INSMED Inc. Files 8-K Report

Ticker: INSM · Form: 8-K · Filed: 2024-05-28T00:00:00.000Z

Sentiment: neutral

Topics: 8-K, disclosure, regulatory

Related Tickers: INSM

TL;DR

INSMED filed an 8-K on 5/28/24, standard disclosure stuff.

AI Summary

On May 28, 2024, INSMED Inc. filed an 8-K report. The filing primarily concerns Regulation FD Disclosure and Other Events, along with Financial Statements and Exhibits. No specific financial figures or material events were detailed in the provided excerpt, but the filing indicates standard reporting procedures.

Why It Matters

This 8-K filing by INSMED Inc. serves as a public disclosure of material information, ensuring transparency for investors and stakeholders regarding company events and regulatory compliance.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report and does not appear to disclose any new material risks or adverse information.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for INSMED Inc.?

The primary purpose of this 8-K filing is for Regulation FD Disclosure, Other Events, and to provide Financial Statements and Exhibits.

When was this 8-K report filed by INSMED Inc.?

This 8-K report was filed on May 28, 2024.

What is INSMED Inc.'s principal executive office address?

INSMED Inc.'s principal executive offices are located at 700 US Highway 202/206, Bridgewater, New Jersey 08807.

What is INSMED Inc.'s telephone number?

INSMED Inc.'s telephone number is (908) 977-9900.

What is INSMED Inc.'s Standard Industrial Classification code?

INSMED Inc.'s Standard Industrial Classification code is 2834, which corresponds to Pharmaceutical Preparations.

Filing Stats: 1,962 words · 8 min read · ~7 pages · Grade level 10.9 · Accepted 2024-05-28 06:30:24

Key Financial Figures

Filing Documents

01 — Regulation FD Disclosure

ITEM 7.01 — Regulation FD Disclosure. On May 28, 2024, Insmed Incorporated (the "Company") issued a press release announcing positive topline results from its Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The Company will host a conference call to discuss the positive topline results of the ASPEN study on May 28, 2024 at 8:00 a.m., Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company's website. A copy of the slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 and incorporated herein by reference. The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act"), as amended, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

01 — Other Events

ITEM 8.01 — Other Events. On May 28, 2024, the Company announced positive topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 trial to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of pulmonary exacerbations ("PEs") versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance. Based on these results, the Company plans to file a New Drug Application with the U.S. Food and Drug Administration ("FDA") for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. Pending regulatory approvals, the Company anticipates a U.S. launch for brensocatib in mid-2025 followed by launches in Europe and Japan in the first half of 2026. If approved, brensocatib would be the first approved treatment for patients with bronchiectasis as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor—a new mechanism of action with the potential to address a range of neutrophil-mediated diseases. Topline efficacy results from the ASPEN study are as follows: Brensocatib 10 mg compared to placebo Brensocatib 25 mg compared to placebo Primary Endpoint Reduction in annualized rate of PEs 21.1% p=0.0019* 19.4% p=0.0046* Secondary Endpoints Prolongation of time to first PE 18.7% p=0.0100* 17.5% p=0.0182* Increase in odds of remaining exacerbation free over 52 weeks 41.2% p=0.0059* 40.0% p=0.0074* Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at week 52 11 mL p=0.3841 38 mL p=0.0054* Reduction in annualized rate of severe PEs 25.8% p=0.1277 26.0% p=0.1025 Change from baseline in the Quality of Life – Bronchiectasis (QOL-B) Respiratory Score at week 52 2.0 points p=0.0594 3.8 point

Forward-Looking Statements

Forward-Looking Statements The forward-looking statements in this Item 8.01 are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that the full data set from the ASPEN study or data generated in further clinical trials of brensocatib will not be consistent with the topline results of the ASPEN study; failure to obtain, or delays in obtaining, regulatory approvals for brensocatib in the U.S., Europe or Japan; failure to successfully commercialize brensocatib, if approved by applicable regulatory authorities, in the U.S., Europe or Japan, or to maintain U.S., European or Japanese approval for brensocatib once approved; uncertainties in the degree of market acceptance of brensocatib by physicians, patients, third-party payors and others in the healthcare community; inaccuracies in the Company's estimates of the size of the potential markets for brensocatib or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; inability of the Company, Esteve Pharmaceuticals, S.A., Thermo Fisher Scientific, Inc. or the Company's other third-party manufacturers to comply with regulatory requirements related to brensocatib; the Company's inability to obtain adequate reimbursement from government or third-party payors for brensocatib or acceptable prices for brensocatib; development of unexpected safety or efficacy concerns related to brensocatib; failure to obtain regulatory approval for potential future brensocatib indications; restricti

01 – Financial Statements and Exhibits

ITEM 9.01 – Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by Insmed Incorporated on May 28, 2024. 99.2 Insmed Incorporated May 28, 2024 ASPEN Presentation. 104 Cover Page Interactive Date File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: May 28, 2024 INSMED INCORPORATED By: /s/ Michael A. Smith Name: Michael A. Smith Title: Chief Legal Officer and Corporate Secretary

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