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    Personalis Reports Third Quarter 2023 Financial Results

    11/7/23 4:01:00 PM ET
    $PSNL
    Medical Specialities
    Health Care
    Get the next $PSNL alert in real time by email

    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

    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

    • Achieved third quarter revenue of $18.2 million, representing an increase of 23% over the same period of the prior year
    • Presented compelling clinical data from the collaboration with the TRACERx consortium for lung cancer:
      • 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
    • NeXT Personal® launched to robust demand as a clinical laboratory-developed test ("LDT") for use by oncologists

    "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

    • Reported total company revenue of $18.2 million for the third quarter of 2023, a 23% increase compared with $14.9 million for the third quarter of 2022
      • Revenue from pharma tests, enterprise sales, and other customers of $15.8 million in the third quarter of 2023, representing a 7% increase compared with $14.9 million in the third quarter of 2022; revenue from enterprise customers includes revenue from Natera of $7.8 million in the third quarter of 2023, compared with $7.4 million from Natera in the third quarter of 2022
      • Revenue from population sequencing for the VA MVP of $2.4 million in the third quarter of 2023, compared with zero in the third quarter of 2022 due to the backlog being fulfilled after the second quarter of 2022 and a deferred task order that was received after the second quarter of 2022
    • Cash, cash equivalents, and short-term investments of $120.7 million as of September 30, 2023
    • Net loss of $29.1 million, and net loss per share of $0.60 based on a weighted-average basic and diluted share count of 48.7 million in the third quarter of 2023; the net loss included a one-time non-cash impairment charge of $5.6 million for the Menlo Park facility upon completion of the move to the new Fremont facility

    Fourth Quarter and Full Year 2023 Outlook

    Personalis expects the following for the fourth quarter of 2023:

    • Total company revenue between $19 to $20 million
    • Revenue from pharma tests, enterprise sales, and other customers between $18.5 to $19.5 million
    • Revenue from population sequencing of approximately $0.5 million

    Personalis expects the following for the full year of 2023:

    • Total company revenue between $73 to $74 million; an increase from the prior estimate of $70 to $72 million
    • Revenue from pharma tests, enterprise sales, and all other customers between $64 to $65 million, and revenue from population sequencing of approximately $9 million
    • Net loss of approximately $103 million reduced from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash impairment expense for the vacated Menlo Park facility
    • Cash usage less than $70 million, reduced from $119 million in 2022

    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).

    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.

    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

     

    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

    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

     

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20231107500327/en/

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    Bhandari to drive regulatory strategies for minimal residual disease (MRD) cancer test Personalis achieves ISO 13485:2016 certification, attesting to its ability to deliver medical devices and related services of the highest quality Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomic testing for precision oncology, today announced the appointment of Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance. With over two decades of industry marketing and regulatory affairs experience, Ms. Bhandari will help the company navigate the regulatory requirements for the NeXT Personal® MRD test. She was most recently VP, Regulatory Affairs at GRAIL, and previously held se

    10/18/23 7:15:00 AM ET
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    Health Care

    Dr. Kenneth J. Widder Joins Personalis Board of Directors

    Personalis, Inc. (NASDAQ:PSNL) today announced that it has appointed Kenneth J. Widder, M.D., to its Board of Directors. Dr. Widder currently serves on the boards of QuidelOrtho Corporation and Evoke Pharma, Inc. and has over 40 years of experience working with biomedical companies, having previously served as a founder, director and/or CEO of Sydnexis, Inc., OrphoMed, Inc., Sytera, Inc., NovaCardia, Inc., Santarus, Inc., and Molecular Biosystems Inc., and as a general partner at LVP Life Science Ventures (formerly Latterell Venture Partners) and Windamere Venture Partners. He holds an M.D. from Northwestern University and trained in pathology at Duke University. "We are delighted to ha

    6/13/23 7:01:00 PM ET
    $PSNL
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    Personalis Announces CEO Retirement and Transition

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for precision oncology, today announced that John West, co-founder, CEO and member of the board of directors of Personalis, notified the Company of his decision to retire as CEO and a director at the end of the calendar year. Mr. West has served in the DNA sequencing field for over forty years, and co-founded Personalis with four Stanford professors in 2011. Effective December 31, 2022, Aaron Tachibana, Personalis Chief Financial Officer, will serve as interim CEO and Christopher Hall, Personalis SVP and Head, Diagnostics Business, will be promoted to President. Mr. West will continue to serve as an advisor to the Board. "We th

    12/14/22 4:02:00 PM ET
    $PSNL
    Medical Specialities
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