Risk Factors Update Summary

• Increased focus on potential acquisitions or in-licensing opportunities to diversify and grow.
• Compliance with stringent regulatory requirements for manufacturing, distribution, and data privacy to avoid penalties.
• Added apraglutide to pipeline, requiring extensive development, regulatory approval, and commercial integration.
• Added detailed risks related to licensing agreements, including potential loss of license rights and financial obligations.
• U.S. FDA approved LINZESS for pediatric FC, first FDA-approved therapy for this indication.
• Risks associated with in-licenses, acquisitions, and other transactions, including operational and financial challenges.
• Disclosed risks of losing rights, experiencing delays, and facing liabilities if licenses or relationships are terminated.
• Dependence on contract manufacturers and third parties for manufacturing and distribution, with potential setbacks.
• Importance of orphan drug designation for market exclusivity and financial incentives.
• Risks related to the successful integration of VectivBio's business and personnel post-acquisition.
• Increased debt by $300 million through a Revolving Credit Facility, impacting financial flexibility.
• Uncertainties related to the development and commercialization of in-licensed or acquired product candidates.
• Positive topline data from Phase III trial evaluating linaclotide 72 mcg in pediatric patients.
• Ongoing clinical pediatric programs for LINZESS in IBS-C and FC, aiming to expand indications.
• Potential competition from Takeda and Zealand Pharma in the SBS treatment market.
• Risks related to post-approval requirements for LINZESS in pediatric patients and expansion challenges.
• Uncertainty in obtaining U.S. FDA approval for linaclotide in new indications and patient populations.