Insmed Reports Second-Quarter 2023 Financial Results and Provides Business Update

Recent Pillar Highlights

Pillar 1: ARIKAYCE

• ARIKAYCE global revenue grew 18% in the second quarter of 2023 compared with the second quarter of 2022 and reflects the strongest quarter of sales since commercial launch, supported by contributions from the U.S., Japan, and Europe.
• Insmed continues to advance the post-marketing, confirmatory trial program for ARIKAYCE, consisting of the ARISE and ENCORE studies in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics. Insmed anticipates sharing topline efficacy and safety data from the ARISE study in September of 2023.
• The Company remains on track to enroll 250 patients in the registrational ENCORE study by the end of 2023. Insmed continues to anticipate reevaluating the targeted enrollment for ENCORE following the ARISE data readout.

Pillar 2: Brensocatib

• Insmed continues to expect topline data from the ASPEN study, a global Phase 3 trial designed to assess the efficacy, safety, and tolerability of brensocatib in bronchiectasis, in the second quarter of 2024.
• The fourth meeting of the Data Safety and Monitoring Board was held in May, where it was recommended that the ASPEN study continue as planned.
• The Company plans to initiate a Phase 2 study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) in the fourth quarter of 2023.

Pillar 3: TPIP

• Insmed continues to enroll patients in a Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and a Phase 2 study in pulmonary arterial hypertension (PAH).
• The Company anticipates sharing interim, blinded dose titration and safety and tolerability data from both the PH-ILD and PAH Phase 2 studies in the second half of 2023, pending the rate of enrollment.
• Insmed remains on track to report topline results from the Phase 2 study of TPIP in PH-ILD in the first half of 2024.

Pillar 4: Early-Stage Research

• The Company plans to initiate a clinical trial of its Duchenne muscular dystrophy (DMD) gene therapy in the second half of 2023 and expects to share muscle biopsy data for at least one patient in the first half of 2024.
• Insmed anticipates filing 1-2 investigational new drug (IND) applications for its gene therapy programs in 2024, including one for Stargardt disease. Insmed also anticipates accomplishing full capsid production capabilities from AlgaeneX, its proprietary manufacturing platform, in 2024.
• Insmed expects to submit its first IND filing application from its Deimmunized by Design platform in 2025. The Company also anticipates submitting an IND filing application in ataxia telangiectasia in 2025, which is the result of the June 2023 acquisition of Adrestia Therapeutics Ltd.

Second-Quarter 2023 Financial Results

• Total revenue for the second quarter ended June 30, 2023, was $77.2 million, reflecting the Company's strongest quarter of sales to date and 18% growth compared to total revenue of $65.2 million for the second quarter of 2022.
• Total revenue for the second quarter of 2023 was comprised of ARIKAYCE net sales of $57.7 million in the U.S., $15.6 million in Japan, and $4.0 million in Europe and rest of world, reflecting 22% year-over-year growth in the U.S. This also reflects strong sequential growth from each region compared to first-quarter 2023 revenues.
• Cost of product revenues (excluding amortization of intangibles) was $16.6 million for the second quarter of 2023, compared to $16.4 million for the second quarter of 2022, reflecting increased sales volumes of ARIKAYCE.
• Research and development (R&D) expenses were $197.0 million for the second quarter of 2023, compared to $88.5 million for the second quarter of 2022 and $127.9 million for the first quarter of 2023. The increase in R&D expenses was primarily attributable to the $76.5 million non-cash cost of the acquisition of Adrestia Therapeutics in June 2023, as well as continued investments in ongoing late-stage pipeline programs. Excluding any non-cash charges associated with acquisitions, second-quarter 2023 R&D expenses were comparable with the first quarter of 2023.
• Selling, general and administrative (SG&A) expenses for the second quarter of 2023 were $84.4 million, compared to $60.0 million for the second quarter of 2022 and $79.9 million for the first quarter of 2023. The year-over-year increase in SG&A expenses was primarily driven by commercial readiness activities for brensocatib as well as an increase in headcount.
• Insmed reported a net loss of $244.8 million, or $1.78 per share, for the second quarter of 2023, compared to a net loss of $95.6 million, or $0.80 per share, for the second quarter of 2022, and a net loss of $159.8 million, or $1.17 per share, for the first quarter of 2023.

Balance Sheet, Financial Guidance, and Planned Investments

• As of June 30, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $918 million, down from $999 million as of March 31, 2023, reflecting the ongoing support of the ARIKAYCE franchise, commercial readiness activities for brensocatib, and clinical operations for its mid- to late-stage pipeline programs.
• Insmed is raising its sales guidance for full-year 2023 global revenues for ARIKAYCE to a range of $295 million to $305 million from a range of $285 million to $300 million previously.
• Insmed continues to anticipate that over 80% of total expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company's historical approach to spending.
• The Company plans to invest in the following key activities in 2023:
• commercialization and expansion of ARIKAYCE globally;
• advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis and commercial launch readiness activities, as well as initiation of the Phase 2 trial in patients with CRSsNP;
• advancement of the clinical trial program for ARIKAYCE (ARISE and ENCORE), which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;
• advancement of its Phase 2 clinical development programs for TPIP; and
• development of its early-stage research platforms.

Conference Call 

Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (646) 960-0278 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through September 3, 2023, by dialing (647) 362-9199 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)
	Three Months Ended June 30,				Six Months Ended June 30,
	2023		2022		2023		2022
Product revenues, net	$          77,229		$          65,221		$    142,443		$    118,328
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)	16,594		16,395		30,424		28,586
Research and development	196,969		88,527		324,834		172,883
Selling, general and administrative	84,431		59,974		164,345		116,722
Amortization of intangible assets	1,263		1,263		2,526		2,526
Change in fair value of deferred and contingent consideration liabilities	13,500		(12,622)		4,000		(24,240)
Total operating expenses	312,757		153,537		526,129		296,477
Operating loss	(235,528)		(88,316)		(383,686)		(178,149)
Investment income	11,172		835		21,696		972
Interest expense	(20,619)		(3,357)		(40,622)		(6,648)
Change in fair value of interest rate swap	1,184		-		(349)		-
Other expense, net	(488)		(4,306)		(599)		(5,555)
Loss before income taxes	(244,279)		(95,144)		(403,560)		(189,380)
Provision for income taxes	530		501		1,013		886 Werbung Mehr Nachrichten zur Insmed Inc Aktie kostenlos abonnieren E-Mail-Adresse Bitte überprüfe deine die E-Mail-Adresse. Benachrichtigungen von ARIVA.DE (Mit der Bestellung akzeptierst du die Datenschutzhinweise) -1 Vielen Dank, dass du dich für unseren Newsletter angemeldet hast. Du erhältst in Kürze eine E-Mail mit einem Aktivierungslink. Hinweis: ARIVA.DE veröffentlicht in dieser Rubrik Analysen, Kolumnen und Nachrichten aus verschiedenen Quellen. Die ARIVA.DE AG ist nicht verantwortlich für Inhalte, die erkennbar von Dritten in den „News“-Bereich dieser Webseite eingestellt worden sind, und macht sich diese nicht zu Eigen. Diese Inhalte sind insbesondere durch eine entsprechende „von“-Kennzeichnung unterhalb der Artikelüberschrift und/oder durch den Link „Um den vollständigen Artikel zu lesen, klicken Sie bitte hier.“ erkennbar; verantwortlich für diese Inhalte ist allein der genannte Dritte. Andere Nutzer interessierten sich auch für folgende News 02:00 - PR Newswire BlackRock Income and Growth Investment Trust Plc - Total Voting Rights 02:00 - PR Newswire BlackRock Energy and Resources Income Trust Plc - Total Voting Rights Auf zur INVEST am 26.+ 27.04.2024    Foto: Landesmesse Stuttgart GmbH - Jetzt kostenloses Ticket sichern! weiterlesen» Anzeige wo-site-teaser-box-16688_site-teaser-box_2024-04-17_09%253A00%253A00_2024-04-22_09%253A00%253A59