Xeris Biopharma (XERS) H.C. Wainwright 28th Annual Global Investment Conference summary

Growth strategy and financial outlook

• Revenue is projected to grow at least 33% this year, following 40–50% growth last year, driven by three main products: GVOKE, KEVEYIS, and especially RECORLEV.

• Gross margins are at 85% and improving, enabling reinvestment in both commercial expansion and pipeline development.

• RECORLEV is on track for $1 billion in revenue, with the overall product portfolio targeting $750 million by 2030.

• The company is scaling up operations and workforce to support ongoing and future programs, all funded internally.

• Commercial infrastructure and patient services are positioned to support new launches and continued growth.

XP-8121 development and market opportunity

• XP-8121, a once-weekly subcutaneous levothyroxine, targets a $1–3 billion market opportunity for patients with hypothyroidism who cannot achieve control with current therapies.

• The development plan includes regulatory-focused studies (Cornerstone for non-inferiority) and real-world evidence to define unmet needs.

• Touchstone will further identify and validate patient populations who fail to achieve control, with data potentially enhancing the product label.

• The initial target population is 3–5 million patients with documented failure on generics, with payers expected to require prior authorization based on this history.

• Real-world evidence and clinical trial data will refine patient segmentation and support market launch.

Commercialization and payer strategy

• Differentiation in the label will focus on once-weekly subQ administration and improved GI absorption, addressing a key unmet need.

• Payers are expected to require documentation of failure on generics, which is already well-documented in patient charts.

• Physicians are expected to quickly identify suitable patients, especially those with GI absorption issues or multiple TSH out-of-range events.

• The company’s commercial infrastructure already covers most endocrinologists but may expand further by 2030 to support three products.

• The company is prepared to handle payer requirements and has a robust plan for reimbursement and patient support.