Xeris Biopharma(US:XERS)2023-03-08 15:56Financial Data and Key Metrics Changes - The company reported a net product revenue growth of 52% for Q4 2022 and 38% for the full year on a pro forma basis, finishing the year with $110 million in total revenue [9][34] - Cash on hand exceeded $120 million at year-end 2022, indicating strong liquidity [9] - Total net product revenue for 2022 was over $109 million, achieving the top end of guidance [34] Business Line Data and Key Metrics Changes - Gvoke achieved net revenue of $15 million in Q4 2022, a 36% increase year-over-year, with total prescriptions growing over 42% [11][12] - Keveyis generated approximately $14 million in Q4 2022, representing a 33% increase, and over $49 million for the full year, a 23% increase [17][39] - Recorlev net revenue for Q4 was $3.8 million, a 51% increase from the previous quarter, with total revenue for 2022 at $7.4 million [19][41] Market Data and Key Metrics Changes - The total glucagon market grew 6% in Q4 2022 and 9% for the full year, with Gvoke outpacing market growth [13] - Gvoke's market share of new prescriptions reached approximately 28%, with ready-to-use glucagon products representing nearly 75% of the new prescription market [14] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven in Q4 2023 without needing additional capital, positioning itself as a self-sustaining enterprise [10][52] - The focus is on advancing the levothyroxine program and developing partnerships, such as the collaboration with Horizon Therapeutics for TEPEZZA [21][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth and the potential for a pivotal year in 2023, driven by strong revenue growth and disciplined expense management [31][55] - The company anticipates total revenues between $135 million and $165 million for 2023, reflecting a growth rate of approximately 36% from 2022 [31][42] Other Important Information - The company has not yet experienced a negative impact from the first generic entry of Keveyis, although it remains a concern for the future [17][40] - The company is preparing for potential impacts from deductible resets on patient access to Recorlev, which is common in rare disease products [72] Q&A Session Summary Question: Guidance range and factors affecting it - Management acknowledged the wider guidance range due to multiple moving parts, including the early stage of Recorlev's launch and uncertainty regarding Keveyis' generic impact [56][57] Question: Current market status of Keveyis - Management confirmed that no generics are currently operational in the market, and patient support systems are in place to maintain business [59][60] Question: Titration process for Recorlev - Management indicated that titration is slower in real-world settings compared to clinical studies, with physicians managing doses carefully [64][66] Question: Contribution from other revenues - Management noted that the contribution from partnerships and collaborations is uncertain and depends on the speed of achieving target product profiles [69][70] Question: Payer coverage for Recorlev - Management reported that prior authorization hurdles exist but success rates are better than 50%, with many appeals resulting in approvals [74][76] Question: Gvoke's growth outlook - Management expects Gvoke to continue its growth trajectory, with minimal impact from generics and a rebound in market growth [80][81] Question: Competitive dynamics for Recorlev - Management believes Recorlev is performing well against competitors, with a focus on demonstrating its efficacy compared to existing treatments [82][84] Question: Timeline for levothyroxine injectable product - Management indicated that the earliest filing for the levothyroxine injectable product could be between 2026 and 2028, depending on the Phase 2 study outcomes [87]