BRIDGEWATER, N.J., Aug. 5, 2021 /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, 2021 and provided a
business update.
"Insmed made meaningful progress in the second quarter of 2021,
with important achievements across our four pillars—ARIKAYCE,
brensocatib, TPIP, and translational medicine," commented
Will Lewis, Chair and Chief
Executive Officer of Insmed. "With the launch of ARIKAYCE just last
month in Japan, the largest market
for refractory MAC lung disease that we are pursuing, we're
thrilled that our lead product is now available in three major
territories. We continue to enroll patients in both the Phase 3
ASPEN study of brensocatib in patients with bronchiectasis and the
ARIKAYCE frontline clinical trial program in patients with NTM lung
disease in line with expectations, and we are advancing TPIP to
Phase 2 development in both PAH and PH-ILD. As we carry forward
learnings from the past year and a half in navigating the pandemic,
we have great confidence in our ability to execute on our
commercial and clinical activities around the world."
Recent Corporate Developments & Program
Highlights
ARIKAYCE
- ARIKAYCE launched in Japan in
July of 2021, following its approval by the Ministry of Health,
Labour, and Welfare in March of 2021 for the treatment of patients
with nontuberculous mycobacterial (NTM) lung disease caused by
Mycobacterium avium complex (MAC) who did not sufficiently
respond to prior treatment with a multidrug regimen. ARIKAYCE has
been priced in Japan in line with
list prices in the U.S. and Europe.
- Insmed continues to advance the European launch of ARIKAYCE
following its approval by the European Commission in October of
2020 for the treatment of NTM lung infections caused by MAC in
adults with limited treatment options who do not have cystic
fibrosis (CF). Consideration should be given to official guidance
on the appropriate use of antibacterial agents.
- Enrollment continues in the post-approval confirmatory
frontline clinical trial program of ARIKAYCE in patients with NTM
lung disease caused by MAC. The program consists of ARISE, an
interventional study designed to validate a patient-reported
outcome (PRO) tool in MAC lung disease, and ENCORE, a pivotal trial
designed to establish, using the PRO tool validated in the ARISE
trial, the clinical benefits and evaluate the safety of ARIKAYCE in
patients with newly diagnosed MAC lung disease.
Brensocatib
- Enrollment continues 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. Patients with bronchiectasis due to CF may not be
enrolled in the study.
- The CF Therapeutics Development Network has endorsed Insmed's
study protocol for brensocatib in CF and the process for initiating
study sites for a Phase 2 pharmacokinetic/pharmacodynamic
multiple-dose study is now underway.
TPIP
- Insmed expects to present data from the Phase 1 healthy
volunteer trial of TPIP at the European Society of Cardiology
Congress on August 30, 2021. The
Company reported positive topline data from this study earlier this
year.
- Insmed plans to advance two Phase 2 studies of TPIP in patients
with pulmonary arterial hypertension (PAH). The first study will
measure the impact of TPIP on pulmonary vascular resistance (PVR)
over a 24-hour period. The Company anticipates sharing preliminary
data from a small number of patients in this study in the second
half of 2021. The second study will evaluate the effect of TPIP on
PVR and 6-minute walk distance over a 16-week treatment period. The
Company plans to initiate this study in the fourth quarter of
2021.
- Insmed plans to initiate a Phase 2 study of TPIP in patients
with pulmonary hypertension associated with interstitial lung
disease (PH-ILD) in early 2022.
Corporate Updates
- In July of 2021, Insmed announced the promotion of Michael Smith to the role of General Counsel,
Senior Vice President of Insmed, replacing Christine Pellizzari, who retired from her
position as the Company's Chief Legal Officer. Mike joined Insmed
in 2014 and most recently served as the Company's Senior Vice
President, General Counsel – U.S. In his new role, Mike will have
responsibility for Insmed's global legal function, including
corporate governance, intellectual property, and contract
management.
Second Quarter 2021 Financial Results
- Total revenue for the second quarter ended June 30, 2021 was $45.4
million, compared to total revenue of $42.5 million for the second quarter of
2020.
- Cost of product revenues (excluding amortization of intangible
assets) was $10.8 million for the
second quarter of 2021, compared to $10.0
million for the second quarter of 2020.
- Research and development (R&D) expenses were $64.7 million for the second quarter of 2021,
compared to $35.7 million for the
second quarter of 2020.
- Selling, general and administrative (SG&A) expenses for the
second quarter of 2021 were $57.2
million, compared to $49.7
million for the second quarter of 2020.
- For the second quarter of 2021, Insmed reported a GAAP net loss
of $117.3 million, or $1.07 per share, compared to a GAAP net loss of
$61.9 million, or $0.64 per share, for the second quarter of
2020.
- During the second quarter of 2021, Insmed completed a public
offering of 11,500,000 shares of common stock, including 1,500,000
shares issued pursuant to the exercise in full of the underwriters'
option to purchase additional shares, as well as a public offering
of $575 million aggregate principal
amount of its 0.75% convertible senior notes due 2028 (the 2028
Convertible Notes), including $75
million aggregate principal amount of notes purchased
pursuant to the exercise in full of the underwriters' option to
purchase additional notes, solely to cover over-allotments. The
offerings resulted in net cash proceeds of approximately
$270.1 million and $559.0 million, respectively, after deducting
underwriting discounts and other offering-related expenses. A
portion of the net cash proceeds from the 2028 Convertible Notes
was used to repurchase $225.0 million
of the Company's outstanding 1.75% convertible senior notes due
2025 (2025 Convertible Notes). The offerings resulted in net cash
proceeds of approximately $590.0
million after the repurchase of a portion of the outstanding
2025 Convertible Notes.
Balance Sheet and Planned Investments
As of June 30,
2021, Insmed had cash and cash equivalents of $928.3
million. The Company's total operating expenses for the second
quarter of 2021 were $133.9 million.
Adjusted R&D expenses for the second quarter of 2021 were
$58.9 million and adjusted SG&A
expenses for the second quarter of 2021 were $48.8 million. Adjusted R&D expenses and
adjusted SG&A expenses are non-GAAP measures, which we describe
further below.
The Company plans to continue to invest in the following key
activities in 2021:
(i)
|
U.S.
commercialization of ARIKAYCE;
|
(ii)
|
clinical trial
activities, including (a) advancement of the frontline clinical
trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of
the Phase 3 ASPEN study of brensocatib in patients with
bronchiectasis, (c) advancement of clinical development of TPIP,
and (d) advancement of our translational medicine efforts;
and
|
(iii)
|
launch activities for
ARIKAYCE in initial European countries and in Japan.
|
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 (844)
200-6205 (domestic) or +44-208-0682-558 (international) and
referencing access code 711350. 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
45 minutes after its completion through September 6, 2021 by dialing (929) 458-6194
(domestic) or +44-204-525-0658 (international) and referencing
access code 984249. 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.
Non-GAAP Financial Measures
In addition to the U.S. generally accepted accounting
principles (GAAP) results, this earnings release includes non-GAAP
financial measures: adjusted R&D expenses,
which Insmed defines as R&D expenses less stock-based
compensation expense and depreciation; and adjusted SG&A
expenses, which Insmed defines as SG&A expenses less
stock-based compensation and depreciation. A reconciliation of
these non-GAAP financial measures to their most directly comparable
GAAP financial measure is presented in the table attached to this
press release.
Management believes that these non-GAAP financial measures are
useful to both management and investors in analyzing our ongoing
business and operating performance. Management believes that
providing this non-GAAP information to investors, in addition to
the GAAP results, allows investors to view our financial results in
the way that management views financial results. Management
does not intend the presentation of these non-GAAP financial
measures to be considered in isolation or as a substitute for
results prepared in accordance with GAAP. In addition, these
non-GAAP financial measures may differ from similarly named
measures used by other companies.
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 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 growing
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 timing 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; 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
inhalation 590 mg (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 timely and
successfully complete the study to validate a PRO tool and the
confirmatory post-marketing study 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 or its 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; 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 our 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 adapt to its highly
competitive and changing environment; 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 its 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; 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; 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, 2020 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.
Financial Statements and Reconciliation
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,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
Product revenues,
net
|
$
45,366
|
|
$
42,495
|
|
$
85,580
|
|
$
79,355
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization of intangible
assets)
|
10,837
|
|
9,950
|
|
20,681
|
|
18,388
|
Research and
development
|
64,655
|
|
35,748
|
|
126,045
|
|
71,932
|
Selling, general and
administrative
|
57,177
|
|
49,663
|
|
108,727
|
|
101,009
|
Amortization of
intangible assets
|
1,263
|
|
1,248
|
|
2,526
|
|
2,497
|
Total operating
expenses
|
133,932
|
|
96,609
|
|
257,979
|
|
193,826
|
|
|
|
|
|
|
|
|
Operating
loss
|
(88,566)
|
|
(54,114)
|
|
(172,399)
|
|
(114,471)
|
|
|
|
|
|
|
|
|
Investment
income
|
34
|
|
203
|
|
67
|
|
1,607
|
Interest
expense
|
(10,319)
|
|
(7,469)
|
|
(17,878)
|
|
(14,880)
|
Loss on extingushment
of debt
|
(17,689)
|
|
-
|
|
(17,689)
|
|
-
|
Other expense,
net
|
(159)
|
|
(46)
|
|
(202)
|
|
(10)
|
Loss before income
taxes
|
(116,699)
|
|
(61,426)
|
|
(208,101)
|
|
(127,754)
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
622
|
|
428
|
|
861
|
|
464
|
|
|
|
|
|
|
|
|
Net loss
|
$
(117,321)
|
|
$
(61,854)
|
|
$
(208,962)
|
|
$
(128,218)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(1.07)
|
|
$
(0.64)
|
|
$
(1.97)
|
|
$
(1.38)
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
109,580
|
|
96,633
|
|
106,328
|
|
93,206
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
June 30,
2021
|
|
December 31,
2020
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
928,327
|
|
$
532,756
|
Accounts
receivable
|
|
18,417
|
|
16,562
|
Inventory
|
|
60,385
|
|
49,592
|
Prepaid expenses and
other current assets
|
|
31,066
|
|
23,982
|
Total current
assets
|
|
1,038,195
|
|
622,892
|
|
|
|
|
|
Intangibles,
net
|
|
46,735
|
|
49,261
|
Fixed assets,
net
|
|
53,784
|
|
53,953
|
Finance lease
right-of-use assets
|
|
9,795
|
|
10,334
|
Operating lease
right-of-use assets
|
|
32,037
|
|
32,946
|
Other
assets
|
|
49,237
|
|
26,769
|
Total
assets
|
|
$
1,229,783
|
|
$
796,155
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
31,081
|
|
$
42,853
|
Accrued
expenses
|
|
45,553
|
|
37,807
|
Accrued
compensation
|
|
15,939
|
|
25,591
|
Finance lease
liabilities
|
|
1,158
|
|
1,081
|
Operating lease
liabilities
|
|
5,925
|
|
11,475
|
Total current
liabilities
|
|
99,656
|
|
118,807
|
|
|
|
|
|
Debt,
long-term
|
|
548,745
|
|
356,318
|
Finance lease
liabilities, long-term
|
|
14,114
|
|
14,713
|
Operating lease
liabilities, long-term
|
|
23,409
|
|
21,255
|
Other long-term
liabilities
|
|
12,806
|
|
9,178
|
Total
liabilities
|
|
698,730
|
|
520,271
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
shares,115,239,269
and 102,763,060 issued and outstanding
shares at June 30, 2021 and December 31, 2020,
respectively
|
|
1,152
|
|
1,028
|
Additional paid-in
capital
|
|
2,569,028
|
|
2,105,252
|
Accumulated
deficit
|
|
(2,039,551)
|
|
(1,830,589)
|
Accumulated other
comprehensive income
|
|
424
|
|
193
|
Total shareholders'
equity
|
|
531,053
|
|
275,884
|
Total liabilities and
shareholders' equity
|
|
$
1,229,783
|
|
$
796,155
|
|
|
|
|
|
|
|
|
|
|
INSMED
INCORPORATED
|
|
Reconciliation of
GAAP to Non-GAAP Results
|
|
(in
thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30,
|
|
Six Months
Ended June 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP research and
development
|
$
64,655
|
|
$
35,748
|
|
$
126,045
|
|
$
71,932
|
|
Stock-based compensation expense
|
(4,434)
|
|
(2,979)
|
|
(8,118)
|
|
(5,821)
|
|
Depreciation
|
(1,278)
|
|
(1,186)
|
|
(2,530)
|
|
(2,344)
|
|
Adjusted R&D
expenses (non-GAAP)
|
$
58,943
|
|
$
31,583
|
|
$
115,397
|
|
$
63,767
|
|
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative
|
$
57,177
|
|
$
49,663
|
|
$
108,727
|
|
$
101,009
|
|
Stock-based compensation expense
|
(7,301)
|
|
(6,489)
|
|
(14,152)
|
|
(12,649)
|
|
Depreciation
|
(1,107)
|
|
(1,082)
|
|
(2,243)
|
|
(2,190)
|
|
Adjusted SG&A
expenses (non-GAAP)
|
$
48,769
|
|
$
42,092
|
|
$
92,332
|
|
$
86,170
|
Contact:
Investors:
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated