Full Press Release Details
Insmed Reports First Quarter 2020 Financial
Results and Provides Business Update
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
Recent Corporate Developments & Program Highlights
Brensocatib Program Updates:
As previously announced:
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.
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
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.
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.
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
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.
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.
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.
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
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
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.
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