Risk Factors Update Summary

• Expect to incur operating losses as we commercialize IBSRELA and XPHOZAH, with accumulated deficit increasing from $780.1 million to $846.2 million.
• Expanded collaboration with METiS Therapeutics for TGR5 agonist compounds for all therapeutic areas.
• Received FDA approval for XPHOZAH, generating $2.5 million in net revenue from product sales.
• Seeking and obtaining approval to commercialize tenapanor outside the U.S., including in other territories.
• Increased loan facility by drawing an additional $22.5 million, with the option to draw an additional $50 million.
• Enhanced disaster recovery and business continuity plans to restore critical infrastructure and business functions.
• Expanded into new foreign markets, facing enhanced scrutiny by regulators regarding international data transfers.
• Increased regulatory expenses and potential restrictions for IBSRELA and XPHOZAH post-approval.
• Collaboration partnerships formed for commercialization of tenapanor in Japan, China, and Canada.
• Potential impact of the Inflation Reduction Act of 2022 on drug pricing negotiations and market dynamics.
• Facing risks related to supply chain disruptions due to reliance on single-source manufacturers for IBSRELA and XPHOZAH.
• Uncertainties surrounding patent protection, enforcement, and potential challenges from competitors.
• Increased focus on cybersecurity risk management to protect confidential information and intellectual property.
• Transition from a smaller reporting company status, incurring enhanced disclosure requirements and compliance costs.