Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to...

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Insmed Provides Business Update at 43rd Annual J.P. Morgan Healthcare Conference

<article style="font-family: Arial, sans-serif; line-height: 1.6; padding: 20px; background-color: #f9f9f9;">
    <h1 style="font-size: 24px; color: #333;">Insmed Provides Update on Commercial and Clinical Programs</h1>
    <h2 style="font-size: 20px; color: #555;">ARIKAYCE® (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2024 with Unaudited Global Revenues of Approximately $363.7 Million</h2>
    <p style="margin: 10px 0; color: #444;">2025 Global ARIKAYCE Revenues Expected to be Between $405 Million and $425 Million, Reflecting Continued Double-Digit Growth Compared to 2024.</p>
    <p style="margin: 10px 0; color: #444;">NDA for Brensocatib in Bronchiectasis Submitted to FDA in December 2024, Narrowing the Timing for Expected U.S. Launch to the Third Quarter of 2025, Pending Approval Under Priority Review.</p>
    <p style="margin: 10px 0; color: #444;">Enrollment for Phase 2 Study of TPIP in Patients with PAH Completed in December 2024; Expected Timing for Topline Data Moved Forward to Mid-2025.</p>
    <p style="margin: 10px 0; color: #444;">Phase 3 ENCORE Trial for ARIKAYCE in Patients with Newly Diagnosed or Recurrent MAC Lung Disease Fully Enrolled; Topline Data Anticipated in First Quarter of 2026.</p>
    <p style="margin: 10px 0; color: #444;">IND Cleared for Insmed's First Gene Therapy (INS1201) for Patients with DMD; First Patient Dosing Anticipated in the First Half of 2025.</p>
    <p style="font-weight: bold; margin: 20px 0; color: #000;">BRIDGEWATER, N.J., Jan. 10, 2025 /PRNewswire/ --</p>
    <p style="margin: 10px 0; color: #444;">Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today provided an update on the Company's commercial and clinical programs and its outlook for 2025. These updates will be discussed as part of the Company's presentation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13, 2025, at 3:00 p.m. PT (6:00 p.m. ET).</p>
    <blockquote style="border-left: 5px solid #ccc; padding: 10px; color: #555; margin: 20px 0;">
        <p style="font-style: italic;">"2024 was an extraordinary year for Insmed, and it is only the beginning of our journey. We believe the upcoming clinical and commercial catalysts have the potential to redefine Insmed from a company that can serve approximately 30,000 patients today to one able to reach more than 2.5 million patients by the end of the decade," said Will Lewis, Chair and Chief Executive Officer of Insmed.</p>
    </blockquote>
    <h3 style="font-size: 18px; color: #333;">Preliminary Full-Year 2024 Global Net Product Sales (Unaudited)</h3>
    <p style="margin: 10px 0; color: #444;">Based on preliminary unaudited financial information, the Company expects total global net product sales of ARIKAYCE to be approximately $363.7 million for full-year 2024. This represents 19% year-over-year growth versus full-year 2023, including growth across each of our regions, as follows:</p>
    
    <table style="width: 100%; border-collapse: collapse; margin: 20px 0;">
        <tr style="background-color: #e9ecef;">
            <th style="border: 1px solid #ccc; padding: 8px;">2024 Revenues</th>
            <th style="border: 1px solid #ccc; padding: 8px;">% Change YoY</th>
        </tr>
        <tr>
            <td style="border: 1px solid #ccc; padding: 8px;">United States: $254.8 million</td>
            <td style="border: 1px solid #ccc; padding: 8px;">14%</td>
        </tr>
        <tr style="background-color: #f2f2f2;">
            <td style="border: 1px solid #ccc; padding: 8px;">Japan: $87.7 million</td>
            <td style="border: 1px solid #ccc; padding: 8px;">33%</td>
        </tr>
        <tr>
            <td style="border: 1px solid #ccc; padding: 8px;">Europe: $21.2 million</td>
            <td style="border: 1px solid #ccc; padding: 8px;">39%</td>
        </tr>
        <tr style="background-color: #f2f2f2;">
            <td style="border: 1px solid #ccc; padding: 8px;">Total: $363.7 million</td>
            <td style="border: 1px solid #ccc; padding: 8px;">19%</td>
        </tr>
    </table>
    <p style="margin: 10px 0; color: #444;">These preliminary unaudited results are subject to adjustment. Insmed will report its final and complete fourth-quarter and full-year 2024 financial results in late February 2025. The actual results could be materially different from these preliminary unaudited financial results.</p>

    <h3 style="font-size: 18px; color: #333;">Progress and Anticipated Milestones by Program:</h3>
    <ul style="color: #444;">
        <li>ARIKAYCE</li>
        <li>Brensocatib</li>
        <li>TPIP</li>
        <li>Gene Therapy</li>
        <li>Pre-Clinical Programs</li>
    </ul>

    <h3 style="font-size: 18px; color: #333;">Presentation at the 43rd Annual J.P. Morgan Healthcare Conference</h3>
    <p style="margin: 10px 0; color: #444;">Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 3:00 p.m. PT (6:00 p.m. ET). A live audio webcast of the presentation will be available on the Investor Relations section of the Company's website at <a href="http://www.insmed.com" style="color: #007bff; text-decoration: none;">www.insmed.com</a>. A replay will also be archived for a period of 30 days following the conclusion of the live event.</p>

    <h3 style="font-size: 18px; color: #333;">About ARIKAYCE</h3>
    <p style="margin: 10px 0; color: #444;">ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE® inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function.</p>
    <p style="margin: 10px 0; color: #444;">Insmed's proprietary PULMOVANCE® liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).</p>

    <h3 style="font-size: 18px; color: #333;">About PARI Pharma and the Lamira® Nebulizer System</h3>
    <p style="margin: 10px 0; color: #444;">ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.</p>

    <h3 style="font-size: 18px; color: #333;">About Brensocatib</h3>
    <p style="margin: 10px 0; color: #444;">Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, CRSsNP, HS, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow.</p>

    <h3 style="font-size: 18px; color: #333;">IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S.</h3>
    <p style="margin: 10px 0; color: #444; font-weight: bold;">WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS</p>
    <p style="margin: 10px 0; color: #444;">ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.</p>
    <p style="margin: 10px 0; color: #444;">Hypersensitivity Pneumonitis has been reported in clinical trials at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.</p>
    <p style="margin: 10px 0; color: #444;">Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.</p>
    <p style="margin: 10px 0; color: #444;">Other important safety information pertains to bronchospasm, exacerbations of underlying pulmonary disease, anaphylaxis, ototoxicity, and nephrotoxicity. Please refer to the prescribing information for more details.</p>

    <h3 style="font-size: 18px; color: #333;">About Insmed</h3>
    <p style="margin: 10px 0; color: #444;">Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest.</p>

    <h3 style="font-size: 18px; color: #333;">Forward-looking Statements</h3>
    <p style="margin: 10px 0; color: #444;">This press release contains forward-looking statements that involve substantial risks and uncertainties and should not be relied upon as predictions of future events.</p>

    <footer style="margin-top: 40px; border-top: 1px solid #ccc; padding-top: 10px; color: #888;">
        <p>Contacts:</p>
        <p>Investors: Bryan Dunn, Vice President, Investor Relations (646) 812-4030, [email protected]</p>
        <p>Media: Mandy Fahey, Vice President, Corporate Communications (732) 718-3621, [email protected]</p>
    </footer>
</article>

ARIKAYCE revenues for 2024 reach approximately $363.7 million, up 19%.
Projected revenue growth for ARIKAYCE in 2025 expected at $405-$425 million.
FDA filing for brensocatib in bronchiectasis narrows launch timeline to Q3 2025.
Phase 2 TPIP study enrollment completed; topline data expected mid-2025.
IND cleared for INS1201 gene therapy with first patient dosing expected in 2025.

Insmed Provides Business Update at 43rd Annual J.P. Morgan Healthcare Conference

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