BRIDGEWATER, N.J., April 30, 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 first quarter
ended March 31, 2020, and provided a
business update.
"The start of 2020 saw an unprecedented global event with the
COVID-19 pandemic. We are proud to be fighting this disease
alongside many in the biopharmaceutical industry by supporting an
investigator-initiated study of brensocatib, formerly known as
INS1007, in patients with severe COVID-19. While we continue to
advance this novel treatment candidate in bronchiectasis, we are
hopeful that Insmed can contribute in the fight against COVID-19,"
commented Will Lewis, Chairman and Chief Executive Officer of
Insmed. "I am also pleased that in an incredibly challenging
environment, we have been able to support the NTM lung disease
community remotely and provide an uninterrupted supply of ARIKAYCE
while working to ensure the safety of all stakeholders, including
our employees. With meaningful advances in our pipeline; important
growth catalysts for ARIKAYCE; and a strong balance sheet, we
believe we are well-positioned to stay the course through these
challenging times and continue to serve patients in need."
First Quarter 2020 Financial Results
- Total revenue for the first quarter ended March 31, 2020, was $36.9
million, comprising U.S. net sales of $35.2 million and ex-U.S. net sales of
$1.7 million. This compares to total
revenue of $21.9 million for the
first quarter of 2019.
- Cost of product revenues (excluding amortization of intangible
assets) was $8.4 million for the
first quarter of 2020, compared to $4.2
million for the first quarter of 2019.
- Research and development (R&D) expenses were $36.2 million for the first quarter of 2020,
compared to $31.2 million for the
first quarter of 2019. The increase in R&D expenses is
primarily attributable to an increase in compensation and
benefit-related expenses, including stock-based compensation
expense, due to an increase in headcount and increases in
manufacturing and regulatory, quality assurance, and medical
affairs costs.
- Selling, general, and administrative (SG&A) expenses for
the first quarter of 2020 were $51.3
million, compared to $54.8
million for the first quarter of 2019. The decrease in
SG&A expenses is primarily due to a decrease in compensation
and benefit-related costs and external costs related to
ARIKAYCE® (amikacin liposome inhalation
suspension).
- For the first quarter of 2020, Insmed reported a GAAP net loss
of $66.4 million, or $0.74 per share, compared to a GAAP net loss of
$74.2 million, or $0.96 per share, for the first quarter of
2019.
Recent Corporate Developments & Program
Highlights
Brensocatib Program Updates:
As previously announced:
- Phase 3 Study in Bronchiectasis: Insmed plans to
initiate a Phase 3 program with brensocatib in patients with
bronchiectasis in the second half of 2020, following alignment with
the U.S. Food and Drug Administration (FDA) on trial design.
- Investigator-Initiated Study in Severe COVID-19:
Insmed is supporting an investigator-initiated study of brensocatib
in patients with severe COVID-19. The randomized, double-blind,
placebo-controlled trial is expected to enroll up to 300 patients
hospitalized with confirmed COVID-19 and will be led by the
University of Dundee in the UK.
- AstraZeneca Option Exercise: In March 2020, AstraZeneca AB exercised an option
pursuant to the companies' October
2016 license agreement under which AstraZeneca can advance
clinical development of brensocatib in the indication of chronic
obstructive pulmonary disease (COPD) or asthma up to and including
Phase 2b clinical trials. Insmed
retains full development and commercialization rights for
brensocatib in all other indications and geographies.
ARIKAYCE Label Expansion
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 ARIKAYCE 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.
Global Growth
Insmed remains on track in preparing for potential approvals and
commercial launches of ARIKAYCE in both Japan and Europe. In Japan, the Company announced in March that it
had submitted a new drug application to the Ministry of
Health, Labour and Welfare for ARIKAYCE for the treatment of
patients with NTM lung disease caused by MAC who did not
sufficiently respond to prior treatment. In Europe, pending approval of the marketing
authorization application for ARIKAYCE, the Company anticipates a
potential launch in Germany by the
end of 2020, followed shortly thereafter by the UK.
Treprostinil Palmitil (Formerly INS1009)
Advancement
Insmed is advancing treprostinil palmitil, formerly known as
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 treprostinil palmitil in the second
half of 2020.
COVID-19 Response
In March 2020, Insmed implemented,
and continues to maintain, a number of corporate initiatives in
response to the global COVID-19 pandemic. These include a remote
working policy for all employees, including field-based therapeutic
specialists and employees who support ARIKAYCE prescribers, to aid
the global containment effort. The Company is providing remote
support and engagement options to both healthcare professionals and
patients prescribed ARIKAYCE.
Importantly, Insmed has observed no disruptions to date in its
supply chain for the production of ARIKAYCE. The Company believes
it has enough active pharmaceutical ingredient used in ARIKAYCE to
meet anticipated global requirements, including commercial,
clinical and compassionate use, through the end of 2022.
Balance Sheet
As of March 31,
2020, Insmed had cash and cash equivalents of $428.9
million. The Company's total operating expenses for the first
quarter of 2020 were $88.8 million.
Adjusted operating expenses, as defined below, for the first
quarter of 2020 were $76.3
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 our
earlier-stage research pipeline; and
|
(iii)
|
expansion
in Japan and Europe to support pre-commercial activities
for ARIKAYCE in those regions.
|
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 2121512. 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 May 14, 2020 by
dialing (877) 344-7529 (domestic) or (412) 317-0088 (international)
and referencing replay access code 10142785. 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
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. 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 Brensocatib (Formerly INS1007)
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's earlier-stage clinical pipeline includes
brensocatib, a novel oral reversible inhibitor of dipeptidyl
peptidase 1 with therapeutic potential in non-cystic fibrosis
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: 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; the risk that the full data set from the WILLOW
study, our six-month Phase 2 trial of brensocatib in patients with
NCBFE or data generated in further clinical trials of brensocatib
will not be consistent with the top-line results of the study;
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 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 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
Consolidated
Statements of Net Loss
|
(in thousands,
except per share data)
|
(unaudited)
|
|
|
|
|
|
|
Three Months
Ended March 31,
|
|
|
2020
|
|
2019
|
|
|
|
|
Revenues,
net
|
$
36,860
|
|
$
21,902
|
|
Cost of product
revenues (excluding amortization of intangible
assets)
|
8,438
|
|
4,150
|
|
Gross
profit
|
28,422
|
|
17,752
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
36,184
|
|
31,203
|
|
Selling, general and
administrative
|
51,346
|
|
54,810
|
|
Amortization of
intangible assets
|
1,249
|
|
1,248
|
|
Total operating
expenses
|
88,779
|
|
87,261
|
|
|
|
|
|
|
Operating
loss
|
(60,357)
|
|
(69,509)
|
|
|
|
|
|
|
Investment
income
|
1,404
|
|
2,416
|
|
Interest
expense
|
(7,411)
|
|
(6,726)
|
|
Other income
(expense), net
|
36
|
|
(119)
|
|
Loss before income
taxes
|
(66,328)
|
|
(73,938)
|
|
|
|
|
|
|
Provision for income
taxes
|
36
|
|
215
|
|
|
|
|
|
|
Net loss
|
$
(66,364)
|
|
$
(74,153)
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.74)
|
|
$
(0.96)
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
89,779
|
|
77,541
|
|
|
|
|
|
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
March 31,
2020
|
|
December 31,
2019
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
428,942
|
|
$
487,429
|
Accounts
receivable
|
|
17,154
|
|
19,232
|
Inventory
|
|
30,645
|
|
28,313
|
Prepaid expenses and
other current assets
|
|
15,769
|
|
20,220
|
Total current
assets
|
|
492,510
|
|
555,194
|
|
|
|
|
|
Intangibles,
net
|
|
52,433
|
|
53,682
|
Fixed assets,
net
|
|
58,638
|
|
60,180
|
Finance lease
right-of-use assets
|
|
14,896
|
|
15,256
|
Operating lease
right-of-use assets
|
|
36,137
|
|
37,673
|
Other
assets
|
|
21,911
|
|
20,314
|
Total
assets
|
|
$
676,525
|
|
$
742,299
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
18,188
|
|
$
13,184
|
Accrued
expenses
|
|
32,687
|
|
40,375
|
Accrued
compensation
|
|
8,949
|
|
19,140
|
Finance lease
liabilities
|
|
1,263
|
|
1,221
|
Operating lease
liabilities
|
|
10,367
|
|
11,040
|
Other current
liabilities
|
|
78
|
|
280
|
Total current
liabilities
|
|
71,532
|
|
85,240
|
|
|
|
|
|
Debt,
long-term
|
|
340,939
|
|
335,940
|
Finance lease
liabilities, long-term
|
|
19,196
|
|
19,529
|
Operating lease
liabilities, long-term
|
|
27,197
|
|
29,308
|
Other long-term
liabilities
|
|
10,960
|
|
10,608
|
Total
liabilities
|
|
469,824
|
|
480,625
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
shares, 89,859,549
and 89,682,387 issued and outstanding shares
at March 31, 2020 and December 31, 2019, respectively
|
|
899
|
|
897
|
Additional paid-in
capital
|
|
1,808,712
|
|
1,797,286
|
Accumulated
deficit
|
|
(1,602,863)
|
|
(1,536,499)
|
Accumulated other
comprehensive loss
|
|
(47)
|
|
(10)
|
Total shareholders'
equity
|
|
206,701
|
|
261,674
|
Total liabilities and
shareholders' equity
|
|
$
676,525
|
|
$
742,299
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP Results
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended March 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses - GAAP
|
$
88,779
|
|
$
87,261
|
|
|
Stock-based compensation expense
|
(9,002)
|
|
(6,936)
|
|
|
Depreciation
|
(2,266)
|
|
(1,069)
|
|
|
Amortization of intangibles
|
(1,249)
|
|
(1,248)
|
|
|
Adjusted operating
expenses - Non-GAAP
|
$
76,262
|
|
$
78,008
|
|
|
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