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Insmed 8-K Report, Regulation FD Disclosure (Jan 5, 2024)

Reports
Regulation FD·Exhibits & Filings
Filing Date
Filed January 5, 2024
Period End
January 5, 2024
Security
INSM
In the record · 2016–202610-K1110-Q338-K134

INSM filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 134 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Jan ’18Jan ’18
  2. Leadership change8-K · May ’20May ’20
  3. Material agreement8-K · Oct ’22Oct ’22
  4. Leadership change8-K · Oct ’26Oct ’26

01—Abstract

Summary

Summary of the 8-K filed January 5, 2024. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K under Item 7.01 (Regulation FD Disclosure) on January 5, 2024 to furnish a press release (Exhibit 99.1) and a slide presentation (Exhibit 99.2) for its presentation at the 42nd Annual J.P.

Morgan Healthcare Conference on January 8, 2024. The press release reports preliminary, unaudited full-year 2023 global net product sales of ARIKAYCE of approximately $305.2 milliona, including $224.2 million in the United States, $65.7 million in Japan and $15.3 million in Europe. The company states this is 24% year-over-year growth from 2022, with U.S. growth of 21% and Japan growth of 16%.

Insmed expects 2024 global ARIKAYCE revenues of $340 million to $360 millionb, which it describes as 15% year-over-year growth at the midpoint. The filing lays out 2024 catalysts. The Phase 3 ASPEN topline readout for brensocatib in bronchiectasis is expected in the latter part of the second quarter of 2024, with a U.S. launch anticipated in mid-2025 if successful.

Topline data from the Phase 2 PH-ILD study of TPIP is expected ahead of ASPEN in the second quarter of 2024; that study enrolled 39 patients against a target of 32. Enrollment in the Phase 2 PAH study of TPIP continues, with topline results expected in 2025. The company says its early-stage research will comprise less than 20%c of overall spend.

The company states that the ASPEN Data Safety Monitoring Committee's fifth and final meeting in November 2023 identified no new safety signals and recommended the trial continue as planned. Management also says ENCORE topline data remain expected in 2025, and that it will seek an FDA meeting to finalize the ENCORE statistical plan and enrollment target. The filing notes that the presentation and press release contain forward-looking statements subject to risks that could cause actual results to differ materially.

02—Key points

Key Highlights

  1. Preliminary unaudited full-year 2023 global ARIKAYCE net product sales of approximately $305.2 million, up 24% year-over-year per the filing, exceeding the upper end of guidance.
  2. U.S. ARIKAYCE sales of $224.2 million (21% growth), Japan sales of $65.7 million (16% growth), and Europe sales of $15.3 million.
  3. 2024 global ARIKAYCE revenue guidance of $340 million to $360 million, described as about 15% year-over-year growth at the midpoint.
  4. Phase 3 ASPEN topline readout for brensocatib in non-cystic fibrosis bronchiectasis expected in the latter part of Q2 2024; a U.S. launch is anticipated in mid-2025 if successful.
  5. Phase 2 PH-ILD topline data for TPIP expected in Q2 2024, ahead of ASPEN; enrollment completed at 39 patients against a target of 32.
  6. ASPEN Data Safety Monitoring Committee's final meeting in November 2023 identified no new safety signals and recommended the trial continue as planned.
  7. Management states that the early-stage research pillar will represent less than 20% of overall spend, with more than 30 preclinical programs in development.

03—Questions

Frequently Asked Questions

  1. How did ARIKAYCE perform in full-year 2023?

    Insmed expects total global net product sales of ARIKAYCE of approximately $305.2 million for 2023 on a preliminary, unaudited basis, representing 24% year-over-year growth. U.S. sales were $224.2 million, Japan $65.7 million and Europe $15.3 million. The company says results are subject to adjustment and will report final results in late February 2024.

  2. What revenue does Insmed expect from ARIKAYCE in 2024?

    The company anticipates 2024 global ARIKAYCE revenues between $340 million and $360 million, which it states represents 15% year-over-year growth at the midpoint compared with 2023.

  3. When will the key brensocatib and TPIP data readouts occur?

    Topline data from the Phase 3 ASPEN study of brensocatib are expected in the latter part of the second quarter of 2024. Topline data from the Phase 2 PH-ILD study of TPIP are expected ahead of ASPEN, also in the second quarter of 2024. Topline results from the Phase 2 PAH study of TPIP are expected in 2025.

  4. What is the status of the ASPEN safety monitoring?

    The Data Safety Monitoring Committee held its fifth and final meeting for the ASPEN study in November 2023. The company reports that no new safety signals were identified and the committee unanimously recommended the trial continue as planned.

  5. What did the company say about the ENCORE study?

    Insmed completed original target enrollment of 250 patients in the ENCORE trial, and enrollment remains ongoing. After receiving FDA feedback on patient-reported outcome data from the ARISE study, the company plans to meet with the FDA in the coming months to finalize ENCORE's statistical plan and updated enrollment target. It continues to anticipate an ENCORE topline readout in 2025.

04—Continue

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