AI Earnings Predictions for Insmed Incorporated (INSM)

EX-99.1

2 ef20084500_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Insmed Reports Third-Quarter 2026 Financial Results and Provides Business Update

—Total Company Revenues of $524.4 Million for the Third Quarter of 2026—

—BRINSUPRI® (brensocatib)

Revenues of $400.1 Million for the Third Quarter of 2026, Reflecting 29% Growth Over the Second Quarter of 2026—

—ARIKAYCE® (amikacin liposome inhalation suspension) Revenues of $124.4 Million for the Third Quarter of 2026, Reflecting 9% Growth Over the Third Quarter of 2025—

—Company Raises 2026 BRINSUPRI Revenue Guidance to $1.35 Billion to $1.4 Billion—

—Company Raises 2026 ARIKAYCE Revenue Guidance to $460 Million to $470 Million—

— Insmed Launches BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the Treatment of Non-Cystic Fibrosis Bronchiectasis in Japan—

BRIDGEWATER, N.J., October 29, 2026 — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2026, and provided a business update.

“The third quarter marked another period of meaningful progress, defined by commercial momentum, regulatory achievements, and advancement across our diversified pipeline,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “BRINSUPRI’s U.S. launch continues to exceed expectations and ARIKAYCE continues to grow while in its ninth year on the market. This performance supports our decision to raise the low end of our full-year 2026 revenue guidance for both products. We were also pleased to receive regulatory approval and launch BRINSUPRI in Japan, a profound milestone for patients living with bronchiectasis. In addition, the FDA’s acceptance of the sNDA for ARIKAYCE in MAC lung disease represents an important step toward expanding access to this therapy for eligible patients, including those that are newly diagnosed or facing recurrent infections. As we advance our Phase 3 TPIP programs across four large indications and progress our early-stage pipeline, we remain focused on delivering meaningful innovation and improving the lives of patients with serious diseases.”

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

BRINSUPRI

•

BRINSUPRI global revenue grew 29% in the third quarter of 2026 compared to the second quarter of 2026, driven by strong growth in the U.S. market.

•

In August 2026, Japan's Ministry of Health, Labour and Welfare (MHLW) approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older.

•

In October 2026, Insmed launched BRINSUPRI Tablets 25 mg, the first and only MHLW-approved treatment for NCFB, in Japan.

1

ARIKAYCE

•

ARIKAYCE global revenue grew 9% in the third quarter of 2026 compared to the third quarter of 2025, primarily driven by strong growth in international markets.

•

In September 2026, the U.S. Food and Drug Administration (FDA) accepted Insmed’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA).

•

Insmed plans to submit data from the Phase 3 ENCORE study to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2026 to support potential ARIKAYCE label expansion to all patients with MAC lung disease.

TPIP

•

Insmed has now enrolled more than 35% of patients in the Phase 3 PALM-ILD study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and expects to complete enrollment in the first half of 2028.

•

In July 2026, Insmed enrolled its first patient in the Phase 3 PALM-PAH study of TPIP in patients with pulmonary arterial hypertension (PAH).

•

In September 2026, Insmed initiated the Phase 3 PALM-PPF study of TPIP in patients with progressive pulmonary fibrosis (PPF).

•

Insmed continues to anticipate initiating a Phase 3 study of TPIP in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

INS1148

•

Insmed continues to advance a Phase 2 development program for INS1148, initially targeting IPF, with plans to evaluate PPF and other diseases where inhibition of the pro-inflammatory and pro-fibrotic responses mediated by stem cell factor 248 (SCF248) may be beneficial.

Immunology & Inflammation

INS1033

•

In September 2026, the Phase 1 study of INS1033, a dipeptidyl peptidase 1 (DPP1) inhibitor cleared by the FDA for patients with rheumatoid arthritis (RA), began active enrollment of healthy volunteers.

Neuro & Other Rare

INS1201

•

Insmed completed enrollment of

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.e618d017.1786286655.bae9bd6c

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.c706d217.1784333530.cc9f8351

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.