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): May 8, 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 May 8, 2024, Personalis, Inc. issued a press release announcing its financial results for the quarter ended March 31, 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 May 8, 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: May 8, 2024		Personalis, Inc.
		By:	/s/ Aaron Tachibana
			Aaron Tachibana
			Chief Financial Officer and Chief Operating Officer

 

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Personalis Reports First Quarter 2024 Financial Results

Raises full year revenue guidance due to greater pharma testing demand

FREMONT, Calif. – May 8, 2024 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the first quarter of 2024 ended March 31, 2024, and provided recent business highlights.

 

Recent Business Highlights

 

“We began 2024 with strong execution as we delivered revenue of $19.5 million in the first quarter, exceeding the upper-end of our guidance range, and we continue to develop compelling NeXT Personal clinical evidence as we work towards obtaining Medicare coverage,” said Chris Hall, Chief Executive Officer. “Our efforts in 2024 are focused on executing on the four pillars of our Win-in-MRD strategy: (1) focusing on cancer types where we believe our test provides the most value, (2) generating robust clinical evidence with top KOLs to support our submission for Medicare coverage, (3) leveraging our early success with biopharma customers to accelerate adoption, and (4) working with Tempus AI to expedite commercialization in a capital-efficient manner.”

First Quarter Results

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Second Quarter and Revised Full Year 2024 Outlook

Personalis expects the following for the second quarter of 2024:

 

Personalis expects the following for the full year of 2024:

 

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter of 2024 financial results, as well as plans for 2024, after market close on Wednesday, May 8, 2024, 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 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

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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’ second 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, Personalis’ obtaining Medicare coverage, and the expected benefits of Personalis’ collaboration and partnership agreements with Tempus. 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 Medicare coverage and 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, the impact of Personalis’ abstract presentations at the American Society of Clinical Oncology medical conference in June, 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 and on Form 10-Q for the quarter ended March 31, 2024, being filed with the SEC on May 8, 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, 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

646-277-1279

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 March 31,
		2024				2023
Revenue		$	19,525			$	18,860
Costs and expenses
Cost of revenue			14,032				14,130
Research and development			12,771				16,573
Selling, general and administrative			11,602				14,097
Restructuring and other charges			—				3,885
Total costs and expenses			38,405				48,685
Loss from operations			(18,880	)			(29,825	)
Interest income			1,359				1,253
Interest expense			(9	)			(47	)
Other income (expense), net			4,569				(26	)
Loss before income taxes			(12,961	)			(28,645	)
Provision for income taxes			7				14
Net loss		$	(12,968	)		$	(28,659	)
Net loss per share, basic and diluted		$	(0.26	)		$	(0.61	)
Weighted-average shares outstanding, basic and diluted			50,678,586				46,740,270

 

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PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(in thousands)

 

		Three Months Ended March 31,
		2024				2023
Pharma tests and services		$	9,812			$	6,333
Enterprise sales			7,972				9,458
Population sequencing			1,500				3,005
Other			241				64
Total revenue		$	19,525			$	18,860

 

 

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PERSONALIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(in thousands, except share and per share data)

 

		March 31, 2024				December 31, 2023
Assets
Current assets
Cash and cash equivalents		$	43,981			$	56,984
Short-term investments			51,438				57,195
Accounts receivable, net			11,345				17,730
Inventory and other deferred costs			8,767				10,474
Prepaid expenses and other current assets			4,908				4,361
Total current assets			120,439				146,744
Property and equipment, net			54,529				57,366
Operating lease right-of-use assets			17,515				17,852
Other long-term assets			2,793				3,137
Total assets		$	195,276			$	225,099
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	9,179			$	14,920
Accrued and other current liabilities			16,159				23,941
Contract liabilities			3,526				3,288
Short-term warrant liability			2,509				5,085
Total current liabilities			31,373				47,234
Long-term operating lease liabilities			37,434				38,321
Long-term warrant liability			2,753				4,942
Other long-term liabilities			3,022				5,161
Total liabilities			74,582				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; 51,394,199 and 50,480,694 shares issued and outstanding, respectively			5				5
Additional paid-in capital			602,488				598,364
Accumulated other comprehensive loss			(125	)			(222	)
Accumulated deficit			(481,674	)			(468,706	)
Total stockholders’ equity			120,694				129,441
Total liabilities and stockholders’ equity		$	195,276			$	225,099

 

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v3.24.1.u1

Document and Entity Information	May 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 08, 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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