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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 October 26, 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: October 26, 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 17% in the third quarter of 2023 compared with the third quarter of 2022, reflecting the strongest quarter of sales since commercial launch and continued sequential
quarterly revenue growth in the U.S. and Japan.
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• |
Insmed continues to execute on its post-marketing, confirmatory trial program for ARIKAYCE, including the recently completed ARISE study and the ongoing ENCORE study in patients with newly
diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics.
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• |
The Company announced positive topline efficacy and safety data from the ARISE trial in September of 2023. The study met its primary objective of validating a patient-reported outcome (PRO)
instrument in patients with MAC lung disease. In addition, ARIKAYCE-treated patients had nominally statistically significantly higher culture conversion rates at Month 7 versus the comparator arm. Based on the results of ARISE, Insmed plans
to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease.
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• |
The Company remains on track to enroll 250 patients in the registrational ENCORE study by the end of 2023. Enrollment is expected to continue into 2024, pending additional discussions with the U.S.
Food and Drug Administration (FDA). Insmed anticipates reporting topline data from the ENCORE study in 2025.
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• |
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 patients with non-cystic fibrosis
bronchiectasis, in the second quarter of 2024.
|
• |
The Company has opened several study sites in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and is nearing randomization of the
study’s first patients.
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• |
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).
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• |
In the ongoing studies, 80% of the first 10 PH-ILD patients and 83% of the first 24 PAH patients who reached the Week 5 visit, which is the last possible point
at which the dose can be increased in the trial, were able to titrate up to the maximum dose of 640 micrograms or matching placebo.
|
• |
Adverse events observed to date in these trials have been consistent with the events commonly seen in patients with PAH or PH-ILD and with the known effects of inhaled prostacyclin therapies. In
addition, adverse events related to cough have been mostly mild and there have been no instances of throat irritation or pain to date. A meeting of the Data Safety and Monitoring Board was held in October of 2023, where it was recommended
that both studies continue as planned.
|
• |
Based on a review of 22 patients who had completed 16 weeks of treatment in the ongoing PAH study, including patients receiving placebo, the average reduction
in PVR from baseline was 21.5%. The average PVR reduction among the 64% of patients who had an improvement in PVR was 47%.
|
• |
Insmed remains on track to report topline results from the Phase 2 study of TPIP in PH-ILD in the first half of 2024.
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• |
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 is continuing to advance its gene therapy program in Duchenne muscular dystrophy (DMD), including additional pre-clinical studies to further characterize its novel intrathecal route of
gene therapy administration. Pending completion of this work, the Company expects to initiate clinical trials in patients. In parallel, the Company continues to advance its mid-length dystrophin DMD gene therapy program using its
proprietary RNA-end-joining technology.
|
• |
The Company continues to anticipate the totality of its early-stage research programs will comprise less than 20% of overall spend.
|
• |
Total revenue for the third quarter ended September 30, 2023 was $79.1 million, reflecting the Company’s strongest quarter of sales to date and 17% growth compared to total revenue of $67.7 million
for the third quarter of 2022.
|
• |
Total revenue for the third quarter of 2023 was comprised of ARIKAYCE net sales of $59.2 million in the U.S., $16.0 million in Japan, and $3.8 million in Europe and rest of world. Third-quarter
sales reflect year-over-year growth of 20% and 11% in the U.S. and Japan, respectively, as well as the highest quarter of sales to date in these two regions.
|
• |
Cost of product revenues (excluding amortization of intangibles) was $16.7 million for the third quarter of 2023, compared to $13.5 million for the third quarter of 2022, reflecting increased sales
volumes of ARIKAYCE.
|
• |
Research and development (R&D) expenses were $109.1 million for the third quarter of 2023, compared to $99.9 million for the third quarter of 2022 and $197.0 million for the second quarter of
2023. R&D expenses in third-quarter 2023 reflected continued investment in the Company’s early and mid- to late-stage pipelines.
|
• |
Selling, general and administrative (SG&A) expenses for the third quarter of 2023 were $90.6 million, compared to $75.6 million for the third quarter of 2022 and $84.4 million for the second
quarter of 2023. The year-over-year increase in SG&A expenses resulted primarily from an increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as increased fees
and expenses driven by commercial readiness activities for brensocatib.
|
• |
Insmed reported a net loss of $158.9 million, or $1.11 per share, for the third quarter of 2023, compared to a net loss of $131.1 million, or $1.09 per share, for the third quarter of 2022, and a
net loss of $244.8 million, or $1.78 per share, for the second quarter of 2023.
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• |
As of September 30, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $786 million, down from $918 million as of June 30, 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.
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• |
Insmed is reiterating its sales guidance for full-year 2023 global revenues for ARIKAYCE in the range of $295 million to $305 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 continue to invest in the following key activities during the remainder of 2023:
|
(i) |
commercialization and expansion of ARIKAYCE globally;
|
(ii) |
advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, which is expected to be completed in the second quarter of 2024, and commercial launch readiness
activities, as well as the Phase 2 trial in patients with CRSsNP, which is nearing randomization;
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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 September
30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Product revenues, net
|
$
|
79,072
|
$
|
67,730
|
$
|
221,515
|
$
|
186,058
|
||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product revenues (excluding amortization of intangible assets)
|
16,706
|
13,471
|
47,130
|
42,057
|
||||||||||||
Research and development
|
109,148
|
99,872
|
433,982
|
272,755
|
||||||||||||
Selling, general and administrative
|
90,626
|
75,583
|
254,971
|
192,305
|
||||||||||||
Amortization of intangible assets
|
1,263
|
1,263
|
3,789
|
3,789
|
||||||||||||
Change in fair value of deferred and contingent consideration liabilities
|
8,997
|
5,238
|
12,997
|
(19,002
|
)
|
|||||||||||
Total operating expenses
|
226,740
|
195,427
|
752,869
|
491,904
|
||||||||||||
|
||||||||||||||||
Operating loss
|
(147,668
|
)
|
(127,697
|
)
|
(531,354
|
)
|
(305,846
|
)
|
||||||||
|
||||||||||||||||
Investment income
|
10,583
|
1,791
|
32,279
|
2,763
|
||||||||||||
Interest expense
|
(20,288
|
)
|
(3,353
|
)
|
(60,910
|
)
|
(10,001
|
)
|
||||||||
Change in fair value of interest rate swap
|
(1,301
|
)
|
-
|
(1,650
|
)
|
-
|
||||||||||
Other income (expense), net
|
285
|
(1,514
|
)
|
(314
|
)
|
(7,069
|
)
|
|||||||||
Loss before income taxes
|
(158,389
|
)
|
(130,773
|
)
|
(561,949
|
)
|
(320,153
|
)
|
||||||||
|
||||||||||||||||
Provision for income taxes
|
544
|
372
|
1,557
|
1,258
|
||||||||||||
|
||||||||||||||||
Net loss
|
$
|
(158,933
|
)
|
$
|
(131,145
|
)
|
$
|
(563,506
|
)
|
$
|
(321,411
|
)
|
||||
|
||||||||||||||||
Basic and diluted net loss per share
|
$
|
(1.11
|
)
|
$
|
(1.09
|
)
|
$
|
(4.06
|
)
|
$
|
(2.68
|
)
|
||||
|
||||||||||||||||
Weighted average basic and diluted common shares outstanding
|
142,899
|
120,789
|
138,960
|
119,780
|
As of
September 30, 2023
|
As of
December 31, 2022
|
|||||||
(unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
487,113
|
$
|
1,074,036
|
||||
Marketable securities
|
298,838
|
74,244
|
||||||
Accounts receivable
|
35,579
|
29,713
|
||||||
Inventory
|
77,923
|
69,922
|
||||||
Prepaid expenses and other current assets
|
27,123
|
25,468
|
||||||
Total current assets
|
926,576
|
1,273,383
|
||||||
Fixed assets, net
|
64,630
|
56,491
|
||||||
Finance lease right-of-use assets
|
21,663
|
23,697
|
||||||
Operating lease right-of-use assets
|
18,441
|
21,894
|
||||||
Intangibles, net
|
64,967
|
68,756
|
||||||
Goodwill
|
136,110
|
136,110
|
||||||
Other assets
|
92,486
|
76,104
|
||||||
Total assets
|
$
|
1,324,873
|
$
|
1,656,435
|
||||
Liabilities and shareholders' equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
187,783
|
$
|
182,117
|
||||
Finance lease liabilities
|
2,527
|
1,217
|
||||||
Operating lease liabilities
|
6,418
|
6,909
|
||||||
Total current liabilities
|
196,728
|
190,243
|
||||||
Debt, long-term
|
1,147,519
|
1,125,250
|
||||||
Royalty financing agreement
|
153,430
|
148,015
|
||||||
Contingent consideration
|
69,900
|
51,100
|
||||||
Finance lease liabilities, long-term
|
27,712
|
29,636
|
||||||
Operating lease liabilities, long-term
|
13,023
|
14,853
|
||||||
Other long-term liabilities
|
5,918
|
9,387
|
||||||
Total liabilities
|
1,614,230
|
1,568,484
|
||||||
Shareholders' equity:
|
||||||||
Common stock, $0.01 par value; 500,000,000 authorized shares, 143,049,147
and 135,653,731 issued and outstanding shares at September 30, 2023 and December 31, 2022, respectively
|
1,430
|
1,357
|
||||||
Additional paid-in capital
|
2,971,375
|
2,782,416
|
||||||
Accumulated deficit
|
(3,260,084
|
)
|
(2,696,578
|
)
|
||||
Accumulated other comprehensive (loss) income
|
(2,078
|
)
|
756
|
|||||
Total shareholders' (deficit) equity
|
(289,357
|
)
|
87,951
|
|||||
Total liabilities and shareholders' equity
|
$
|
1,324,873
|
$
|
1,656,435
|
|
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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Cover [Abstract]
Document Type
8-K
Amendment Flag
false
Document Period End Date
Oct. 26, 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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