INSMED Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 8, 2024
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001104506-24-000016
ITEM 1A. Risk FactorsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001104506-24-000026
ITEM 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 15 previous paragraphs and 14 current paragraphs.
13 unchanged; 1 reworded; 0 added; 0 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Reworded paragraphs (1)
Previous wording
We currently rely, and expect to continue to rely, on third parties for significant research, analytical services, preclinical development, clinical development and manufacturing of our product candidates and commercial scale manufacturing of ARIKAYCE and Lamira. For example, we do not own facilities for clinical-scale or commercial manufacturing of our product candidates, and we expect that our future supply requirements for brensocatib and TPIP will be manufactured by CMOs. We currently rely on Resilience Biotechnologies Inc. to provide our clinical and commercial supply of ARIKAYCE, and intend to also rely on Patheon in the future. We currently primarily rely on Esteve Pharmaceuticals, S.A. and Thermo Fisher to provide our clinical supply for brensocatib. Additionally, almost all of our clinical trial work is done by
Current wording
We currently rely, and expect to continue to rely, on third parties for significant research, analytical services, preclinical development, clinical development and manufacturing of our product candidates and commercial scale manufacturing of ARIKAYCE and Lamira. For example, we do not own facilities for clinical-scale or commercial manufacturing of our product candidates, and we expect that our future supply requirements for brensocatib and TPIP will be manufactured by CMOs. We currently rely on Resilience Biotechnologies Inc. to provide our clinical and commercial supply of ARIKAYCE, and intend to also rely on Patheon in the future. We currently primarily rely on Esteve Pharmaceuticals, S.A. and Thermo Fisher to provide our clinical supply for brensocatib. Additionally, almost all of our clinical trial work is done by CROs, such as PPD Development, L.P., our CRO for the ARISE, ENCORE, ASPEN, BiRCh, and TPIP trials, and clinical laboratories. In addition, we rely on third parties to manufacture clinical materials for our early-stage research programs. Reliance on these third parties poses a number of risks, including the following:
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
CROs, such as PPD Development, L.P., our CRO for the ARISE, ENCORE, ASPEN, BiRCh, and TPIP trials, and clinical laboratories. In addition, we rely on third parties to manufacture clinical materials for our early-stage research programs. Reliance on these third parties poses a number of risks, including the following: