Insmed Reports Third Quarter 2019 Financial

Insmed Reports Third Quarter 2019 Financial

Results and Provides Business Update

liposome inhalation suspension) Total Revenue of $38.9 Million for the Third Quarter of 2019-

-Company Raises Full-Year

2019 ARIKAYCE Revenue Guidance to Range of $133 Million to $138 Million-

-Martina Flammer, M.D., M.B.A.,

appointed as Chief Medical Officer-

BRIDGEWATER, N.J., October 30, 2019 /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, 2019 and provided a business update.

remain very pleased with the continued strong performance of the US launch of ARIKAYCE (amikacin liposome

inhalation suspension). "Insmed remains guided by our desire to have a positive impact on patients' lives and

is powered by our shared sense of purpose to deliver therapies to small patient populations experiencing big health problems,"

commented Will Lewis, Chairman and Chief Executive Officer of Insmed. "We are also progressing well with our global

expansion efforts including filing for regulatory approval of ARIKAYCE in the EU last quarter and advancing our planned regulatory

filings in Japan in first half of 2020. We are also looking forward to the topline results from the WILLOW study which we

expect in the first quarter of 2020."

Third Quarter 2019 Financial Results

Recent Corporate Developments & Program Highlights

Insmed completed enrollment in the six-month Phase 2 WILLOW

study of INS1007 for patients with non-cystic fibrosis (CF) bronchiectasis during the 2nd quarter of 2019 and continues

to expect top-line data in the first quarter of 2020.

ARIKAYCE Launch and Lifecycle Management

Insmed continues to advance the post-approval confirmatory clinical

trial for ARIKAYCE and the Company has initiated efforts to develop an appropriate patient reported outcome (PRO) tool that will

enable the assessment of therapies for the treatment of NTM lung disease. Insmed plans to conduct the confirmatory study of ARIKAYCE

in a frontline setting of patients with MAC lung disease as well as a separate study in patients with NTM lung disease caused by

Mycobacterium abscessus.

Insmed Appoints Chief Medical Officer

Martina Flammer, M.D., M.B.A., has been appointed Chief

Medical Officer at Insmed, effective mid-December 2019. Dr. Flammer has more than 17 years of experience in both medical

and commercial roles. She has launched global brands and managed pipeline portfolios across therapeutic areas and

geographies, including the U.S., Europe, Japan and China. Dr. Flammer was most recently Head of Corporate Division Customer

Value, Senior Vice President at Boehringer Ingelheim International. She has previously held various roles at Boehringer

Ingelheim, including Vice President Clinical Development & Medical Affairs, Specialty Care Business Unit, and Chief

Medical Officer, Vice President of Medicine, Regulatory Affairs & Pharmacovigilance, Boehringer Ingelheim Canada. Prior

to that, Dr. Flammer held commercial and medical roles at Pfizer. She holds a medical degree from the University of Vienna

Medical School, Austria and a Master of Business Administration degree from New

York University Stern School of Business.

Financial Guidance and Balance Sheet

As of September 30, 2019, Insmed had cash and cash

equivalents of $535.6 million. The Company's total costs and expenses for the third quarter of 2019 were $95.4 million, compared

with total costs and expenses for the third quarter of 2018 of $84.0 million. Cash-based operating expenses, as defined below,

for the third quarter of 2019 were $72.6 million, compared with cash-based operating expenses for the third quarter of 2018 of

The Company now expects full-year 2019 total revenue for ARIKAYCE

to be in the range of $133 million to $138 million.

The Company plans to continue to invest in the following key

Insmed continues to expect cash-based operating expenses to

be in the range of $140 million to $155 million for the second half of 2019. In addition, the Company continues to expect capital

expenditures, including those related to its new corporate headquarters facility as well as payments classified within other assets

for the future right-of-use asset related to the buildout of an additional third-party manufacturing facility, to be in the range

of $20 million to $30 million for the second half of 2019.

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 6042526.

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 November 6, 2019 by dialing

(877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing replay access code 10136134. 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.

to the U.S. generally accepted accounting principles (GAAP) results, this earnings release includes cash-based operating

expenses, a non-GAAP financial measure, which Insmed defines as total costs and expenses excluding cost of product revenues,

stock-based compensation expense, depreciation, amortization of intangibles and milestone payments related to ARIKAYCE.

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.

IMPORTANT SAFETY INFORMATION

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.