エドガーで原本を確認する
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Virginia
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000-30739
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54-1972729
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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700 US Highway 202/206
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08807
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Bridgewater, New Jersey
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(Zip Code)
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(Address of principal executive offices)
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| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.01 per share
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INSM
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Nasdaq Global Select Market
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| Item 2.02. |
Results of Operations and Financial Condition.
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Item 9.01.
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Financial Statements and Exhibits.
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Exhibit
No.
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Description
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Press Release by Insmed Incorporated on October 27, 2022.
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104
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Cover Page Interactive Date File (embedded within the Inline XBRL document).
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INSMED INCORPORATED
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Dated: October 27, 2022
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By:
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/s/ Michael Smith
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Name:
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Michael Smith
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Title:
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General Counsel and Corporate Secretary
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• |
In the third quarter of 2022, ARIKAYCE revenue grew 45% over the third quarter of 2021, reflecting strong growth in U.S. sales, ongoing encouraging performance in Japan, and
contributions from European markets.
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• |
In Europe, Insmed recently secured a favorable reimbursement approval for ARIKAYCE in England. ARIKAYCE is now commercially available in Germany, the Netherlands, the United
Kingdom, Italy, and Belgium.
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• |
Enrollment remains on track in the post-marketing confirmatory, frontline clinical trial program of ARIKAYCE in patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC), consisting of the ARISE and ENCORE trials. Insmed anticipates completing enrollment in ARISE in the coming weeks and
sharing data from the trial over the course of 2023. The Company also continues to anticipate completing enrollment in ENCORE by the end of 2023.
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Enrollment remains on track in the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled trial to assess the efficacy, safety, and tolerability of brensocatib
in patients with bronchiectasis. Insmed anticipates completing enrollment in this trial in the first quarter of 2023 and sharing topline data in the second quarter of 2024.
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Insmed is conducting a Phase 2 pharmacokinetic/pharmacodynamic study of brensocatib in patients with cystic fibrosis (CF), which includes both patients who are and who are not on
background CF transmembrane conductance regulator (CFTR) modulator drugs. This study is fully enrolled and the Company anticipates having topline data by the end of 2022 for both sets of patients.
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As previously shared, Insmed plans to develop brensocatib in two new potential indications – chronic rhinosinusitis without nasal polyps (CRSsNP) and hidradenitis suppurativa (HS).
Insmed anticipates moving brensocatib into clinical development for CRSsNP by the middle of 2023, followed by HS.
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Insmed is currently enrolling two Phase 2 studies of treprostinil palmitil inhalation powder (TPIP). These include a Phase 2 study to assess the safety and tolerability of TPIP in
patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) over a 16-week treatment period, as well as a Phase 2b study to evaluate the effect of TPIP on pulmonary vascular resistance (PVR) and 6-minute walk
distance over a 16-week treatment period in patients with pulmonary arterial hypertension (PAH).
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Insmed is advancing a translational medicine portfolio encompassing a wide range of technologies and modalities, including gene therapy, gene editing, protein deimmunization, and
manufacturing capabilities. The Company anticipates filing one to two Investigational New Drug Applications from this portfolio in 2023 and one to two more in 2024.
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Total revenue for the third quarter ended September 30, 2022, was $67.7 million, compared to total revenue of $46.8 million for the third quarter of 2021. Total revenue for the
third quarter of 2022 comprised ARIKAYCE net sales of $49.5 million in the U.S., $14.5 million in Japan, and $3.7 million in Europe and rest of world.
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Cost of product revenues (excluding amortization of intangible assets) was $13.5 million for the third quarter of 2022, compared to $10.2 million for the third quarter of 2021.
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Research and development (R&D) expenses were $99.9 million for the third quarter of 2022, compared to $70.3 million for the third quarter of 2021.
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Selling, general and administrative (SG&A) expenses for the third quarter of 2022 were $75.6 million, compared to $60.3 million for the third quarter of 2021.
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For the third quarter of 2022, Insmed reported a net loss of $131.1 million, or $1.09 per share, compared to a net loss of $112.7 million, or $0.96 per share, for the third quarter
of 2021.
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(i) |
commercialization and expansion of ARIKAYCE globally;
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(ii) |
advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis and commercial launch readiness activities;
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(iii) |
advancement of the confirmatory, frontline clinical trial program for ARIKAYCE (ARISE and ENCORE); and
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(iv) |
advancement of our earlier-stage pipeline, including the Phase 2 clinical development programs for TPIP and advancing our translational medicine efforts.
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WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis,
bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2022
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2021
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2022
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2021
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Product revenues, net
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$
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67,730
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$
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46,757
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$
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186,058
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$
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132,337
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Operating expenses:
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Cost of product revenues (excluding amortization of intangible assets)
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13,471
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10,183
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42,057
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30,864
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Research and development
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99,872
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70,347
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272,755
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196,392
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Selling, general and administrative
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75,583
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60,280
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192,305
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169,007
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Amortization of intangible assets
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1,263
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1,264
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3,789
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3,790
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Change in fair value of deferred and contingent consideration liabilities
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5,238
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8,300
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(19,002
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)
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8,300
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Total operating expenses
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195,427
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150,374
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491,904
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408,353
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Operating loss
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(127,697
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)
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(103,617
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)
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(305,846
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)
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(276,016
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)
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Investment income
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1,791
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46
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2,763
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113
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Interest expense
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(3,353
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)
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(11,245
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)
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(10,001
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)
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(29,123
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)
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Loss on extingushment of debt
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-
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-
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-
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(17,689
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)
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Other expense, net
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(1,514
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)
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(476
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)
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(7,069
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)
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(678
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)
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Loss before income taxes
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(130,773
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)
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(115,292
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)
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(320,153
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)
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(323,393
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)
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Provision (benefit) for income taxes
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372
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(2,578
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)
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1,258
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(1,717
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)
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Net loss
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$
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(131,145
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)
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$
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(112,714
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)
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$
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(321,411
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)
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$
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(321,676
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)
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Basic and diluted net loss per share
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$
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(1.09
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)
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$
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(0.96
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)
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$
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(2.68
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)
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$
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(2.93
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)
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Weighted average basic and diluted common shares outstanding
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120,789
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117,092
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119,780
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109,955
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As of
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As of
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September 30, 2022
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December 31, 2021
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(unaudited)
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Assets
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Current assets:
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Cash and cash equivalents
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$
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414,633
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$
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716,782
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Marketable securities
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98,662
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-
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Accounts receivable
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27,401
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24,351
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Inventory
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66,276
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67,009
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Prepaid expenses and other current assets
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25,193
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28,898
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Total current assets
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632,165
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837,040
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Marketable securities, non-current
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-
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50,043
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Fixed assets, net
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53,684
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52,955
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Finance lease right-of-use assets
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16,697
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9,256
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Operating lease right-of-use assets
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22,430
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33,305
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Intangibles, net
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70,020
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73,809
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Goodwill
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136,110
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136,110
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Other assets
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63,711
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50,990
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Total assets
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$
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994,817
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$
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1,243,508
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Liabilities and shareholders' equity
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Current liabilities:
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Accounts payable and accrued liabilities
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$
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131,861
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$
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125,030
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Finance lease liabilities
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337
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609
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Operating lease liabilities
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5,456
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9,527
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Total current liabilities
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137,654
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135,166
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Debt, long-term
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784,799
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566,588
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Contingent consideration
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51,800
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75,668
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Finance lease liabilities, long-term
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22,679
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14,103
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Operating lease liabilities, long-term
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16,504
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21,441
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Other long-term liabilities
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11,340
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20,074
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Total liabilities
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1,024,776
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833,040
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Shareholders' equity:
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||||||||
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Common stock, $0.01 par value; 500,000,000 authorized shares, 121,726,199 and 118,738,266 issued and outstanding shares at September 30, 2022 and December 31, 2021, respectively
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1,217
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1,187
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Additional paid-in capital
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2,506,665
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2,673,556
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Accumulated deficit
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(2,536,455
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)
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(2,265,243
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)
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Accumulated other comprehensive (loss) income
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(1,386
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)
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968
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|||||
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Total shareholders' (deficit) equity
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(29,959
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)
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410,468
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Total liabilities and shareholders' equity
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$
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994,817
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$
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1,243,508
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