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): November 7, 2023

 

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 November 7, 2023, Personalis, Inc. issued a press release announcing its financial results for the quarter ended September 30, 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 November 7, 2023.
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: November 7, 2023		Personalis, Inc.
		By:	/s/ Aaron Tachibana
			Aaron Tachibana
			Chief Financial Officer and Chief Operating Officer

 

 

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Exhibit 99.1

 

 

Personalis Reports Third Quarter 2023 Financial Results

Increased third quarter revenue 23% to $18.2 million and increased full year guidance

Presented data supporting Next Personal’s market leading sensitivity for cancer recurrence detection

FREMONT, Calif. – November 7, 2023 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the third quarter ended September 30, 2023 and provided recent business highlights.

Third Quarter and Recent Highlights

 

– Higher sensitivity, up to 4x higher, than other liquid biopsy tests analyzed by TRACERx

– Identified lung cancer 6-11 months ahead of standard imaging and significantly ahead of other tests

– Ability to determine low and high recurrence risk which could lead to improved therapy decisions

 

“We continue to evolve Personalis into a clinical testing leader–launching NeXT Personal for patient testing, presenting compelling data in early-stage lung cancer, and deepening our set of collaborators in breast cancer all while delivering exceptional Q3 revenue growth of 23% year over year,” said Chris Hall, President, and CEO of Personalis. “We continue to focus on driving towards Medicare coverage for NeXT Personal.”

Third Quarter Financial Highlights

 

 

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Fourth Quarter and Full Year 2023 Outlook

Personalis expects the following for the fourth quarter of 2023:

Personalis expects the following for the full year of 2023:

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results after market close on Tuesday, November 7, 2023 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 844-826-3035 for domestic callers or 412-317-5195 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 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.

 

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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 Personalis’ ability to become a clinical testing leader, the company’s fourth quarter and full year financial guidance, expected revenue growth, cash runway, 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 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: our ability to replicate the clinical data results of the collaboration with TRACERx in other cancer indications; continued demand for NeXT Personal as a LDT; the timing and pace of new orders from customers, including from Natera, which accounted for 43% of the company’s total revenue in the third quarter, and the VA MVP; 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 evolution of cancer therapies and market adoption of the company’s services; risks associated with health epidemics or pandemics; 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 the outcome of 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, 2023, filed with the SEC on August 8, 2023, and in Personalis’ Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, 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:

pr@personalis.com

 

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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,
		2023				2022				2023				2022
Revenue		$	18,247			$	14,858			$	53,806			$	48,325
Costs and expenses
Cost of revenue			14,766				12,379				40,803				37,287
Research and development			16,738				14,957				51,163				48,343
Selling, general and administrative			11,971				14,781				38,202				46,141
Lease impairment			5,565				—				5,565				—
Restructuring and other charges			—				—				4,037				—
Total costs and expenses			49,040				42,117				139,770				131,771
Loss from operations			(30,793	)			(27,259	)			(85,964	)			(83,446	)
Interest income			1,706				743				4,424				1,236
Interest expense			(15	)			(45	)			(101	)			(154	)
Other income, net			32				80				7				149
Loss before income taxes			(29,070	)			(26,481	)			(81,634	)			(82,215	)
Provision for income taxes			28				11				78				32
Net loss		$	(29,098	)		$	(26,492	)		$	(81,712	)		$	(82,247	)
Net loss per share, basic and diluted		$	(0.60	)		$	(0.58	)		$	(1.71	)		$	(1.81	)
Weighted-average shares outstanding, basic and diluted			48,694,324				45,921,411				47,701,369				45,518,334

 

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PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(in thousands)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Pharma tests and services		$	7,997			$	7,333			$	20,413			$	22,152
Enterprise sales			7,812				7,383				24,656				18,390
Population sequencing			2,400				—				8,405				7,556
Other			38				142				332				227
Total revenue		$	18,247			$	14,858			$	53,806			$	48,325

 

 

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PERSONALIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(in thousands, except share and per share data)

 

		September 30, 2023				December 31, 2022
Assets
Current assets
Cash and cash equivalents		$	72,192			$	89,128
Short-term investments			48,471				78,530
Accounts receivable, net			13,666				16,642
Inventory and other deferred costs			8,225				8,591
Prepaid expenses and other current assets			5,661				6,808
Total current assets			148,215				199,699
Property and equipment, net			56,751				61,935
Operating lease right-of-use assets			18,167				26,480
Other long-term assets			3,503				4,586
Total assets		$	226,636			$	292,700
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	8,963			$	12,854
Accrued and other current liabilities			19,821				19,013
Contract liabilities			3,694				1,264
Total current liabilities			32,478				33,131
Long-term operating lease liabilities			39,166				41,041
Other long-term liabilities			3,786				389
Total liabilities			75,430				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; 49,013,483 and 46,707,084 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively			5				5
Additional paid-in capital			593,625				579,456
Accumulated other comprehensive loss			(302	)			(912	)
Accumulated deficit			(442,122	)			(360,410	)
Total stockholders’ equity			151,206				218,139
Total liabilities and stockholders’ equity		$	226,636			$	292,700

 

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v3.23.3

Document and Entity Information	Nov. 07, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 07, 2023
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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