PSNL Personalis Inc

 

 

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): February 28, 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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On February 28, 2024, Personalis, Inc. issued a press release announcing its financial results for the quarter and fiscal year ended December 31, 2023. 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 February 28, 2024.
104		Cover Page Interactive Data File (embedded within the inline XBRL document)

 

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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: February 28, 2024		Personalis, Inc.
		By:	/s/ Aaron Tachibana
			Aaron Tachibana
			Chief Financial Officer and Chief Operating Officer

 

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Personalis Reports Fourth Quarter and Full Year 2023 Financial Results

FREMONT, Calif. – February 28, 2024 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent business highlights.

Recent Business Highlights

“We ended 2023 with strong execution as we delivered on many commitments that include launching NeXT Personal Dx (LDT) with an early access program, establishing commercial partnerships with Tempus, Myriad, and Moderna, and presenting compelling early-stage lung cancer clinical MRD data with TRACERx for NeXT Personal,” said Chris Hall, Chief Executive Officer. “Our efforts in 2024 continue to be focused on executing our Win-in-MRD strategy for NeXT Personal. This effort has four key pillars: focusing on cancer types where our test provides the most value, generating robust clinical evidence with top KOLs to submit for Medicare coverage, leveraging our early success with biopharma customers to accelerate adoption, and utilizing a partner-centric strategy to accelerate commercialization in a capital-efficient manner.”

Fourth Quarter Results

 

 

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Full Year 2023 Financial Results

 

 

 

 

 

 

First Quarter and Full Year 2024 Outlook

 

Personalis expects the following for the first quarter of 2024:

 

Personalis expects the following for the full year of 2024:

 

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Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2023 financial results, as well as plans for 2024, after market close on Wednesday, February 28, 2024, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 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 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).

 

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’ first quarter and full year 2024 outlook for revenue, net loss, and cash usage, the attributes, advantages or clinical validity of the NeXT Personal Dx test, Personalis’ use of clinical evidence to support obtaining reimbursement, and the expected benefits of Personalis’ collaboration and partnership agreements with Tempus, Myriad and ClearNote. 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 VA MVP; 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, Personalis’ ability to obtain reimbursement, Personalis’ achievement of milestones set forth in the collaboration and co-commercialization agreement with Tempus, the success of Tempus’ sales and marketing efforts, the expected benefits or success of Personalis’ relationships with research collaborators and key opinion leaders, 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’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 7, 2023, and in its Annual Report on Form 10-K for the year ended December 31, 2023, being filed with the Securities and Exchange Commission (SEC) on February 28, 2024. 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,

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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:

pr@personalis.com

 

 

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PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
		Three Months Ended December 31,								Year Ended December 31,
		2023				2022				2023				2022
Revenue		$	19,675			$	16,722			$	73,481			$	65,047
Costs and expenses
Cost of revenue			14,470				14,410				55,273				51,697
Research and development			13,613				16,569				64,776				64,912
Selling, general and administrative			11,524				17,828				49,726				63,969
Lease impairment			—				—				5,565				—
Restructuring and other charges			4,040				—				8,077				—
Total costs and expenses			43,647				48,807				183,417				180,578
Loss from operations			(23,972	)			(32,085	)			(109,936	)			(115,531	)
Interest income			1,477				1,160				5,901				2,396
Interest expense			(9	)			(47	)			(110	)			(201	)
Other income (expense), net			(4,075	)			(88	)			(4,068	)			61
Loss before income taxes			(26,579	)			(31,060	)			(108,213	)			(113,275	)
Provision for income taxes			5				8				83				40
Net loss		$	(26,584	)		$	(31,068	)		$	(108,296	)		$	(113,315	)
Net loss per share, basic and diluted		$	(0.54	)		$	(0.67	)		$	(2.25	)		$	(2.48	)
Weighted-average shares outstanding, basic and diluted			49,596,698				46,264,217				48,175,201				45,704,805

 

 

 

 

 

 

 

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PERSONALIS, INC.
SUPPLEMENTAL REVENUE INFORMATION (unaudited)
(in thousands)
		Three Months Ended December 31,								Year Ended December 31,
		2023				2022				2023				2022
Pharma tests and services		$	11,491			$	7,400			$	31,904			$	29,552
Enterprise sales			7,073				8,251				31,729				26,641
Population sequencing			1,007				887				9,412				8,443
Other			104				184				436				411
Total revenue		$	19,675			$	16,722			$	73,481			$	65,047

 

 

 

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PERSONALIS, INC.
CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands, except share and per share data)
		December 31, 2023				December 31, 2022
Assets
Current assets
Cash and cash equivalents		$	56,984			$	89,128
Short-term investments			57,195				78,530
Accounts receivable, net			17,730				16,642
Inventory and other deferred costs			10,474				8,591
Prepaid expenses and other current assets			4,361				6,808
Total current assets			146,744				199,699
Property and equipment, net			57,366				61,935
Operating lease right-of-use assets			17,852				26,480
Other long-term assets			3,137				4,586
Total assets		$	225,099			$	292,700
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	14,920			$	12,854
Accrued and other current liabilities			23,941				19,013
Contract liabilities			3,288				1,264
Short-term warrant liability			5,085				—
Total current liabilities			47,234				33,131
Long-term operating lease liabilities			38,321				41,041
Long-term warrant liability			4,942				—
Other long-term liabilities			5,161				389
Total liabilities			95,658				74,561
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; 50,480,694 and 46,707,084 shares issued and outstanding, respectively			5				5
Additional paid-in capital			598,364				579,456
Accumulated other comprehensive loss			(222	)			(912	)
Accumulated deficit			(468,706	)			(360,410	)
Total stockholders’ equity			129,441				218,139
Total liabilities and stockholders’ equity		$	225,099			$	292,700

 

 

 

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v3.24.0.1

Document and Entity Information	Feb. 28, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 28, 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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