BRIDGEWATER, N.J., Feb. 25, 2021 /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, 2020
and provided a business update.
"2020 was the most productive and significant year in Insmed's
history, as we evolved from a single-product company with a
successful U.S. launch to a truly global organization advancing
three distinct, value-creating programs. I am incredibly proud of
our team's performance, which is all the more exemplary against the
backdrop of COVID-19," commented Will Lewis, Chair and Chief
Executive Officer of Insmed. "In the fourth quarter, we initiated
both the Phase 3 ASPEN study of brensocatib in patients with
bronchiectasis and the ARIKAYCE frontline clinical trial program in
patients with NTM lung disease caused by MAC; advanced our ARIKAYCE
launch in Europe and prepared for
a potential approval and launch in Japan while maintaining steady performance in
the U.S.; and advanced the development of TPIP, for which we
announced positive Phase 1 data just last week. We begin 2021 with
incredible momentum and believe we have the capabilities and talent
to achieve our ambitious vision."
Recent Corporate Developments & Program
Highlights
ARIKAYCE
- ARIKAYCE has now been launched in both Germany and the
Netherlands following approval by the European Commission in
October 2020 for the treatment of NTM
lung infections caused by MAC in adults with limited treatment
options who do not have cystic fibrosis (CF). Consideration should
be given to official guidance on the appropriate use of
antibacterial agents. Insmed will continue to work to secure
reimbursement and launch in other European markets throughout 2021
and into 2022.
- In Japan, Insmed continues to
anticipate launching ARIKAYCE in mid-2021, pending approval by the
Ministry of Health, Labour, and Welfare of our application for the
treatment of patients with NTM lung disease caused by MAC who did
not sufficiently respond to prior treatment.
- In December 2020, the first
patient was dosed in the post-approval confirmatory frontline
clinical trial program of ARIKAYCE in patients with NTM lung
disease caused by MAC. The program consists of ARISE, an
interventional study designed to validate a patient-reported
outcome (PRO) tool in MAC lung disease, and ENCORE, a pivotal trial
designed to establish, using the PRO tool validated in the ARISE
trial, the clinical benefits and evaluate the safety of ARIKAYCE in
patients with newly diagnosed MAC lung disease. More information on
these studies is available at clinicaltrials.gov (ARISE:
NCT04677543; ENCORE: NCT04677569).
Brensocatib
- In November 2020, the European
Medicines Agency (EMA) granted Priority Medicines (PRIME)
designation to brensocatib for the treatment of non-cystic fibrosis
bronchiectasis (NCFBE), recognizing the potential for brensocatib
to offer a new treatment approach for patients with
bronchiectasis.
- In December 2020, the first
patient was dosed in the Phase 3 ASPEN study of brensocatib in
patients with bronchiectasis. ASPEN is a global, randomized, double-blind,
placebo-controlled Phase 3 study to assess the efficacy, safety,
and tolerability of brensocatib in patients with bronchiectasis.
Patients with bronchiectasis due to CF may not be enrolled in the
study. More information on this study is available at
clinicaltrials.gov (NCT04594369).
- Insmed plans to initiate a Phase 2 pharmacokinetic
multiple-dose study of brensocatib in patients with CF by
mid-2021.
- Insmed anticipates that topline data from STOP-COVID19, the
investigator-initiated trial of brensocatib in hospitalized
patients with COVID-19, will be shared by early Q2 2021.
TPIP
- Insmed has completed the Phase 1 healthy volunteer trial
designed to assess the pharmacokinetics and tolerability profile of
TPIP. As reported on February 19,
2021, data from the study demonstrated that TPIP was
generally well tolerated, with a pharmacokinetic profile that
supports continued development with once-daily dosing. Insmed plans
to present full data from this study at an upcoming medical
meeting.
- Insmed plans to advance the development of TPIP with two
parallel studies in patients with pulmonary arterial hypertension
(PAH). One is an open-label, proof-of-mechanism study to understand
the impact of TPIP on pulmonary vascular resistance (PVR) over a
24-hour period. The Company anticipates sharing topline data from
this study in the second half of 2021. The other study will aim to
investigate the effect of TPIP on PVR and 6-minute walk distance
over a 16-week treatment period using an up-titration, once-daily
dosing schedule. The Company plans to initiate this trial in the
fourth quarter of 2021.
- The Company also plans to initiate a study of TPIP in patients
with pulmonary hypertension associated with interstitial lung
disease (PH-ILD).
Fourth Quarter and Full-Year 2020 Financial Results
- Total revenue for the fourth quarter ended December 31, 2020 was $41.4 million, compared to total revenue of
$45.7 million for the fourth quarter
of 2019. Total revenue for the full year 2020 was $164.4 million, compared to total revenue of
$136.5 million for the full year
2019.
- Cost of product revenues (excluding amortization of intangible
assets) was $10.9 million for the
fourth quarter of 2020, compared to $8.7
million for the fourth quarter of 2019. For the full year
2020, cost of product revenues was $39.9
million compared to $24.2
million in 2019.
- Research and development (R&D) expenses were $67.8 million for the fourth quarter of 2020,
compared to $32.6 million for the
fourth quarter of 2019. For the full year 2020, R&D expenses
were $181.2 million compared to
$131.7 million in 2019.
- Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2020 were $56.0
million, compared to $50.2
million for the fourth quarter of 2019. For the full year
2020, SG&A expenses were $203.6
million, compared to $210.8
million in 2019.
- For the fourth quarter of 2020, Insmed reported a GAAP net loss
of $102.2 million, or $1.00 per share, compared to a GAAP net loss of
$53.0 million, or $0.59 per share, for the fourth quarter of 2019.
For the full year 2020, Insmed reported a GAAP net loss of
$294.1 million, or $3.01 per share, compared to a GAAP net loss of
$254.3 million, or $3.01 per share, in 2019.
Balance Sheet and Planned Investments
As of December 31,
2020, Insmed had cash and cash equivalents of $532.8
million. The Company's total operating expenses for the fourth
quarter of 2020 were $136.0 million
and for the full year 2020 were $429.6
million. Adjusted R&D expenses for the fourth quarter of
2020 were $63.6 million and for the
full year 2020 were $164.6 million.
Adjusted SG&A expenses for the fourth quarter were $49.1 million and for the full year 2020 were
$174.8 million. Adjusted R&D
expenses and adjusted SG&A expenses are non-GAAP measures,
which we describe further below.
The Company plans to invest in the following key activities in
2021:
(i)
|
U.S.
commercialization of ARIKAYCE;
|
(ii)
|
clinical trial
activities, including (a) advancement of the frontline clinical
trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of
the Phase 3 ASPEN study of brensocatib in patients with
bronchiectasis, (c) advancement of clinical development of TPIP,
and (d) the advancement of our earlier-stage research pipeline;
and
|
(iii)
|
launch activities for
ARIKAYCE in initial European countries and potential launch
activities for ARIKAYCE in Japan.
|
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 (833)
340-0284 (domestic) or (236) 712-2425 (international) and
referencing conference ID number 4261618. The call will also be
webcast live on the company's website at www.insmed.com.
A replay of the conference call will be accessible approximately
two hours after its completion through March
27, 2021 by dialing (800) 585-8367 (domestic) or (416)
621-4642 (international) and referencing conference ID number
4261618. 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 non-GAAP
financial measures: adjusted R&D expenses,
which Insmed defines as R&D expenses less stock-based
compensation expense and depreciation; and adjusted SG&A
expenses, which Insmed defines as SG&A expenses less
stock-based compensation, depreciation, and certain milestones
related to ARIKAYCE, which are payable under our amended agreements
with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT). A
reconciliation of these non-GAAP financial measures to their most
directly comparable GAAP financial measure is presented in the
table attached to this press release.
Management believes that these non-GAAP financial measures are
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 these non-GAAP financial
measures to be considered in isolation or as a substitute for
results prepared in accordance with GAAP. In addition, these
non-GAAP financial measures may differ from similarly named
measures used by other companies.
About ARIKAYCE
ARIKAYCE is approved in the United
States as ARIKAYCE® (amikacin liposome inhalation
suspension) and in the EU as ARIKAYCE® Liposomal 590 mg
Nebuliser Dispersion. Current international treatment guidelines
recommend the use of ARIKAYCE for appropriate patients. 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 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 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 to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of
dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the
treatment of patients with non-cystic fibrosis bronchiectasis
(NCFBE) and other neutrophil-mediated diseases. 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. Brensocatib is an investigational drug product
that has not been approved for any indication in any
jurisdiction.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder
formulation of treprostinil palmitil, a treprostinil prodrug
consisting of treprostinil linked by an ester bond to a 16-carbon
chain. Developed entirely in Insmed's laboratories, TPIP is a
potentially highly differentiated prostanoid being evaluated for
the treatment of patients with PAH and other rare and serious
pulmonary disorders. TPIP is administered in a capsule-based
inhalation device. TPIP is an investigational drug product that has
not been approved for any indication in any jurisdiction.
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 is a first-in-disease
therapy approved in the United
States and the European Union to treat a chronic,
debilitating lung disease. The Company is also progressing a robust
pipeline of investigational therapies targeting areas of serious
unmet need, including neutrophil-mediated inflammatory diseases and
rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing
footprint across Europe and in
Japan. 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 Europe, or for the Company's product
candidates in the U.S., Europe, Japan or other
markets; failure to successfully commercialize ARIKAYCE, the
Company's only approved product, in the U.S. or Europe (amikacin liposome inhalation
suspension and Liposomal 590 mg Nebuliser Dispersion,
respectively), or to maintain U.S. or European approval for
ARIKAYCE; 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 the Company's business, employees, including
key personnel, patients, partners and suppliers; risk that
brensocatib does not prove effective or safe for patients in
ongoing and future clinical studies, including the ASPEN study; risk that TPIP does not prove to
be effective or safe for patients in ongoing and future clinical
studies; 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 U.S. Food and Drug Administration,
including the risk that the Company will not timely and
successfully complete the study to validate a PRO tool and the
confirmatory post-marketing study required for full approval of
ARIKAYCE; inability of the Company, PARI Pharma GmbH (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
the Company's product candidates; inaccuracies in the Company's
estimates of the size of the potential markets for ARIKAYCE or its
product candidates 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 or any of
the Company's product candidates that are approved in the future;
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, TPIP and
the Company's other product candidates due to the Company's limited
experience in conducting preclinical development activities and
clinical trials necessary for regulatory approval and its potential
inability to enroll or retain sufficient patients to conduct and
complete the trials or generate data necessary for regulatory
approval, among other things; risks that our 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 the
Company's agreements or 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 third-party
manufacturing facility approved by the appropriate regulatory
authorities 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, 2020 and any subsequent Company filings
with the Securities and Exchange Commission (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
December 31,
|
|
Twelve
Months Ended
December 31,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
Product revenues,
net
|
$
41,415
|
|
$
45,708
|
|
$
164,413
|
|
$
136,467
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization of intangible assets)
|
10,862
|
|
8,706
|
|
39,872
|
|
24,212
|
Research and
development
|
67,814
|
|
32,630
|
|
181,157
|
|
131,711
|
Selling, general and
administrative
|
56,019
|
|
50,206
|
|
203,613
|
|
210,796
|
Amortization of
intangible assets
|
1,258
|
|
1,248
|
|
5,003
|
|
4,993
|
Total operating
expenses
|
135,953
|
|
92,790
|
|
429,645
|
|
371,712
|
|
|
|
|
|
|
|
|
Operating
loss
|
(94,538)
|
|
(47,082)
|
|
(265,232)
|
|
(235,245)
|
|
|
|
|
|
|
|
|
Investment
income
|
26
|
|
2,042
|
|
1,703
|
|
9,921
|
Interest
expense
|
(7,499)
|
|
(7,348)
|
|
(29,564)
|
|
(27,705)
|
Other income
(expense), net
|
419
|
|
(276)
|
|
405
|
|
(531)
|
Loss before income
taxes
|
(101,592)
|
|
(52,664)
|
|
(292,688)
|
|
(253,560)
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
621
|
|
324
|
|
1,402
|
|
777
|
|
|
|
|
|
|
|
|
Net loss
|
$
(102,213)
|
|
$
(52,988)
|
|
$
(294,090)
|
|
$
(254,337)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(1.00)
|
|
$
(0.59)
|
|
$
(3.01)
|
|
$
(3.01)
|
|
|
|
|
|
|
|
|
Weighted average
basic and diluted common shares outstanding
|
102,297
|
|
89,466
|
|
97,605
|
|
84,560
|
INSMED
INCORPORATED
|
Consolidated
Balance Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
532,756
|
|
$
487,429
|
Accounts
receivable
|
|
16,562
|
|
19,232
|
Inventory
|
|
49,592
|
|
28,313
|
Prepaid expenses and
other current assets
|
|
23,982
|
|
20,220
|
Total current
assets
|
|
622,892
|
|
555,194
|
|
|
|
|
|
Intangibles,
net
|
|
49,261
|
|
53,682
|
Fixed assets,
net
|
|
53,953
|
|
60,180
|
Finance lease
right-of-use assets
|
|
10,334
|
|
15,256
|
Operating lease
right-of-use assets
|
|
32,946
|
|
37,673
|
Other
assets
|
|
26,769
|
|
20,314
|
Total
assets
|
|
$
796,155
|
|
$
742,299
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
42,853
|
|
$
13,184
|
Accrued
expenses
|
|
37,807
|
|
40,375
|
Accrued
compensation
|
|
25,591
|
|
19,140
|
Finance lease
liabilities
|
|
1,081
|
|
1,221
|
Operating lease
liabilities
|
|
11,475
|
|
11,040
|
Other current
liabilities
|
|
-
|
|
280
|
Total current
liabilities
|
|
118,807
|
|
85,240
|
|
|
|
|
|
Debt,
long-term
|
|
356,318
|
|
335,940
|
Finance lease
liabilities, long-term
|
|
14,713
|
|
19,529
|
Operating lease
liabilities, long-term
|
|
21,255
|
|
29,308
|
Other long-term
liabilities
|
|
9,178
|
|
10,608
|
Total
liabilities
|
|
520,271
|
|
480,625
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01
par value; 500,000,000 authorized
|
|
|
|
|
shares, 102,763,060
and 89,682,387 issued and outstanding shares at December 31, 2020
and December 31, 2019, respectively
|
|
1,028
|
|
897
|
Additional paid-in
capital
|
|
2,105,252
|
|
1,797,286
|
Accumulated
deficit
|
|
(1,830,589)
|
|
(1,536,499)
|
Accumulated other
comprehensive income (loss)
|
|
193
|
|
(10)
|
Total shareholders'
equity
|
|
275,884
|
|
261,674
|
Total liabilities and
shareholders' equity
|
|
$
796,155
|
|
$
742,299
|
INSMED
INCORPORATED
|
Reconciliation of
GAAP to Non-GAAP Results
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve
Months Ended
December 31,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP research and
development
|
$
67,814
|
|
$
32,630
|
|
$
181,157
|
|
$
131,711
|
Stock-based compensation expense
|
(3,010)
|
|
(1,630)
|
|
(11,789)
|
|
(8,210)
|
Depreciation
|
(1,205)
|
|
(883)
|
|
(4,751)
|
|
(2,695)
|
Adjusted R&D
expenses (non-GAAP)
|
$
63,599
|
|
$
30,117
|
|
$
164,617
|
|
$
120,806
|
|
|
|
|
|
|
|
|
GAAP selling,
general and administrative
|
$
56,019
|
|
$
50,206
|
|
$
203,613
|
|
$
210,796
|
Stock-based compensation expense
|
(5,769)
|
|
(4,258)
|
|
(24,369)
|
|
(18,761)
|
Depreciation
|
(1,113)
|
|
(1,056)
|
|
(4,396)
|
|
(2,493)
|
CFFT milestone payments
|
-
|
|
-
|
|
-
|
|
(10,249)
|
Adjusted SG&A
expenses (non-GAAP)
|
$
49,137
|
|
$
44,892
|
|
$
174,848
|
|
$
179,293
|
Contact:
Investors:
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 487-7468
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated