Ardelyx (ARDX) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic priorities and financial outlook

• Focus on achieving profitability by 2027, driven by growth in IBSRELA and XPHOZAH sales.

• Capital allocation prioritizes investment in marketed products, advancing pipeline assets, opportunistic M&A, and maintaining financial discipline.

• Profitability is expected as operating expenses level off and revenue growth accelerates, with a strong gross profit margin of 98%.

• Cash generation is expected to support both internal development and future business development opportunities.

• Long-term guidance for IBSRELA remains at $1 billion, though timing has been adjusted due to growth rate changes.

IBSRELA performance and market access

• IBSRELA saw over 73% growth year-over-year, with 2024 guidance targeting 50% growth and $350–$370 million in revenue.

• Payer-imposed hurdles such as step edits and stricter prior authorizations have increased, prompting expanded field reimbursement support and a push toward specialty pharmacy channels.

• The number of field reimbursement managers was doubled to 40 to help offices navigate payer requirements.

• Contracting with payers is being approached gradually to avoid steep discounts and preserve long-term value, leveraging strong IP protection through 2042.

• Direct-to-consumer outreach has expanded via targeted digital and connected TV campaigns.

Competitive landscape and intellectual property

• LINZESS going generic and price reductions are seen as potentially expanding the overall IBS-C market.

• IBSRELA’s IP, including the 299 patent, extends to 2042, with additional filings and pediatric trials potentially adding six months.

• The molecule is difficult to manufacture and requires a clinical trial for generic approval, making near-term generic competition unlikely.