to as “Personalis (Shanghai) Ltd” herein, in October 2020. The Company terminated its operations in China during 2023 and completed the process of dissolving the entity in the first quarter of 2024. Refer to Note 9 for further information. The Company operates and manages its business as one reportable operating segment, which is the sale of sequencing and data analysis services.

The Company has incurred losses to date and expects to incur additional losses for the foreseeable future. The Company continues to invest the majority of its resources in the development and growth of its business, including investments in product development and sales and marketing efforts. The Company’s activities have been financed to date primarily through the sale of its equity securities and cash from operations.

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

The condensed consolidated financial statements include the accounts of Personalis, Inc. and its wholly owned subsidiaries, Personalis (UK) Ltd. and Personalis (Shanghai) Ltd (the latter entity until its dissolution during the first quarter of 2024). All intercompany balances and transactions have been eliminated in consolidation. Upon dissolution of Personalis (Shanghai) Ltd during the first quarter of 2024, an accumulated foreign currency translation adjustment of $0.2 million was reclassified from accumulated other comprehensive loss to net loss within Other income (expense), net.

The condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year ending December 31, 2024.

Use of Estimates

The preparation of consolidated 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 consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. The estimates include, but are not limited to, revenue recognition, useful lives assigned to long-lived assets, discount rates for lease accounting, the valuation of stock options, the valuation of common stock warrants, provisions for income taxes, and fair value of lease right-of-use assets. Actual results could differ from these estimates, and such differences could be material to the Company’s consolidated financial position and results of operations.

At-the-Market Equity Offerings

In December 2021, the Company entered into an At-the-Market ("ATM") Sales Agreement with BTIG, LLC (“BTIG”), as amended in December 2023 (the "Sales Agreement"), under which it may offer and sell its common stock from time to time through BTIG as its sales agent. BTIG will use commercially reasonable efforts to sell the Company’s common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay BTIG a commission of up to 3% of the gross sales proceeds of any common stock sold under the Sales Agreement. The Company is not obligated to make any sales of common stock under the Sales Agreement.

11


During the three months ended June 30, 2024, the Company issued and sold 1,020,143 shares of its common stock under the Sales Agreement at a weighted-average price of $1.40 per share and received $1.4 million in proceeds, net of commissions. During the six months ended June 30, 2024, the Company issued and sold 1,900,143 shares of its common stock under the Sales Agreement at a weighted-average price of $1.53 per share and received $2.8 million in proceeds, net of commissions.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company is subject to credit risk from its portfolio of cash and cash equivalents. The Company’s cash and cash equivalents are deposited with high-quality financial institutions. Deposits at these institutions may, at times, exceed federally insured limits. Management believes these financial institutions are financially sound and, accordingly, that minimal credit risk exists.

The Company also invests in investment-grade debt instruments and has policy limits for the amount it can invest in any one type of security, except for securities issued or guaranteed by the U.S. government. The goals of the Company’s investment policy are as follows: preservation of principal; liquidity of investments sufficient to meet cash flow requirements; avoidance of inappropriate concentration and credit risk; competitive after-tax rate of returns; and fiduciary control of cash and investments. Under its investment policy, the Company limits the amounts invested in such securities by credit rating, maturity, investment type, and issuer. As a result, management believes that these financial instruments do not expose the Company to any significant concentrations of credit risk.

The Company purchases various reagents and sequencing materials from sole source suppliers. Any extended interruption in the supply of these materials could result in the Company’s inability to secure sufficient materials to conduct business and meet customer demand.

The Company routinely assesses the creditworthiness of its customers and does not require collateral. Historically, the Company has not experienced significant credit losses from accounts receivable. Multiple customers have provided more than 10% of total revenue in the periods presented, or accounted for more than 10% of accounts receivable at each respective balance sheet date, as follows:

 

 

Revenue

 

Accounts Receivable

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

June 30, 2024

 

December 31, 2023

 

 

2024

 

2023

 

2024

 

2023

 

 

 

 

Natera, Inc.

 

35%

 

44%

 

38%

 

47%

 

42%

 

36%

Moderna, Inc.

 

26%

 

*

 

25%

 

*

 

*

 

*

VA MVP

 

*

 

18%

 

*

 

17%

 

*

 

*

Merck & Co., Inc.

 

*

 

10%

 

*

 

*

 

23%

 

*

* Less than 10% of revenue or accounts receivable

 

Significant Accounting Policies

As of June 30, 2024, the Company’s significant accounting policies are consistent with those discussed in Note 2 - “Summary of Significant Accounting Policies” in its consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Recent Accounting Pronouncements

New Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The guidance will be effective for the Company's annual period ending December 31, 2025. The Company is currently evaluating the impact of the new guidance on its income tax disclosures.

Note 3. Revenue

The Company disaggregates revenue by the following four customer types:

Pharma tests and services includes sales of testing services and data analytics for clinical trials and research to pharmaceutical companies in support of their drug development programs. Contracts typically contemplate a single project and involve a range of tests and analytics to fulfill the requirements of each particular project.
Enterprise sales includes sales of tumor profiling and diagnostic tests directly to another business as an input to their products. The Company is typically contracted to deliver specified tests and analytics in high volume over time. Revenue from the Company's partnership with Natera to provide advanced tumor analysis for use in Natera's molecular residual disease ("MRD") test makes up substantially all of the revenue in this category.

12


Population sequencing includes sales of genomic sequencing services and data analytics to support large-scale genetic research programs. The Company is typically contracted to perform whole genome sequencing and provide data that can be used for analysis across a large volume of samples. All of the revenue within this category is from the Company's partnership with the VA MVP.
Other includes sales of genomic tests and analytics to universities and non-profits. Other also includes sales of diagnostics tests ordered by healthcare providers for cancer patients.

The following table presents the Company’s revenue disaggregated by customer type (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Pharma tests and services

 

$

13,197

 

 

$

6,083

 

 

$

23,009

 

 

$

12,416

 

Enterprise sales

 

 

7,958

 

 

 

7,386

 

 

 

15,930

 

 

 

16,844

 

Population sequencing

 

 

1,280

 

 

 

3,000

 

 

 

2,780

 

 

 

6,005