Virginia |
000-30739 |
54-1972729 |
(State or other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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700 US Highway 202/206
Bridgewater,
New Jersey
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08807
(Zip Code)
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(Address of principal executive offices)
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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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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☐
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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 |
Nasdaq Global Select Market
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Item 2.02. |
Results of Operations and Financial Condition.
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Item 5.02. |
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
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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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Press Release by Insmed Incorporated on February 17, 2022.
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Insmed Incorporated February 17, 2022 Presentation.
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104 |
Cover Page Interactive Date File (embedded within the Inline XBRL document). |
INSMED INCORPORATED
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Dated: February 17, 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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• |
Insmed launched ARIKAYCE in Japan in July of 2021, and early launch progress has been strong, with several positive trends.
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• |
In Europe, ARIKAYCE has now been launched in Germany, the Netherlands, Wales, and Scotland. The Company is pursuing country-by-country reimbursement and launches throughout Europe, with a near-term focus on
Italy, France, and England.
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• |
Insmed continues to advance the post-marketing confirmatory frontline clinical trial program of ARIKAYCE in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The ARISE trial, an interventional study designed to validate a patient-reported outcome (PRO) tool in MAC lung disease, is now 50% enrolled. The Company anticipates
completing enrollment in the ARISE study in 2022 and having topline data in the first half of 2023. Insmed anticipates completing enrollment in ENCORE, a pivotal study evaluating the clinical benefits and safety of ARIKAYCE in patients with
newly diagnosed MAC lung disease using the PRO tool, by the end of 2023.
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• |
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, is now 50% enrolled. Insmed
anticipates completing enrollment in this study in early 2023.
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• |
A Phase 2 pharmacokinetic/pharmacodynamic study of brensocatib in patients with cystic fibrosis is underway and Insmed anticipates sharing data from this study by early 2023.
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• |
Insmed plans to develop brensocatib in two additional neutrophil-mediated diseases – chronic rhinosinusitis without nasal polyps (CRS) and hidradenitis suppurativa (HS) – and to advance one indication into the
clinic in 2022. Both CRS and HS are serious diseases in which patients today face significant unmet needs.
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• |
Insmed is advancing two Phase 2 studies of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). The Phase 2a study will measure the impact of TPIP on pulmonary
vascular resistance (PVR) over a 24-hour period. The Company anticipates having preliminary data from a small number of patients in this study this year. The Phase 2b study will evaluate the effect of TPIP on PVR and 6-minute walk distance
over a 16-week treatment period. As planned, site initiation for this study began in late 2021.
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• |
Site initiation is underway for a Phase 2 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This study will assess the safety and tolerability of TPIP over
a 16-week treatment period.
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• |
Insmed is advancing a translational medicine portfolio consisting of several technology programs running in parallel. The Company anticipates filing an Investigational New Drug Application in a non-pulmonary
indication for our first candidate from this portfolio by the end of 2022.
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• |
Total revenue for the fourth quarter ended December 31, 2021 was $56.1 million, compared to total revenue of $41.4 million for the fourth quarter of 2020. Total revenue for the full year 2021 was $188.5 million, compared to total revenue of $164.4 million for the full year 2020.
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• |
Total revenue for the full year 2021 comprised ARIKAYCE net sales of $159.5 million in the U.S., $16.0 million in Japan, and $12.9 million in Europe and rest of world. This compares to net sales of $157.5 million
in the U.S. and $6.9 million in Europe for the full year 2020.
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• |
Cost of product revenues (excluding amortization of intangible assets) was $13.3 million for the fourth quarter of 2021, compared to $10.9 million for the fourth quarter of 2020. For the full year 2021, cost of
product revenues (excluding amortization of intangible assets) was $44.2 million compared to $39.9 million in 2020.
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• |
Research and development (R&D) expenses were $76.4 million for the fourth quarter of 2021, compared to $67.8 million for the fourth quarter of 2020. For the full year 2021, R&D expenses were $272.7
million compared to $181.2 million in 2020.
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• |
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2021 were $65.3 million, compared to $56.0 million for the fourth quarter of 2020. For the full year 2021, SG&A expenses were
$234.3 million, compared to $203.6 million in 2020.
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• |
For the fourth quarter of 2021, Insmed reported a net loss of $113.0 million, or $0.95 per share, compared to a net loss of $102.2 million, or $1.00 per share, for the fourth quarter of 2020. For the full year
2021, Insmed reported a net loss of $434.7 million, or $3.88 per share, compared to a net loss of $294.1 million, or $3.01 per share, in 2020.
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(i) |
commercialization and expansion of ARIKAYCE globally;
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(ii) |
launch activities for ARIKAYCE in initial European countries and in Japan; and
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(iii) |
clinical trial activities, including (a) advancement of the frontline clinical trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of brensocatib, including the Phase 3 ASPEN study in patients with
bronchiectasis, (c) advancement of the Phase 2 clinical development programs of TPIP, and (d) advancement of our translational medicine efforts.
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WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis,
bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
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Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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|||||||||||||||
2021
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2020
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2021
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2020
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|||||||||||||
Product revenues, net
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$
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56,124
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$
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41,415
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$
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188,461
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$
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164,413
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||||||||
Operating expenses:
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||||||||||||||||
Cost of product revenues (excluding amortization of intangible assets)
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13,288
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10,862
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44,152
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39,872
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||||||||||||
Research and development
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76,352
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67,814
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272,744
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181,157
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||||||||||||
Selling, general and administrative
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65,266
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56,019
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234,273
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203,613
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||||||||||||
Amortization of intangible assets
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1,262
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1,258
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5,052
|
5,003
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||||||||||||
Change in fair value of deferred and contingent consideration liabilities
|
(966
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)
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-
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7,334
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-
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|||||||||||
Total operating expenses
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155,202
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135,953
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563,555
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429,645
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||||||||||||
Operating loss
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(99,078
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)
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(94,538
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)
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(375,094
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)
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(265,232
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)
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||||||||
Investment income
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61
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26
|
174
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1,703
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||||||||||||
Interest expense
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(11,350
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)
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(7,499
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)
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(40,473
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)
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(29,564
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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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(17,689
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)
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-
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|||||||||||
Other (expense) income, net
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(2,652
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)
|
419
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(3,330
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)
|
405
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||||||||||
Loss before income taxes
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(113,019
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)
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(101,592
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)
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(436,412
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)
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(292,688
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)
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||||||||
(Benefit) provision for income taxes
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(41
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)
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621
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(1,758
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)
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1,402
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||||||||||
Net loss
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$
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(112,978
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)
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$
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(102,213
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)
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$
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(434,654
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)
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$
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(294,090
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)
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||||
Basic and diluted net loss per share
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$
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(0.95
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)
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$
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(1.00
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)
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$
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(3.88
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)
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$
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(3.01
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)
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||||
Weighted average basic and diluted common shares outstanding
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118,502
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102,297
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112,111
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97,605
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As of
December 31, 2021
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As of
December 31, 2020
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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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716,782
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$
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532,756
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||||
Accounts receivable
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24,351
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16,562
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||||||
Inventory
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67,009
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49,592
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||||||
Prepaid expenses and other current assets
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28,898
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23,982
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||||||
Total current assets
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837,040
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622,892
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||||||
Marketable securities
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50,043
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-
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||||||
Fixed assets, net
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52,955
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53,953
|
||||||
Finance lease right-of-use assets
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9,256
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10,334
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||||||
Operating lease right-of-use assets
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33,305
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32,946
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||||||
Intangibles, net
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73,809
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49,261
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||||||
Goodwill
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136,110
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-
|
||||||
Other assets
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50,990
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26,769
|
||||||
Total assets
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$
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1,243,508
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$
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796,155
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||||
Liabilities and shareholders' equity
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||||||||
Current liabilities:
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||||||||
Accounts payable
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$
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35,784
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$
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42,853
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||||
Accrued liabilities
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60,665
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37,807
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||||||
Accrued compensation
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28,581
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25,591
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||||||
Finance lease liabilities
|
609
|
1,081
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||||||
Operating lease liabilities
|
9,527
|
11,475
|
||||||
Total current liabilities
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135,166
|
118,807
|
||||||
Debt, long-term
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566,588
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356,318
|
||||||
Contingent consideration
|
75,668
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-
|
||||||
Finance lease liabilities, long-term
|
14,103
|
14,713
|
||||||
Operating lease liabilities, long-term
|
21,441
|
21,255
|
||||||
Other long-term liabilities
|
20,074
|
9,178
|
||||||
Total liabilities
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833,040
|
520,271
|
||||||
Shareholders' equity:
|
||||||||
Common stock, $0.01 par value; 500,000,000 authorized shares, 118,738,266 and 102,763,060 issued and outstanding shares at
December 31, 2021 and December 31, 2020, respectively
|
1,187
|
1,028
|
||||||
Additional paid-in capital
|
2,673,556
|
2,105,252
|
||||||
Accumulated deficit
|
(2,265,243
|
)
|
(1,830,589
|
)
|
||||
Accumulated other comprehensive income
|
968
|
193
|
||||||
Total shareholders' equity
|
410,468
|
275,884
|
||||||
Total liabilities and shareholders' equity
|
$
|
1,243,508
|
$
|
796,155
|