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    Xeris Biopharma Reports Second Quarter 2023 Financial Results

    8/8/23 7:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $XERS alert in real time by email

    Achieved record revenue of $38.0M – a 14% increase from prior quarter, and a 50% increase from same period prior year

    Ended Q2 with over $80M in cash, cash equivalents and short-term investments

    Tightens full-year 2023 guidance: total net revenue of $145M-$165M; cash utilization of $57M-$67M; 2023 year-end cash balance of $55M-$65M

    Remains on track to achieve cash flow breakeven by year-end 2023

    Hosting conference call and webcast today at 8:30 a.m. ET

    Xeris Biopharma Holdings, Inc. (NASDAQ:XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2023 and corporate highlights.

    "We posted another record quarter of revenue due to the continued strong demand of all three products, as well as contributions from our partnerships," said Paul R. Edick, Chairman and CEO of Xeris Biopharma. "Our differentiated business model, exceptional year-to-date performance, and expectations for the remainder of the year gives us the confidence to tighten our 2023 guidance by raising the low end of the total revenue range to $145 to $165 million from $135 to $165 million; reducing cash utilization range to $57 to $67 million from $57 to $77 million; improving year-end cash range to $55 to $65 million. And, we expect to be at the cash flow breakeven point in the fourth quarter and continue being a self-sustaining enterprise."

    Second Quarter 2023 Highlights

     

    Three Months Ended June 30,

     

    Change

     

     

    2023

     

    2022

     

    $

    %

     

    Product revenue (in thousands):

     

     

     

     

     

     

     

    Gvoke

    $

    15,638

     

    $

    11,479

     

    $

    4,159

    36.2

     

    Keveyis

     

    14,088

     

     

    12,812

     

     

    1,276

    10.0

     

    Recorlev

     

    7,167

     

     

    969

     

     

    6,198

    nm

     

    Product revenue, net

     

    36,893

     

     

    25,260

     

     

    11,633

    46.1

     

    Royalty, contract and other revenue

     

    1,115

     

     

    46

     

     

    1,069

    nm

     

    Total revenue

    $

    38,008

     

    $

    25,306

     

    $

    12,702

    50.2

     

     

    nm - not meaningful

     

    Commercial Products

    • Gvoke®: Second quarter 2023 net revenue was $15.6 million as compared to $11.5 million in the second quarter of 2022 – an increase of approximately 36%. Gvoke prescriptions topped 51,000 for the first time, growing 50% compared to the same period in 2022. Gvoke's market share of the retail TRx glucagon market grew to approximately 29% at the end of July.
    • Keveyis®: Second quarter net revenue was $14.1 million – an increase of 10% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 11% from the same period in 2022.
    • Recorlev®: Second quarter net revenue was $7.2 million – an increase of $6.2 million compared to the second quarter of 2022, the first full quarter since its launch. The average number of patients on Recorlev increased over 400% from the same period in 2022.

    Pipeline Program

    • XeriSol® levothyroxine (XP-8121): Xeris began dosing patients in its Phase 2 clinical study in the second quarter. The Company anticipates completing the study in the first half of 2024.

    Year-to-Date 2023 Financial Results

     

    Six Months Ended June 30,

     

    Change

     

    2023

     

    2022

     

    $

    %

    Product revenue (in thousands):

     

     

     

     

     

     

    Gvoke

    $

    30,671

     

    $

    23,932

     

    $

    6,739

    28.2

    Keveyis

     

    26,843

     

     

    22,136

     

     

    4,707

    21.3

    Recorlev

     

    11,644

     

     

    1,102

     

     

    10,542

    nm

    Product revenue, net

     

    69,158

     

     

    47,170

     

     

    21,988

    46.6

    Royalty, contract and other revenue

     

    2,046

     

     

    209

     

     

    1,837

    nm

    Total revenue

    $

    71,204

     

    $

    47,379

     

    $

    23,825

    50.3

     

    nm - not meaningful

    • Gvoke®: Net revenue was $30.7 million for the six months ended June 30, 2023, a 28% increase compared to prior year. Gvoke prescriptions for the first half of 2023 were over 97,000 TRx's, growing 50% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing.
    • Keveyis®: Net revenue was $26.8 million for the six months ended June 30, 2023, a 21% increase from last year. This increase was driven by a 9% increase in sales volume and an increase in net pricing.
    • Recorlev®: Net revenue was $11.6 million for the six months ended June 30,2023, a $10.5 million increase from last year, driven primarily by increases in the number of patients on therapy.

    Cost of goods sold increased by $2.7 million or 57.1% for the three months ended June 30, 2023 compared to the same period ended June 30, 2022. The increase was attributable to higher product sales and product mix. Cost of goods sold increased by $1.8 million or 16.2% for the six months ended June 30, 2023 compared to the same period ended June 30, 2022. The increase was attributable to higher product sales and product mix, partially offset by a one-time contract credit in the first quarter of 2023.

    Research and development expenses increased by $2.4 million or 63.7% and $1.0 million or 9.6% for the three and six months ended June 30, 2023, respectively, compared to the same periods ended June 30, 2022. The increases in both periods were due to higher spending on the Open-label Treatment in Cushing's Syndrome (OPTICS) study for Recorlev and higher product development costs.

    Selling, general and administrative expenses increased by $4.7 million or 14.1% and $2.3 million or 3.4% for the three and six months ended 2023, respectively, compared to the same periods ended June 30, 2022, due to higher personnel costs, marketing expenses and rent expenses related to the new lease commenced in April 2023.

    Net Loss for the three months ended June 30, 2023, was $19.8 million, or $0.14 per share, and a net loss of $36.7 million, or $0.27 per share, for the six months ended June 30, 2023.

    Cash, cash equivalents, and short-term investments at June 30, 2023 was $80.7 million compared to $122.0 million at December 31, 2022. Total shares outstanding at July 31, 2023 was 138,065,993.

    Conference Call and Webcast Details

    Xeris will host a conference call and webcast today, Tuesday, August 8, 2023, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: https://www.netroadshow.com/events/login?show=73c6056b&confId=53289 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Tuesday, August 22, 2023 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 729515.

    In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit "Events" on investor relations page of the Company's website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/901721849

    About Xeris

    Xeris (NASDAQ:XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing's syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.

    Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn, or Instagram.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2023, including projections regarding year-end 2023 cash estimates and total revenue, the Company's expectations regarding its cash flow breakeven timeline, the market and therapeutic potential of its products and product candidates, continued growth of Gvoke, Keveyis and Recorlev, continued use of Xeris' formulation sciences in development and partnered programs, potentially new partnerships and collaborations, expectations regarding clinical data or results from planned clinical trials, the timing of clinical trials, including advancement of its levothyroxine clinical program and a related Phase 2 study results in the first half of 2024, the potential utility of its formulation platforms, cash management, becoming a self-sustaining enterprise, and other statements containing the words "will," "would," "continue," "expect," "anticipate" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris' experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris' actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators' ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional information about potential impacts of COVID-19, financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris' filings, including its most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while believed to be reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

    XERIS BIOPHARMA HOLDINGS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share data)

    (unaudited)

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2023

     

     

     

    2022

     

     

     

    2023

     

     

     

    2022

     

    Product revenue, net

    $

    36,893

     

     

    $

    25,260

     

     

    $

    69,158

     

     

    $

    47,170

     

    Royalty, contract and other revenue

     

    1,115

     

     

     

    46

     

     

     

    2,046

     

     

     

    209

     

    Total revenue

     

    38,008

     

     

     

    25,306

     

     

     

    71,204

     

     

     

    47,379

     

    Costs and expenses:

     

     

     

     

     

     

     

    Cost of goods sold

     

    7,555

     

     

     

    4,810

     

     

     

    12,874

     

     

     

    11,083

     

    Research and development

     

    6,087

     

     

     

    3,718

     

     

     

    10,925

     

     

     

    9,968

     

    Selling, general and administrative

     

    37,635

     

     

     

    32,984

     

     

     

    71,240

     

     

     

    68,897

     

    Amortization of intangible assets

     

    2,710

     

     

     

    2,710

     

     

     

    5,421

     

     

     

    5,421

     

    Total costs and expenses

     

    53,987

     

     

     

    44,222

     

     

     

    100,460

     

     

     

    95,369

     

    Loss from operations

     

    (15,979

    )

     

     

    (18,916

    )

     

     

    (29,256

    )

     

     

    (47,990

    )

    Other expense

     

    (4,538

    )

     

     

    (7,608

    )

     

     

    (8,095

    )

     

     

    (12,656

    )

    Net loss before benefit from income taxes

     

    (20,517

    )

     

     

    (26,524

    )

     

     

    (37,351

    )

     

     

    (60,646

    )

    Benefit from income taxes

     

    675

     

     

     

    339

     

     

     

    675

     

     

     

    747

     

    Net loss

    $

    (19,842

    )

     

    $

    (26,185

    )

     

    $

    (36,676

    )

     

    $

    (59,899

    )

     

     

     

     

     

     

     

     

    Net loss per common share - basic and diluted

    $

    (0.14

    )

     

    $

    (0.19

    )

     

    $

    (0.27

    )

     

    $

    (0.44

    )

     

     

     

     

     

     

     

     

    Weighted average common shares outstanding - basic and diluted

     

    137,338,071

     

     

     

    135,529,968

     

     

     

    137,250,465

     

     

     

    135,282,749

     

    XERIS BIOPHARMA HOLDINGS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    June 30, 2023

     

    December 31, 2022

     

    (unaudited)

     

     

    Assets

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    46,170

     

    $

    121,966

    Short-term investments

     

    34,498

     

     

    —

    Trade accounts receivable, net

     

    30,225

     

     

    30,830

    Inventory

     

    36,538

     

     

    24,735

    Prepaid expenses and other current assets

     

    8,310

     

     

    9,287

    Total current assets

     

    155,741

     

     

    186,818

    Property and equipment, net

     

    6,552

     

     

    5,516

    Intangible assets, net

     

    115,186

     

     

    120,607

    Goodwill

     

    22,859

     

     

    22,859

    Operating lease right-of-use assets

     

    23,632

     

     

    3,992

    Other assets

     

    4,808

     

     

    4,730

    Total assets

    $

    328,778

     

    $

    344,522

    Liabilities and Stockholders' Equity

     

     

     

    Current liabilities:

     

     

     

    Accounts payable

    $

    11,621

     

    $

    4,606

    Current operating lease liabilities

     

    1,935

     

     

    1,580

    Other accrued liabilities

     

    19,413

     

     

    36,786

    Accrued trade discounts and rebates

     

    17,034

     

     

    16,818

    Accrued returns reserve

     

    11,320

     

     

    11,173

    Current portion of contingent value rights

     

    16,637

     

     

    —

    Other current liabilities

     

    1,718

     

     

    2,658

    Total current liabilities

     

    79,678

     

     

    73,621

    Long-term debt, net of unamortized debt issuance costs

     

    188,182

     

     

    187,075

    Non-current contingent value rights

     

    6,911

     

     

    25,688

    Non-current operating lease liabilities

     

    34,871

     

     

    9,402

    Deferred tax liabilities

     

    2,843

     

     

    3,518

    Other liabilities

     

    2,652

     

     

    31

    Total liabilities

     

    315,137

     

     

    299,335

    Total stockholders' equity

     

    13,641

     

     

    45,187

    Total liabilities and stockholders' equity

    $

    328,778

     

    $

    344,522

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20230808594869/en/

    Get the next $XERS alert in real time by email

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    4/17/25 7:00:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    2/24/25 8:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
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    Xeris Biopharma Announces CEO Succession Plan

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    Biotechnology: Pharmaceutical Preparations
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    SEC Form SC 13G filed by Xeris Biopharma Holdings Inc.

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    2/13/24 5:17:37 PM ET
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    Biotechnology: Pharmaceutical Preparations
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    SEC Form SC 13G/A filed by Xeris Biopharma Holdings Inc. (Amendment)

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    2/13/24 4:34:36 PM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
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    SEC Form SC 13G filed by Xeris Biopharma Holdings Inc.

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    Biotechnology: Pharmaceutical Preparations
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    Xeris Biopharma to Report Third Quarter 2025 Financial Results on November 6, 2025

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    10/23/25 7:30:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
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    Xeris Biopharma Reports Record Financial Results for the Second Quarter 2025 and Raises Full Year Revenue Guidance

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    8/7/25 7:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Xeris Biopharma to Report Second Quarter 2025 Financial Results on August 7, 2025

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    7/31/25 7:30:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care