Insmed Provides Business Update At 42nd Annual J.P. Morgan Healthcare Conference; Sees 2024 Global ARIKAYCE Revenues $340M-$360M; Delivers FY23 Revenues Exceeding The Upper End Of Guidance Range With Unaudited Global Net Product Sales Of ~$305.2M

Author: Benzinga Newsdesk | January 05, 2024 09:06am

—ARIKAYCE® (amikacin liposome inhalation suspension) Delivers Full-Year 2023 Revenues Exceeding the Upper End of Guidance Range with Unaudited Global Net Product Sales of Approximately $305.2 Million—

—2024 Global ARIKAYCE Revenues Expected to be Between $340 Million and $360 Million, Reflecting Double-Digit Growth Compared to 2023—

—Topline Data from the Phase 3 ASPEN Study of Brensocatib in Adult Patients with Bronchiectasis Remains on Track to Read Out in the Latter Part of Second-Quarter 2024—

—Enrollment in the Phase 2 Study of TPIP in Patients with PH-ILD Completed in November 2023; Topline Data Expected in Second-Quarter 2024—

BRIDGEWATER, N.J., Jan. 5, 2024 /PRNewswire/ -- Insmed Incorporated (NASDAQ:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today provided an update on the Company's four pillars and outlook for 2024. These updates will be discussed as part of the Company's presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8, 2024, at 3:00 p.m. PT (6:00 p.m. ET).

"The year ahead will mark the most transformational period in Insmed's history as we strive to become the next great biotechnology company," said Will Lewis, Chair and Chief Executive Officer of Insmed. "From the readout of our highly anticipated Phase 3 ASPEN study, to our first Phase 2 topline TPIP data, to the advancement of our ARIKAYCE label expansion program, 2024 is the moment we have been waiting for. Each of these three programs, if successful, has the potential to achieve peak sales of more than $1 billion. Over the next 12 months, we have the opportunity to truly break out from the pack, delivering tangible results for our shareholders, while, more importantly, making a meaningful impact in the lives of patients with serious and rare diseases."

Preliminary Full Year 2023 Global Net Product Sales (Unaudited)

Based on preliminary unaudited financial information, the Company expects total global net product sales of ARIKAYCE to be approximately $305.2 million for the full year 2023, with net sales across the United States, Japan, and Europe as follows. This represents 24% year-over-year growth from the full year 2022, including growth in the U.S. of 21% and in Japan of 16%.

Preliminary Unaudited Full Year 2023 Global Net Product Sales by Region
United States	$224.2 million
Japan	$65.7 million
Europe	$15.3 million
Total	$305.2 million

These preliminary unaudited results are subject to adjustment. Insmed will report its final and complete fourth-quarter and full-year 2022 financial results in late February 2024, and the actual results could be materially different from these preliminary unaudited financial results.

Progress and Anticipated Milestones by Pillar:

Pillar 1: ARIKAYCE

• Insmed anticipates 2024 global ARIKAYCE revenues to be between $340 million and $360 million, representing 15% year-over-year growth at the midpoint compared to 2023.
• The Company has completed its original target enrollment of 250 patients in the ENCORE trial in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics. Enrollment in the study remains ongoing.
• Insmed received encouraging written feedback from the U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 ARISE study in December 2023. As expected, the Company will seek a meeting with the Agency in the coming months to gain additional insights and guidance, from which it will finalize its statistical plans for the Phase 3 ENCORE study, including an updated enrollment target for the study.
• The Company continues to anticipate a topline readout for ENCORE in 2025.

Pillar 2: Brensocatib

• Insmed expects topline data from the Phase 3 ASPEN study of brensocatib in adult patients with non-cystic fibrosis bronchiectasis in the latter part of the second quarter of 2024. If successful, the Company anticipates a launch in the U.S. in mid-2025, followed by launches in Europe and Japan in the first half of 2026.
• The Data Safety Monitoring Committee for the ASPEN study held its fifth and final meeting in November 2023. No new safety signals were identified, and the Committee unanimously recommended that the trial continue as planned.
• Insmed anticipates providing topline data from the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) in 2025.
• The Company expects to initiate a Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) in the second half of 2024.

Pillar 3: TPIP

• Insmed has completed enrollment in the Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Company exceeded its enrollment target of 32 patients, with 39 patients enrolled. Topline data from the study are anticipated ahead of Phase 3 ASPEN data in the second quarter of 2024.
• Enrollment in the Phase 2 study of TPIP in pulmonary arterial hypertension (PAH) remains ongoing. The Company anticipates enrolling 99 patients in the study, 45 of whom had been enrolled by year-end 2023, with topline results expected in 2025.

Pillar 4: Early-Stage Research

• Insmed's early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies.
• The Company continues to anticipate that the totality of its early-stage research programs will comprise less than 20% of overall spend.

Presentation at the 42nd Annual J.P. Morgan Healthcare Conference

Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, 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 www.insmed.com. A replay will also be archived for a period of 30 days following the conclusion of the live event.

About ARIKAYCE

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. 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).

About PARI Pharma and the Lamira® Nebulizer System

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.

About Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis 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. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with PAH, PH-ILD, and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.

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