Marketing Authorization Application for
ARIKAYCETM Validated by the European Medicines Agency
Insmed Incorporated (Nasdaq: INSM) today reported financial
results for the fourth quarter and year ended December 31,
2014.
Highlights of the fourth quarter of 2014 and recent weeks
include:
- Received validation of the Company’s
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) for ARIKAYCE following the approval of the Pediatric
Investigation Plan (PIP) by the EMA’s Pediatric Committee;
- Advanced progress of the Company’s
phase 3 global trial (the “212” trial) for patients with treatment
resistant nontuberculous mycobacteria (NTM) lung infections
including the activation of multiple clinical trial sites;
- Appointed Myrtle Potter to its Board of
Directors;
- Appointed Dr. Olaf Bartsch as Vice
President - Europe, General Manager - Germany and Dr. Francois
Cornu as Vice President - Europe, General Manager - France to
commence the build-out of operations in Europe. Both Drs. Bartsch
and Cornu will report to Will Lewis, President and Chief Executive
Officer;
- Launched a comprehensive NTM disease
state awareness website www.ntmfakten.de for the education of
healthcare providers in Germany;
- Entered into a partnership with the
European Respiratory Society (ERS) that established an inaugural
award in NTM research entitled, ERS Research Award: Innovation in
Non-Tuberculous Mycobacteria Science and Medicine, which is
designed to advance the science and understanding of NTM lung
disease; and
- Company to host an Analyst and Investor
Day in New York City on Tuesday, March 24.
“We remain focused on our primary goal of advancing the 212
trial, our global phase 3 study in NTM patients who failed prior
standard-of-care treatment. We have activated multiple sites and we
continue to expect preliminary top-line clinical results in
mid-2016,” said Mr. Lewis. “We are also pleased with our progress
in Europe on several fronts. The validation of our MAA filing with
the EMA starts the formal review process for ARIKAYCE, the hiring
of Drs. Bartsch and Cornu to lead our operations and the
partnership with ERS show our commitment to bringing ARIKAYCE to
patients with NTM lung disease and to CF patients with pseudomonas
lung infections. Finally, we are encouraged by the progress we have
made with INS1009 treprostinil prodrug for the treatment of
pulmonary arterial hypertension (PAH), which remains on track for
an investigational new drug (IND) filing and the initiation of a
phase 1 clinical trial later this year.”
Fourth Quarter 2014 Financial Results
For the fourth quarter of 2014, Insmed posted a net loss of
$17.6 million, or ($0.36) per share, compared with a net loss of
$16.2 million, or ($0.41) per share, for the fourth quarter of
2013. The increase in net loss was primarily due to increases in
personnel costs, manufacturing expenses and pre-commercial
activities, offset in part by a benefit from income taxes resulting
from the sale of a portion of the Company’s New Jersey Net
Operating Losses (NOLs) under the State of New Jersey’s Technology
Business Tax Certificate Transfer Program.
Research and development expense for the fourth quarter of 2014
increased to $14.8 million from $9.6 million in the fourth quarter
of 2013. The increase in research and development expense was
primarily due to the build-out of additional third-party
manufacturing capacity for the production of ARIKAYCE and higher
compensation and personnel-related expenses.
General and administrative expense for the fourth quarter of
2014 was $8.3 million compared with $6.0 million in the fourth
quarter of 2013. The increase in general and administrative expense
primarily resulted from greater personnel costs due to an increase
in headcount and an increase in pre-commercial activities.
Full Year 2014 Financial Results
For 2014, Insmed posted a net loss of $79.2 million, or ($1.84)
per share, compared with a net loss of $56.1 million, or ($1.60)
per share, for the 2013 fiscal year. The increase in net loss was
primarily due to $11.5 million in other revenue received in 2013
related to a one-time payment for the sale of the Company’s right
to receive future royalties under its license agreement with Shire.
Also contributing to the net loss in the current year were
increases in personnel costs, manufacturing expenses and
pre-commercial activities. The impact of these items was offset in
part by a benefit from income taxes resulting from the sale of a
portion of the Company’s New Jersey NOLs under the State of New
Jersey’s Technology Business Tax Certificate Transfer Program. The
$10.4 million benefit from income taxes for the year ended December
31, 2014 represents two sales of NOLs in 2014 as compared to only
one sale in the year ended December 31, 2013.
Research and development expense for 2014 increased to $56.3
million from $44.3 million in 2013. The increase in research and
development expense was primarily due to the build-out of
additional third-party manufacturing capacity, the completion of
certain process improvement projects at a third party manufacturing
partner and the manufacture of ARIKAYCE for clinical supply. In
addition, there was an increase in internal expenses, specifically
compensation and personnel-related expenses, including non-cash
stock compensation.
General and administrative expense for 2014 was $31.1 million
compared with $22.2 million in 2013. The increase in general and
administrative expense primarily resulted from an increase in
pre-commercial activities and greater personnel costs due to an
increase in headcount and expenses related to our new headquarters
and laboratory facility in Bridgewater, New Jersey.
Balance Sheet Highlights and Cash Guidance
As of December 31, 2014, the Company had cash and cash
equivalents of $159.2 million. The cash balance reflects the fourth
quarter sale of NJ NOLs in the amount of $5.0 million, a
modification of existing debt which generated proceeds of $5.0
million, and the sale of equity securities which generated proceeds
of $1.0 million. In addition, during the fourth quarter of 2014 the
Company paid $1.5 million for capital expenditures, primarily
related to the build-out of its laboratory facilities in
Bridgewater, New Jersey. Excluding depreciation and non-cash stock
compensation expense, the Company’s cash operating expenses for the
quarter ended December 31, 2014 was $20.0 million. The Company
ended 2014 with $25.0 million in long term debt and had working
capital of $145.1 million.
In 2015, the Company plans to continue to fund further clinical
development of ARIKAYCE and INS-1009, fund investment in
third-party manufacturing capacity, support efforts to obtain
regulatory approvals and prepare for ARIKAYCE commercialization in
Europe. As a result, Insmed estimates that its cash operating
expenses for the first half of 2015 will be in the range of $46
million to $56 million. The Company will discuss its 2015 cash
operating expenses at the Company’s upcoming Analyst and Investor
Day in March 2015. The Company expects current cash balances will
be sufficient to fund operations into 2016.
Analyst and Investor Day
Insmed will host an Analyst and Investor Day on Tuesday, March
24, 2015 at 8:30 a.m. in New York City. Members of Insmed's senior
management team will provide a business update and an overview of
the Company's strategies to drive long-term growth. The event will
be webcast live beginning at 8:30 a.m. Eastern Time. The live
webcast and an archived presentation following the event will be
available on the Investor Relations section of Insmed's corporate
website at www.insmed.com.
About ARIKAYCE
ARIKAYCE is a form of the antibiotic amikacin, which is enclosed
in nanocapsules of lipid called liposomes. This advanced pulmonary
liposome technology prolongs the release of amikacin in the lungs
while minimizing systemic exposure. The treatment uses
biocompatible lipids endogenous to the lung that are formulated
into small (0.3 micron), charge-neutral liposomes. ARIKAYCE is
administered once-daily using an optimized, investigational eFlow®
Nebulizer System manufactured by PARI Pharma GmbH, a novel, highly
efficient and portable aerosol delivery system.
About eFlow® Technology and PARI Pharma
ARIKAYCE is delivered by an investigational eFlow® Nebulizer
System developed by PARI Pharma and optimized specifically for
ARIKAYCE. The optimized device uses eFlow Technology to enable
highly efficient aerosolization of medication including liposomal
formulations via a vibrating, perforated membrane that includes
thousands of laser-drilled holes. Compared with other nebulization
technologies, eFlow Technology produces aerosols with a very high
density of active drug, a precisely defined droplet size and a high
proportion of respirable droplets delivered in the shortest
possible period of time. eFlow Technology is not an ultrasonic
nebulizer technology and is not a general purpose electronic
aerosol generator nebulizer technology. Combined with its quiet
mode of operation, small size, light weight and battery use, eFlow
Technology reduces the burden of taking daily, inhaled
treatments.
About Nontuberculous Mycobacteria (NTM)
Nontuberculous mycobacteria (NTM) are organisms found in the
soil and water that can cause serious lung disease in susceptible
individuals, for which there are currently limited effective
treatments and no approved therapies. The prevalence of NTM disease
is reported to be increasing, and according to reports from the
American Thoracic Society is believed to be greater than that of
tuberculosis in the U.S. According to the National Center for
Biotechnology Information, epidemiological studies show that
presence of NTM infection is increasing in developing countries,
perhaps because of the implementation of tap water. Women with
characteristic phenotype are believed to be at higher risk of
acquiring NTM infection along with patients with defects on cystic
fibrosis transmembrane conductance regulators.
NTM lung disease is often a chronic condition that can lead to
progressive inflammation and lung damage, and is characterized by
bronchiectasis and cavitary disease. NTM infections often require
lengthy hospital stays for medical management. Treatment usually
involves multi-drug regimens that can be poorly tolerated and have
limited effectiveness, especially in patients with severe disease
or in those who have failed prior treatment attempts. According to
a company-sponsored patient chart study conducted by Clarity Pharma
Research, approximately 50,000 patients suffering from NTM lung
disease visited physician offices in the U.S. during 2011.
About INS1009
INS1009, the Company’s inhaled treprostinil prodrug for the
treatment of pulmonary arterial hypertension (PAH), a chronic,
life-threatening disorder characterized by abnormally high blood
pressure in the arteries between the heart and lungs. Insmed has
applied its product design, drug development and sustained-release
formulation expertise to advance INS1009 with the goal of
addressing current limitations of inhaled prostacyclin therapies in
the treatment of PAH. INS1009 is expected to be delivered
once-daily via inhalation. It is designed to provide consistent,
effective drug levels and may also reduce the acute systemic
effects of current treatment options.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension, or PAH, is a chronic,
life-threatening form of pulmonary hypertension that is
characterized by abnormally high blood pressure in the arteries
between the heart and lungs. Pulmonary arteries carry blood from
the heart to the lungs, where it picks up oxygen to be delivered
throughout the body. In PAH, the pulmonary arteries constrict
abnormally. This forces the heart to pump harder to maintain
adequate blood flow, which causes blood pressure within the lungs
to rise. Common early symptoms include shortness of breath,
fatigue, weakness, chest pain and syncope (fainting), particularly
during physical activity. PAH worsens over time and is
life-threatening because the pressure in a patient's pulmonary
arteries rises to dangerously high levels, which strains the heart
and may lead to heart failure. The one-year mortality rate among
patients with PAH is 15% despite currently available treatments.
The cause of some cases of PAH is unknown and there is no cure. PAH
is considered an orphan disease, afflicting 30,000 to 40,000 people
in the U.S. and 200,000 people globally.
There are several prescription medications approved by the U.S.
Food and Drug Administration (FDA) to treat the symptoms of PAH and
patients typically are treated with combination therapy including
endothelin receptor antagonists, PDE-5 inhibitors and prostacyclin
agonists. With annual sales exceeding $1 billion, prostacyclins are
the preferred choice for treating late-stage disease. Prostacyclin
formulations used to treat PAH include oral, intravenous,
subcutaneous and inhaled formulations. All existing prostacyclin
compounds have the limitation of a short half-life in the body and
require multiple dosing sessions per day for inhaled and oral
formulations, or the invasiveness of continuous infusion for
injectable formulations.
About the European Respiratory Society
The European Respiratory Society (ERS) is the leading
professional organization in its field in Europe. It is
broad-based, with some 10,000 members and counting in over 100
countries. Its scope covers both basic science and clinical
medicine. ERS seeks to alleviate suffering from respiratory disease
and promote lung health through research, sharing of knowledge and
through medical and public education. For further information,
visit www.ersnet.org/ntmawa.
About Insmed
Insmed Incorporated is a biopharmaceutical company dedicated to
improving the lives of patients battling serious lung diseases.
Insmed is focused on the development and commercialization of
ARIKAYCE, or liposomal amikacin for inhalation, for at least two
identified orphan patient populations: patients with nontuberculous
mycobacteria (NTM) lung infections and cystic fibrosis (CF)
patients with Pseudomonas aeruginosa lung infections. Insmed is
also focused on the development of INS1009, the Company’s inhaled
treprostinil prodrug for the treatment of pulmonary arterial
hypertension (PAH), a chronic, life-threatening disorder
characterized by abnormally high blood pressure in the arteries
between the heart and lungs. For more information, please visit
http://www.insmed.com.
Forward-looking statements
This release contains forward-looking statements. Words, and
variations of words, such as “intend,” “expect,” “will,”
“anticipate,” “believe,” “continue,” “propose” and similar
expressions are intended to identify forward-looking statements.
Investors are cautioned that such statements in this release,
including statements relating to the status, results and timing of
clinical trials and clinical data, the anticipated benefits of
Insmed’s products, the anticipated timing of regulatory
submissions, and the ability to obtain required regulatory
approvals, bring products to market and successfully commercialize
products constitute forward-looking statements that involve risks
and uncertainties that could cause actual results to differ
materially from those in the forward-looking statements. Such risks
and uncertainties include, without limitation, failure or delay of
European, Canadian, U.S. Food and Drug Administration and other
regulatory reviews and approvals, competitive developments
affecting the Company’s product candidates, delays in product
development or clinical trials or other studies, patent disputes
and other intellectual property developments relating to the
Company’s product candidates, unexpected regulatory actions, delays
or requests, the failure of clinical trials or other studies or
results of clinical trials or other studies that do not meet
expectations, the fact that subsequent analyses of clinical trial
or study data may lead to different (including less favorable)
interpretations of trial or study results or may identify important
implications of a trial or study that are not reflected in
Company’s prior disclosures, and the fact that trial or study
results or subsequent analyses may be subject to differing
interpretations by regulatory agencies, the inability to
successfully develop the Company’s product candidates or receive
necessary regulatory approvals, the inability to make product
candidates commercially successful, changes in anticipated
expenses, changes in the Company’s financing requirements or
ability to raise additional capital, and other risks and challenges
detailed in the Company’s filings with the U.S. Securities and
Exchange Commission, including its Annual Report on Form 10-K
for the year ended December 31, 2014. Investors are cautioned
not to place undue reliance on any forward-looking statements that
speak only as of the date of this news release. The Company
undertakes no obligation to update these forward-looking statements
to reflect events or circumstances or changes in its
expectations.
INSMED INCORPORATED Consolidated Statements of
Comprehensive Loss (in thousands, except per share data)
Three Months Ended December 31,
Years Ended December 31, 2014 2013 2014
2013 Other revenue $ - $ - $ - $ 11,500
Operating expenses: Research and development 14,799
9,625 56,292 44,279 General and administrative 8,267
5,969 31,073 22,236 Total
operating expenses 23,066 15,594
87,365 66,515 Operating loss (23,066 )
(15,594 ) (87,365 ) (55,015 ) Investment income 17 25 58 166
Interest expense (620 ) (610 ) (2,415 ) (2,412 ) Other income /
(expense), net (11 ) (35 ) 141
(33 ) Loss before income taxes (23,680 ) (16,214 ) (89,581 )
(57,294 ) Benefit from income taxes (6,033 ) -
(10,422 ) (1,221 ) Net loss and
comprehensive loss $ (17,647 ) $ (16,214 ) $ (79,159 ) $ (56,073 )
Basic and diluted net loss per share $ (0.36 ) $ (0.41 ) $
(1.84 ) $ (1.60 ) Weighted average basic and diluted common
shares outstanding 49,662 39,116
43,095 34,980
Investor Relations Contacts:LHAAnne Marie Fields,
Senior Vice President212-838-3777afields@lhai.comorBruce Voss,
Managing Director310-691-7100bvoss@lhai.com
Insmed (NASDAQ:INSM)
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