0000950170-24-092712.txt : 20240807 0000950170-24-092712.hdr.sgml : 20240807 20240807160009 ACCESSION NUMBER: 0000950170-24-092712 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20240807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240807 DATE AS OF CHANGE: 20240807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Personalis, Inc. CENTRAL INDEX KEY: 0001527753 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 275411038 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38943 FILM NUMBER: 241183418 BUSINESS ADDRESS: STREET 1: 6600 DUMBARTON CIRCLE CITY: FREMONT STATE: CA ZIP: 94555 BUSINESS PHONE: 650-752-1300 MAIL ADDRESS: STREET 1: 6600 DUMBARTON CIRCLE CITY: FREMONT STATE: CA ZIP: 94555 8-K 1 psnl-20240807.htm 8-K 8-K
0001527753false00015277532024-08-072024-08-07

 

 

 

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): August 7, 2024

 

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.)

 

 

 

6600 Dumbarton Circle

Fremont, California

 

94555

(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 August 7, 2024, Personalis, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2024. 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 August 7, 2024.

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: August 7, 2024

Personalis, Inc.

 

By:

/s/ Aaron Tachibana

Aaron Tachibana

Chief Financial Officer and Chief Operating Officer

 

 

 EX-99.1 2 psnl-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

img208356292_0.jpg 

Personalis Reports Second Quarter 2024 Financial Results

Strong Revenue Growth of 35% Year-over-Year Driven by 117% Growth from Biopharma Business

Raises 2024 Full Year Revenue Guidance

 

FREMONT, Calif. – August 7, 2024 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the second quarter ended June 30, 2024, and provided recent business accomplishments.

 

Recent Business Accomplishments

•
Highlighted clinical performance of NeXT Personal® at the American Society of Clinical Oncology (ASCO) meeting in May
o
Compelling breast cancer detection results were presented by Dr. Isaac Garcia-Murillas (Institute of Cancer Research, London) and Prof. Nicolas Turner (Royal Marsden NHS Foundation Trust UK). In this study, they found:
▪
NeXT Personal detected cancer recurrence approximately 15 months before imaging
▪
100% of patients that recurred were detected with NeXT Personal and 100% of patients that were ctDNA negative were cancer-free at follow up time points
o
A presentation by Dr. Rodrigo Toledo of the Vall d’Hebron Institute of Oncology highlighted the importance of NeXT Personal’s use for immunotherapy monitoring. This data showed:
▪
Baseline levels of ctDNA and the changes detected by NeXT Personal predict therapy response and clinical outcomes for late-stage cancer patients receiving immunotherapy
▪
NeXT Personal detected cancer progression 81 days before imaging on average
•
Delivered 561 total molecular tests in the second quarter of 2024, a 66% increase compared with the prior quarter, and commenced NeXT Personal Dx commercialization efforts with Tempus AI, Inc. (Tempus)
•
Announced a cross-license agreement with Myriad Genetics, Inc. covering patent estates for tumor-informed approaches to detect minimal residual disease (MRD)
•
Successfully settled the IP lawsuit with Foresight Diagnostics, Inc. (Foresight) with Foresight agreeing to license Personalis’ MRD patents

Second Quarter 2024 Results Compared to Second Quarter 2023

 

•
Reported total company revenue of $22.6 million in the second quarter of 2024, an increase of 35% compared with $16.7 million
o
Revenue from pharma testing and services of $13.2 million in the second quarter of 2024, an increase of 117% compared with $6.1 million

1

 

 

o
Revenue from Enterprise customers of $8.0 million in the second quarter of 2024, an increase of 8% compared with $7.4 million
o
Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program of $1.3 million in the second quarter of 2024, a decrease of 57% compared with $3.0 million
•
Other Income of $3.0 million in the second quarter of 2024, which consists of a non-cash gain of $3.0 million related to fair-value accounting for the outstanding warrants issued to Tempus
•
Net loss of $12.8 million in the second quarter of 2024, a decrease of 47% compared with $24.0 million
•
Cash, cash equivalents, and short-term investments of $87.0 million as of June 30, 2024

 

“The revenue growth depicts growing customer confidence in both our technology and platform. Importantly, the growth in our clinical testing volume means that we can see the impact on patient lives. Now that our collaborators have presented compelling NeXT Personal clinical evidence, we expect to leverage that towards obtaining Medicare coverage and materially increasing the number of patients we can help,” said Chris Hall, Chief Executive Officer. “As we continue to execute on our Win-in-MRD strategy, we are more confident than ever in our ability to drive broad adoption for patient testing.”

 

Third Quarter and Revised Full Year 2024 Outlook

Personalis expects the following for the third quarter of 2024:

 

•
Total company revenue in the range of $21.0 to $22.0 million
•
Revenue from pharma tests, enterprise sales, and other customers in the range of $17.0 to $18.0 million
•
Revenue from population sequencing of approximately $4.0 million

Personalis expects the following for the full year of 2024:

 

•
Total company revenue in the range of $79.0 to $81.0 million, an increase from $76.0 to $78.0 million
•
Revenue from pharma tests, enterprise sales, and all other customers in the range of $71.0 to $73.0 million, an increase from prior guidance of $68.0 to $70.0 million
•
Revenue from population sequencing of approximately $8.0 million
•
Non-GAAP net loss of approximately $75.0 million, a decrease from our prior guidance of $77.0 million and excludes any non-cash gain or loss from the outstanding warrants issued to Tempus
•
Cash usage of approximately $60.0 million, a decrease from our prior guidance of $62.0 million

Webcast and Conference Call Information


Personalis will host a conference call to discuss the second quarter of 2024 financial results, as well as plans for 2024, after market close on Wednesday, August 7, 2024, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 800-717-1738 for domestic callers or 646-307-1865 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

2

 

 

even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable the 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 X (Twitter).

 

Non-GAAP Financial Measure

 

To supplement our financial guidance presented in accordance with GAAP, we are presenting expected non-GAAP net loss for the full year ending December 31, 2024, which excludes income and expense from the outstanding warrants issued to Tempus from GAAP net loss. We are excluding income and expense attributable to the fair value of the outstanding warrants issued to Tempus because they are non-cash financial measures that require remeasurement of the fair value, derived from the then-current trading price of our Common Stock, as of each reporting date, and consequently there is substantial uncertainty associated with forecasting the fair value of the Tempus warrants at the future measurement dates. For this reason, we have not provided a reconciliation of our forward-looking non-GAAP net loss to GAAP net loss (the most directly comparable GAAP financial measure), in reliance on the “unreasonable efforts” exception set forth in the applicable regulations.

Forward-Looking Statements


This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “anticipate,” “estimate,” “expect,” “if,” “may,” “future,” “will” or similar expressions. These statements include statements relating to: Personalis’ third quarter and full year 2024 outlook for revenue, non-GAAP net loss, and cash usage, the attributes, advantages or clinical validity of the NeXT Personal Dx test, broad adoption of the NeXT Personal Dx test for patient testing and the benefits to patients from use of the same, and Personalis’ obtaining Medicare coverage. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the timing and pace of new orders from customers, including from Natera and the U.S. Department of Veterans Affairs Million Veterans Program; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter-over-quarter and year-over-year; Personalis’ ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal Dx test, the rate of adoption of the NeXT Personal Dx test, Personalis’ ability to obtain Medicare coverage and reimbursement, Personalis’ achievement of milestones set forth in the collaboration and co-commercialization agreement with Tempus, the success of Personalis’ clinical sales team and Tempus’ sales and marketing efforts, the expected benefits or success of Personalis’ relationships with research collaborators, the impact of Personalis’ abstract presentations at the American Society of Clinical Oncology medical conference in May, and the adoption and use of the NeXT Personal Dx test by oncologists. 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, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, as updated by Personalis’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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.

3

 

 

Contacts:

Investor Relations Contact:

Caroline Corner

investors@personalis.com

646-277-1279

Media:

pr@personalis.com

 

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

 

 

5

 

 

PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(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

 

Other

 

 

145

 

 

 

230

 

 

 

386

 

 

 

294

 

Total revenue

 

$

22,580

 

 

$

16,699

 

 

$

42,105

 

 

$

35,559

 

 

 

6

 

 

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

 

 

7

 

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Document and Entity Information
Aug. 07, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 07, 2024
Entity Registrant Name Personalis, Inc.
Entity Central Index Key 0001527753
Entity Emerging Growth Company false
Entity File Number 001-38943
Entity Incorporation State Country Code DE
Entity Tax Identification Number 27-5411038
Entity Address, Address Line One 6600 Dumbarton Circle
Entity Address, City or Town Fremont
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94555
City Area Code 650
Local Phone Number 752-1300
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.0001 par value per share
Trading Symbol PSNL
Security Exchange Name NASDAQ
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