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    Ionis reports first quarter 2024 financial results

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

    WAINUATM launch on track; EU and Canada approval decisions expected this year

    Olezarsen NDA submitted to FDA for FCS; preparing EU regulatory submission

    Positive Phase 3 donidalorsen data for HAE; preparing regulatory submissions

    On track to achieve 2024 financial guidance

    CARLSBAD, Calif., May 7, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) (the "Company"), today reported financial results for the first quarter ended March 31, 2024.

    Ionis logo (PRNewsfoto/Ionis Pharmaceuticals, Inc.)

    "Ionis is off to a great start in 2024, as we continue to execute on our vision to bring better futures to people with serious diseases. The WAINUA launch for hereditary ATTR polyneuropathy is progressing well with AstraZeneca. And we are one step closer to our first independent launch with our NDA submission for olezarsen, which is supported by robust data positioning olezarsen to make a profound difference for people with FCS," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "We look forward to presenting positive Phase 3 donidalorsen data, along with data from our open-label extension and 'switch' studies in patients with HAE at EAACI later this month, setting the stage for Ionis' second independent launch. Additionally, we have multiple upcoming data readouts from our mid-stage programs that, if positive, could advance into Phase 3 development, further strengthening our ability to deliver a steady cadence of potentially transformational medicines for years to come."

    First Quarter 2024 Summary Financial Results(1):





    Three months ended

    March 31,





    2024



    2023





    (amounts in millions)

    Total revenue



    $119



    $131

    Operating expenses



    $269



    $245

    Operating expenses on a non-GAAP basis



    $238



    $218

    Loss from operations



    ($150)



    ($114)

    Loss from operations on a non-GAAP basis



    ($119)



    ($87)



    (1)  Reconciliation of GAAP to non-GAAP basis contained later in this release.

    Financial Highlights

    • Revenue for the first quarter of 2024 earned from numerous diverse sources, including a new source of royalty revenue with the launch of WAINUA in the U.S.
    • Continued strategic investments to bring WAINUA, olezarsen and donidalorsen to patients drove increased operating expenses in the first quarter of 2024 compared to the same period last year
    • Cash and short-term investments of $2.2 billion as of March 31, 2024 enable continued investments to drive increasing value, including supporting our planned upcoming launches
    • Reaffirmed 2024 financial guidance

    Recent Marketed Medicines Highlights

    • WAINUA for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN) generated sales of $5 million in the first partial quarter of launch resulting in royalty revenue of $1 million for Ionis in the first quarter of 2024
    • SPINRAZA for the treatment of spinal muscular atrophy (SMA) generated global sales of $341 million resulting in royalty revenue of $38 million in the first quarter of 2024
      • Biogen presented new positive neurofilament light chain (NfL) biomarker data from the Phase 4 RESPOND study of SMA patients adding further evidence supporting the potential benefit of SPINRAZA in infants and toddlers who had unmet medical needs after treatment with gene therapy

    Recent Late-Stage Pipeline Highlights

    • Eplontersen granted Fast Track designation by the FDA for the treatment of patients with ATTR cardiomyopathy
    • Olezarsen achieved multiple milestones advancing it closer to potentially addressing two distinct populations of patients with urgent unmet need, familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG):
      • Submitted NDA to the FDA for FCS
      • Presented positive Phase 3 Balance study data in patients with FCS with a simultaneous publication in the New England Journal of Medicine
      • Presented positive Phase 2b Bridge study data in patients with HTG and sHTG with a simultaneous publication in the New England Journal of Medicine
      • Opened Expanded Access Program (EAP) for FCS in the U.S.
      • Granted Breakthrough Therapy and Orphan Drug designations by the FDA for the treatment of patients with FCS
      • Completed enrollment of the Phase 3 CORE pivotal study and ESSENCE supportive exposure study for sHTG; CORE2 confirmatory pivotal study on track to fully enroll mid-year
    • Donidalorsen achieved multiple milestones advancing it closer to potentially becoming a first-in-class RNA-targeted prophylactic treatment for people with hereditary angioedema (HAE):
      • Reported positive topline data from the Phase 3 OASIS-HAE study in patients treated every four weeks or every eight weeks; preparing to submit NDA
      • Opened EAP for HAE in the U.S.
      • Granted Orphan Drug designation by EMA
    • Bepirovirsen granted Fast Track designation by the FDA for the treatment of patients with chronic hepatitis B (CHB)

    Recent Other Pipeline Highlights

    • Reported positive Phase 2 data for ION224 (DGAT2) in patients with metabolic dysfunction-associated steatohepatitis (MASH)
    • Initiated the Phase 1/2 Orbit study of ION356 (PLP1) in patients with Pelizaeus-Merzbacher disease (PMD)

    First Quarter 2024 Financial Results

    "Our first quarter results keep us on track to achieve our 2024 financial guidance. With the launch of WAINUA in the U.S. underway, we are excited to add WAINUA royalties to our meaningful revenues in the first quarter. We believe WAINUA is uniquely positioned in this growing market to address the needs of ATTRv-PN patients who remain significantly underserved, especially as it is the only approved medicine with monthly dosing that can be self-administered via an auto injector," said Elizabeth L. Hougen, chief financial officer of Ionis. "We continued to invest our capital resources in our near-term commercial opportunities, wholly owned pipeline and technology. We expect our modest expense growth this year to be driven by our activities to support the WAINUA launch and planned launches for olezarsen and donidalorsen with R&D expenses approaching steady state as several late-stage studies have recently ended. We believe the investments we are making today and plan to make over the next few years position Ionis to drive increasing value for patients and stakeholders."

    Revenue

    Ionis' revenue was comprised of the following:





    Three months ended





    March 31,





    2024



    2023

    Revenue:



    (amounts in millions)

         Commercial revenue:









    SPINRAZA royalties



    $38



    $50

    WAINUA royalties



    1



    -

    Other commercial revenue:









    TEGSEDI and WAYLIVRA revenue, net



    9



    7

    Licensing and other royalty revenue



    11



    11

    Total commercial revenue



    59



    68

    Research and development revenue:









    Amortization from upfront payments



    42



    16

    Milestone payments



    7



    23

    Collaborative agreement revenue



    49



    39

    WAINUA joint development revenue



    11



    24

    Total research and development revenue



    60



    63

    Total revenue



    $119



    $131

    Commercial revenue in the first quarter of 2024 included a new source of royalty revenue with the launch of WAINUA in the U.S. during the first quarter of 2024. While the number of patients on SPINRAZA treatment remained consistent globally, royalties decreased year over year primarily due to the timing of shipments in several markets outside the U.S. Ionis' commercial revenue in the first quarter of 2024 also included royalties from the net sales of QALSODY, which Biogen launched in the second quarter of 2023.

    R&D revenue in the first quarter of 2024 included increased revenue from the amortization of upfront payments compared to the same period last year due to the new collaborations Ionis entered into last year with Roche and Novartis. This increase was offset by decreases in milestone payments due to timing and WAINUA joint development revenue, which decreased as development activities relating to ATTRv-PN wound down with the launch of WAINUA underway.

    Operating Expenses

    Ionis' operating expenses increased in the first quarter of 2024 compared to the same period in 2023, consistent with expectations. SG&A expenses increased year over year primarily due to the launch of WAINUA in the U.S. and launch preparation activities for olezarsen and donidalorsen. R&D expenses increased compared to the same period last year due to the timing of development activities and are expected to stabilize in 2024 as several late-stage studies have ended.

    Balance Sheet

    As of March 31, 2024, Ionis' cash, cash equivalents and short-term investments decreased to $2.2 billion compared to $2.3 billion at December 31, 2023. As the year progresses, the Company plans to continue deploying its capital resources toward growth opportunities. Ionis' working capital also decreased over the same period primarily due to the Company's lower cash and short-term investments balance.

    Webcast

    Management will host a conference call and webcast to discuss Ionis' first quarter 2024 results at 11:30 a.m. Eastern time on Tuesday, May 7, 2024. 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 first quarter 2024 earnings slides click here.

    For more information about SPINRAZA and QALSODY, visit https://www.spinraza.com/ and https://www.qalsody.com/, respectively. QALSODY is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s).

    INDICATION for WAINUA™ (eplontersen)

    WAINUA injection, for subcutaneous use, 45 mg is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

    IMPORTANT SAFETY INFORMATION for WAINUA™ (eplontersen)

    WARNINGS AND PRECAUTIONS

    Reduced Serum Vitamin A Levels and Recommended Supplementation WAINUA leads to a decrease in serum vitamin A levels. Supplement with recommended daily allowance of vitamin A. Refer patient to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

    ADVERSE REACTIONS

    Most common adverse reactions (≥9% in WAINUA-treated patients) were vitamin A decreased (15%) and vomiting (9%).

    Please see link to U.S. Full Prescribing Information for WAINUA. 

    About Ionis Pharmaceuticals, Inc.

    For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has five marketed medicines and a leading pipeline in neurology, cardiology, and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionispharma.com and follow us on X (Twitter) and LinkedIn. 

    Ionis' Forward-looking Statement

    This press release includes forward-looking statements regarding Ionis' business, financial guidance and the therapeutic and commercial potential of our commercial medicines, additional medicines in development and technologies. 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. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. 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, 2023, 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. WAINUATM is a registered trademark of the AstraZeneca group of companies.

    Ionis Investor Contact:

    D. Wade Walke, Ph.D.

    [email protected] 760-603-2331

    Ionis Media Contact:

    Hayley Soffer

    [email protected] 760-603-4679 

     

    IONIS PHARMACEUTICALS, INC.

    SELECTED FINANCIAL INFORMATION

    Condensed Consolidated Statements of Operations

    (In Millions, Except Per Share Data)











    Three months ended,

    March 31,

    2024



    2023





    (unaudited)

    Revenue:









         Commercial revenue:









    SPINRAZA royalties



    $38



    $50

    WAINUA royalties



    1



    -

    Other commercial revenue



    20



    18

              Total commercial revenue



    59



    68

    Research and development revenue:









    Collaborative agreement revenue



    49



    39

    WAINUA joint development revenue



    11



    24

              Total research and development revenue



    60



    63

    Total revenue



    119



    131

    Expenses:









        Cost of sales



    2



    1

        Research, development and patent



    214



    198

        Selling, general and administrative



    53



    46

    Total operating expenses



    269



    245

    Loss from operations



    (150)



    (114)











    Other income (expense):









    Interest expense related to the sale of future royalties



    (18)



    (16)

    Other income, net



    25



    17

    Loss before income tax expense



    (143)



    (113)











    Income tax expense



    -



    (11)











    Net loss



    ($143)



    ($124)











    Basic and diluted net loss per share



    ($0.98)



    ($0.87)

    Shares used in computing basic and diluted net loss per share



    146



    143

     

    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

    March 31,

    2024



    2023





    (unaudited)

    As reported research, development and patent expenses according to GAAP



    $214



    $198

        Excluding compensation expense related to equity awards      



    (22)



    (20)

    Non-GAAP research, development and patent expenses



    $192



    $178











    As reported selling, general and administrative expenses according to GAAP



    $53



    $46

        Excluding compensation expense related to equity awards      



    (9)



    (7)

    Non-GAAP selling, general and administrative expenses



    $44



    $39











    As reported operating expenses according to GAAP



    $269



    $245

    Excluding compensation expense related to equity awards      



    (31)



    (27)

    Non-GAAP operating expenses



    $238



    $218











    As reported loss from operations according to GAAP



    ($150)



    ($114)

        Excluding compensation expense related to equity awards      



    (31)



    (27)

    Non-GAAP loss from operations



    ($119)



    ($87)











    As reported net loss according to GAAP



    ($143)



    ($124)

        Excluding compensation expense related to equity awards and related tax effects              



    (31)



    (27)

    Non-GAAP net loss



    ($112)



    ($97)

    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)















    March 31,



    December 31, 





    2024



    2023





    (unaudited)





    Assets:









      Cash, cash equivalents and short-term investments



    $2,206



    $2,331

      Contracts receivable



    5



    98

      Other current assets



    204



    213

      Property, plant and equipment, net



    73



    71

      Right-of-use assets



    169



    172

      Other assets



    107



    105

         Total assets



    $2,764



    $2,990











    Liabilities and stockholders' equity:









      Current portion of deferred contract revenue



    $130



    $151

      0.125% convertible senior notes, net – short-term



    44



    44

      Other current liabilities



    153



    253

      1.75% convertible senior notes, net



    563



    562

      0% convertible senior notes, net



    626



    625

      Liability related to sale of future royalties, net



    525



    514

      Long-term lease liabilities



    169



    171

      Long-term obligations, less current portion



    42



    42

      Long-term deferred contract revenue



    215



    241

      Total stockholders' equity



    297



    387

        Total liabilities and stockholders' equity



    $2,764



    $2,990

    Key 2024 Value Driving Events(1) 

    New Product Launches

    Program

    Indication

    Achieved

    WAINUA

    ATTRv-PN

    •

    Olezarsen

    FCS



    QALSODY (EU)

    SOD1-ALS





    Regulatory Actions

    Program

    Indication

    Regulatory Action

    Achieved

    Eplontersen

    ATTRv-PN

    Additional OUS filings

    •

    EMA approval decision



    Additional OUS approval decision(s)



    Olezarsen

    FCS

    NDA filing



    FDA approval decision



    EU filing



    Canada filing



    Donidalorsen

    HAE

    NDA filing



    QALSODY

    SOD1-ALS

    EMA approval decision





    Key Phase 3 Clinical Data Events

    Program

    Indication

    Event

    Achieved

    Olezarsen

    FCS

    Balance study full data

    •

    Donidalorsen

    HAE

    OASIS-HAE topline data

    •

    Donidalorsen

    HAE

    OASIS-HAE full data



    Donidalorsen

    HAE

    OASIS-Plus: OLE + Switch data





    Key Phase 2 Clinical Data Events

    Program

    Indication

    Event

    Achieved

    Donidalorsen

    HAE

    3-year Phase 2 OLE data



    IONIS-FB-LRx

    IgAN

    Phase 2 data



    IONIS-FB-LRx

    GA

    GOLDEN study data



    ION224 (DGAT2)

    NASH

    Phase 2 data

    •

    ION582 (UBE3A)

    Angelman syndrome

    HALOS study data



    ION541 (ATXN2)

    ALS

    ALSpire study data





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

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ionis-reports-first-quarter-2024-financial-results-302137316.html

    SOURCE Ionis Pharmaceuticals, Inc.

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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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    Insider Trading

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    • Director Hayden Michael R bought $477,900 worth of shares (15,000 units at $31.86), increasing direct ownership by 43% to 50,219 units (SEC Form 4)

      4 - IONIS PHARMACEUTICALS INC (0000874015) (Issuer)

      5/2/25 4:38:26 PM ET
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    • EVP, Corp and Development Ops Birchler Brian converted options into 1,875 shares and sold $19,292 worth of shares (680 units at $28.37), increasing direct ownership by 2% to 56,660 units (SEC Form 4)

      4 - IONIS PHARMACEUTICALS INC (0000874015) (Issuer)

      4/17/25 4:53:27 PM ET
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    • EVP, Chf GL Pdt Str Ofcr Jenne Kyle sold $85,534 worth of shares (3,016 units at $28.36) and converted options into 12,226 shares, increasing direct ownership by 463% to 11,199 units (SEC Form 4)

      4 - IONIS PHARMACEUTICALS INC (0000874015) (Issuer)

      4/17/25 4:53:18 PM ET
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    • Director Hayden Michael R bought $477,900 worth of shares (15,000 units at $31.86), increasing direct ownership by 43% to 50,219 units (SEC Form 4)

      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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    • 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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    • 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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