BRIDGEWATER, N.J., Aug. 6, 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 second quarter
ended June 30, 2020, and provided a
business update.
"I am incredibly proud of the Insmed team's performance in the
second quarter of 2020, which saw significant progress across our
programs even against the backdrop of the continued COVID-19
pandemic," commented Will Lewis, Chair and Chief Executive
Officer of Insmed. "ARIKAYCE U.S. sales showed strong sequential
growth from the first quarter as we continued to support patients
and physicians through both virtual and in-person efforts, and we
are excited about its inclusion in the new international treatment
guidelines as well as the recent positive CHMP opinion. At the same
time, we continued to advance brensocatib, which we believe offers
a significant opportunity to address unmet needs in bronchiectasis
and other neutrophil-driven diseases, along with our earlier-stage
clinical pipeline."
Second Quarter 2020 Financial Results
- Total revenue for the second quarter ended June 30, 2020, was $42.5
million, comprising U.S. net sales of $41.0
million and ex-U.S. net sales of $1.5 million. This
compares to total revenue of $30.0
million for the second quarter of 2019.
- Cost of product revenues (excluding amortization of intangible
assets) was $10.0 million for the
second quarter of 2020, compared to $4.9
million for the second quarter of 2019.
- Research and development (R&D) expenses were $35.7
million for the second quarter of 2020, compared to $33.5
million for the second quarter of 2019.
- Selling, general, and administrative (SG&A) expenses for
the second quarter of 2020 were $49.7 million, compared
to $52.4 million for the second quarter of 2019.
- For the second quarter of 2020, Insmed reported a
GAAP net loss of $61.9 million, or $0.64 per share,
compared to a GAAP net loss of $66.5 million, or $0.81
per share, for the second quarter of 2019.
- During the second quarter of 2020, Insmed completed a public
offering of 11,155,000 shares of common stock, including 1,455,000
shares issued pursuant to the exercise in full of the underwriters'
option to purchase additional shares, that resulted in net cash
proceeds of $245.9 million, after
deducting underwriting discounts and other offering-related
expenses.
Recent Corporate Developments & Program
Highlights
Brensocatib Advancement
Insmed presented final results from the Phase 2 WILLOW study of
brensocatib in patients with non-cystic fibrosis bronchiectasis
(NCFBE) during a virtual session of the American Thoracic society
in June 2020. Also in June, Insmed
received Breakthrough Therapy Designation from the U.S. Food and
Drug Administration (FDA) for brensocatib for the treatment of
adult patients with NCFBE for reducing exacerbations. The Company
remains on track to initiate its planned Phase 3 program with
brensocatib in patients with bronchiectasis by the end of 2020.
ARIKAYCE Global Advancement
In July 2020, Insmed received a
positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) recommending ARIKAYCE Liposomal 590 mg Nebuliser
Dispersion for the treatment of nontuberculous mycobacterial (NTM)
lung infections caused by Mycobacterium avium complex (MAC)
in non-CF patients with limited treatment options. Pending approval
of the marketing authorization application by the European
Commission (EC), the Company anticipates a potential launch in
Germany by the end of 2020,
followed shortly thereafter by the UK.
Insmed has also submitted a new drug application for ARIKAYCE to
Japan's Ministry of Health,
Labour and Welfare (MHLW) for the treatment of patients with
NTM lung disease caused by MAC who did not sufficiently respond to
prior treatment. In June 2020, a
Japanese Medical Device Notification (JMDN) was submitted to the
MHLW for Lamira, the designated device for administration of
ARIKAYCE. The JMDN was accepted and Lamira is authorized for use in
Japan.
New International NTM Treatment Guidelines
In July 2020, the American
Thoracic Society, European Respiratory Society, European Society of
Clinical Microbiology and Infectious Diseases, and Infectious
Diseases Society of America issued new treatment guidelines for the
management of NTM lung disease. The guidelines strongly recommend
the addition of ARIKAYCE to the standard treatment regimen for
patients with MAC lung disease who have failed to convert to a
negative sputum culture after at least six months of treatment.
ARIKAYCE Label Expansion
Insmed continues to advance the post-approval confirmatory
clinical trial for ARIKAYCE in a front-line setting of patients
with MAC lung disease as well as the development of an appropriate
patient reported outcome (PRO) tool that will enable the assessment
of ARIKAYCE for the treatment of NTM lung disease. Insmed plans to
initiate both the confirmatory study and a study to validate the
PRO by the end of 2020 and to run these studies in parallel,
pending alignment with the FDA.
Treprostinil Palmitil Advancement
Insmed is advancing treprostinil palmitil, a dry powder, inhaled
treprostinil prodrug formulation, for the potential treatment of
pulmonary arterial hypertension and plans to initiate a Phase 1
study by the end of 2020.
Balance Sheet
As of June 30,
2020, Insmed had cash and cash equivalents of $641.9
million. The Company's total operating expenses for the second
quarter of 2020 were $86.7 million.
Adjusted operating expenses, as defined below, for the second
quarter of 2020 were $73.7
million.
The Company plans to continue investing 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, the initiation of a study to validate the PRO and, in
parallel, a confirmatory clinical study of ARIKAYCE, (b) the
advancement of brensocatib into a Phase 3 program in patients with
bronchiectasis, and (c) the advancement of treprostinil palmitil;
and
(iii) expansion in
Japan and Europe to support pre-commercial activities
for ARIKAYCE in those regions and, pending approval of the
marketing authorization application by the EC, launch activities in
initial European countries.
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 9359069. 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 20, 2020 by
dialing (877) 344-7529 (domestic) or (412) 317-0088 (international)
and referencing replay access code 10146257. 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 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
are payable under our amended agreements with Cystic Fibrosis
Foundation Therapeutics, Inc. (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. Current international treatment guidelines recommend
the use of ARIKAYCE in combination with a multidrug regimen in
patients with MAC lung disease who have failed standard therapy
after at least six months of treatment. ARIKAYCE is a novel,
inhaled, once-daily formulation of amikacin, an established
antibiotic that was historically administered intravenously and
associated with severe toxicity to hearing, balance, and kidney
function. Insmed's proprietary PULMOVANCE™ liposomal technology
enables the delivery of amikacin directly to the lungs, where
liposomal amikacin is taken up by lung macrophages where the
infection resides, while limiting systemic exposure. ARIKAYCE is
administered once daily using the Lamira® Nebulizer
System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer
System
ARIKAYCE® (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 Brensocatib
Brensocatib 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.
Brensocatib may decrease the damaging effects of inflammatory
diseases such as bronchiectasis by inhibiting DPP1 and its
activation of NSPs.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF
INCREASED RESPIRATORY ADVERSE REACTIONS
|
ARIKAYCE has been
associated with an increased risk of respiratory adverse reactions,
including hypersensitivity pneumonitis, hemoptysis, bronchospasm,
and exacerbation of underlying pulmonary disease that have led to
hospitalizations in some cases.
|
Hypersensitivity Pneumonitis has been reported with the
use of ARIKAYCE in the clinical trials. Hypersensitivity
pneumonitis (reported as allergic alveolitis, pneumonitis,
interstitial lung disease, allergic reaction to ARIKAYCE) was
reported at a higher frequency in patients treated with ARIKAYCE
plus background regimen (3.1%) compared to patients treated with a
background regimen alone (0%). Most patients with hypersensitivity
pneumonitis discontinued treatment with ARIKAYCE and received
treatment with corticosteroids. If hypersensitivity pneumonitis
occurs, discontinue ARIKAYCE and manage patients as medically
appropriate.
Hemoptysis has been reported with the use of ARIKAYCE in
the clinical trials. Hemoptysis was reported at a higher frequency
in patients treated with ARIKAYCE plus background regimen (17.9%)
compared to patients treated with a background regimen alone
(12.5%). If hemoptysis occurs, manage patients as medically
appropriate.
Bronchospasm has been reported with the use of
ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma,
bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea
exertional, prolonged expiration, throat tightness, wheezing) was
reported at a higher frequency in patients treated with ARIKAYCE
plus background regimen (28.7%) compared to patients treated
with a background regimen alone (10.7%). If bronchospasm occurs
during the use of ARIKAYCE, treat patients as medically
appropriate.
Exacerbations of underlying pulmonary disease has
been reported with the use of ARIKAYCE in the clinical trials.
Exacerbations of underlying pulmonary disease (reported as chronic
obstructive pulmonary disease (COPD), infective exacerbation of
COPD, infective exacerbation of bronchiectasis) have been reported
at a higher frequency in patients treated with ARIKAYCE plus
background regimen (14.8%) compared to patients treated with
background regimen alone (9.8%). If exacerbations of
underlying pulmonary disease occur during the use of ARIKAYCE,
treat patients as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions: Serious
and potentially life-threatening hypersensitivity reactions,
including anaphylaxis, have been reported in patients taking
ARIKAYCE. Signs and symptoms include acute onset of skin and
mucosal tissue hypersensitivity reactions (hives, itching,
flushing, swollen lips/tongue/uvula), respiratory difficulty
(shortness of breath, wheezing, stridor, cough), gastrointestinal
symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and
cardiovascular signs and symptoms of anaphylaxis (tachycardia, low
blood pressure, syncope, incontinence, dizziness). Before therapy
with ARIKAYCE is instituted, evaluate for previous hypersensitivity
reactions to aminoglycosides. If anaphylaxis or a hypersensitivity
reaction occurs, discontinue ARIKAYCE and institute appropriate
supportive measures.
Ototoxicity has been reported with the use of ARIKAYCE in
the clinical trials. Ototoxicity (including deafness, dizziness,
presyncope, tinnitus, and vertigo) were reported with a higher
frequency in patients treated with ARIKAYCE plus background regimen
(17%) compared to patients treated with background
regimen alone (9.8%). This was primarily driven by tinnitus
(7.6% in ARIKAYCE plus background regimen vs 0.9% in the background
regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background
regimen vs 2.7% in the background regimen alone arm). Closely
monitor patients with known or suspected auditory or vestibular
dysfunction during treatment with ARIKAYCE. If ototoxicity occurs,
manage patients as medically appropriate, including potentially
discontinuing ARIKAYCE.
Nephrotoxicity was observed during the clinical
trials of ARIKAYCE in patients with MAC lung disease but not at a
higher frequency than background regimen alone. Nephrotoxicity has
been associated with the aminoglycosides. Close monitoring of
patients with known or suspected renal dysfunction may be needed
when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular
disorders were not enrolled in ARIKAYCE clinical trials. Patients
with known or suspected neuromuscular disorders, such as myasthenia
gravis, should be closely monitored since aminoglycosides may
aggravate muscle weakness by blocking the release of acetylcholine
at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause
fetal harm when administered to a pregnant woman. Aminoglycosides,
including ARIKAYCE, may be associated with total, irreversible,
bilateral congenital deafness in pediatric patients exposed in
utero. Patients who use ARIKAYCE during pregnancy, or become
pregnant while taking ARIKAYCE should be apprised of the potential
hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in
patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse
reactions in Trial 1 at an incidence ≥5% for patients using
ARIKAYCE plus background regimen compared to patients treated with
background regimen alone were dysphonia (47% vs 1%), cough (39% vs
17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%),
ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%),
musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs
10%), exacerbation of underlying pulmonary disease (15% vs 10%),
diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%),
headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash
(6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs
1%), and chest discomfort (5% vs 3%).
Drug Interactions: Avoid concomitant use of ARIKAYCE
with medications associated with neurotoxicity, nephrotoxicity, and
ototoxicity. Some diuretics can enhance aminoglycoside toxicity by
altering aminoglycoside concentrations in serum and tissue. Avoid
concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea,
or intravenous mannitol.
Overdosage: Adverse reactions specifically associated
with overdose of ARIKAYCE have not been identified. Acute toxicity
should be treated with immediate withdrawal of ARIKAYCE, and
baseline tests of renal function should be undertaken. Hemodialysis
may be helpful in removing amikacin from the body. In all cases of
suspected overdosage, physicians should contact the Regional Poison
Control Center for information about effective treatment.
U.S. INDICATION
LIMITED POPULATION: ARIKAYCE® is
indicated in adults, who have limited or no alternative treatment
options, for the treatment of Mycobacterium
avium complex (MAC) lung disease as part of a combination
antibacterial drug regimen in patients who do not achieve negative
sputum cultures after a minimum of 6 consecutive months of a
multidrug background regimen therapy. As only limited clinical
safety and effectiveness data for ARIKAYCE are currently available,
reserve ARIKAYCE for use in adults who have limited or no
alternative treatment options. This drug is indicated for
use in a limited and specific population of patients.
This indication is approved under accelerated approval based
on achieving sputum culture conversion (defined as 3 consecutive
negative monthly sputum cultures) by Month 6. Clinical benefit has
not yet been established. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied
in patients with refractory MAC lung disease defined as patients
who did not achieve negative sputum cultures after a minimum of 6
consecutive months of a multidrug background regimen therapy. The
use of ARIKAYCE is not recommended for patients with non-refractory
MAC lung disease.
Patients are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1–800–FDA–1088. You
can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing
Information.
About Insmed
Insmed Incorporated is a global biopharmaceutical company on a
mission to transform the lives of patients with serious and rare
diseases. Insmed's first commercial product, 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 is also advancing brensocatib, a novel oral
reversible inhibitor of dipeptidyl peptidase 1 with therapeutic
potential in bronchiectasis and other inflammatory diseases, and
treprostinil palmitil, 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 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 to successfully
commercialize or maintain U.S. approval for ARIKAYCE, the Company's
only approved product; the risk that brensocatib does not prove
effective or safe for patients in the STOP-COVID19 study; business
or economic disruptions due to catastrophes or other events,
including natural disasters or public health crises; impact of the
novel coronavirus (COVID-19) pandemic and efforts to reduce its
spread on our business, employees, including key personnel,
patients, partners and suppliers; 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 of
ARIKAYCE; inability of the Company, PARI or the Company's other
third party manufacturers to comply with regulatory requirements
related to ARIKAYCE or the Lamira® Nebulizer
System; the Company's inability to obtain adequate reimbursement
from government or third-party payors for ARIKAYCE or acceptable
prices for ARIKAYCE; development of unexpected safety or efficacy
concerns related to ARIKAYCE or brensocatib; inaccuracies in the
Company's estimates of the size of the potential markets for
ARIKAYCE or brensocatib 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, brensocatib and the Company's other
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 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, our Quarterly Report on Form 10-Q for
the quarter ended March 31, 2020 and any subsequent
Company filings with the SEC.
The Company cautions readers not to place undue reliance on any
such forward-looking statements, which speak only as of the date of
this press release. The Company disclaims any obligation, except as
specifically required by law and the rules of the SEC, to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
Financial Statements and Reconciliation Follow
|
INSMED
INCORPORATED
|
|
Consolidated
Statements of Net Loss
|
|
(in thousands,
except per share data)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30,
|
|
Six Months
Ended June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
Revenues,
net
|
$
42,495
|
|
$
29,972
|
|
$
79,355
|
|
$
51,874
|
|
Cost of product
revenues (excluding amortization of intangible assets)
|
9,950
|
|
4,919
|
|
18,388
|
|
9,069
|
|
Gross
profit
|
32,545
|
|
25,053
|
|
60,967
|
|
42,805
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
35,748
|
|
33,538
|
|
71,932
|
|
64,741
|
|
Selling, general and
administrative
|
49,663
|
|
52,433
|
|
101,009
|
|
107,243
|
|
Amortization of
intangible assets
|
1,248
|
|
1,248
|
|
2,497
|
|
2,496
|
|
Total operating
expenses
|
86,659
|
|
87,219
|
|
175,438
|
|
174,480
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(54,114)
|
|
(62,166)
|
|
(114,471)
|
|
(131,675)
|
|
|
|
|
|
|
|
|
|
|
Investment
income
|
203
|
|
2,578
|
|
1,607
|
|
4,994
|
|
Interest
expense
|
(7,469)
|
|
(6,785)
|
|
(14,880)
|
|
(13,511)
|
|
Other expense,
net
|
(46)
|
|
(51)
|
|
(10)
|
|
(170)
|
|
Loss before income
taxes
|
(61,426)
|
|
(66,424)
|
|
(127,754)
|
|
(140,362)
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
428
|
|
90
|
|
464
|
|
305
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(61,854)
|
|
$
(66,514)
|
|
$
(128,218)
|
|
$
(140,667)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.64)
|
|
$
(0.81)
|
|
$
(1.38)
|
|
$
(1.77)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
96,633
|
|
81,806
|
|
93,206
|
|
79,685
|
|
|
|
|
|
|
|
|
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
June 30,
2020
|
|
December 31,
2019
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
641,911
|
|
$
487,429
|
Accounts
receivable
|
|
15,173
|
|
19,232
|
Inventory
|
|
35,473
|
|
28,313
|
Prepaid expenses and
other current assets
|
|
14,755
|
|
20,220
|
Total current
assets
|
|
707,312
|
|
555,194
|
|
|
|
|
|
Intangibles,
net
|
|
51,185
|
|
53,682
|
Fixed assets,
net
|
|
56,826
|
|
60,180
|
Finance lease
right-of-use assets
|
|
14,536
|
|
15,256
|
Operating lease
right-of-use assets
|
|
31,901
|
|
37,673
|
Other
assets
|
|
23,605
|
|
20,314
|
Total
assets
|
|
$
885,365
|
|
$
742,299
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
25,005
|
|
$
13,184
|
Accrued
expenses
|
|
31,924
|
|
40,375
|
Accrued
compensation
|
|
13,021
|
|
19,140
|
Finance lease
liabilities
|
|
1,305
|
|
1,221
|
Operating lease
liabilities
|
|
7,499
|
|
11,040
|
Other current
liabilities
|
|
-
|
|
280
|
Total current
liabilities
|
|
78,754
|
|
85,240
|
|
|
|
|
|
Debt,
long-term
|
|
346,001
|
|
335,940
|
Finance lease
liabilities, long-term
|
|
18,855
|
|
19,529
|
Operating lease
liabilities, long-term
|
|
25,099
|
|
29,308
|
Other long-term
liabilities
|
|
11,338
|
|
10,608
|
Total
liabilities
|
|
480,047
|
|
480,625
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
shares, 101,434,104
and 89,682,387 issued and outstanding shares at June 30, 2020 and
December 31, 2019, respectively
|
|
1,014
|
|
897
|
Additional paid-in
capital
|
|
2,069,119
|
|
1,797,286
|
Accumulated
deficit
|
|
(1,664,717)
|
|
(1,536,499)
|
Accumulated other
comprehensive loss
|
|
(98)
|
|
(10)
|
Total shareholders'
equity
|
|
405,318
|
|
261,674
|
Total liabilities and
shareholders' equity
|
|
$
885,365
|
|
$
742,299
|
|
|
|
|
|
INSMED
INCORPORATED
|
Reconciliation of
GAAP to Non-GAAP Results
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30,
|
|
Six Months
Ended June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses - GAAP
|
$
86,659
|
|
$
87,219
|
|
$
175,438
|
|
$
174,480
|
Stock-based compensation expense
|
(9,468)
|
|
(7,353)
|
|
(18,470)
|
|
(14,289)
|
Depreciation
|
(2,268)
|
|
(1,176)
|
|
(4,534)
|
|
(2,245)
|
Amortization of intangibles
|
(1,248)
|
|
(1,248)
|
|
(2,497)
|
|
(2,496)
|
CFFT milestone payments
|
-
|
|
(3,000)
|
|
-
|
|
(3,000)
|
Adjusted operating
expenses - Non-GAAP
|
$
73,675
|
|
$
74,442
|
|
$
149,937
|
|
$
152,450
|
|
|
|
|
|
|
|
|
Contact:
Investors:
Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902
insmed@argotpartners.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated