Xeris Biopharma Holdings (XERS) investor relations material

Business performance and growth outlook

• Achieved adjusted EBITDA positivity last year and maintains strong 85% gross margins, supporting self-funded growth.

• Revenue growth is driven by three key products: Gvoke®, Keveyis®, and Recorlev®, with Recorlev® identified as the largest and fastest-growing.

• Recorlev® targets a billion-dollar market opportunity, fueled by increased screening for hypercortisolemia and Cushing's syndrome.

• Commercial footprint is scaling in line with market growth, with ongoing investments planned through 2027 to support expansion.

• Capital deployment focuses on maximizing ROI, prioritizing Recorlev® and pipeline asset XP8121, leveraging strong revenue and margin profile.

Product pipeline and innovation

• XP8121, a once-weekly subcutaneous levothyroxine, is phase 3-ready and targets patients with GI absorption issues, addressing a significant unmet need.

• Phase 3 trial for XP8121 will be a one-year, non-inferiority study with at least 1,000 patients, aiming for robust clinical and payer-relevant data.

• XP8121 is estimated as a $1–3 billion market opportunity, with innovation expected to drive payer acceptance due to unmet needs.

• Gvoke® continues to grow in the diabetes market, focusing on education and guideline compliance, with long-term double-digit growth expected.

• Keveyis® remains resilient despite generic competition, consistently adding new and returning patients in the ultra-rare disease segment.

Market dynamics and competitive positioning

• Recorlev®'s unique mechanism of action allows for gradual cortisol reduction, differentiating it from competitors that block at the receptor level.

• Increased screening and detection in the market are seen as positive, expanding the overall opportunity and not posing a significant threat.

• Commercial investments are ongoing to support both short- and long-term growth, including sales, patient services, and reimbursement support.

• Payer strategy for XP8121 includes targeting patients with multiple TSH tests out of range, leveraging clinical evidence to address reimbursement challenges.

• The company leverages its technology and experience in drug-device combinations to support new product launches in endocrinology.