INSMED Inc

Previous report

We rely on third parties including collaborators, CROs, clinical and analytical laboratories, CMOs and other providers for many services that are critical to our business. If we are unable to form and sustain these relationships, or if any third-party arrangements that we may enter into are unsuccessful, including due to non-compliance by such third parties with our agreements or applicable law, our ability to develop and commercialize our products may be materially adversely affected.

Previous report

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:

Previous report

•The diversion of management time and cost of third-party advisers associated with the negotiation, documentation and implementation of agreements with third parties in the pharmaceutical industry;

Previous report

•The inability to control whether third parties devote sufficient resources to our programs or products, including with respect to meeting contractual deadlines;

Previous report

•The inability to control the regulatory and contractual compliance of third parties, including their quality systems, processes and procedures, systems utilized to collect and analyze data, and equipment used to test drug product and/or clinical supplies;

Previous report

•The inability to establish and implement collaborations or other alternative arrangements on favorable terms;

Previous report

•Disputes with third parties, including CROs, leading to loss of intellectual property rights, delay or termination of research, development, or commercialization of product candidates or litigation or arbitration;

Previous report

•Contracts with our collaborators fail to provide sufficient protection of our intellectual property; and

Previous report

•Difficulty enforcing our contractual rights if one of these third parties fails to perform.

Previous report

We also rely on third parties to select and enter into agreements with clinical investigators to conduct clinical trials to support approval of our product candidates, and the failure of these third parties to appropriately carry out such evaluation and selection can adversely affect the quality of the data from these studies and, potentially, the approval of our products. In particular, as part of future drug approval submissions to the FDA, we must disclose certain financial interests of investigators who participated in any of the clinical studies being submitted in support of approval, or must certify to the absence of such financial interests. The FDA evaluates the information contained in such disclosures to determine whether disclosed interests may have an impact on the reliability of a study. If the FDA determines that financial interests of any clinical investigator raise serious questions of data integrity, the FDA can institute a data audit, request that we submit further data analyses, conduct additional independent studies to confirm the results of the questioned study, or refuse to use the data from the questioned study as a basis for approval. A finding by the FDA that a financial relationship of an investigator raises serious questions of data integrity could delay or otherwise adversely affect approval of our products.

Previous report

In January 2024, the US House of Representatives introduced the BIOSECURE Act (H.R. 7085) and the Senate advanced a substantially similar bill (S.3558), which legislation, if passed and enacted into law, would potentially restrict our ability to purchase services or products from, or otherwise collaborate with, any "biotechnology company of concern,” which includes certain Chinese biotechnology companies, without losing the ability to contract with, or otherwise receive funding from, the US government. We do business with companies in China and it is possible some of our contractual counterparties could be impacted by this legislation.

Previous report — wording carried elsewhere

These risks could materially harm our business, financial condition, results of operations and prospects and the value of our common stock.