BRIDGEWATER, N.J., Feb. 25, 2020 /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, 2019
and provided a business update.
"2019 was a transformative year for Insmed as we evolved into a
commercial-stage organization and advanced our global
infrastructure. I am incredibly proud of our team's performance in
the first full year of the ARIKAYCE U.S. launch, and we look
forward to serving even more patients with the same level of
dedication as we prepare for a potential approval and commercial
launch in Europe and regulatory
filings in Japan,"
commented Will Lewis, Chairman and Chief Executive Officer of
Insmed. "With our recent announcement of positive top-line Phase 2
data for INS1007 in non-cystic fibrosis bronchiectasis, in addition
to other meaningful advancements in our pipeline, we are well on
our way toward building a robust portfolio of therapies that
address the unmet needs of small patient populations experiencing
big health problems."
Fourth Quarter and Full-Year 2019 Financial Results
- Total revenue for the fourth quarter ended December 31, 2019 was $45.7 million, comprising U.S. net sales of
$44.3 million and ex-U.S. net sales
of $1.4 million. Total revenue for
the full year 2019 was $136.5
million, comprising U.S. net sales of $132.1 million and ex-U.S. net sales of
$4.4 million. This compares to total
revenue of $9.8 million for the
fourth quarter and full year 2018.
- Cost of product revenues (excluding amortization of intangible
assets) was $8.7 million for the
fourth quarter of 2019, compared to $2.4
million for the fourth quarter of 2018. For the full year
2019, cost of product revenues was $24.2
million compared to $2.4
million in 2018. The increase in cost of product revenues is
attributable to the increase in revenues.
- R&D expenses were $32.6
million for the fourth quarter of 2019, compared to
$39.9 million for the fourth quarter
of 2018. For the full year 2019, R&D expenses were $131.7 million compared to $145.3 million in 2018. The decrease in R&D
is primarily due to the Company capitalizing inventory subsequent
to the September 2018 U.S. Food and
Drug Administration (FDA) approval of ARIKAYCE and capitalizing
certain costs related to the investment in our long-term production
capacity at Patheon in 2019.
- Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2019 were $50.2
million, compared to $54.0
million for the fourth quarter of 2018. For the full year
2019, SG&A expenses were $210.8
million, compared to $168.2
million in 2018. The decrease in SG&A in the fourth
quarter is primarily due to a decrease in external expenses related
to ARIKAYCE. The increase in SG&A for the full year is
primarily due to an increase in external expenses related to
ARIKAYCE and a milestone owed in connection with amended agreements
with the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT).
- For the fourth quarter of 2019, Insmed reported a GAAP net loss
of $53.0 million, or $0.59 per share, compared to a GAAP net loss of
$91.6 million, or $1.19 per share, for the fourth quarter of 2018.
For the full year 2019, Insmed reported a GAAP net loss of
$254.3 million, or $3.01 per share, compared to a GAAP net loss of
$324.3 million, or $4.22 per share, in 2018.
Recent Corporate Developments & Program
Highlights
Positive Top-Line Results from WILLOW Study
On February 3, 2020, Insmed
announced positive top-line results from the Phase 2 WILLOW study
evaluating the efficacy, safety, and pharmacokinetics of INS1007 in
adults with non-cystic fibrosis bronchiectasis. The study met both
its primary endpoint of time to first pulmonary exacerbation over
the 24-week treatment period as well as a key secondary endpoint of
reduction in the frequency of pulmonary exacerbations versus
placebo. The Company plans to advance INS1007 to Phase 3
development.
ARIKAYCE Lifecycle Management
Insmed continues to advance the post-approval confirmatory
clinical trial for ARIKAYCE in a front-line setting of patients
with Mycobacterium avium complex (MAC) lung disease as well
as the development of an appropriate patient reported outcome (PRO)
tool that will enable the assessment of therapies for the treatment
of nontuberculous mycobacterial (NTM) lung disease. Insmed plans to
initiate both the confirmatory study and a study to validate the
PRO in the second half of 2020 and to run these studies in
parallel, pending alignment with the FDA. The Company also plans to
advance into a separate registrational Phase 3 study in patients
with NTM lung disease caused by Mycobacterium abscessus.
INS1009 Advancement
Insmed is advancing INS1009, a dry powder, inhaled treprostinil
prodrug formulation, for the potential treatment of pulmonary
arterial hypertension. The Company plans to file an Investigational
New Drug application and initiate a Phase 1 study of INS1009 this
year.
Global Expansion
Pending the approval of our marketing authorization application
in Europe, Insmed anticipates a
potential launch of ARIKAYCE in Germany by the end of 2020, followed shortly
thereafter by the UK. The Company plans to file for approval of
ARIKAYCE in Japan in the first
quarter of 2020. In addition, Insmed has engaged DKSH Korea Ltd. to
provide services to support an expanded access program on a named
patient basis in South Korea.
Leadership Updates
Recent senior leadership appointments include Fred Zussa, Senior
Vice President, Business Development, and Anjan Chatterjee, MD, MBA, MPH, Senior Vice
President, Medical Affairs. Fred joins the Company from Celgene
Corporation, where he was a senior member of the Corporate Strategy
and Development group. He is responsible for sourcing, evaluating,
and transacting business development activities for
Insmed. Anjan joins Insmed from Boehringer Ingelheim, where he
most recently served as Corporate Vice President. He is responsible
for expanding and leading the global Medical Affairs function for
ARIKAYCE as well as for our pipeline candidates as they advance
toward late-stage development.
Financial Guidance and Balance Sheet
As of December 31,
2019, Insmed had cash and cash equivalents of $487.4
million. The Company's total operating expenses for the fourth
quarter of 2019 were $84.1 million
and for the full year of 2019 were $347.5
million. Adjusted operating expenses, as defined below, for
the fourth quarter of 2019 were $75.0
million and for the full year 2019 were $300.1 million.
The Company expects full-year 2020 revenues for ARIKAYCE to be
in the range of $180 million to
$220 million.
The Company plans to invest in the following key activities in
2020:
(i)
|
U.S.
commercialization of ARIKAYCE;
|
(ii)
|
clinical trial
activities, including (a) the development of a PRO for NTM lung
disease as well as the initiation of a study to validate the PRO
and, in parallel, a confirmatory clinical study of
ARIKAYCE (b) the advancement of INS1007 into a Phase 3 program
in patients with bronchiectasis, and (c) the advancement of INS1009
and our earlier-stage research pipeline; and
|
(iii)
|
expansion in Europe
and Japan to support pre-commercial activities for ARIKAYCE in
those regions and potential regulatory filings in Japan.
|
As a result of these activities, Insmed expects adjusted
operating expenses to be in the range of $340 million to $360
million for 2020.
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 (888)
317-6003 (domestic) or (412) 317-6061 (international) and
referencing conference ID number 3317351. 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 March 3, 2020 by
dialing (877) 344-7529 (domestic) or (412) 317-0088 (international)
and referencing replay access code 10139238. A webcast of the call
will also be archived for 90 days under the Investors 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 adjusted
operating expenses, a non-GAAP financial measure,
which Insmed defines as total operating expenses less
stock-based compensation expense, depreciation, amortization of
intangibles and certain milestones related to ARIKAYCE, which
is payable under our amended agreements with CFFT. 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 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.
About INS1007
INS1007 is a small molecule, oral, reversible inhibitor of
dipeptidyl peptidase I (DPP1) being developed by Insmed for the
treatment of patients with bronchiectasis. 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. INS1007
may decrease the damaging effects of inflammatory diseases such as
bronchiectasis by inhibiting DPP1 and its activation of NSPs.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE
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, ARIKAYCE®
(amikacin liposome inhalation suspension), is the first and only
therapy approved in the United
States for the treatment of refractory 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 chronic,
debilitating condition that can cause severe and permanent lung
damage. 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 payors 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 timely and successfully complete the study to
validate a 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
payors 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; risks
that the full set of data from the WILLOW study will not be
consistent with the top-line results of the study; 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 the
United Kingdom as a result of its
recent exit from the European Union; 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 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 FDA-approved 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 factors discussed in Item 1A, "Risk Factors," in the
Company's Annual Report on Form 10-K for the year
ended December 31, 2019 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,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Revenues,
net
|
$
45,708
|
|
$
9,835
|
|
$
136,467
|
|
$
9,835
|
|
Cost of product
revenues (excluding amortization of intangible
assets)
|
8,706
|
|
2,423
|
|
24,212
|
|
2,423
|
|
Gross
profit
|
37,002
|
|
7,412
|
|
112,255
|
|
7,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
32,630
|
|
39,925
|
|
131,711
|
|
145,283
|
|
Selling, general and
administrative
|
50,206
|
|
53,960
|
|
210,796
|
|
168,218
|
|
Amortization of
intangible assets
|
1,248
|
|
1,249
|
|
4,993
|
|
1,249
|
|
Total operating
expenses
|
84,084
|
|
95,134
|
|
347,500
|
|
314,750
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(47,082)
|
|
(87,722)
|
|
(235,245)
|
|
(307,338)
|
|
|
|
|
|
|
|
|
|
|
Investment
income
|
2,042
|
|
2,831
|
|
9,921
|
|
10,341
|
|
Interest
expense
|
(7,348)
|
|
(6,667)
|
|
(27,705)
|
|
(25,472)
|
|
Loss on
extinguishment of debt
|
-
|
|
-
|
|
-
|
|
(2,209)
|
|
Other (expense)
income, net
|
(276)
|
|
52
|
|
(531)
|
|
602
|
|
Loss before income
taxes
|
(52,664)
|
|
(91,506)
|
|
(253,560)
|
|
(324,076)
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
324
|
|
67
|
|
777
|
|
201
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(52,988)
|
|
$
(91,573)
|
|
$
(254,337)
|
|
$
(324,277)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.59)
|
|
$
(1.19)
|
|
$
(3.01)
|
|
$
(4.22)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
89,466
|
|
77,096
|
|
84,560
|
|
76,889
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
December 31,
2019
|
|
December 31,
2018
|
|
|
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
487,429
|
|
$
495,072
|
Accounts
receivable
|
|
19,232
|
|
5,515
|
Inventory
|
|
28,313
|
|
7,032
|
Prepaid expenses and
other current assets
|
|
20,220
|
|
11,327
|
Total current
assets
|
|
555,194
|
|
518,946
|
|
|
|
|
|
Intangibles,
net
|
|
53,682
|
|
58,675
|
Fixed assets,
net
|
|
60,180
|
|
22,636
|
Finance lease
right-of-use assets
|
|
15,256
|
|
-
|
Operating lease
right-of-use assets
|
|
37,673
|
|
-
|
Other
assets
|
|
20,314
|
|
4,299
|
Total
assets
|
|
$
742,299
|
|
$
604,556
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
13,184
|
|
$
17,741
|
Accrued
expenses
|
|
40,375
|
|
38,254
|
Accrued
compensation
|
|
19,140
|
|
22,208
|
Finance lease
liabilities
|
|
1,221
|
|
-
|
Operating lease
liabilities
|
|
11,040
|
|
-
|
Other current
liabilities
|
|
280
|
|
1,529
|
Total current
liabilities
|
|
85,240
|
|
79,732
|
|
|
|
|
|
Debt,
long-term
|
|
335,940
|
|
316,558
|
Finance lease
liabilities, long-term
|
|
19,529
|
|
-
|
Operating lease
liabilities, long-term
|
|
29,308
|
|
-
|
Other long-term
liabilities
|
|
10,608
|
|
-
|
Total
liabilities
|
|
480,625
|
|
396,290
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
shares, 89,682,387
and 77,307,521 issued and outstanding
shares at December 31, 2019 and 2018, respectively
|
|
897
|
|
773
|
Additional paid-in
capital
|
|
1,797,286
|
|
1,489,664
|
Accumulated
deficit
|
|
(1,536,499)
|
|
(1,282,162)
|
Accumulated other
comprehensive loss
|
|
(10)
|
|
(9)
|
Total shareholders'
equity
|
|
261,674
|
|
208,266
|
Total liabilities and
shareholders' equity
|
|
$
742,299
|
|
$
604,556
|
INSMED
INCORPORATED
|
Reconciliation of
GAAP to Non-GAAP Results
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve
Months Ended
December 31,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses - GAAP
|
|
|
$
84,084
|
|
$
95,134
|
|
$
347,500
|
|
$
314,750
|
Stock-based compensation expense
|
|
|
(5,888)
|
|
(6,035)
|
|
(26,971)
|
|
(26,240)
|
Depreciation
|
|
|
(1,939)
|
|
(925)
|
|
(5,188)
|
|
(3,577)
|
Amortization of intangibles
|
|
|
(1,248)
|
|
(1,249)
|
|
(4,993)
|
|
(1,249)
|
CFFT milestone payments
|
|
|
-
|
|
-
|
|
(10,249)
|
|
-
|
Adjusted operating
expenses - Non-GAAP
|
|
|
$
75,009
|
|
$
86,925
|
|
$
300,099
|
|
$
283,684
|
Contact:
Investors:
Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902
insmed@argotpartners.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 487-7468
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated