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    Ionis reports second quarter 2023 financial results

    8/9/23 7:00:00 AM ET
    $IONS
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $IONS alert in real time by email

    Reported Phase 3 data showing eplontersen continued to show improvement in ATTRv-PN through 85 weeks; December 22, 2023 PDUFA date

    Completed enrollment in donidalorsen OASIS-HAE study and eplontersen CARDIO-TTRansform ATTR-CM study keeping Phase 3 data readouts on track

    On track to achieve 2023 financial guidance

    CARLSBAD, Calif., Aug. 9, 2023 /PRNewswire/ -- – Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) (the "Company"), today reported financial results for the second quarter of 2023. Financial results are summarized below:

    (PRNewsfoto/Ionis Pharmaceuticals, Inc.)

     





    Three months ended

    June 30,



    Six months ended

    June 30,





    2023



    2022



    2023



    2022





    (amounts in millions)

    Total revenue



    $188



    $134



    $319



    $276

    Operating expenses



    $279



    $220



    $523



    $419

    Operating expenses on a non-GAAP basis



    $252



    $195



    $469



    $368

    Loss from operations



    ($91)



    ($86)



    ($204)



    ($143)

    Loss from operations on a non-GAAP basis



    ($64)



    ($61)



    ($150)



    ($92)

     

    Financial Highlights

    • Revenue increased for the second quarter and first half of 2023 by 40% and 16% compared to the same periods last year, respectively, driven by significant partner payments
    • Operating expenses increased in the second quarter and first half of 2023 compared to the prior year as planned, reflecting investments in advancing Ionis' pipeline and go-to-market activities for eplontersen, olezarsen and donidalorsen
    • Cash and short-term investments of $2.4 billion as of June 30, 2023 enables continued investments to drive increasing value
    • Well-capitalized balance sheet reflects 2024 convertible note refinancing that extended maturity to 2028 while maintaining a low coupon and retaining the flexibility to mitigate potential equity dilution
    • Reaffirmed 2023 financial guidance

    "Ionis is creating significant value in 2023 as we successfully execute on our strategy to bring a steady cadence of transformational medicines to the market. Our growing late-stage pipeline now includes eight medicines for 10 indications, highlighted by eplontersen. Based on the strong and consistent data generated to date and an attractive self-administration profile, we expect eplontersen to be an important new medicine for people with ATTRv-polyneuropathy. We also added QALSODY to our commercial portfolio, a breakthrough treatment for people with SOD1-ALS further strengthening Ionis' leadership in RNA-based therapies for neurological diseases," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "In the second half, we expect continued positive momentum including the Phase 3 readout for olezarsen in familial chylomicronemia syndrome and the potential approval of eplontersen for ATTRv-PN in December."

    Recent Highlights From Commercial Medicines 

    • Biogen presented interim data from the Phase 4 RESPOND study of SMA patients demonstrating improved motor function in most participants treated with SPINRAZA who had unmet medical needs after treatment with gene therapy
    • FDA granted Biogen accelerated approval of QALSODY (tofersen), a first-in-class medicine for patients with SOD1-ALS

    Recent Highlights From Near-Term Commercial Opportunities

    • Reported positive results from the Phase 3 NEURO-TTRansform study in patients with ATTRv-PN showing eplontersen continued to halt neuropathy disease progression and improve quality of life through 85 weeks
    • Completed enrollment of the Phase 3 CARDIO-TTRansform study of eplontersen in patients with ATTR cardiomyopathy, the largest study ever conducted in ATTR-CM; on track for data readout as early as H1:2025
    • Licensed eplontersen Latin America rights to AstraZeneca
    • Completed enrollment of the Phase 3 OASIS-HAE study of donidalorsen in patients with hereditary angioedema; on track for data readout in H1:2024
    • Reported positive topline Phase 2 open label extension data of donidalorsen in patients with hereditary angioedema treated for two years

    Recent Highlights From Partnered Programs 

    • Roche advanced IONIS-FB-LRx into Phase 3 development in patients with immunoglobulin A nephropathy
    • GSK presented durable response data from the Phase 2 B-Sure long-term follow-up study of bepirovirsen in complete responder patients from the Phase 2b B-Clear study of patients with HBV
    • Completed enrollment in the Phase 2 GOLDEN study of IONIS-FB-LRx in patients with geographic atrophy
    • AstraZeneca initiated a Phase 2b study of ION839 (AZD2693) targeting PNPLA3 to treat patients with NASH
    • Entered collaboration with Novartis to advance a next generation program targeting Lp(a) for cardiovascular disease

    Second Quarter 2023 Financial Results

    "Our results for the first half of the year keep us on track to achieve our 2023 guidance. We continued to generate substantial and sustained revenue, that together with our well-capitalized balance sheet, allows us to continue investing in key opportunities across our business," said Elizabeth L. Hougen, chief financial officer of Ionis. "With three near-term commercial opportunities that have a combined multi-billion-dollar peak sales potential and a steady cadence of medicines poised to follow closely behind, we are positioned to drive substantial revenue growth and long-term value for shareholders."

    Revenue

    Ionis' revenue was comprised of the following:





    Three months ended



    Six months ended





    June 30,



    June 30,





    2023



    2022



    2023



    2022

    Revenue:



    (amounts in millions)

         Commercial revenue:

















    SPINRAZA royalties



    $61



    $60



    $111



    $113

    Other commercial revenue:

















    TEGSEDI and WAYLIVRA revenue, net



    11



    10



    17



    17

    Licensing and royalty revenue



    6



    8



    18



    20

    Total commercial revenue



    78



    78



    146



    150

    Research and development revenue:

















    Amortization from upfront payments



    15



    18



    29



    36

    Milestone payments



    51



    18



    74



    45

    License fees



    20



    -



    20



    2

    Other services



    4



    3



    6



    6

    Collaborative agreement revenue



    90



    39



    129



    89

    Eplontersen joint development revenue



    20



    17



    44



    37

    Total research and development revenue



    110



    56



    173



    126

    Total revenue



    $188



    $134



    $319



    $276

     

    Ionis' revenue increased in the second quarter and first half of 2023 compared to the same periods in 2022 because of increased payments from partnered programs. Ionis believes its substantial and sustainable revenue is an important source of funding that supports the Company's investments to bring potentially transformational medicines to the market.

    Commercial revenue for the second quarter and first half of 2023 included $61 million and $111 million from SPINRAZA royalties, respectively. Global SPINRAZA product sales of $437 million and $880 million were essentially flat for the second quarter and first half of 2023, respectively, compared to the same periods last year reflecting SPINRAZA's resilience against emerging competition. Ionis' commercial revenue in the second quarter and first half of 2023 also included royalties from the U.S. launch of QALSODY.

    R&D revenue essentially doubled for the second quarter of 2023 and increased more than 35% for the first half of 2023 compared to the same periods in 2022 reflecting the value Ionis' technology is creating as numerous partnered programs advanced.

    Operating Expenses

    Ionis' operating expenses increased in the second quarter and first half of 2023 compared to the same periods in 2022, consistent with expectations. As Ionis advanced its robust pipeline, study costs increased as most of the Company's Phase 3 studies were either fully enrolled or approaching full enrollment resulting in higher R&D expenses year over year. Additionally, as Ionis prepares to launch eplontersen, olezarsen and donidalorsen, the Company's SG&A expenses also increased year over year.

    Balance Sheet

    As of June 30, 2023, Ionis' cash, cash equivalents and short-term investments increased to $2.4 billion compared to $2.0 billion at December 31, 2022 primarily due to the $500 million Ionis received from Royalty Pharma in January 2023. Ionis' working capital also increased over the same period primarily due to the Company's higher cash and short-term investments balance. In the first quarter of 2023 the Company recorded a long-term liability for future royalties due to Royalty Pharma. In June 2023 Ionis issued $575 million of senior convertible notes due in June 2028 with an interest rate of 1.75%. Ionis used the majority of the proceeds to repurchase $434 million of its 2024 convertible notes. The Company plans to utilize the residual proceeds to settle the 2024 notes that remain outstanding.

    Webcast

    Management will host a conference call and webcast to discuss Ionis' second quarter 2023 results at 11:30 a.m. Eastern time on Wednesday, August 9, 2023. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address. To access the Company's second quarter 2023 earnings slides click here.

    About Ionis Pharmaceuticals, Inc.

    For more than 30 years, Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care. Ionis currently has four marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.         

    To learn more about Ionis visit www.ionispharma.com or follow us on Twitter @ionispharma.

    Ionis' Forward-looking Statement

    This press release includes forward-looking statements regarding Ionis' business, financial guidance and the therapeutic and commercial potential of QALSODY (tofersen), SPINRAZA (nusinersen), TEGSEDI (inotersen), WAYLIVRA (volanesorsen), eplontersen, olezarsen, donidalorsen, ulefnersen, pelacarsen, bepirovirsen, IONIS-FB-LRx, Ionis' technologies and Ionis' other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2022, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.

    In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our" and "us" all refer to Ionis Pharmaceuticals and its subsidiaries.

    Ionis Pharmaceuticals® is a registered trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics® is a registered trademark of Akcea Therapeutics, Inc. TEGSEDI® is a registered trademark of Akcea Therapeutics, Inc. WAYLIVRA® is a registered trademark of Akcea Therapeutics, Inc. QALSODYTM is a trademark of Biogen. SPINRAZA® is a registered trademark of Biogen.

     

    IONIS PHARMACEUTICALS, INC.

    SELECTED FINANCIAL INFORMATION

    Condensed Consolidated Statements of Operations

    (In Millions, Except Per Share Data)





    Three months ended,



    Six months ended





    June 30,



    June 30,





    2023



    2022



    2023



    2022





    (unaudited)

    Revenue:

















         Commercial revenue:

















    SPINRAZA royalties



    $61



    $60



    $111



    $113

    Other commercial revenue



    17



    18



    35



    37

    Total commercial revenue



    78



    78



    146



    150

    Research and development revenue:

















    Collaborative agreement revenue



    90



    39



    129



    89

    Eplontersen joint development revenue



    20



    17



    44



    37

    Total research and development revenue



    110



    56



    173



    126

    Total revenue



    188



    134



    319



    276

    Expenses:

















           Cost of sales



    3



    5



    4



    9

        Research, development and patent



    230



    181



    428



    342

        Selling, general and administrative



    46



    34



    91



    68

    Total operating expenses



    279



    220



    523



    419

    Loss from operations



    (91)



    (86)



    (204)



    (143)



















    Other income (expense):

















    Interest expense related to the sale of future royalties:



    (18)



    -



    (33)



    -

    Other income (expense), net



    32



    (17)



    47



    (24)

    Loss before income tax expense



    (77)



    (103)



    (190)



    (167)



















    Income tax expense



    (8)



    (2)



    (20)



    (3)



















    Net loss



    ($85)



    ($105)



    ($210)



    ($170)



















    Basic and diluted net loss per share



    ($0.60)



    ($0.74)



    ($1.47)



    ($1.20)

    Shares used in computing basic and diluted net loss per share



    143



    142



    143



    142

     

     

    IONIS PHARMACEUTICALS, INC.

    Reconciliation of GAAP to Non-GAAP Basis:

    Condensed Consolidated Operating Expenses, Loss From Operations, and Net Loss

    (In Millions)















    Three months ended

    June 30,



    Six months ended

    June 30,





    2023



    2022



    2023



    2022





    (unaudited)

    As reported research, development and patent expenses according to GAAP



    $230



    $181



    $428



    $342

        Excluding compensation expense related to equity awards      



    (19)



    (19)



    (39)



    (38)

    Non-GAAP research, development and patent expenses



    $211



    $162



    $389



    $304



















     

    As reported selling, general and administrative expenses according to GAAP



    $46



    $34



    $91



    $68

        Excluding compensation expense related to equity awards      



    (7)



    (6)



    (14)



    (13)

    Non-GAAP selling, general and administrative expenses



    $39



    $28



    $77



    $55



















    As reported operating expenses according to GAAP



    $279



    $220



    $523



    $419

    Excluding compensation expense related to equity awards      



    (27)



    (25)



    (54)



    (51)

    Non-GAAP operating expenses



    $252



    $195



    $469



    $368



















    As reported loss from operations according to GAAP



    ($91)



    ($86)



    ($204)



    ($143)

        Excluding compensation expense related to equity awards      



    (27)



    (25)



    (54)



    (51)

    Non-GAAP loss from operations



    ($64)



    ($61)



    ($150)



    ($92)



















    As reported net loss according to GAAP



    ($85)



    ($105)



    ($210)



    ($170)

        Excluding compensation expense related to equity awards and related tax effects              



    (27)



    (25)



    (54)



    (51)

    Non-GAAP net loss



    ($58)



    ($80)



    ($156)



    ($119)

     

    Reconciliation of GAAP to Non-GAAP Basis

    As illustrated in the Selected Financial Information in this press release, non-GAAP operating expenses, non-GAAP loss from operations, and non-GAAP net loss were adjusted from GAAP to exclude compensation expense related to equity awards and the related tax effects. Compensation expense related to equity awards are non-cash. These measures are provided as supplementary information and are not a substitute for financial measures calculated in accordance with GAAP. Ionis reports these non-GAAP results to better enable financial statement users to assess and compare its historical performance and project its future operating results and cash flows. Further, the presentation of Ionis' non-GAAP results is consistent with how Ionis' management internally evaluates the performance of its operations.

     

    IONIS PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In Millions)


















    June 30,



    December 31,







    2023



    2022







    (unaudited)







    Assets:











      Cash, cash equivalents and short-term investments



    $2,385



    $1,987



      Contracts receivable



    28



    26



      Other current assets



    203



    190



      Property, plant and equipment, net



    92



    74



      Right-of-use assets



    177



    182



      Other assets



    86



    75



         Total assets



    $2,971



    $2,534















    Liabilities and stockholders' equity:











      Other current liabilities



    $192



    $221



      Current portion of deferred contract revenue



    96



    91



      1.75% convertible senior notes, net



    561



    -

      0% convertible senior notes, net



    624



    622



      0.125% convertible senior notes, net



    114



    545



      Liability related to sale of future royalties, net



    510



    -

      Long-term lease liabilities



    175



    178



      Long-term obligations, less current portion



    17



    16



      Long-term deferred contract revenue



    254



    288



      Total stockholders' equity



    428



    573



        Total liabilities and stockholders' equity



    $2,971



    $2,534



















     

    2023 Key Value Driving Events(1) 

    Regulatory Actions

    Program

    Indication

    Regulatory Action

    Achieved

    QALSODY

    SOD1-ALS

    NDA approval

    •

    EU approval2



    Eplontersen (TTR)

    ATTRv polyneuropathy

    NDA approval



    OUS filings





    Key Clinical Data Events

    Program

    Indication

    Event

    Achieved

    Eplontersen (TTR)

    ATTRv polyneuropathy

    Phase 3 data (week 35, 66 & 85)

    •

    Olezarsen (APOCIII)

    FCS

    Phase 3 data



    Donidalorsen (PKK)

    HAE

    Phase 2, OLE 1-year data

    •

    Donidalorsen (PKK)

    HAE

    Phase 2, OLE 2-year data

    •



    Enrollment Achievements

    Program

    Indication

    Event

    Achieved

    Eplontersen (TTR)

    ATTR cardiomyopathy

    Phase 3 full enrollment

    •

    Donidalorsen (PKK)

    HAE

    Phase 3 full enrollment

    •

    IONIS-FB-LRx

    Geographic Atrophy

    Phase 2 full enrollment

    •



    Phase 3 Initiations

    Program

    Indication

    Achieved

    Bepirovirsen (HBV)

    Hepatitis B virus infection

    •

    IONIS-FB-LRx

    Immunoglobulin A nephropathy

    •



    (1)  Timing expectations based on current assumptions and subject to change.

    (2)  CHMP opinion anticipated in Q4:2023.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ionis-reports-second-quarter-2023-financial-results-301896301.html

    SOURCE Ionis Pharmaceuticals, Inc.

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      4 - IONIS PHARMACEUTICALS INC (0000874015) (Issuer)

      5/2/25 4:38:26 PM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Director Hayden Michael R bought $181,079 worth of shares (5,000 units at $36.22), increasing direct ownership by 17% to 35,219 units (SEC Form 4)

      4 - IONIS PHARMACEUTICALS INC (0000874015) (Issuer)

      12/26/24 4:57:52 PM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Ionis reports first quarter 2025 financial results

      - Encouraging start to first independent launch with TRYNGOLZATM - - On track for second independent launch with donidalorsen PDUFA August 21, 2025 - - Increasing 2025 financial guidance by more than 20% - Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) (the "Company") today reported financial results for the first quarter ended March 31, 2025. "With an encouraging start to the TRYNGOLZA launch for familial chylomicronemia syndrome, the first of four independent launches expected over the next two years, Ionis' new chapter as a fully integrated, commercial-stage biotechnology company is well underway," said Brett P. Monia, Ph.D., chief executive officer, Ionis. "We look forward to continued m

      4/30/25 7:00:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2024 Financial Results

      Up to four programs in registrational phase by 2025 Planned interim analysis for ulixacaltamide Essential3 Study 1 to be conducted in Q4 2024 Topline results for Phase 2 EMBOLD study of relutrigine (PRAX-562) in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) expected in Q3 2024 PRAX-628 Phase 2/3 POWER1 study to initiate in Q4 2024 Initiation of additional Phase 2 study (RADIANT) for PRAX-628 in focal and generalized epilepsy in 2H 2024, with topline results expected in 1H 2025 Cash and investments of $434 million as of June 30, 2024, maintains runway into 2027 BOSTON, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a

      8/13/24 7:00:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Ionis reports second quarter 2024 financial results

      WAINUATM U.S. launch progressing well; approved in Canada; EU approval decision expected this year Olezarsen PDUFA December 19, 2024 for FCS Positive Phase 3 donidalorsen data for HAE; preparing U.S. and EU regulatory submissions On track to achieve 2024 financial guidance CARLSBAD, Calif., Aug. 1, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) (the "Company"), today reported financial results for the second quarter of 2024. "Over the first half of this year, we continued to deliver on our goal to bring a steady cadence of medicines to people with serious dise

      8/1/24 7:00:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Alltrna Announces Updates to Its Board of Directors

      Chris Schade appointed as Board ChairpersonLynne Parshall, Robert Plenge, M.D., Ph.D., and Nancy Simonian, M.D., appointed to Board of DirectorsCAMBRIDGE, Mass., July 17, 2024 /PRNewswire/ -- Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, today announced the appointment of Chris Schade, Growth Partner at Flagship Pioneering, as Chairperson of the Board, succeeding Noubar Afeyan, Ph.D., Co-Founder of Alltrna and Founder and CEO of Flagship Pioneering. In addition, Alltrna also announced the appointments to the company's Board of Directors of Lynne Parshall, founding Chief Opera

      7/17/24 8:00:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
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    • Contineum Therapeutics Announces Appointment of Sarah Boyce to Board of Directors

      Contineum Therapeutics, Inc. (NASDAQ:CTNM), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies that target biological pathways associated with specific clinical impairments for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced the appointment of Sarah Boyce, President and Chief Executive Officer of Avidity Biosciences, Inc. (NASDAQ:RNA), as an independent member of its Board of Directors. Ms. Boyce brings over 25 years of global commercial and clinical development expertise in the life sciences industry to Contineum's board. Ms. Boyce has extensive expertise in global pharmaceut

      6/24/24 4:05:00 PM ET
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      Biotechnology: Pharmaceutical Preparations
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      Major Pharmaceuticals
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    • Ionis announces the appointment of Michael Yang to Board of Directors

      CARLSBAD, Calif., Dec. 14, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced the appointment of Michael Yang, an experienced biopharmaceutical executive, to the Ionis Board of Directors. Mr. Yang's appointment expands the total number of Ionis Board members to 10. Mr. Yang has more than 20 years of broad senior level leadership experience in biotech, pharmaceutical and medical device companies, where he launched new platforms, expanded global revenues and diversified product lines. He most recently served as President, Chief Executive Officer and B

      12/14/23 4:05:00 PM ET
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      Biotechnology: Pharmaceutical Preparations
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