BRIDGEWATER, N.J., Aug. 1, 2019 /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, 2019 and provided a business update.
"We are very excited about the continued strength of the U.S.
launch of ARIKAYCE® (amikacin liposome inhalation
suspension), the first and only FDA-approved treatment for
patients with refractory MAC lung disease, including the breadth
and depth of prescribing, addition of new patients, and positive
reception from the payer community throughout the first three
quarters of launch," commented Will
Lewis, Chairman and Chief Executive Officer of Insmed.
"While the U.S. launch remains our greatest area of focus, we are
pleased to have made significant progress on our other strategic
priorities this quarter, including filing for regulatory approval
of ARIKAYCE in the EU, advancing our planned regulatory filings in
Japan, and completing enrollment
in the Phase 2 WILLOW study of INS1007. As we move into the second
half of the year as a fully operational commercial-stage company,
we plan to execute against these priorities with a disciplined
approach to investment."
Second Quarter 2019 Financial Results
- Total revenue for the second quarter ended June 30, 2019 was $30.0 million, comprising U.S. net sales
of $29.0 million and ex-U.S. net sales of $1.0
million. The ex-U.S. net product sales include $0.9 million from the Temporary Authorization for
Use (Autorisation Temporaire d'Utilisation or ATU) program in
France and $0.1 million from the named patient program in
Germany, both compassionate use
programs.
- Cost of product revenues (excluding amortization of intangible
assets) was $4.9 million for the
second quarter of 2019.
- Research and development expenses were $33.5
million for the second quarter of 2019, compared
with $35.7 million for the second quarter of 2018.
- Selling, general and administrative expenses for the second
quarter of 2019 were $52.4 million, compared with $37.2
million for the second quarter of 2018. The increase was
primarily due to higher expenses related to commercial activities
for ARIKAYCE, including disease awareness, patient support
activities, and field operations and, to a lesser extent, an
increase in headcount, including non-cash stock-based
compensation.
- For the second quarter of 2019, Insmed reported a
GAAP net loss of $66.5 million, or $0.81 per share,
compared with a GAAP net loss of $76.4 million, or $1.00
per share, for the second quarter of 2018.
- During the second quarter of 2019, Insmed completed a public
offering of 10.7 million new shares of common stock that resulted
in net cash proceeds of $261.2
million, after deducting underwriting discounts
and commissions and other offering-related expenses.
Recent Corporate Developments & Program
Highlights
Global Expansion Efforts Advance with Submission of MAA
for ARIKAYCE to EMA
In July, Insmed submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) for ARIKAYCE for the
treatment of persistent MAC lung infection as part of a combination
antibacterial drug regimen in adults. The MAA was subsequently
validated by the EMA. The proposed indication reflects the same
population of refractory MAC lung disease patients for which
ARIKAYCE is approved in the U.S.
ARIKAYCE previously received Orphan Drug Designation in the
European Union (EU) for the treatment of nontuberculous
mycobacterial (NTM) lung disease. MAC is the predominant pathogenic
species in NTM lung disease in the United
States, Europe, and
Japan. The Company anticipates a
12-month review cycle with a potential launch of ARIKAYCE in
certain European countries as early as the second half of 2020 if
the MAA is approved.
In addition, the Company remains on track to submit a new drug
application for ARIKAYCE in Japan
in the first half of 2020.
Additional EU Patent Granted for ARIKAYCE
In July, the European Patent Office issued an additional patent
to Insmed for ARIKAYCE in MAC lung disease. The claims of the
patent relate in part to pharmaceutical compositions of amikacin
encapsulated in liposomes, including ARIKAYCE, for treating or
providing prophylaxis against MAC lung disease, where the
composition is administered via aerosolization to the lungs of a
patient once daily in a single dosing session for at least three
months. The patent extends exclusivity of ARIKAYCE in Europe to May 15, 2035.
ARIKAYCE Launch and Lifecycle Management
Insmed continues to advance the U.S. launch of ARIKAYCE, which
was granted accelerated approval by the U.S. Food and Drug
Administration (FDA) in September
2018 for the treatment of refractory MAC lung disease as
part of a combination antibacterial drug regimen for adult patients
who have limited or no alternative treatment options.
As a next step toward advancing a post-approval confirmatory
clinical trial for ARIKAYCE, the Company has initiated efforts to
develop an appropriate patient reported outcome (PRO) tool that
will enable the assessment of therapies for the treatment of NTM
lung disease. If the PRO tool is verified, Insmed plans to
conduct the confirmatory study of ARIKAYCE in a frontline setting
of patients with MAC lung disease as well as a separate study in
patients with NTM lung disease caused by Mycobacterium
abscessus.
Data from Phase 3 CONVERT Study Presented as Late-Breaker
at ATS
In May, longer-term data on the sustainability and durability of
culture conversion from the Phase 3 CONVERT Study of ARIKAYCE were
presented in a late-breaking oral session at the American Thoracic
Society International Conference. The data showed that among
patients who achieved culture conversion by Month 6, 80.0% (52/65)
of those receiving ARIKAYCE plus guideline-based therapy (GBT)
sustained culture conversion for up to 12 months of treatment after
the first dose that defined culture conversion compared to 30.0%
(3/10) of patients receiving GBT alone (p=0.0014). Three months
after the completion of treatment, 63.1% (41/65) of patients
receiving ARIKAYCE plus GBT maintained durable culture conversion,
compared to 0.0% (0/10) of patients receiving GBT alone
(p=0.0002).
Enrollment Completed in WILLOW Study
Insmed has completed enrollment in the six-month Phase 2 WILLOW
study of INS1007 for patients with non-cystic fibrosis (CF)
bronchiectasis. Top-line data are expected in early 2020.
Financial Guidance and Balance Sheet
As of June 30,
2019, Insmed had cash and cash equivalents of $601.3
million. The Company's total costs and expenses for the second
quarter of 2019 were $92.1 million,
compared with total costs and expenses for the second quarter of
2018 of $72.9 million. Cash-based
operating expenses for the second quarter of 2019 were $77.4 million, compared with cash-based operating
expenses for the second quarter of 2018 of $65.3 million.
The Company now expects full-year 2019 revenues for ARIKAYCE to
be in the range of $110 million to
$120 million.
The Company plans to continue to invest in the following key
activities in 2019:
(i)
|
support of the U.S.
launch and commercialization of ARIKAYCE;
|
(ii)
|
clinical trials
including (a) the development and verification of a PRO for NTM
lung disease as a pivotal step toward initiating a confirmatory
clinical study of ARIKAYCE, (b) the six-month Phase 2 WILLOW study
of INS1007 in patients with non-CF bronchiectasis, and (c) the
advancement of other pipeline programs including INS1009 and our
earlier-stage research pipeline;
|
(iii)
|
global expansion in
Europe and Japan to support pre-commercial activities in those
regions and potential regulatory filings in Japan; and
|
(iv)
|
buildout of an
additional third-party manufacturing facility to increase long-term
production capacity for ARIKAYCE and a new corporate headquarters
facility.
|
Insmed expects cash-based operating expenses to be in the range
of $140 million to $155 million for the second half of 2019. In
addition, the Company expects capital expenditures, including those
related to the buildout of a new corporate headquarters facility as
well as payments classified within other assets for the future
right-of-use asset related to the buildout of an additional
third-party manufacturing facility, to be in the range of
$20 million to $30 million for the second half of
2019.
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 1-888-317-6003 (domestic) or 1-412-317-6061 (international)
and referencing conference ID number 5579948. 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
one hour after its completion through August
8, 2019 by dialing 1-877-344-7529 (domestic) or
1-412-317-0088 (international) and referencing replay access code
10133256. 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
cash-based operating expenses, a non-GAAP financial measure,
which Insmed defines as total costs and expenses
excluding cost of product revenues, stock-based compensation
expense, depreciation and amortization of intangibles. A
reconciliation of this non-GAAP financial measure to its most
directly comparable GAAP financial measure is presented in the
table attached to this press release.
Management believes that this non-GAAP financial measure is
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 this non-GAAP financial measure
to be considered in isolation or as a substitute for results
prepared in accordance with GAAP. In addition, this non-GAAP
financial measure may differ from similarly named measures used by
other companies.
About MAC Lung Disease
Mycobacterium avium complex (MAC) lung disease is a rare
and serious disorder that can significantly increase morbidity and
mortality. Patients with MAC lung disease can experience a range of
symptoms that often worsen over time, including chronic cough,
dyspnea, fatigue, fever, weight loss, and chest pain. In some
cases, MAC lung disease can cause severe, even permanent damage to
the lungs, and can be fatal.
MAC lung disease is an emerging public health concern worldwide
with significant unmet needs. Current guideline-based treatment
involves the use of multi-drug regimens that are not specifically
approved for MAC lung disease. The course of treatment is often two
years or more and is inadequate in treating the disease in many
patients.
About ARIKAYCE® (amikacin liposome
inhalation suspension)
ARIKAYCE is the first and only FDA-approved therapy indicated
for the treatment of Mycobacterium avium complex (MAC) lung
disease as part of a combination antibacterial drug regimen for
adult patients with limited or no alternative treatment
options. 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. This approach prolongs the
release of amikacin in the lungs 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® (amikacin liposome inhalation
suspension) 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 liquid
medications, including liposomal formulations such as 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 and new
pharmaceutical formulations that work together to improve patient
care.
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.
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
ARIKAYCE® (amikacin liposome inhalation
suspension), which is approved in the
United States for the treatment of Mycobacterium
avium complex (MAC) lung disease as part of a combination
antibacterial drug regimen for adult patients with limited or no
alternative treatment options. MAC lung disease is a rare and
often chronic infection that can cause irreversible lung damage and
can be fatal. Insmed's earlier-stage clinical pipeline
includes INS1007, a novel oral reversible inhibitor of dipeptidyl
peptidase 1 with therapeutic potential in non-cystic fibrosis
bronchiectasis and other inflammatory diseases, and INS1009, an
inhaled formulation of a treprostinil prodrug that may offer a
differentiated product profile for rare pulmonary disorders,
including pulmonary arterial hypertension. 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) 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 successfully commercialize or maintain U.S.
approval for ARIKAYCE, the Company's only approved product;
uncertainties in the degree of market acceptance of ARIKAYCE by
physicians, patients, third-party payers and others in the
healthcare community; the Company's inability to obtain full
approval of ARIKAYCE from the FDA, including the risk that the
Company will not successfully develop and validate the PRO tool and
complete the confirmatory post-marketing study required for full
approval; 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 payers for ARIKAYCE or acceptable
prices for ARIKAYCE; development of unexpected safety or efficacy
concerns related to ARIKAYCE; inaccuracies in the Company's
estimates of the size of the potential markets for ARIKAYCE 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; failure to obtain regulatory approval to
expand ARIKAYCE's indication to a broader patient population;
failure to successfully conduct future clinical trials for ARIKAYCE
and the Company's product candidates, including due to the
Company's limited experience in conducting preclinical development
activities and clinical trials necessary for regulatory approval
and the Company's inability to enroll or retain sufficient patients
to conduct and complete the trials or generate data necessary for
regulatory approval; risks that the Company's clinical studies will
be delayed or that serious side effects will be identified during
drug development; failure to obtain, or delays in obtaining,
regulatory approvals for ARIKAYCE outside the U.S. or for the
Company's product candidates in the
U.S., Europe, Japan or other markets, including as a
result of the United Kingdom's
planned exit from the EU; 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 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 its 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
agreements related to ARIKAYCE or the Company's product candidates,
including the Company's license agreements with PARI and
AstraZeneca AB, and failure to comply with the Company's
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 and
failure to comply with such laws and regulations; inability to
repay the Company's existing indebtedness and uncertainties with
respect to its ability to access future capital; and delays in the
execution of plans to build out and move into the leased space at
the Company's new headquarters and to build out an additional
third-party manufacturing facility 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 risk factors discussed in Item 1A, "Risk Factors," in the
Company's Annual Report on Form 10-K for the year
ended December 31, 2018 and in the Company's subsequent
filings with the Securities and Exchange Commission.
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 Securities and
Exchange Commission, 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,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
Revenues,
net
|
$
29,972
|
|
$
-
|
|
$
51,874
|
|
$
-
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization of
intangible assets)
|
4,919
|
|
-
|
|
9,069
|
|
-
|
Research and
development
|
33,538
|
|
35,722
|
|
64,741
|
|
65,820
|
Selling, general and
administrative
|
52,433
|
|
37,160
|
|
107,243
|
|
69,813
|
Amortization of
intangible assets
|
1,248
|
|
-
|
|
2,496
|
|
-
|
Total costs and
expenses
|
92,138
|
|
72,882
|
|
183,549
|
|
135,633
|
|
|
|
|
|
|
|
|
Operating
loss
|
(62,166)
|
|
(72,882)
|
|
(131,675)
|
|
(135,633)
|
|
|
|
|
|
|
|
|
Investment
income
|
2,578
|
|
2,729
|
|
4,994
|
|
4,769
|
Interest
expense
|
(6,785)
|
|
(6,488)
|
|
(13,511)
|
|
(12,130)
|
Loss on extingushment
of debt
|
-
|
|
-
|
|
-
|
|
(2,209)
|
Other (expense)
income, net
|
(51)
|
|
244
|
|
(170)
|
|
330
|
Loss before income
taxes
|
(66,424)
|
|
(76,397)
|
|
(140,362)
|
|
(144,873)
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
90
|
|
40
|
|
305
|
|
88
|
|
|
|
|
|
|
|
|
Net loss
|
$
(66,514)
|
|
$
(76,437)
|
|
$
(140,667)
|
|
$
(144,961)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.81)
|
|
$
(1.00)
|
|
$
(1.77)
|
|
$
(1.89)
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
81,806
|
|
76,767
|
|
79,685
|
|
76,693
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
June 30,
2019
|
|
December 31,
2018
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
601,260
|
|
$
495,072
|
Accounts
receivable
|
|
11,638
|
|
5,515
|
Inventory
|
|
20,160
|
|
7,032
|
Prepaid expenses and
other current assets
|
|
15,856
|
|
11,327
|
Total current
assets
|
|
648,914
|
|
518,946
|
|
|
|
|
|
Intangibles,
net
|
|
56,179
|
|
58,675
|
Fixed assets,
net
|
|
38,913
|
|
22,636
|
Operating lease
right-of-use assets
|
|
42,316
|
|
-
|
Other
assets
|
|
16,461
|
|
4,299
|
Total
assets
|
|
$
802,783
|
|
$
604,556
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
17,031
|
|
$
17,741
|
Accrued
expenses
|
|
49,363
|
|
38,254
|
Accrued
compensation
|
|
10,218
|
|
22,208
|
Lease
liabilities
|
|
9,184
|
|
-
|
Other current
liabilities
|
|
234
|
|
1,529
|
Total current
liabilities
|
|
86,030
|
|
79,732
|
|
|
|
|
|
Debt,
long-term
|
|
326,128
|
|
316,558
|
Long-term lease
liabilities
|
|
33,530
|
|
-
|
Other long-term
liabilities
|
|
522
|
|
-
|
Total
liabilities
|
|
446,210
|
|
396,290
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
authorized shares,
89,207,455 and 77,307,521 issued and outstanding shares at June 30,
2019 and December 31, 2018, respectively
|
|
892
|
|
773
|
Additional paid-in
capital
|
|
1,778,517
|
|
1,489,664
|
Accumulated
deficit
|
|
(1,422,829)
|
|
(1,282,162)
|
Accumulated other
comprehensive loss
|
|
(7)
|
|
(9)
|
Total shareholders'
equity
|
|
356,573
|
|
208,266
|
Total liabilities and
shareholders' equity
|
|
$
802,783
|
|
$
604,556
|
|
|
|
|
|
|
INSMED
INCORPORATED
|
|
Reconciliation of
GAAP to Non-GAAP Results
|
|
(in
thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and
expenses - GAAP
|
$
92,138
|
|
$
72,882
|
|
$
183,549
|
|
$
135,633
|
|
Cost of product revenues (excluding amortization of intangible
assets)
|
(4,919)
|
|
-
|
|
(9,069)
|
|
-
|
|
Stock-based compensation expense
|
(7,353)
|
|
(6,629)
|
|
(14,289)
|
|
(12,303)
|
|
Depreciation
|
(1,176)
|
|
(929)
|
|
(2,245)
|
|
(1,698)
|
|
Amortization of intangibles
|
(1,248)
|
|
-
|
|
(2,496)
|
|
-
|
|
Cash-based
operating expenses - Non-GAAP
|
$
77,442
|
|
$
65,324
|
|
$
155,450
|
|
$
121,632
|
|
|
|
|
|
|
|
|
|
Contact:
Blaine Davis
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com
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SOURCE Insmed Incorporated