Full Press Release Details
Second Quarter 2020 Financial Results and Provides Business Update
(amikacin liposome inhalation suspension) Total Revenue of $42.5 Million for Second Quarter 2020-
Included in New International Treatment Guidelines for NTM Lung Disease; Positive CHMP Opinion in European Union to Advance Global
Receives FDA Breakthrough Therapy Designation in Patients with Non-Cystic Fibrosis Bronchiectasis-
BRIDGEWATER, N.J., August 6, 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 second quarter ended June 30, 2020, and provided a business update.
"I am incredibly proud of the Insmed team's performance
in the second quarter of 2020, which saw significant progress across our programs even against the backdrop of the continued COVID-19
pandemic," commented Will Lewis, Chair and Chief Executive Officer of Insmed. "ARIKAYCE U.S. sales showed strong
sequential growth from the first quarter as we continued to support patients and physicians through both virtual and in-person
efforts, and we are excited about its inclusion in the new international treatment guidelines as well as the recent positive CHMP
opinion. At the same time, we continued to advance brensocatib, which we believe offers a significant opportunity to address unmet
needs in bronchiectasis and other neutrophil-driven diseases, along with our earlier-stage clinical pipeline."
Second Quarter 2020 Financial Results
Recent Corporate Developments & Program Highlights
Brensocatib Advancement
Insmed presented final results from the Phase 2 WILLOW study
of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFBE) during a virtual session of the American Thoracic society
in June 2020. Also in June, Insmed received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA)
for brensocatib for the treatment of adult patients with NCFBE for reducing exacerbations. The Company remains on track to initiate
its planned Phase 3 program with brensocatib in patients with bronchiectasis by the end of 2020.
ARIKAYCE Global Advancement
In July 2020, Insmed received a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of nontuberculous
mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in non-CF patients with limited treatment
options. Pending approval of the marketing authorization application by the European Commission (EC), the Company anticipates
a potential launch in Germany by the end of 2020, followed shortly thereafter by the UK.
Insmed has also submitted a new drug application for ARIKAYCE
to Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with NTM lung disease caused
by MAC who did not sufficiently respond to prior treatment. In June 2020, a Japanese Medical Device Notification (JMDN) was submitted
to the MHLW for Lamira, the designated device for administration of ARIKAYCE. The JMDN was accepted and Lamira is authorized for
New International NTM Treatment Guidelines
In July 2020, the American Thoracic Society, European Respiratory
Society, European Society of Clinical Microbiology and Infectious Diseases, and Infectious Diseases Society of America issued
new treatment guidelines for the management of NTM lung disease. The guidelines strongly recommend the addition of ARIKAYCE to
the standard treatment regimen for patients with MAC lung disease who have failed to convert to a negative sputum culture after
at least six months of treatment.
ARIKAYCE Label Expansion
Insmed continues to advance the post-approval confirmatory
clinical trial for ARIKAYCE in a front-line setting of patients with 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 NTM lung disease. Insmed
plans to initiate both the confirmatory study and a study to validate the PRO by the end of 2020 and to run these studies in parallel,
pending alignment with the FDA.
Treprostinil Palmitil Advancement
Insmed is advancing treprostinil palmitil, a dry powder, inhaled
treprostinil prodrug formulation, for the potential treatment of pulmonary arterial hypertension and plans to initiate a Phase
1 study by the end of 2020.
As of June 30, 2020, Insmed had cash and cash equivalents
of $641.9 million. The Company's total operating expenses for the second quarter of 2020 were $86.7 million. Adjusted operating
expenses, as defined below, for the second quarter of 2020 were $73.7 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 9359069. The
call will also be webcast live on the company's website at www.insmed.com.
A replay of the conference call will be accessible approximately
one hour after its completion through August 20, 2020 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international)
and referencing replay access code 10146257. 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.
In addition to the U.S. generally
accepted accounting principles (GAAP) results, this earnings release includes adjusted operating expenses, a non-GAAP financial
measure, which Insmed defines as total operating expenses less stock-based compensation expense, depreciation, amortization
of intangibles and certain milestones related to ARIKAYCE, which are payable under our amended agreements with Cystic Fibrosis
Foundation Therapeutics, Inc. (CFFT). A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP
financial measure is presented in the table attached to this press release.
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. Current international treatment guidelines recommend
the use of ARIKAYCE in combination with a multidrug regimen in patients with MAC lung disease who have failed standard therapy
after at least six months of treatment. 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
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.
Brensocatib is a small molecule, oral, reversible inhibitor
of dipeptidyl peptidase I (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis. DPP1 is an enzyme
responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed
in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction
and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive
active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases
such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory
adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary
disease that have led to hospitalizations in some cases.
Hypersensitivity Pneumonitis has