PSNL Personalis Inc

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, 2022, and provided recent business highlights.

Recent Business Highlights

• Announced a continuing partnership with Moderna to provide genomic testing for their upcoming clinical studies evaluating mRNA-4157/V940, an investigational personalized cancer vaccine, jointly developed by Moderna and Merck
• Partnered with Criterium and the Academic Breast Cancer Consortium (ABRCC) to conduct a prospective clinical trial to validate the clinical performance of the NeXT Personal® assay to evaluate minimal residual disease (MRD) and subsequent recurrence in patients with early-stage, resectable triple negative breast cancer (TNBC)
• Initiated a research collaboration with University Medical Center Hamburg-Eppendorf (UKE) and its new Fleur-Hiege Center for Skin Cancer Research, where Dr. Klaus Pantel, Dr. Christoffer Gebhardt, and team are using NeXT Personal to track tumor response to immunotherapy (IO) in patients with melanoma, with the aim of gathering evidence to advance the use of ultra-sensitive MRD detection in routine clinical practice for IO therapy monitoring

“We are excited to have completed our strategic review of the business, which has resulted in a new threefold focus on winning in MRD, leveraging our technology to power companies working on personalized cancer vaccines, and supporting pharmaceutical customers with clinical trials,” said Aaron Tachibana, Interim Chief Executive Officer and Chief Financial Officer. “Our partnership with Moderna using our NeXT Platform to provide genomic testing is an example of how we enable customers. With our sharpened focus in both our clinical and biopharma businesses, we believe we are well-positioned to advance the standard of care by transforming cancer recurrence detection and ongoing therapy monitoring.”

Fourth Quarter Highlights

• Reported total company revenue of $16.7 million for the fourth quarter of 2022 and $65.0 million for the full year of 2022.
  • Revenue from pharma tests, enterprise, and other customers of $15.8 million in the fourth quarter of 2022 compared with $15.4 million in the fourth quarter of 2021; revenue from enterprise customers includes revenue from Natera of $8.2 million in the fourth quarter of 2022
  • Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $0.9 million in the fourth quarter of 2022, which is initial revenue from the new contract awarded in September 2022, compared with $5.3 million in the fourth quarter of 2021
• Cash, cash equivalents, and short-term investments of $167.7 million as of December 31, 2022

Fourth Quarter and Full Year 2022 Financial Results

• Revenue of $16.7 million in the fourth quarter 2022; revenue of $65.0 million in the full year 2022
• Net loss of $31.1 million, and net loss per share of $0.67 based on a weighted-average basic and diluted share count of 46.3 million in the fourth quarter 2022; net loss of $113.3 million, and net loss per share of $2.48 based on a weighted-average basic and diluted share count of 45.7 million in the full year 2022

First Quarter and Full Year 2023 Outlook

Personalis expects the following for the first quarter of 2023:

• Total company revenue of approximately $17.5 million
• Revenue from pharma tests, enterprise sales, and other customers of approximately $14.5 million
• Revenue from population sequencing of approximately $3.0 million

Personalis expects the following for the full year of 2023:

• Total company revenue in the range of $68 million to $72 million, based on its strategic review of accounts and pruning of unprofitable business
• Revenue from pharma tests, enterprise sales, and all other customers in the range of $59 million to $63 million
• Revenue from population sequencing of approximately $9.0 million
• Net loss of approximately $103 million, down from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash depreciation expense for the new facility
• Cash usage of approximately $75 million, down from $119 million in 2022

Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on Thursday, February 23, 2023 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 first quarter and full year financial guidance, 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: the timing and pace of new orders from customers, including from Natera, which accounted for an estimated 49% of the company’s total revenue in the fourth quarter and an estimated 41% for the full year of 2022; 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 COVID-19 or other 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 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 quarter ended September 30, 2022, filed with the Securities and Exchange Commission (SEC) on November 2, 2022, and its Annual Report on Form 10-K for the year ended December 31, 2022, being filed with the SEC later 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.

PERSONALIS, INC.

 

CONSOLIDATED STATEMENTS OF OPERATIONS

 

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Revenue

 

$

16,722

 

 

$

20,682

 

 

$

65,047

 

 

$

85,494

 

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

14,410

 

 

 

12,686

 

 

 

51,697

 

 

 

53,837

 

Research and development

 

 

16,569

 

 

 

14,512

 

 

 

64,912

 

 

 

49,312

 

Selling, general and administrative

 

 

17,828

 

 

 

13,709

 

 

 

63,969

 

 

 

47,698

 

Total costs and expenses

 

 

48,807

 

 

 

40,907

 

 

 

180,578

 

 

 

150,847

 

Loss from operations

 

 

(32,085

)

 

 

(20,225

)

 

 

(115,531

)

 

 

(65,353

)

Interest income

 

 

1,160

 

 

 

81

 

 

 

2,396

 

 

 

367

 

Interest expense

 

 

(47

)

 

 

(59

)

 

 

(201

)

 

 

(184

)

Other income (expense), net

 

 

(88

)

 

 

1

 

 

 

61

 

 

 

(42

)

Loss before income taxes

 

 

(31,060

)

 

 

(20,202

)

 

 

(113,275

)

 

 

(65,212

)

Provision for (benefit from) income taxes

 

 

8

 

 

 

(3

)

 

 

40

 

 

 

14

 

Net loss

 

$

(31,068

)

 

$

(20,199

)

 

$

(113,315

)

 

$

(65,226

)

Net loss per share, basic and diluted

 

$

(0.67

)

 

$

(0.45

)

 

$

(2.48

)

 

$

(1.49

)

Weighted-average shares outstanding, basic and diluted

 

 

46,264,217

 

 

 

44,808,998

 

 

 

45,704,805

 

 

 

43,886,730

 

PERSONALIS, INC.

 

SUPPLEMENTAL REVENUE INFORMATION

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Pharma tests and services

 

$

7,400

 

 

$

9,335

 

 

$

29,552

 

 

$

30,282

 

Enterprise sales

 

 

8,251

 

 

 

5,807

 

 

 

26,641

 

 

 

8,774

 

Population sequencing

 

 

887

 

 

 

5,304

 

 

 

8,443

 

 

 

45,671

 

Other

 

 

184

 

 

 

236

 

 

 

411

 

 

 

767

 

Total revenue

 

$

16,722

 

 

$

20,682

 

 

$

65,047

 

 

$

85,494

 

PERSONALIS, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

 

 

December 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

89,128

 

 

$

105,585

 

Short-term investments

 

 

78,530

 

 

 

181,479

 

Accounts receivable, net

 

 

16,642

 

 

 

18,468

 

Inventory and other deferred costs

 

 

8,591

 

 

 

5,610

 

Prepaid expenses and other current assets

 

 

6,808

 

 

 

7,089

 

Total current assets

 

 

199,699

 

 

 

318,231

 

Property and equipment, net

 

 

61,935

 

 

 

19,650

 

Operating lease right-of-use assets

 

 

26,480

 

 

 

53,822

 

Other long-term assets

 

 

4,586

 

 

 

4,825

 

Total assets

 

$

292,700

 

 

$

396,528

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

12,854

 

 

$

9,221

 

Accrued and other current liabilities

 

 

19,013

 

 

 

18,110

 

Contract liabilities

 

 

1,264

 

 

 

3,982

 

Total current liabilities

 

 

33,131

 

 

 

31,313

 

Long-term operating lease liabilities

 

 

41,041

 

 

 

52,797

 

Other long-term liabilities

 

 

389

 

 

 

2,117

 

Total liabilities

 

 

74,561

 

 

 

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; 46,707,084 and 44,904,512 shares issued and outstanding at December 31, 2022 and 2021, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

579,456

 

 

 

557,558

 

Accumulated other comprehensive loss

 

 

(912

)

 

 

(166

)

Accumulated deficit

 

 

(360,410

)

 

 

(247,095

)

Total stockholders’ equity

 

 

218,139

 

 

 

310,301

 

Total liabilities and stockholders’ equity

 

$

292,700

 

 

$

396,528

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230223005193/en/

Investor Relations Contact: Caroline Corner investors@personalis.com 415-202-5678

Media Contact: Jennifer Temple pr@personalis.com 650-752-1300