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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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(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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| Item 2.02. |
Results of Operations and Financial Condition.
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| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
No.
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Description
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|
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Press Release by Insmed Incorporated on May 5, 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: May 5, 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 first quarter of 2022, ARIKAYCE revenue grew 32% over the first quarter of 2021, reflecting steady U.S. performance and ongoing launch activities in Japan and
Europe.
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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
2022 and having topline data in the first half of 2023; the Company also anticipates completing enrollment in ENCORE by the end of 2023.
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| • |
Insmed announced that it will present data at the American Thoracic Society (ATS) 2022 International Conference, taking place May 13-18, 2022, highlighting the reduction in
hospitalizations after initiation of ARIKAYCE treatment in a retrospective cohort study of patients in real-world settings.
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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 continues to anticipate completing enrollment in this trial in early 2023.
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| • |
A Phase 2 pharmacokinetic/pharmacodynamic study of brensocatib in patients with cystic fibrosis is underway and Insmed continues to anticipate sharing data by early 2023.
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| • |
As previously shared, Insmed plans to develop brensocatib in two new potential indications – chronic rhinosinusitis without nasal polyps and hidradenitis suppurativa.
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| • |
Insmed will present data at the ATS 2022 International Conference evaluating the benefit-risk profile in a post-hoc analysis of the Phase 2 WILLOW study of brensocatib in
patients with bronchiectasis.
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| • |
Insmed is also advancing a Phase 2b study to evaluate the effect of TPIP on PVR and 6-minute walk distance over a 16-week treatment period in patients with PAH, and 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.
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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 at least one Investigational New Drug Application per year from this portfolio.
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| • |
Cost of product revenues (excluding amortization of intangible assets) was $12.2 million for the first quarter of 2022, compared to $9.8 million for the first quarter of
2021.
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| • |
Research and development (R&D) expenses were $84.4 million for the first quarter of 2022, compared to $61.4 million for the first quarter of 2021.
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| • |
Selling, general and administrative (SG&A) expenses for the first quarter of 2022 were $56.7 million, compared to $51.6 million for the first quarter of 2021.
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| • |
For the first quarter of 2022, Insmed reported a net loss of $94.6 million, or $0.80 per share, compared to a net loss of $91.6 million, or $0.89 per share, for the first
quarter of 2021.
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| (i) |
commercialization and expansion of ARIKAYCE globally;
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| (ii) |
launch activities for ARIKAYCE in Japan; and
|
| (iii) |
clinical trial activities, including (a) advancement of the confirmatory, frontline clinical trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of brensocatib,
including the Phase 3 ASPEN study in patients with bronchiectasis, (c) advancement of the Phase 2 clinical development programs for TPIP, and (d) advancement of our translational medicine efforts.
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|
|
Three Months Ended March 31,
|
|||||||
|
|
2022
|
2021
|
||||||
|
|
||||||||
|
Product revenues, net
|
$
|
53,107
|
$
|
40,214
|
||||
|
|
||||||||
|
Operating expenses:
|
||||||||
|
Cost of product revenues (excluding amortization of intangible assets)
|
12,191
|
9,844
|
||||||
|
Research and development
|
84,356
|
61,390
|
||||||
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Selling, general and administrative
|
56,748
|
51,550
|
||||||
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Amortization of intangible assets
|
1,263
|
1,263
|
||||||
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Change in fair value of deferred and contingent consideration liabilities
|
(11,618
|
)
|
-
|
|||||
|
Total operating expenses
|
142,940
|
124,047
|
||||||
|
|
||||||||
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Operating loss
|
(89,833
|
)
|
(83,833
|
)
|
||||
|
|
||||||||
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Investment income
|
137
|
33
|
||||||
|
Interest expense
|
(3,291
|
)
|
(7,559
|
)
|
||||
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Other expense, net
|
(1,249
|
)
|
(43
|
)
|
||||
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Loss before income taxes
|
(94,236
|
)
|
(91,402
|
)
|
||||
|
|
||||||||
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Provision for income taxes
|
385
|
239
|
||||||
|
|
||||||||
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Net loss
|
$
|
(94,621
|
)
|
$
|
(91,641
|
)
|
||
|
|
||||||||
|
Basic and diluted net loss per share
|
$
|
(0.80
|
)
|
$
|
(0.89
|
)
|
||
|
|
||||||||
|
Weighted average basic and diluted common shares outstanding
|
118,929
|
103,040
|
||||||
|
|
As of
March 31, 2022
|
As of
December 31, 2021
|
||||||
|
|
(Unaudited)
|
|||||||
|
Assets
|
||||||||
|
Current assets:
|
||||||||
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Cash and cash equivalents
|
$
|
515,704
|
$
|
716,782
|
||||
|
Marketable securities
|
119,415
|
-
|
||||||
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Accounts receivable
|
25,722
|
24,351
|
||||||
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Inventory
|
64,145
|
67,009
|
||||||
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Prepaid expenses and other current assets
|
31,154
|
28,898
|
||||||
|
Total current assets
|
756,140
|
837,040
|
||||||
|
|
||||||||
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Marketable securities, long-term
|
29,551
|
50,043
|
||||||
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Fixed assets, net
|
52,676
|
52,955
|
||||||
|
Finance lease right-of-use assets
|
17,814
|
9,256
|
||||||
|
Operating lease right-of-use assets
|
31,277
|
33,305
|
||||||
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Intangibles, net
|
72,546
|
73,809
|
||||||
|
Goodwill
|
136,110
|
136,110
|
||||||
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Other assets
|
57,201
|
50,990
|
||||||
|
Total assets
|
$
|
1,153,315
|
$
|
1,243,508
|
||||
|
|
||||||||
|
Liabilities and shareholders’ equity
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
48,571
|
$
|
35,784
|
||||
|
Accrued liabilities
|
53,289
|
60,665
|
||||||
|
Accrued compensation
|
13,639
|
28,581
|
||||||
|
Finance lease liabilities
|
125
|
609
|
||||||
|
Operating lease liabilities
|
9,625
|
9,527
|
||||||
|
Total current liabilities
|
125,249
|
135,166
|
||||||
|
|
||||||||
|
Debt, long-term
|
783,156
|
566,588
|
||||||
|
Contingent consideration
|
66,120
|
75,668
|
||||||
|
Finance lease liabilities, long-term
|
23,509
|
14,103
|
||||||
|
Operating lease liabilities, long-term
|
19,875
|
21,441
|
||||||
|
Other long-term liabilities
|
15,526
|
20,074
|
||||||
|
Total liabilities
|
1,033,435
|
833,040
|
||||||
|
|
||||||||
|
Shareholders’ equity:
|
||||||||
|
Common stock, $0.01 par value; 500,000,000 authorized shares, 119,345,962 and 118,738,266 issued and outstanding shares at March
31, 2022 and December 31, 2021, respectively
|
1,193
|
1,187
|
||||||
|
Additional paid-in capital
|
2,428,582
|
2,673,556
|
||||||
|
Accumulated deficit
|
(2,309,665
|
)
|
(2,265,243
|
)
|
||||
|
Accumulated other comprehensive income
|
(230
|
)
|
968
|
|||||
|
Total shareholders’ equity
|
119,880
|
410,468
|
||||||
|
Total liabilities and shareholders’ equity
|
$
|
1,153,315
|
$
|
1,243,508
|
||||