8-K
0001527753false00015277532022-11-022022-11-02

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 2, 2022

 

Personalis, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38943

27-5411038

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

1330 O’Brien Drive

Menlo Park, California 94025

 

94025

(Address of Principal Executive Offices)

 

 

(Zip Code)

(650) 752-1300

Registrant’s Telephone Number, Including Area Code

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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, $0.0001 par value per share

 

PSNL

 

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On November 2, 2022, Personalis, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2022. 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

 

Description

99.1

 

Press release of Personalis, Inc., dated November 2, 2022.

104

 

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: November 2, 2022

 

Personalis, Inc.

 

 

 

 

 

 

By:

/s/ Aaron Tachibana

 

 

 

Aaron Tachibana

 

 

 

Chief Financial Officer

 

 


EX-99.1

Exhibit 99.1

 

https://cdn.kscope.io/783c057350aae88b708cda3622190e67-img208356292_0.jpg 

Personalis Reports Third Quarter 2022 Financial Results

MENLO PARK, Calif. – November 2, 2022– Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the third quarter ended September 30, 2022.

 

Third Quarter and Recent Highlights

 

Reported quarterly revenue of $14.9 million in the third quarter of 2022 compared with $22.3 million in the third quarter of 2021

 

o
Revenue from biopharma and other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), of $14.9 million in the third quarter of 2022 compared with $8.6 million in the third quarter of 2021, a 73% increase

 

o
Revenue from biopharma and other customers includes revenue of $7.4 million from Natera in the third quarter of 2022

 

Launched a research collaboration with BC Cancer using NeXT Personal™ to determine the optimal time for ctDNA sampling for molecular residual disease (MRD) detection in colorectal and pancreatic cancers, with the aim of identifying cancer progression before current standard of care tests

 

Announced a research collaboration with Duke University, deploying NeXT Personal™ to profile and accurately track MRD in patients with advanced gastroesophageal cancer over the course of therapy with the aim of better predicting a patient’s immune response to therapy

 

Appointed Christopher Hall as SVP who will lead the company’s Diagnostic Business, bringing 20 years of experience including leading the commercial organization at Veracyte and growing its business to nearly $100M in diagnostic revenue

 

Launched marketing and sales outreach to oncologists to begin generating demand for NeXT Dx™, the company’s tissue-based clinical test that covers the whole exome and transcriptome and assesses genomic alterations in matched tumor and normal specimens to report variants and help oncologists with decision-making for therapy selection

 

Won an exclusive five-year contract and received the initial order from the VA MVP (contract work is pending the resolution of a bidder protest)

 

Cash, cash equivalents, and short-term investments were $192.8 million as of September 30, 2022

 

“We are pleased with the pace of our oncology revenue growth, as well as the continued adoption of our NeXT Platform,” said John West, Chief Executive Officer of Personalis. “We are making excellent progress on our strategic priorities, as demonstrated with the addition of new collaborations with leading cancer institutions that will use our extremely sensitive MRD offering, NeXT Personal™, in studies designed to advance the field of oncology with the aim of enhancing the standard of care.”

1

 


 

 

Third Quarter 2022 Financial Results

 

Revenue was $14.9 million in the three months ended September 30, 2022
Gross margin was 16.7% in the three months ended September 30, 2022
Operating expenses were $29.7 million in the three months ended September 30, 2022
Net loss was $26.5 million in the three months ended September 30, 2022, and net loss per share was $0.58 based on a weighted-average basic and diluted share count of 45.9 million
Cash, cash equivalents, and short-term investments were $192.8 million as of September 30, 2022

 

Full Year 2022 Outlook

 

Personalis expects the following for the full year of 2022:

 

Total company revenue is expected to be in the range of $63.0 million to $64.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be in the range of $55.5 million to $56.5 million
Net loss is expected to be in the range of $111.0 million to $114.0 million

 

Webcast and Conference Call Information


Personalis will host a conference call to discuss the third quarter 2022 financial results after market close on Wednesday, November 2, 2022 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. 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.

 

Personalis, Inc. is a leader in advanced cancer genomics, enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single sample. To enable cancer sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. For more information, visit the Personalis website and News Center, and follow Personalis on LinkedIn and Twitter.

 

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 the company’s full year financial guidance, the use of NeXT Personal in new collaborations and studies, 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

2

 


 

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 50% of the company’s total revenue in the third quarter of 2022; the outcome of the bidder protest for our latest VA MVP contract award; 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 expected benefits or success of Personalis’ collaborations including with Moores Cancer Center at UC San Diego Health, BC Cancer, Duke University, Olink Proteomics AB, and others; the success of the company’s international expansion plans; the evolution of cancer therapies and market adoption of the company’s services; the ongoing COVID-19 pandemic; 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 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’ Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, filed with the Securities and Exchange Commission (SEC) on August 3, 2022, and in Personalis’ Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, being filed with the SEC 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 Contact:

Jennifer Temple

pr@personalis.com

650-752-1300

 

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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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue

 

$

14,858

 

 

$

22,261

 

 

$

48,325

 

 

$

64,812

 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

12,379

 

 

 

14,195

 

 

 

37,287

 

 

 

41,151

 

Research and development

 

 

14,957

 

 

 

13,617

 

 

 

48,343

 

 

 

34,800

 

Selling, general and administrative

 

 

14,781

 

 

 

12,140

 

 

 

46,141

 

 

 

33,989

 

Total costs and expenses

 

 

42,117

 

 

 

39,952

 

 

 

131,771

 

 

 

109,940

 

Loss from operations

 

 

(27,259

)

 

 

(17,691

)

 

 

(83,446

)

 

 

(45,128

)

Interest income

 

 

743

 

 

 

88

 

 

 

1,236

 

 

 

286

 

Interest expense

 

 

(45

)

 

 

(60

)

 

 

(154

)

 

 

(125

)

Other income (expense), net

 

 

80

 

 

 

5

 

 

 

149

 

 

 

(43

)

Loss before income taxes

 

 

(26,481

)

 

 

(17,658

)

 

 

(82,215

)

 

 

(45,010

)

Provision for income taxes

 

 

11

 

 

 

12

 

 

 

32

 

 

 

17

 

Net loss

 

$

(26,492

)

 

$

(17,670

)

 

$

(82,247

)

 

$

(45,027

)

Net loss per share, basic and diluted

 

$

(0.58

)

 

$

(0.40

)

 

$

(1.81

)

 

$

(1.03

)

Weighted-average shares outstanding, basic and diluted

 

 

45,921,411

 

 

 

44,511,534

 

 

 

45,518,334

 

 

 

43,579,308

 

 

4

 


 

PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(in thousands)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

VA MVP

 

$

 

 

$

13,650

 

 

$

7,556

 

 

$

40,367

 

All other customers

 

 

14,858

 

 

 

8,611

 

 

 

40,769

 

 

 

24,445

 

Total revenue

 

$

14,858

 

 

$

22,261

 

 

$

48,325

 

 

$

64,812

 

 

5

 


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(in thousands, except share and per share data)

 

 

 

September 30, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

83,522

 

 

$

105,585

 

Short-term investments

 

 

109,234

 

 

 

181,479

 

Accounts receivable, net

 

 

13,592

 

 

 

18,468

 

Inventory and other deferred costs

 

 

7,543

 

 

 

5,610

 

Prepaid expenses and other current assets

 

 

8,017

 

 

 

7,089

 

Total current assets

 

 

221,908

 

 

 

318,231

 

Property and equipment, net

 

 

61,219

 

 

 

19,650

 

Operating lease right-of-use assets

 

 

30,045

 

 

 

53,822

 

Other long-term assets

 

 

4,689

 

 

 

4,825

 

Total assets

 

$

317,861

 

 

$

396,528

 

Liabilities and Stockholders Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

10,784

 

 

$

9,221

 

Accrued and other current liabilities

 

 

22,658

 

 

 

18,110

 

Contract liabilities

 

 

297

 

 

 

3,982

 

Total current liabilities

 

 

33,739

 

 

 

31,313

 

Long-term operating lease liabilities

 

 

41,349

 

 

 

52,797

 

Other long-term liabilities

 

 

374

 

 

 

2,117

 

Total liabilities

 

 

75,462

 

 

 

86,227

 

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; 45,955,866 and 44,904,512 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

573,158

 

 

 

557,558

 

Accumulated other comprehensive loss

 

 

(1,422

)

 

 

(166

)

Accumulated deficit

 

 

(329,342

)

 

 

(247,095

)

Total stockholders equity

 

 

242,399

 

 

 

310,301

 

Total liabilities and stockholders equity

 

$

317,861

 

 

$

396,528

 

 

6