Exhibit 99.1
Insmed Reports Second Quarter 2022 Financial Results and Provides Business Update
—ARIKAYCE® (amikacin liposome inhalation suspension) Achieves 44%
Year Over Year Growth for the Second Quarter of 2022 with Total Revenue of $65.2 Million, Marking the Strongest Quarter Since Launch—
—All Clinical Programs Progressing on Track—
—Company Reiterates Guidance of at Least 30% Revenue Growth in 2022 and Cash Runway into 2024 to Support Ongoing Programs—
BRIDGEWATER, N.J., August 4, 2022 /PRNewswire/ — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to
transform the lives of patients with serious and rare diseases, today reported financial results for the second quarter ended June 30, 2022 and provided a business update.
“Insmed finished the second quarter of 2022 in a stronger position than ever before, with significant sales growth for ARIKAYCE and steady progress across our clinical
programs, which continue to track in line with expectations,” commented Will Lewis, Chair and Chief Executive Officer of Insmed. “We begin the second half of the year with meaningful commercial momentum and a strong financial position that we
believe will support continued execution across our commercial business, clinical pipeline, and early-stage research. I am incredibly proud of our talented, patient-focused team and excited about the future of our organization as we prepare to
serve significantly more patients with serious and rare diseases.”
Recent Pillar Highlights
ARIKAYCE
| • |
In the second quarter of 2022, ARIKAYCE revenue grew 44% over the second quarter of 2021, reflecting strong growth in U.S. sales and ongoing launch activities in Japan.
|
| • |
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 patient screening in ARISE by the end of August 2022, completing enrollment by the end of 2022, and sharing data from the trial over the course of
2023; the Company also anticipates completing enrollment in ENCORE by the end of 2023.
|
Brensocatib
| • |
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 the first quarter of 2023.
|
| • |
A Phase 2 pharmacokinetic/pharmacodynamic study of brensocatib in patients with cystic fibrosis (CF), which includes both patients who are on background CF transmembrane conductance regulator (CFTR) modulator drugs and patients who are
not on CFTR modulator drugs, is underway. Enrollment is now complete in the CFTR modulator arm of the study, and Insmed anticipates having top-line data by end of 2022.
|
1
| • |
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.
|
TPIP
| • |
Insmed is advancing a Phase 2 study to assess the safety and tolerability of treprostinil palmitil inhalation powder (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).
|
Translational Medicine
| • |
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 per year from this portfolio.
|
Second Quarter 2022 Financial Results
| • |
Cost of product revenues (excluding amortization of intangible assets) was $16.4 million for the second quarter of 2022, compared to $10.8 million for the second quarter of 2021.
|
| • |
Research and development (R&D) expenses were $88.5 million for the second quarter of 2022, compared to $64.7 million for the second quarter of 2021.
|
| • |
Selling, general and administrative (SG&A) expenses for the second quarter of 2022 were $60.0 million, compared to $57.2 million for the second quarter of 2021.
|
| • |
For the second quarter of 2022, Insmed reported a net loss of $95.6 million, or $0.80 per share, compared to a net loss of $117.3 million, or $1.07 per share, for the second quarter of 2021.
|
Balance Sheet, Financial Guidance, and Planned Investments
As of June 30, 2022, Insmed had cash and cash equivalents and marketable securities of $564.6 million. The Company’s total operating expenses for the second quarter of
2022 were $153.5 million.
Insmed continues to expect full-year 2022 global revenues for ARIKAYCE to increase at least 30% year over year from 2021. The Company also
continues to anticipate that its cash on hand will support its ongoing business into 2024.
The Company plans to continue to invest in the following key activities during the remainder of 2022:
| (i) |
commercialization and expansion of ARIKAYCE globally;
|
2
| (ii) |
advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis and commercial launch readiness activities;
|
| (iii) |
advancement of the confirmatory, frontline clinical trial program for ARIKAYCE (ARISE and ENCORE); and
|
| (iv) |
advancement of our earlier-stage pipeline, including the Phase 2 clinical development programs for TPIP and our translational medicine efforts.
|
Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) or (646) 960-0278 (international) and referencing access code 7862189.
The call will also be webcast live on the company's website at www.insmed.com.
A replay of the conference call will be accessible approximately 2 hours after its completion through September 3, 2022, by dialing (800) 770-2030 (U.S.) or (647)
362-9199 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company's website at www.insmed.com.
About ARIKAYCE
ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in
Europe as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE® inhalation 590 mg (amikacin sulfate inhalation drug product). Current
international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and
associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary PULMOVANCE® liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once
daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System,
developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI’s
100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis
and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of
white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and
inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any
indication in any jurisdiction.
3
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of
treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed’s laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with PAH, PH-ILD, and other rare and
serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.
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.
Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a
higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and
received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
Hemoptysis has
been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone
(12.5%). If hemoptysis occurs, manage patients as medically appropriate.
Bronchospasm
has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a
higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of
ARIKAYCE, treat patients as medically appropriate.
Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD,
infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening
hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen
lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low
blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and
institute appropriate supportive measures.
4
Ototoxicity has
been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen
(17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and
dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular
dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.
Nephrotoxicity
was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close
monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate
muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible,
bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to
the fetus.
Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs
17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs
10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
Drug Interactions:
Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid
concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline
tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective
treatment.
5
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen
therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is
indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3
consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung
disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call
1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
About Insmed
Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's
first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas
of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a footprint across Europe and in Japan. For more information, visit www.insmed.com.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term
is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify
forward-looking statements.
6
The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown
risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected,
anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S., Europe or
Japan, or for the Company’s product candidates in the U.S., Europe, Japan or other markets, including separate regulatory approval for the Lamira® Nebulizer System
and other product candidate devices in each market and for each usage; failure to successfully commercialize ARIKAYCE, the Company's only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg
Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters
or public health crises; impact of the COVID-19 pandemic and efforts to reduce its spread on the Company’s business, employees, including key personnel, patients, partners and suppliers; risk that
brensocatib does not prove effective or safe for patients in ongoing and future clinical studies, including the ASPEN study; risk that TPIP does not prove to be effective or safe for patients in ongoing and
future clinical studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company’s inability to obtain
full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that the Company will not successfully or in a timely manner complete the study to validate a patient reported outcome tool and the confirmatory
post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI or the Company’s other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira® Nebulizer System; the Company’s inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE;
development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company’s product candidates; inaccuracies in the Company’s estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or the Company’s other
product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company’s inability to create an effective
direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company’s product candidates that are approved in the future; failure
to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; risk that the Company’s competitors may obtain orphan drug exclusivity for a product that is essentially the
same as a product the Company is developing for a particular indication; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy
products; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company’s other product candidates due to the Company’s limited experience in conducting preclinical
development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other
things; risks that the Company’s clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to
manufacture sufficient quantities of ARIKAYCE or the Company’s product candidates for commercial or clinical needs, to conduct the Company’s clinical trials, or to comply with the Company’s agreements or laws and regulations that impact the
Company’s business or agreements with the Company; the Company’s inability to attract and retain key personnel or to effectively manage the Company’s growth; the Company’s inability to successfully
integrate its recent acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that the Company’s acquired technologies, products and product candidates are not commercially
successful; the Company’s inability to adapt to its highly competitive and changing environment; risk that the Company is unable to maintain its significant customers; risk that government healthcare reform
materially increases the Company’s costs and damages its financial condition; the Company’s inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs
associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by agreements related to ARIKAYCE or the Company’s product candidates, including its license agreements with PARI
and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability
claims; risk that the Company’s operations are subject to a material disruption in the event of a cybersecurity attack or issue; business disruptions or expenses related to the upgrade to the Company’s enterprise resource planning system; the
Company’s limited experience operating internationally; changes in laws and regulations applicable to the Company’s business, including any pricing reform, and failure to comply with such laws and regulations; the Company’s history of operating
losses, and the possibility that the Company may never achieve or maintain profitability; goodwill impairment charges affecting the Company’s results of operations and financial condition; inability to repay the Company’s existing indebtedness
and uncertainties with respect to the Company’s ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected
expenses associated with those plans.
7
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because,
by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may
affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and any subsequent Company filings with the Securities and Exchange
Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press
release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on
which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
8
Financial Statements Follow
INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
|||||||||||||
|
Product revenues, net
|
$
|
65,221
|
$
|
45,366
|
$
|
118,328
|
$
|
85,580
|
||||||||
|
Operating expenses:
|
||||||||||||||||
|
Cost of product revenues (excluding amortization of intangible assets)
|
16,395
|
10,837
|
28,586
|
20,681
|
||||||||||||
|
Research and development
|
88,527
|
64,655
|
172,883
|
126,045
|
||||||||||||
|
Selling, general and administrative
|
59,974
|
57,177
|
116,722
|
108,727
|
||||||||||||
|
Amortization of intangible assets
|
1,263
|
1,263
|
2,526
|
2,526
|
||||||||||||
|
Change in fair value of deferred and contingent consideration liabilities
|
(12,622
|
)
|
-
|
(24,240
|
)
|
-
|
||||||||||
|
Total operating expenses
|
153,537
|
133,932
|
296,477
|
257,979
|
||||||||||||
|
Operating loss
|
(88,316
|
)
|
(88,566
|
)
|
(178,149
|
)
|
(172,399
|
)
|
||||||||
|
Investment income
|
835
|
34
|
972
|
67
|
||||||||||||
|
Interest expense
|
(3,357
|
)
|
(10,319
|
)
|
(6,648
|
)
|
(17,878
|
)
|
||||||||
|
Loss on extingushment of debt
|
-
|
(17,689
|
)
|
-
|
(17,689
|
)
|
||||||||||
|
Other expense, net
|
(4,306
|
)
|
(159
|
)
|
(5,555
|
)
|
(202
|
)
|
||||||||
|
Loss before income taxes
|
(95,144
|
)
|
(116,699
|
)
|
(189,380
|
)
|
(208,101
|
)
|
||||||||
|
Provision for income taxes
|
501
|
622
|
886
|
861
|
||||||||||||
|
Net loss
|
$
|
(95,645
|
)
|
$
|
(117,321
|
)
|
$
|
(190,266
|
)
|
$
|
(208,962
|
)
|
||||
|
Basic and diluted net loss per share
|
$
|
(0.80
|
)
|
$
|
(1.07
|
)
|
$
|
(1.60
|
)
|
$
|
(1.97
|
)
|
||||
|
Weighted average basic and diluted common shares outstanding
|
119,602
|
109,580
|
119,267
|
106,328
|
||||||||||||
9
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
|
As of
June 30, 2022
|
As of
December 31, 2021
|
|||||||
|
(Unaudited)
|
||||||||
|
Assets
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
416,078
|
$
|
716,782
|
||||
|
Marketable securities
|
138,790
|
-
|
||||||
|
Accounts receivable
|
29,481
|
24,351
|
||||||
|
Inventory
|
67,017
|
67,009
|
||||||
|
Prepaid expenses and other current assets
|
23,360
|
28,898
|
||||||
|
Total current assets
|
674,726
|
837,040
|
||||||
|
Marketable securities, non-current
|
9,764
|
50,043
|
||||||
|
Fixed assets, net
|
53,946
|
52,955
|
||||||
|
Finance lease right-of-use assets
|
17,178
|
9,256
|
||||||
|
Operating lease right-of-use assets
|
24,047
|
33,305
|
||||||
|
Intangibles, net
|
71,283
|
73,809
|
||||||
|
Goodwill
|
136,110
|
136,110
|
||||||
|
Other assets
|
66,300
|
50,990
|
||||||
|
Total assets
|
$
|
1,053,354
|
$
|
1,243,508
|
||||
|
Liabilities and shareholders' equity
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
31,144
|
$
|
35,784
|
||||
|
Accrued liabilities
|
58,770
|
60,665
|
||||||
|
Accrued compensation
|
18,653
|
28,581
|
||||||
|
Finance lease liabilities
|
212
|
609
|
||||||
|
Operating lease liabilities
|
5,037
|
9,527
|
||||||
|
Total current liabilities
|
113,816
|
135,166
|
||||||
|
Debt, long-term
|
783,977
|
566,588
|
||||||
|
Contingent consideration
|
55,600
|
75,668
|
||||||
|
Finance lease liabilities, long-term
|
23,135
|
14,103
|
||||||
|
Operating lease liabilities, long-term
|
18,201
|
21,441
|
||||||
|
Other long-term liabilities
|
14,384
|
20,074
|
||||||
|
Total liabilities
|
1,009,113
|
833,040
|
||||||
|
Shareholders' equity:
|
||||||||
|
Common stock, $0.01 par value; 500,000,000 authorized shares, 119,865,023 and 118,738,266 issued and outstanding shares at June
30, 2022 and December 31, 2021, respectively
|
1,199
|
1,187
|
||||||
|
Additional paid-in capital
|
2,449,281
|
2,673,556
|
||||||
|
Accumulated deficit
|
(2,405,310
|
)
|
(2,265,243
|
)
|
||||
|
Accumulated other comprehensive (loss) income
|
(929
|
)
|
968
|
|||||
|
Total shareholders' equity
|
44,241
|
410,468
|
||||||
|
Total liabilities and shareholders' equity
|
$
|
1,053,354
|
$
|
1,243,508
|
||||
10
Contact:
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Executive Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
11