-- ARIKAYCE® (amikacin
liposome inhalation suspension) Total Revenue of $77.2 Million for the Second Quarter of 2023
Reflects Highest Quarter of Sales Since Launch and 18% Growth
Compared to the Second Quarter of 2022 --
-- Company Raises Full-Year 2023 Guidance
Range for Global ARIKAYCE Revenues to $295 Million to $305
Million --
-- Topline Data from Post-Marketing ARISE
Study of ARIKAYCE Expected in September of 2023 --
-- Blended Blinded Dose Titration Data
for TPIP in PH-ILD and PAH Expected in Second Half of
2023 --
-- Topline Data from the Phase 3 ASPEN Trial
of Brensocatib in Adult Patients with Bronchiectasis Remains on
Track to Read Out in the Second Quarter of 2024 --
BRIDGEWATER, N.J., Aug. 3, 2023 /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, 2023 and provided a
business update.
"The second quarter of 2023 demonstrated the strongest quarter
of ARIKAYCE sales since launch, reflecting positive momentum in the
U.S. and earlier than anticipated signs of growth in Japan," commented Will
Lewis, Chair and Chief Executive Officer of Insmed. "In the
midst of this strong commercial performance, we are preparing for a
series of data readouts that we hope will drive shareholder value
and meaningful outcomes for patients. Leveraging our growing
commercial business, mid- to late-stage pipeline assets, and
early-stage research efforts, we are strategically constructing
what we hope will be the next leading and self-sustaining
biotechnology company."
Recent Pillar Highlights
Pillar 1: ARIKAYCE
- ARIKAYCE global revenue grew 18% in the second quarter of 2023
compared with the second quarter of 2022 and reflects the strongest
quarter of sales since commercial launch, supported by
contributions from the U.S., Japan, and Europe.
- Insmed continues to advance the post-marketing, confirmatory
trial program for ARIKAYCE, consisting of the ARISE and ENCORE
studies in patients with newly diagnosed or recurrent
Mycobacterium avium complex (MAC) lung infection who have
not started antibiotics. Insmed anticipates sharing topline
efficacy and safety data from the ARISE study in September of
2023.
- The Company remains on track to enroll 250 patients in the
registrational ENCORE study by the end of 2023. Insmed continues to
anticipate reevaluating the targeted enrollment for ENCORE
following the ARISE data readout.
Pillar 2: Brensocatib
- 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
bronchiectasis, in the second quarter of 2024.
- The fourth meeting of the Data Safety and Monitoring Board was
held in May, where it was recommended that the ASPEN study continue as planned.
- The Company plans to initiate a Phase 2 study of brensocatib in
patients with chronic rhinosinusitis without nasal polyps (CRSsNP)
in the fourth quarter of 2023.
Pillar 3: TPIP
- 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).
- The Company anticipates sharing interim, blinded dose titration
and safety and tolerability data from both the PH-ILD and PAH Phase
2 studies in the second half of 2023, pending the rate of
enrollment.
- Insmed remains on track to report topline results from the
Phase 2 study of TPIP in PH-ILD in the first half of 2024.
Pillar 4: Early-Stage Research
- The Company plans to initiate a clinical trial of its Duchenne
muscular dystrophy (DMD) gene therapy in the second half of 2023
and expects to share muscle biopsy data for at least one
patient in the first half of 2024.
- Insmed anticipates filing 1-2 investigational new drug (IND)
applications for its gene therapy programs in 2024, including one
for Stargardt disease. Insmed also anticipates accomplishing full
capsid production capabilities from AlgaeneX, its proprietary
manufacturing platform, in 2024.
- Insmed expects to submit its first IND filing application from
its Deimmunized by Design platform in 2025. The Company also
anticipates submitting an IND filing application in ataxia
telangiectasia in 2025, which is the result of the June 2023 acquisition of Adrestia Therapeutics
Ltd.
Second-Quarter 2023 Financial Results
- Total revenue for the second quarter ended June 30, 2023, was $77.2
million, reflecting the Company's strongest quarter of sales
to date and 18% growth compared to total revenue of $65.2 million for the second quarter of
2022.
- Total revenue for the second quarter of 2023 was comprised of
ARIKAYCE net sales of $57.7 million
in the U.S., $15.6 million in
Japan, and $4.0 million in Europe and rest of world, reflecting 22%
year-over-year growth in the U.S. This also reflects strong
sequential growth from each region compared to first-quarter 2023
revenues.
- Cost of product revenues (excluding amortization of
intangibles) was $16.6 million for
the second quarter of 2023, compared to $16.4 million for the second quarter of 2022,
reflecting increased sales volumes of ARIKAYCE.
- Research and development (R&D) expenses were $197.0 million for the second quarter of 2023,
compared to $88.5 million for the
second quarter of 2022 and $127.9
million for the first quarter of 2023. The increase in
R&D expenses was primarily attributable to the $76.5 million non-cash cost of the acquisition of
Adrestia Therapeutics in June 2023,
as well as continued investments in ongoing late-stage pipeline
programs. Excluding any non-cash charges associated with
acquisitions, second-quarter 2023 R&D expenses were comparable
with the first quarter of 2023.
- Selling, general and administrative (SG&A) expenses for the
second quarter of 2023 were $84.4
million, compared to $60.0
million for the second quarter of 2022 and $79.9 million for the first quarter of 2023. The
year-over-year increase in SG&A expenses was primarily driven
by commercial readiness activities for brensocatib as well as an
increase in headcount.
- Insmed reported a net loss of $244.8
million, or $1.78 per share,
for the second quarter of 2023, compared to a net loss of
$95.6 million, or $0.80 per share, for the second quarter of 2022,
and a net loss of $159.8 million, or
$1.17 per share, for the first
quarter of 2023.
Balance Sheet, Financial Guidance, and Planned
Investments
- As of June 30, 2023, Insmed had
cash, cash equivalents, and marketable securities totaling
$918 million, down from $999 million as of March
31, 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.
- Insmed is raising its sales guidance for full-year 2023 global
revenues for ARIKAYCE to a range of $295
million to $305 million from a
range of $285 million to $300 million previously.
- 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:
-
- commercialization and expansion of ARIKAYCE globally;
- advancement of brensocatib, including the Phase 3 ASPEN
study in patients with bronchiectasis and commercial launch
readiness activities, as well as initiation of the Phase 2 trial in
patients with CRSsNP;
- 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;
- advancement of its Phase 2 clinical development programs
for TPIP; and
- development of its early-stage research platforms.
Conference Call
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 (646) 960-0278 (U.S. and 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
1 hour after its completion through September 3, 2023, by dialing (647) 362-9199
(U.S. and 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.
INSMED INCORPORATED
|
Consolidated Statements of Net
Loss
|
(in thousands, except per share
data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended June
30,
|
|
Six Months Ended June
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
Product revenues,
net
|
$
77,229
|
|
$
65,221
|
|
$
142,443
|
|
$
118,328
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization of intangible assets)
|
16,594
|
|
16,395
|
|
30,424
|
|
28,586
|
Research and
development
|
196,969
|
|
88,527
|
|
324,834
|
|
172,883
|
Selling, general and
administrative
|
84,431
|
|
59,974
|
|
164,345
|
|
116,722
|
Amortization of
intangible assets
|
1,263
|
|
1,263
|
|
2,526
|
|
2,526
|
Change in fair value of
deferred and contingent consideration liabilities
|
13,500
|
|
(12,622)
|
|
4,000
|
|
(24,240)
|
Total operating
expenses
|
312,757
|
|
153,537
|
|
526,129
|
|
296,477
|
|
|
|
|
|
|
|
|
Operating
loss
|
(235,528)
|
|
(88,316)
|
|
(383,686)
|
|
(178,149)
|
|
|
|
|
|
|
|
|
Investment
income
|
11,172
|
|
835
|
|
21,696
|
|
972
|
Interest
expense
|
(20,619)
|
|
(3,357)
|
|
(40,622)
|
|
(6,648)
|
Change in fair value of
interest rate swap
|
1,184
|
|
-
|
|
(349)
|
|
-
|
Other expense,
net
|
(488)
|
|
(4,306)
|
|
(599)
|
|
(5,555)
|
Loss before income
taxes
|
(244,279)
|
|
(95,144)
|
|
(403,560)
|
|
(189,380)
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
530
|
|
501
|
|
1,013
|
|
886
|
|
|
|
|
|
|
|
|
Net loss
|
$ (244,809)
|
|
$
(95,645)
|
|
$
(404,573)
|
|
$
(190,266)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(1.78)
|
|
$
(0.80)
|
|
$
(2.95)
|
|
$
(1.60)
|
|
|
|
|
|
|
|
|
Weighted average basic
and diluted common shares outstanding
|
137,553
|
|
119,602
|
|
136,957
|
|
119,267
|
INSMED INCORPORATED
|
Consolidated Balance Sheets
|
(in thousands, except par value and share
data)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
June 30, 2023
|
|
December 31, 2022
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
612,882
|
|
$
1,074,036
|
Marketable
securities
|
|
304,886
|
|
74,244
|
Accounts
receivable
|
|
30,947
|
|
29,713
|
Inventory
|
|
77,349
|
|
69,922
|
Prepaid expenses and
other current assets
|
|
26,360
|
|
25,468
|
Total current
assets
|
|
1,052,424
|
|
1,273,383
|
|
|
|
|
|
Fixed assets,
net
|
|
62,113
|
|
56,491
|
Finance lease
right-of-use assets
|
|
22,341
|
|
23,697
|
Operating lease
right-of-use assets
|
|
16,476
|
|
21,894
|
Intangibles,
net
|
|
66,230
|
|
68,756
|
Goodwill
|
|
136,110
|
|
136,110
|
Other assets
|
|
83,445
|
|
76,104
|
Total assets
|
|
$
1,439,139
|
|
$
1,656,435
|
|
|
|
|
|
Liabilities and shareholders'
equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
197,653
|
|
$
182,117
|
Finance lease
liabilities
|
|
2,445
|
|
1,217
|
Operating lease
liabilities
|
|
4,159
|
|
6,909
|
Total current
liabilities
|
|
204,257
|
|
190,243
|
|
|
|
|
|
Debt,
long-term
|
|
1,139,805
|
|
1,125,250
|
Royalty financing
agreement
|
|
152,020
|
|
148,015
|
Contingent
consideration
|
|
46,400
|
|
51,100
|
Finance lease
liabilities, long-term
|
|
28,370
|
|
29,636
|
Operating lease
liabilities, long-term
|
|
12,871
|
|
14,853
|
Other long-term
liabilities
|
|
11,161
|
|
9,387
|
Total
liabilities
|
|
1,594,884
|
|
1,568,484
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01 par
value; 500,000,000 authorized
|
|
|
|
|
shares, 142,750,463 and
135,653,731 issued and outstanding
shares at June 30, 2023 and December 31, 2022,
respectively
|
|
1,428
|
|
1,357
|
Additional paid-in
capital
|
|
2,945,229
|
|
2,782,416
|
Accumulated
deficit
|
|
(3,101,151)
|
|
(2,696,578)
|
Accumulated other
comprehensive (loss) income
|
|
(1,251)
|
|
756
|
Total shareholders'
(deficit) equity
|
|
(155,745)
|
|
87,951
|
Total liabilities and
shareholders' equity
|
|
$
1,439,139
|
|
$
1,656,435
|
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.
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.
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.
U.S. INDICATION
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.
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 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 or TPIP does not prove to
be effective or safe for patients in ongoing and future clinical
studies, including, for brensocatib, the ASPEN study; 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,
brensocatib, TPIP or the Company's other 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 risks and uncertainties associated with,
and the perceived benefits of, the Company's secured senior loan
with certain funds managed by Pharmakon Advisors, LP and the
Company's royalty financing with OrbiMed Royalty & Credit
Opportunities IV, LP, including our ability to maintain compliance
with the covenants in the agreements for the senior secured loan
and royalty financing and the perceived impact of the restrictions
on the Company's operations under these agreements; 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; deterioration in general economic
conditions in the U.S., Europe,
Japan and globally, including the
effect of prolonged periods of inflation, affecting the Company,
its suppliers, third-party service providers and potential
partners; 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.
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, 2022 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.
Contact:
Investors:
Bryan Dunn
Executive Director, Investor Relations
Insmed
(646) 812-4030
bryan.dunn@insmed.com
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
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SOURCE Insmed Incorporated