BRIDGEWATER, N.J., Feb. 22, 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 fourth quarter
and full year ended December 31, 2018 and provided a
business update.
"2018 was a pivotal year for Insmed, with the U.S. approval and
launch of ARIKAYCE® (amikacin liposome inhalation
suspension), the first and only FDA-approved treatment for
patients with refractory Mycobacterium avium complex (MAC)
lung disease. We are very pleased with the strong momentum we've
seen since launch, including a wide breadth of prescribers, steady
additions of new patients, and positive reimbursement trends,"
commented Will Lewis, Chairman and
Chief Executive Officer of Insmed. "In 2019, we are focused on
continuing our efforts to execute a successful U.S. launch while
pursuing our strategic priorities, including completing the design
and protocol of the confirmatory study required for the full U.S.
approval of ARIKAYCE, which is intended to support use of ARIKAYCE
in a front-line setting; accelerating our global expansion to
support potential regulatory filings for ARIKAYCE in Europe and Japan; and advancing our pipeline to bring
other potential therapies to market for patients with serious and
rare diseases."
Fourth Quarter and Full-Year 2018 Financial Results
- Total revenue for the fourth quarter and full year ended
December 31, 2018 was $9.8 million, comprising U.S. net sales of
$9.2 million and ex-U.S. net sales of
$0.6 million. The ex-U.S. net sales
reflect utilization from the Temporary Authorization for Use
(Autorisation Temporaire d'Utilisation or ATU) program in
France.
- Cost of product revenues (excluding amortization of intangible
assets) was $2.4 million for the
fourth quarter of 2018. Prior to the approval of ARIKAYCE, the
company expensed manufacturing and material costs as research and
development expenses.
- Research and development expenses were $39.9 million for the fourth quarter of 2018,
compared with $33.9 million for the
fourth quarter of 2017. For the full year of 2018, research and
development expenses were $145.3
million compared with $109.7
million for the full year of 2017. The increase was
primarily due to an increase in external manufacturing expenses and
higher compensation and related expenses due to an increase in
headcount.
- Selling, general and administrative expenses for the fourth
quarter of 2018 were $54.0 million,
compared with $31.4 million for the
fourth quarter of 2017. For the full year of 2018, selling, general
and administrative expenses were $168.2
million compared with $79.2
million for the full year of 2017. The increase was
primarily due to higher compensation and related expenses due to an
increase in headcount and an increase in expenses relating to
pre-commercial planning activities in preparation for the launch of
ARIKAYCE.
- For the fourth quarter of 2018, Insmed reported a net loss of
$91.6 million, or $1.19 per share, compared with a net loss of
$65.4 million, or $0.85 per share, for the fourth quarter of 2017.
For the full year of 2018, Insmed reported a net loss of
$324.3 million, or $4.22 per share, compared with a net loss of
$192.6 million, or $2.89 per share, for the full year of 2017.
Recent Corporate Developments & Program
Highlights
Strong Start to U.S. ARIKAYCE Launch
ARIKAYCE was granted accelerated approval by the U.S. Food and
Drug Administration (FDA) on September 28,
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 previously
reported, as of December 31, 2018,
more than 500 patients in the U.S. had initiated treatment with
ARIKAYCE and approximately 600 physicians in the U.S had written at
least one prescription for the therapy.
The Company expects to complete the design and protocol of the
confirmatory clinical study during the first half of 2019 required
for the full U.S. approval of ARIKAYCE by the FDA, which is
intended to support the use of ARIKAYCE in a front-line setting for
patients with MAC lung disease.
Global Expansion Under Way
The Company is continuing its global expansion efforts to
support potential regulatory filings for ARIKAYCE in Europe in mid-2019 and in Japan in the first half of 2020. In
January 2019, Insmed opened a new
office in Tokyo to support the
growth of the workforce in Japan.
The Company is also progressing with the buildout of its new,
state-of-the-art corporate headquarters in Bridgewater, NJ, with an anticipated move
during the second half of 2019. Insmed also continues to invest in
the buildout of an additional contract manufacturing facility with
Patheon UK Limited to increase the long-term production capacity
for ARIKAYCE commercial inventory.
Enrollment Remains on Track for WILLOW Study
Insmed continues to advance the development of INS1007 for
patients with non-CF bronchiectasis and expects to complete
enrollment in the six-month Phase 2 WILLOW study in mid-2019.
Financial Guidance and Balance Sheet
As of December 31,
2018, Insmed had cash and cash equivalents of $495.1
million. The Company's total costs and expenses for the fourth
quarter of 2018 were $97.6 million
and for the full year of 2018 were $317.2
million. The cash-based operating expenses for the fourth
quarter of 2018 were $86.9 million
and for the full year of 2018 were $283.7
million.
The Company expects full-year 2019 revenues for ARIKAYCE to be
in the range of $80 million to
$90 million.
The Company is investing in the following key activities in
2019:
|
(i)
|
continued support of
the U.S. launch and commercialization of ARIKAYCE;
|
|
(ii)
|
clinical trials
including (a) the ARIKAYCE post-marketing confirmatory study, which
will be conducted in a front-line setting, (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 regulatory and pre-commercial
activities in those regions; and
|
|
(iv)
|
build-out of an
additional third-party manufacturing facility to increase long-term
production capacity for ARIKAYCE and a new corporate headquarters
facility.
|
As a result of these activities, Insmed expects cash-based
operating expenses to be in the range of $150 million to $170
million for the first half of 2019. In addition, the
Company expects capital expenditures to be in the range of
$25 million to $35 million for the first 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 5106939. 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
two hours after its completion through March
1, 2019 by dialing 1-877-344-7529 (domestic) or
1-412-317-0088 (international) and referencing conference ID number
10128650. 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 presentation, 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
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.
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 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) 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 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 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; the expected rates of patient
uptake or the duration of expected treatment; 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 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 regulatory approvals for
ARIKAYCE outside the U.S. or for the Company's product candidates
in the U.S., Europe, Japan or other markets; 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 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 imposed on the
Company by its material license agreements, 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; 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 the Company's 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 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, 2018 and any subsequent
Company 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)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve
Months Ended
December 31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
$
9,835
|
|
$
-
|
|
$
9,835
|
|
$
-
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization
of intangible assets)
|
2,423
|
|
-
|
|
2,423
|
|
-
|
Research and
development
|
39,925
|
|
33,949
|
|
145,283
|
|
109,749
|
Selling, general and
administrative
|
53,960
|
|
31,404
|
|
168,218
|
|
79,171
|
Amortization of
intangible assets
|
1,249
|
|
-
|
|
1,249
|
|
-
|
Total costs and
expenses
|
97,557
|
|
65,353
|
|
317,173
|
|
188,920
|
|
|
|
|
|
|
|
|
Operating
loss
|
(87,722)
|
|
(65,353)
|
|
(307,338)
|
|
(188,920)
|
|
|
|
|
|
|
|
|
Investment
income
|
2,831
|
|
975
|
|
10,341
|
|
1,624
|
Interest
expense
|
(6,667)
|
|
(1,466)
|
|
(25,472)
|
|
(5,925)
|
Loss on extingushment
of debt
|
-
|
|
-
|
|
(2,209)
|
|
-
|
Other income,
net
|
52
|
|
94
|
|
602
|
|
300
|
Loss before income
taxes
|
(91,506)
|
|
(65,750)
|
|
(324,076)
|
|
(192,921)
|
|
|
|
|
|
|
|
|
Provision (benefit)
for income taxes
|
67
|
|
(366)
|
|
201
|
|
(272)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(91,573)
|
|
$
(65,384)
|
|
$
(324,277)
|
|
$
(192,649)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(1.19)
|
|
$
(0.85)
|
|
$
(4.22)
|
|
$
(2.89)
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common
shares outstanding
|
77,096
|
|
76,596
|
|
76,889
|
|
66,576
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
December 31,
2018
|
|
December 31,
2017
|
|
|
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
495,072
|
|
$
381,165
|
Accounts
receivable
|
|
5,515
|
|
-
|
Inventory,
net
|
|
7,032
|
|
-
|
Prepaid expenses and
other current assets
|
|
11,327
|
|
8,279
|
Total current
assets
|
|
518,946
|
|
389,444
|
|
|
|
|
|
Intangible assets,
net
|
|
58,675
|
|
58,200
|
Fixed assets,
net
|
|
22,636
|
|
12,432
|
Other
assets
|
|
4,299
|
|
1,971
|
Total
assets
|
|
$
604,556
|
|
$
462,047
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
17,741
|
|
$
14,671
|
Accrued
expenses
|
|
38,254
|
|
17,142
|
Accrued
compensation
|
`
|
22,208
|
|
12,197
|
Other current
liabilities
|
|
1,529
|
|
646
|
Total current
liabilities
|
|
79,732
|
|
44,656
|
|
|
|
|
|
Long-term debt,
net
|
|
316,558
|
|
55,567
|
Other long-term
liabilities
|
|
-
|
|
765
|
Total
liabilities
|
|
396,290
|
|
100,988
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000
|
|
|
|
|
authorized shares,
77,307,521 and 76,610,508 issued
and outstanding shares at December 31, 2018 and
December 31, 2017, respectively
|
|
773
|
|
766
|
Additional paid-in
capital
|
|
1,489,664
|
|
1,318,181
|
Accumulated
deficit
|
|
(1,282,162)
|
|
(957,885)
|
Accumulated other
comprehensive loss
|
|
(9)
|
|
(3)
|
Total shareholders'
equity
|
|
208,266
|
|
361,059
|
Total liabilities and
shareholders' equity
|
|
$
604,556
|
|
$
462,047
|
|
INSMED
INCORPORATED
|
|
Reconciliation of
GAAP to Non-GAAP Results
|
|
(in
thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve
Months Ended
December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
Total costs and
expenses - GAAP
|
$
97,557
|
|
$
65,353
|
|
$
317,173
|
|
$
188,920
|
|
Cost of product revenues (excluding amortization of intangible
assets)
|
(2,423)
|
|
-
|
|
(2,423)
|
|
-
|
|
Stock-based compensation expense
|
(6,035)
|
|
(4,741)
|
|
(26,240)
|
|
(18,073)
|
|
Depreciation
|
(925)
|
|
(733)
|
|
(3,577)
|
|
(2,901)
|
|
Amortization of intangibles
|
(1,249)
|
|
-
|
|
(1,249)
|
|
-
|
|
Cash-based
operating expenses - Non-GAAP
|
$
86,925
|
|
$
59,879
|
|
$
283,684
|
|
$
167,946
|
Contact:
Blaine Davis
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com
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SOURCE Insmed Incorporated