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     125  0 Kommentare Personalis Reports Fourth Quarter and Full Year 2023 Financial Results

    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

    • Obtained final Medicare coverage determination for its NeXT Dx comprehensive tumor genomic profiling test, providing access for the 66 million Medicare and Medicare Advantage beneficiaries
    • Entered into a strategic partnership with Tempus AI, Inc. (formerly known as Tempus Labs) to co-commercialize NeXT Personal Dx in tumor-informed MRD testing for lung and breast cancers, and for immunotherapy monitoring
    • Partnered with Myriad Genetics to market Personalis’ ImmunoID NeXT ultra-comprehensive biomarker discovery offering to Myriad’s pharmaceutical partners
    • Established a partnership with ClearNote Health to expand Personalis’ pharmaceutical service offerings by distributing ClearNote’s epigenomic platform
    • Amended agreement with Natera to extend minimum volume commitment through the end of 2024

    “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

    • Reported total company revenue of $19.7 million in the fourth quarter of 2023, compared with $16.7 million in the fourth quarter of 2022, an 18% increase
    • Revenue from pharma tests, enterprise, and other customers of $18.7 million in the fourth quarter of 2023, compared with $15.8 million in the fourth quarter of 2022; revenue from enterprise customers includes revenue from Natera of $7.1 million in the fourth quarter of 2023, compared with $8.2 million from Natera in the fourth quarter of 2022
    • Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $1.0 million in the fourth quarter of 2023, compared with $0.9 million in the fourth quarter of 2022
    • Other expense of $4.1 million in the fourth quarter of 2023, compared with $0.1 million in the fourth quarter of 2022; included in other expense is the $4.0 million non-cash expense related to fair-value accounting for the outstanding warrants issued to Tempus
    • Net loss of $26.6 million, and net loss per share of $0.54 based on a weighted-average basic and diluted share count of 49.6 million in the fourth quarter 2023; 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 of 2022
    • Cash, cash equivalents, and short-term investments of $114.2 million as of December 31, 2023

    Full Year 2023 Financial Results

    • Revenue of $73.5 million in the full year of 2023, compared with revenue of $65.0 million in the full year of 2022, a 13% increase
    • Revenue from pharma tests, enterprise, and other customers of $64.1 million in the full year of 2023 compared with $56.6 million in the full year of 2022; revenue from enterprise customers includes revenue from Natera of $31.7 million in the full year of 2023, compared with $26.6 million from Natera in the full year of 2022
    • Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $9.4 million in the full year of 2023, compared with $8.4 million in the full year of 2022
    • Other expense of $4.1 million in the full year of 2023, compared with other income of $0.1 million in the full year of 2022; included in other expense is the $4.0 million non-cash expense related to fair-value accounting for the outstanding warrants issued to Tempus
    • Net loss of $108.3 million, and net loss per share of $2.25 based on a weighted-average basic and diluted share count of 48.2 million in the full year of 2023, compared with a 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
    • Cash usage of $53.5 million in the full year of 2023, compared with $119.4 million in the full year of 2022

    First Quarter and Full Year 2024 Outlook

    Personalis expects the following for the first quarter of 2024:

    • Total company revenue to be in the range of $18.0 to $19.0 million
    • Revenue from pharma tests, enterprise sales, and other customers to be in the range of $16.0 to $17.0 million
    • Revenue from population sequencing of approximately $2.0 million

    Personalis expects the following for the full year of 2024:

    • Total company revenue in the range of $73.0 to $75.0 million
    • Revenue from pharma tests, enterprise sales, and all other customers in the range of $65.0 to $67.0 million
    • Revenue from population sequencing of approximately $8.0 million
    • Net loss of approximately $80.0 million, down from $108.3 million in 2023 due to realization of savings from the reduction in headcount, partially offset by investments in clinical evidence generation and costs for non-reimbursed clinical tests; the net loss estimate does not include any income or expense from the outstanding warrants issued to Tempus
    • Cash usage of approximately $62.0 million, inclusive of approximately $3.0 million for employee severance payments from the headcount reductions in the fourth quarter of 2023

    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, 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 (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

     

    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

    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

     

     


    The Personalis Stock at the time of publication of the news with a fall of -1,67 % to 1,475USD on Nasdaq stock exchange (28. Februar 2024, 21:49 Uhr).


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    Personalis Reports Fourth Quarter and Full Year 2023 Financial Results 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 …

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