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    Xeris Biopharma Reports First Quarter 2024 Financial Results and Recent Events

    5/9/24 7:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $XERS alert in real time by email

    Q1 2024 Total Revenue of $40.6M – up 22% over Q1 2023

    Tightening full-year 2024 total revenue guidance to $175M-$200M

    Ended Q1 with $87.4M in cash, cash equivalents, and short-term investments, lowered borrowing rate of Hayfin debt by 2.05%

    Entered into a worldwide license agreement for XeriJect® formulation of teprotumumab

    Announced an exclusive worldwide agreement with Beta Bionics for development of a new XeriSol™ formulation of glucagon for bi-hormonal pumps and pump systems

    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 first quarter ended March 31, 2024 and recent events.

    "We grew total product revenue 25% in the first quarter compared to last year, despite an estimated $3 million negative impact to Gvoke revenue from the Change Healthcare cyberattack. This strong growth was driven by impressive momentum in Recorlev sales, Keveyis' resilience in the marketplace, and Gvoke's growing market share," said Paul R. Edick, Xeris' Chairman and CEO. "With these results, a strong start to the second quarter, along with our new technology partnership with Beta Bionics, we are confident in tightening our 2024 total revenue guidance to $175 million to $200 million."

    First Quarter 2024 Highlights

     

    Three months ended March 31,

     

    Change

     

    2024

     

    2023

     

    $

    %

    Product revenue (in thousands):

     

     

     

     

     

     

     

     

    Gvoke

    $

    16,579

     

     

    $

    15,033

     

     

    $

    1,546

     

    10.3

     

    Keveyis

     

    13,085

     

     

     

    12,755

     

     

     

    330

     

    2.6

     

    Recorlev

     

    10,599

     

     

     

    4,477

     

     

     

    6,122

     

    136.7

     

    Product revenue, net

     

    40,263

     

     

     

    32,265

     

     

     

    7,998

     

    24.8

     

    Royalty, contract and other revenue

     

    375

     

     

     

    931

     

     

     

    (556

    )

    (59.7

    )

    Total revenue

    $

    40,638

     

     

    $

    33,196

     

     

    $

    7,442

     

    22.4

     

    Commercial Products

    • Gvoke®: First quarter net revenue was $16.6 million as compared to $15.0 million in the first quarter of 2023 – an increase of approximately 10%. Gvoke's market share of the retail TRx glucagon market grew to over 36% through late April and weekly Gvoke TRxs broke the 5,000 level in late April.
    • Keveyis®: First quarter net revenue remained very strong at $13.1 million – an increase of approximately 3% compared to the same period in 2023. Keveyis patient referrals remained strong with considerably lower patient loss in the quarter than anticipated.
    • Recorlev®: First quarter net revenue was $10.6 million – an increase of $6.1 million compared to the same period in 2023. The average number of patients on Recorlev increased 139% from the same period in 2023 and 18% compared to the fourth quarter 2023.

    Pipeline Program

    • XeriSol™ levothyroxine (XP-8121): Successfully completed the Phase 2 clinical study. Data from the Phase 2 study will be available mid-2024.

    Technology Partnerships

    • XeriSol™: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique formulation of liquid stable glucagon for use in a bi-hormonal pump and pump systems.
    • XeriJect®: In January, Xeris entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris' XeriJect® technology in Thyroid Eye Disease (TED). Under the terms of the License Agreement, Xeris has the potential to receive $75 million in development, regulatory, and sales-based milestones, as well as escalating single-digit royalties based on future sales of TEPEZZA® using the XeriJect ® technology.

    Cost of goods sold increased by $0.7 million for the three months ended March 31, 2024 compared to the same period ended in 2023. This increase was mainly attributable to higher product sales.

    Research and development expenses increased by $3.0 million for the three months ended March 31, 2024 compared to the same period in 2023, driven by strategic investments in our pipeline, notably XP-8121, and our emerging technology partnership business as well as higher personnel costs.

    Selling, general and administrative expenses increased by $4.8 million for the three ended March 31, 2024 compared to the same period in 2023, due to higher personnel costs and rent expenses related to our headquarter lease, which commenced in April 2023.

    Net Loss was $19.0 million, or $0.14 per share, for the three months ended March 31, 2024.

    Cash, cash equivalents, and short-term investments at March 31, 2024 was $87.4 million compared to $72.5 million at December 31, 2023.

    Shares outstanding at April 30, 2024 was 148,255,663.

    First Quarter Conference Call and Webcast Details

    Xeris will host a conference call and webcast on Thursday, May 9, 2024 at 8:30 a.m. Eastern Time.

    To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=7144015a&confId=62782. 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 Thursday, May 23, 2024 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: 952508

    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/702822810

    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®, a proven 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 X, LinkedIn, or Instagram.

    Forward-Looking Statements

    Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding total revenue guidance for 2024, Xeris' potential to receive milestones and royalties under a license agreement with Amgen, the expansion of collaboration partnerships such as with Beta Bionics, the impact of the Change Healthcare cyberattack, the timing of the availability of clinical study data, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, and other statements containing the words "will," "would," "continue," "expect," "should," "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, but are not limited to, 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 risks and information about potential impacts of 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 Quarterly Report on Form 10-Q 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 we believe our assumptions are 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 March 31,

     

     

    2024

     

     

     

    2023

     

    Product revenue, net

    $

    40,263

     

     

    $

    32,265

     

    Royalty, contract and other revenue

     

    375

     

     

     

    931

     

    Total revenue

     

    40,638

     

     

     

    33,196

     

    Costs and expenses:

     

     

     

    Cost of goods sold

     

    5,971

     

     

     

    5,319

     

    Research and development

     

    7,821

     

     

     

    4,838

     

    Selling, general and administrative

     

    38,380

     

     

     

    33,605

     

    Amortization of intangible assets

     

    2,711

     

     

     

    2,711

     

    Total costs and expenses

     

    54,883

     

     

     

    46,473

     

    Loss from operations

     

    (14,245

    )

     

     

    (13,277

    )

    Other expense

     

    (4,428

    )

     

     

    (3,557

    )

    Net loss before benefit from income taxes

     

    (18,673

    )

     

     

    (16,834

    )

    Income tax (expense) benefit

     

    (307

    )

     

     

    —

     

    Net loss

    $

    (18,980

    )

     

    $

    (16,834

    )

     

     

     

     

    Net loss per common share - basic and diluted

    $

    (0.14

    )

     

    $

    (0.12

    )

     

     

     

     

    Weighted average common shares outstanding - basic and diluted

     

    140,513,907

     

     

     

    137,142,565

     

     

    XERIS BIOPHARMA HOLDINGS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    March 31, 2024

     

    December 31, 2023

     

    (unaudited)

     

     

    Assets

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    62,690

     

     

    $

    67,449

     

    Short-term investments

     

    24,662

     

     

     

    5,002

     

    Trade accounts receivable, net

     

    37,414

     

     

     

    39,197

     

    Inventory

     

    40,878

     

     

     

    38,838

     

    Prepaid expenses and other current assets

     

    7,636

     

     

     

    5,778

     

    Total current assets

     

    173,280

     

     

     

    156,264

     

    Property and equipment, net

     

    5,783

     

     

     

    5,971

     

    Intangible assets, net

     

    107,053

     

     

     

    109,764

     

    Goodwill

     

    22,859

     

     

     

    22,859

     

    Operating lease right-of-use assets

     

    23,027

     

     

     

    23,204

     

    Other assets

     

    4,614

     

     

     

    4,540

     

    Total assets

    $

    336,616

     

     

    $

    322,602

     

    Liabilities and Stockholders' Equity

     

     

     

    Current liabilities:

     

     

     

    Accounts payable

    $

    7,094

     

     

    $

    11,565

     

    Current operating lease liabilities

     

    4,624

     

     

     

    3,495

     

    Other accrued liabilities

     

    22,391

     

     

     

    23,510

     

    Accrued trade discounts and rebates

     

    22,560

     

     

     

    22,149

     

    Accrued returns reserve

     

    14,593

     

     

     

    14,198

     

    Current portion of contingent value rights

     

    1,021

     

     

     

    19,109

     

    Other current liabilities

     

    801

     

     

     

    1,167

     

    Total current liabilities

     

    73,084

     

     

     

    95,193

     

    Long-term debt, net of unamortized debt issuance costs

     

    229,674

     

     

     

    190,932

     

    Non-current contingent value rights

     

    —

     

     

     

    1,379

     

    Non-current operating lease liabilities

     

    34,397

     

     

     

    34,764

     

    Deferred tax liabilities

     

    2,575

     

     

     

    2,268

     

    Other liabilities

     

    6,064

     

     

     

    4,848

     

    Total liabilities

     

    345,794

     

     

     

    329,384

     

    Total stockholders' equity (deficit)

     

    (9,178

    )

     

     

    (6,782

    )

    Total liabilities and stockholders' equity (deficit)

    $

    336,616

     

     

    $

    322,602

     

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20240509287355/en/

    Get the next $XERS alert in real time by email

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    Kenneth Johnson, PharmD, SVP Global Development & Medical Affairs to retire 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 that Dr. Anh Nguyen has joined Xeris as Chief Medical Officer (CMO) succeeding Ken Johnson PharmD, SVP, Global Development and Medical Affairs who will retire April 1, 2025. Dr. Nguyen will develop and lead the entire product portfolio vision and strategic direction for the Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions, reporting to John Shannon, X

    2/24/25 8:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Xeris Biopharma Announces CEO Succession Plan

    John Shannon, President and Chief Operating Officer, to succeed Paul Edick as new CEO and Board Director Transition timing aligns with the solid financial position of the Company, including consistently strong growth from its commercial franchise, healthy cash position, and the track record of its leadership team Q2 '24 total revenue is anticipated to exceed $47 million, representing more than 23% growth over last year 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 a CEO succession plan effective August 1, 20

    7/8/24 7:00:00 AM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $XERS
    Large Ownership Changes

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    SEC Form SC 13G filed by Xeris Biopharma Holdings Inc.

    SC 13G - Xeris Biopharma Holdings, Inc. (0001867096) (Subject)

    2/13/24 5:17:37 PM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13G/A filed by Xeris Biopharma Holdings Inc. (Amendment)

    SC 13G/A - Xeris Biopharma Holdings, Inc. (0001867096) (Subject)

    2/13/24 4:34:36 PM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13G filed by Xeris Biopharma Holdings Inc.

    SC 13G - Xeris Biopharma Holdings, Inc. (0001867096) (Subject)

    1/26/24 4:23:46 PM ET
    $XERS
    Biotechnology: Pharmaceutical Preparations
    Health Care