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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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Exhibit
No.
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Description
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Press release issued by Insmed Incorporated on May 4, 2023.
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104
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Cover Page Interactive Date File (embedded within the Inline XBRL document).
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Dated: May 4, 2023
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INSMED INCORPORATED
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By:
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/s/ Michael A. Smith
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Name:
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Michael A. Smith
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Title:
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General Counsel and Corporate Secretary
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• |
ARIKAYCE global revenue grew 23% in the first quarter of 2023 compared with the first quarter of 2022, reflecting strong performance in the U.S., as well as the ongoing launches in
Japan and Europe.
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• |
Insmed continues to advance the post-marketing, confirmatory trial program for ARIKAYCE, consisting of the ARISE and ENCORE trials in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics. Insmed continues to anticipate sharing topline efficacy and safety
data from the ARISE study in the third quarter of 2023 and completing enrollment in the ENCORE study by the end of 2023.
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• |
Enrollment has been completed in over 1,700 adult patients across nearly 40 countries in the pivotal ASPEN study, a global Phase 3 trial designed to assess the efficacy, safety,
and tolerability of brensocatib in bronchiectasis. Insmed continues to expect the topline data readout from the ASPEN study in the second quarter of 2024.
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• |
Baseline characteristics for evaluable adult patients enrolled in the ASPEN study were made available this morning and can be found at https://investor.insmed.com/download/ASPEN_Baseline.pdf. The preliminary comparison to the respective baseline characteristics from the Phase 2 WILLOW study demonstrates a broadly similar baseline profile
for participants in both studies across key metrics.
|
• |
Due to the rapid enrollment of ASPEN, Insmed expects the pace of enrollment of its planned Phase 2 study of brensocatib in patients with chronic rhinosinusitis without nasal polyps
(CRSsNP) to be stronger than previously expected. For that reason, Insmed has chosen to adjust the initiation timing of the CRSsNP study from mid-2023 to the fourth quarter of 2023, which has the added benefit of reducing near-term cash
deployment.
|
• |
Insmed is currently enrolling a Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease
(PH-ILD) and a Phase 2 study in patients with pulmonary arterial hypertension (PAH).
|
• |
The Company continues to anticipate sharing interim, blinded dose titration and safety and tolerability data from both the PH-ILD and PAH studies in the second half of 2023,
pending the rate of enrollment. Topline results from the PH-ILD study are on track to be shared in the first half of 2024.
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• |
On May 8, 2023, Insmed plans to provide a detailed update on its early-stage research portfolio, encompassing artificial intelligence (AI)-driven protein engineering, gene therapy,
and protein manufacturing. The Company will provide an in-depth introduction to several of its early-stage programs as well as the experts leading each of these research engines. The event, titled “The Future of Rare at Insmed: Functional
Genes, AI-Enhanced Proteins, Glowing Algae, and More,” will be held in New York and will also be webcast live.
|
• |
As previously shared, Insmed anticipates having at least six investigational new drug (IND) applications filed from this portfolio by the end of 2025.
|
• |
The Company expects to initiate a Phase 1/2 study of its first gene therapy candidate in the second half of 2023 and anticipates sharing early clinical data from that program in
the first half of 2024.
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• |
In April 2023, Insmed appointed Makoto Nakamura to the role of General Manager in Japan, where he will oversee commercial operations for ARIKAYCE and support the preparation of
potential future product launches in the country. Mr. Nakamura has extensive experience leading commercial divisions in Japan for global pharmaceutical companies including Gilead Sciences and Pfizer, Inc.
|
• |
Total revenue for the first quarter ended March 31, 2023, was $65.2 million, reflecting 23% year-over-year growth compared to total revenue of $53.1 million for the first quarter
of 2022.
|
• |
Total revenue for the first quarter of 2023 was comprised of ARIKAYCE net sales of $49.1 million in the U.S., $13.2 million in Japan, and $3.0 million in Europe and rest of world,
reflecting 20% and 23% year-over-year growth in the U.S. and Japan, respectively.
|
• |
Cost of product revenues (excluding amortization of intangibles) was $13.8 million for the first quarter of 2023, compared to $12.2 million for the first quarter of 2022.
|
• |
Research and development (R&D) expenses were $127.9 million for the first quarter of 2023, compared to $84.4 million for the first quarter of 2022 and $124.8 million for the
fourth quarter of 2022. The increase in R&D expenses compared to fourth-quarter 2022 was driven by a non-cash charge of $10.3 million related to the acquisition of Vertuis Bio, Inc. in January 2023.
|
• |
Selling, general and administrative (SG&A) expenses for the first quarter of 2023 were $79.9 million, compared to $56.7 million for the first quarter of 2022 and $73.5 million
for the fourth quarter of 2022. The modest increase in SG&A expenses compared to fourth-quarter 2022 primarily reflects additional investments in launch readiness activities.
|
• |
Insmed reported a net loss of $159.8 million, or $1.17 per share, for the first quarter of 2023, compared to a net loss of $94.6 million, or $0.80 per share, for the first quarter
of 2022, and a net loss of $160.1 million, or $1.21 per share, for the fourth quarter of 2022.
|
• |
As of March 31, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $999 million, down from $1.15 billion as of December 31, 2022. Higher cash burn in
first-quarter 2023 was primarily driven by items that are not expected to recur in the remaining quarters of 2023, such as the annual employee incentive compensation payout.
|
• |
Insmed continues to expect full-year 2023 global revenues for ARIKAYCE to be between $285 million and $300 million.
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• |
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:
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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, as well as development across additional
neutrophil-mediated diseases;
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(iii) |
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;
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(iv) |
advancement of its Phase 2 clinical development programs for TPIP; and
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(v) |
development of its early-stage research platforms.
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Three Months Ended
March 31,
|
||||||||
2023
|
2022
|
|||||||
Product revenues, net
|
$
|
65,214
|
$
|
53,107
|
||||
Operating expenses:
|
||||||||
Cost of product revenues (excluding amortization of intangible assets)
|
13,830
|
12,191
|
||||||
Research and development
|
127,865
|
84,356
|
||||||
Selling, general and administrative
|
79,914
|
56,748
|
||||||
Amortization of intangible assets
|
1,263
|
1,263
|
||||||
Change in fair value of deferred and contingent consideration liabilities
|
(9,500
|
)
|
(11,618
|
)
|
||||
Total operating expenses
|
213,372
|
142,940
|
||||||
Operating loss
|
(148,158
|
)
|
(89,833
|
)
|
||||
Investment income
|
10,524
|
137
|
||||||
Interest expense
|
(20,003
|
)
|
(3,291
|
)
|
||||
Change in fair value of interest rate swap
|
(1,533
|
)
|
-
|
|||||
Other expense, net
|
(111
|
)
|
(1,249
|
)
|
||||
Loss before income taxes
|
(159,281
|
)
|
(94,236
|
)
|
||||
Provision for income taxes
|
483
|
385
|
||||||
Net loss
|
$
|
(159,764
|
)
|
$
|
(94,621
|
)
|
||
Basic and diluted net loss per share
|
$
|
(1.17
|
)
|
$
|
(0.80
|
)
|
||
Weighted average basic and diluted common shares outstanding
|
136,355
|
118,929
|
As of
March 31, 2023
|
As of
December 31, 2022
|
|||||||
(unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
968,907
|
$
|
1,074,036
|
||||
Marketable securities
|
29,774
|
74,244
|
||||||
Accounts receivable
|
30,523
|
29,713
|
||||||
Inventory
|
71,317
|
69,922
|
||||||
Prepaid expenses and other current assets
|
28,542
|
25,468
|
||||||
Total current assets
|
1,129,063
|
1,273,383
|
||||||
Fixed assets, net
|
59,556
|
56,491
|
||||||
Finance lease right-of-use assets
|
23,019
|
23,697
|
||||||
Operating lease right-of-use assets
|
21,154
|
21,894
|
||||||
Intangibles, net
|
67,493
|
68,756
|
||||||
Goodwill
|
136,110
|
136,110
|
||||||
Other assets
|
81,322
|
76,104
|
||||||
Total assets
|
$
|
1,517,717
|
$
|
1,656,435
|
||||
Liabilities and shareholders' equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
179,005
|
$
|
182,117
|
||||
Finance lease liabilities
|
2,158
|
1,217
|
||||||
Operating lease liabilities
|
6,821
|
6,909
|
||||||
Total current liabilities
|
187,984
|
190,243
|
||||||
Debt, long-term
|
1,132,188
|
1,125,250
|
||||||
Royalty financing agreement
|
150,173
|
148,015
|
||||||
Contingent consideration
|
38,600
|
51,100
|
||||||
Finance lease liabilities, long-term
|
29,015
|
29,636
|
||||||
Operating lease liabilities, long-term
|
14,534
|
14,853
|
||||||
Other long-term liabilities
|
9,876
|
9,387
|
||||||
Total liabilities
|
1,562,370
|
1,568,484
|
||||||
Shareholders' equity:
|
||||||||
Common stock, $0.01 par value; 500,000,000 authorized shares, 136,429,216 and 136,653,731 issued and outstanding shares at March 31, 2023 and December 31, 2022, respectively
|
1,364
|
1,357
|
||||||
Additional paid-in capital
|
2,809,242
|
2,782,416
|
||||||
Accumulated deficit
|
(2,856,342
|
)
|
(2,696,578
|
)
|
||||
Accumulated other comprehensive income
|
1,083
|
756
|
||||||
Total shareholders' (deficit) equity
|
(44,653
|
)
|
87,951
|
|||||
Total liabilities and shareholders' equity
|
$
|
1,517,717
|
$
|
1,656,435
|
Document and Entity Information |
May 04, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 04, 2023 |
Entity File Number | 000-30739 |
Entity Registrant Name | INSMED INCORPORATED |
Entity Central Index Key | 0001104506 |
Entity Incorporation, State or Country Code | VA |
Entity Tax Identification Number | 54-1972729 |
Entity Address, Address Line One | 700 US Highway 202/206 |
Entity Address, City or Town | Bridgewater |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08807 |
City Area Code | 908 |
Local Phone Number | 977-9900 |
Title of 12(b) Security | Common Stock, par value $0.01 per share |
Trading Symbol | INSM |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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