—ARIKAYCE® (amikacin liposome
inhalation suspension) Achieves 45% Year Over Year Growth for the
Third Quarter of 2022 with Total Revenue of $67.7 Million, Marking the Strongest Quarter
Since Launch—
—Clinical Programs Progressing on Track;
Company Expects to Complete Enrollment in Phase 3 ASPEN Trial of
Brensocatib in First Quarter of 2023 and Share Topline Data in
Second Quarter of 2024—
—Recent Strategic Financings Increase Cash and
Cash Equivalents and Marketable Securities to Approximately
$1.3 Billion to Support Key Upcoming
Milestones Across Four Pillars—
BRIDGEWATER, N.J., Oct. 27,
2022 /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 third quarter ended
September 30, 2022 and provided a
business update.
"The third quarter of 2022 marked a critical inflection point
for Insmed as we advanced strong revenue growth for ARIKAYCE,
continued to successfully enroll our clinical trials, and, more
recently, secured meaningful financing to advance our four pillars
through key upcoming clinical trial readouts," commented Will
Lewis, Chair and Chief Executive Officer of Insmed. "As we head
into the final months of the year, we are extremely well-positioned
for the potential transformation that could be ahead for Insmed. We
are executing around the world across all aspects of our business
and are tremendously excited for the opportunity to serve many more
patients with serious and rare diseases."
Recent Pillar Highlights
ARIKAYCE
- In the third quarter of 2022, ARIKAYCE revenue grew 45% over
the third quarter of 2021, reflecting strong growth in U.S. sales,
ongoing encouraging performance in Japan, and contributions from European
markets.
- In Europe, Insmed recently
secured a favorable reimbursement approval for ARIKAYCE in
England. ARIKAYCE is now
commercially available in Germany,
the Netherlands, the United Kingdom, Italy, and Belgium.
- Enrollment remains on track in the post-marketing confirmatory,
frontline clinical trial program of ARIKAYCE in patients with
nontuberculous mycobacterial lung disease caused by
Mycobacterium avium complex (MAC), consisting of the ARISE
and ENCORE trials. Insmed anticipates completing enrollment in
ARISE in the coming weeks and sharing data from the trial over the
course of 2023. The Company also continues to anticipate completing
enrollment in ENCORE by the end of 2023.
Brensocatib
- Enrollment remains on track in the Phase 3 ASPEN study, a
global, randomized, double-blind, placebo-controlled trial to
assess the efficacy, safety, and tolerability of brensocatib in
patients with bronchiectasis. Insmed anticipates completing
enrollment in this trial in the first quarter of 2023 and sharing
topline data in the second quarter of 2024.
- Insmed is conducting a Phase 2 pharmacokinetic/pharmacodynamic
study of brensocatib in patients with cystic fibrosis (CF), which
includes both patients who are and who are not on background CF
transmembrane conductance regulator (CFTR) modulator drugs. This
study is fully enrolled and the Company anticipates having topline
data by the end of 2022 for both sets of patients.
- As previously shared, Insmed plans to develop brensocatib in
two new potential indications – chronic rhinosinusitis without
nasal polyps (CRSsNP) and hidradenitis suppurativa (HS). Insmed
anticipates moving brensocatib into clinical development for CRSsNP
by the middle of 2023, followed by HS.
TPIP
- Insmed is currently enrolling two Phase 2 studies of
treprostinil palmitil inhalation powder (TPIP). These include a
Phase 2 study to assess the safety and tolerability of TPIP in
patients with pulmonary hypertension associated with interstitial
lung disease (PH-ILD) over a 16-week treatment period, as well as a
Phase 2b study to evaluate the effect
of TPIP on pulmonary vascular resistance (PVR) and 6-minute walk
distance over a 16-week treatment period in patients with pulmonary
arterial hypertension (PAH).
Translational Medicine
- Insmed is advancing a translational medicine portfolio
encompassing a wide range of technologies and modalities, including
gene therapy, gene editing, protein deimmunization, and
manufacturing capabilities. The Company anticipates filing one to
two Investigational New Drug Applications from this portfolio in
2023 and one to two more in 2024.
Third Quarter 2022 Financial Results
- Total revenue for the third quarter ended September 30, 2022, was $67.7 million, compared to total revenue of
$46.8 million for the third quarter
of 2021. Total revenue for the third quarter of 2022 comprised
ARIKAYCE net sales of $49.5 million
in the U.S., $14.5 million in
Japan, and $3.7 million in Europe and rest of world.
- Cost of product revenues (excluding amortization of intangible
assets) was $13.5 million for the
third quarter of 2022, compared to $10.2
million for the third quarter of 2021.
- Research and development (R&D) expenses were $99.9 million for the third quarter of 2022,
compared to $70.3 million for the
third quarter of 2021.
- Selling, general and administrative (SG&A) expenses for the
third quarter of 2022 were $75.6
million, compared to $60.3
million for the third quarter of 2021.
- For the third quarter of 2022, Insmed reported a net loss of
$131.1 million, or $1.09 per share, compared to a net loss of
$112.7 million, or $0.96 per share, for the third quarter of
2021.
Balance Sheet, Financial Guidance, and Planned
Investments
As of September 30,
2022, Insmed had cash and cash equivalents and marketable
securities of $513.3 million. On October 19, 2022, Insmed announced strategic
financings resulting in aggregate gross proceeds of $775 million that will place the Company in a
position to deliver clinical data from each of its four pillars.
The Company's total operating expenses for the third quarter of
2022 were $195.4 million.
Insmed continues to expect full-year 2022 global revenues for
ARIKAYCE to increase at least 30% year over year from 2021.
The Company plans to continue to invest in the following key
activities during the remainder of 2022:
(i)
|
commercialization and
expansion of ARIKAYCE globally;
|
(ii)
|
advancement of
brensocatib, including the Phase 3 ASPEN study in patients with
bronchiectasis and commercial launch readiness
activities;
|
(iii)
|
advancement of the
confirmatory, frontline clinical trial program for ARIKAYCE (ARISE
and ENCORE); and
|
(iv)
|
advancement of our
earlier-stage pipeline, including the Phase 2 clinical development
programs for TPIP and advancing our translational medicine
efforts.
|
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 (844)
200-6205 (U.S.) or (929) 526-1599 (international) and referencing
access code 889963. 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
2 hours after its completion through November 26, 2022, by
dialing (866) 813-9403 (U.S.) or (+44) 204-525-0658 (international)
and referencing access code 035584. 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.
About ARIKAYCE
ARIKAYCE is approved in the United States as
ARIKAYCE® (amikacin liposome inhalation
suspension), in Europe as
ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion,
and in Japan as
ARIKAYCE® inhalation 590 mg (amikacin sulfate inhalation
drug product). 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 bronchiectasis 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, PH-ILD, 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, Europe, and
Japan 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 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 timings 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., Europe or Japan, or for the Company's product candidates
in the U.S., Europe, Japan or other markets,
including separate regulatory approval for the
Lamira® Nebulizer System and other product
candidate devices in each market and for each usage; failure to
successfully commercialize ARIKAYCE, the Company's only approved
product, in the U.S., Europe or
Japan (amikacin liposome
inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and
amikacin sulfate inhalation drug product, respectively), or to
maintain U.S., European or Japanese approval for ARIKAYCE; business
or economic disruptions due to catastrophes or other events,
including natural disasters or public health crises; impact of the
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 successfully or in a
timely manner complete the study to validate a patient reported
outcome tool and the confirmatory post-marketing clinical trial
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
the Company's product candidates; inaccuracies in the Company's
estimates of the size of the potential markets for ARIKAYCE,
brensocatib, TPIP or the Company's other 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 risks and uncertainties
associated with, and the perceived benefits of, our secured senior
loan with certain funds managed by Pharmakon Advisors, LP and our
royalty financing with OrbiMed Royalty & Credit Opportunities
IV, LP, including our ability to maintain compliance with the
covenants in the agreements for the senior secured loan and royalty
financing and the perceived impact of the restrictions on our
operations under these agreements; 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; risk that the Company's competitors may obtain
orphan drug exclusivity for a product that is essentially the same
as a product the Company is developing for a particular
indication; failure to successfully predict the time and cost
of development, regulatory approval and commercialization for novel
gene therapy products; 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 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 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
successfully integrate its recent acquisitions and appropriately
manage the amount of management's time and attention devoted to
integration activities; risks that the Company's acquired
technologies, products and product candidates are not commercially
successful; the Company's inability to adapt to its highly
competitive and changing environment; risk that the Company is
unable to maintain its significant customers; risk that government
healthcare reform materially increases the Company's costs and
damages its financial condition; 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 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; risk
that the Company's operations are subject to a material disruption
in the event of a cybersecurity attack or issue; business
disruptions or expenses related to the upgrade to the Company's
enterprise resource planning system; 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; the Company's history of operating losses, and the
possibility that the Company may never achieve or maintain
profitability; goodwill impairment charges affecting the Company's
results of operations and financial condition; 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, 2021 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 Follow
INSMED
INCORPORATED
|
Consolidated
Statements of Net Loss
|
(in thousands,
except per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
Product revenues,
net
|
$
67,730
|
|
$
46,757
|
|
$ 186,058
|
|
$ 132,337
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
revenues (excluding amortization of intangible
assets)
|
13,471
|
|
10,183
|
|
42,057
|
|
30,864
|
Research and
development
|
99,872
|
|
70,347
|
|
272,755
|
|
196,392
|
Selling, general and
administrative
|
75,583
|
|
60,280
|
|
192,305
|
|
169,007
|
Amortization of
intangible assets
|
1,263
|
|
1,264
|
|
3,789
|
|
3,790
|
Change in fair value of
deferred and contingent consideration
liabilities
|
5,238
|
|
8,300
|
|
(19,002)
|
|
8,300
|
Total operating
expenses
|
195,427
|
|
150,374
|
|
491,904
|
|
408,353
|
|
|
|
|
|
|
|
|
Operating
loss
|
(127,697)
|
|
(103,617)
|
|
(305,846)
|
|
(276,016)
|
|
|
|
|
|
|
|
|
Investment
income
|
1,791
|
|
46
|
|
2,763
|
|
113
|
Interest
expense
|
(3,353)
|
|
(11,245)
|
|
(10,001)
|
|
(29,123)
|
Loss on extingushment
of debt
|
-
|
|
-
|
|
-
|
|
(17,689)
|
Other expense,
net
|
(1,514)
|
|
(476)
|
|
(7,069)
|
|
(678)
|
Loss before income
taxes
|
(130,773)
|
|
(115,292)
|
|
(320,153)
|
|
(323,393)
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
372
|
|
(2,578)
|
|
1,258
|
|
(1,717)
|
|
|
|
|
|
|
|
|
Net loss
|
$ (131,145)
|
|
$ (112,714)
|
|
$
(321,411)
|
|
$
(321,676)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(1.09)
|
|
$
(0.96)
|
|
$
(2.68)
|
|
$
(2.93)
|
|
|
|
|
|
|
|
|
Weighted average basic
and diluted common shares outstanding
|
120,789
|
|
117,092
|
|
119,780
|
|
109,955
|
INSMED
INCORPORATED
|
Consolidated Balance
Sheets
|
(in thousands,
except par value and share data)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
September 30,
2022
|
|
December 31,
2021
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
414,633
|
|
$
716,782
|
Marketable
securities
|
|
98,662
|
|
-
|
Accounts
receivable
|
|
27,401
|
|
24,351
|
Inventory
|
|
66,276
|
|
67,009
|
Prepaid expenses and
other current assets
|
|
25,193
|
|
28,898
|
Total current
assets
|
|
632,165
|
|
837,040
|
|
|
|
|
|
Marketable securities,
non-current
|
|
-
|
|
50,043
|
Fixed assets,
net
|
|
53,684
|
|
52,955
|
Finance lease
right-of-use assets
|
|
16,697
|
|
9,256
|
Operating lease
right-of-use assets
|
|
22,430
|
|
33,305
|
Intangibles,
net
|
|
70,020
|
|
73,809
|
Goodwill
|
|
136,110
|
|
136,110
|
Other assets
|
|
63,711
|
|
50,990
|
Total assets
|
|
$
994,817
|
|
$
1,243,508
|
|
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
131,861
|
|
$
125,030
|
Finance lease
liabilities
|
|
337
|
|
609
|
Operating lease
liabilities
|
|
5,456
|
|
9,527
|
Total current
liabilities
|
|
137,654
|
|
135,166
|
|
|
|
|
|
Debt,
long-term
|
|
784,799
|
|
566,588
|
Contingent
consideration
|
|
51,800
|
|
75,668
|
Finance lease
liabilities, long-term
|
|
22,679
|
|
14,103
|
Operating lease
liabilities, long-term
|
|
16,504
|
|
21,441
|
Other long-term
liabilities
|
|
11,340
|
|
20,074
|
Total
liabilities
|
|
1,024,776
|
|
833,040
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
Common stock, $0.01 par
value; 500,000,000 authorized
|
|
|
|
|
shares, 121,726,199 and
118,738,266 issued and
outstanding shares at September 30, 2022 and December
31, 2021, respectively
|
|
1,217
|
|
1,187
|
Additional paid-in
capital
|
|
2,506,665
|
|
2,673,556
|
Accumulated
deficit
|
|
(2,536,455)
|
|
(2,265,243)
|
Accumulated other
comprehensive (loss) income
|
|
(1,386)
|
|
968
|
Total shareholders'
(deficit) equity
|
|
(29,959)
|
|
410,468
|
Total liabilities and
shareholders' equity
|
|
$
994,817
|
|
$
1,243,508
|
Contact:
Investors:
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Executive Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/insmed-reports-third-quarter-2022-financial-results-and-provides-business-update-301660592.html
SOURCE Insmed Incorporated