Xeris Biopharma(XERS)2023-11-09 20:17Financial Data and Key Metrics - Total net revenue for Q3 2023 was $48 million, a 63% increase compared to Q3 2022 and a 27% increase from Q2 2023 [5] - Full-year 2023 revenue guidance was tightened to $160 million to $165 million, expecting to hit the top end of the original guidance [6] - Cash position at the end of Q3 2023 was approximately $66 million, with expectations to achieve cash flow breakeven in Q4 2023 [21][35] Business Line Performance - Gvoke generated $17.7 million in net revenue in Q3 2023, a 30% increase compared to Q3 2022, with total prescriptions growing 52% year-over-year [7][24] - Recorlev generated $8.1 million in net revenue in Q3 2023, a 221% increase compared to Q3 2022 and a 13% increase from Q2 2023 [11][26] - Keveyis generated $15.9 million in net revenue in Q3 2023, a 19% increase compared to Q3 2022 and a 13% increase from Q2 2023 [13][27] Market Performance - Gvoke's market share in the retail glucagon market grew to approximately 33% for new prescriptions and 31% for total prescriptions by the end of October 2023 [8] - The glucagon prescription market grew 16% in Q3 2023, with Gvoke's total prescriptions growing 14% in the same period [25] - Recorlev's patient demand grew 12% over Q2 2023, with strong referrals indicating future growth potential [11][26] Strategic Direction and Industry Competition - The company is focused on building a patient-centric, self-sustaining biopharma enterprise, with strong execution across its three business pillars: commercial products, new product development, and technology partnerships [5][6] - Gvoke continues to outpace competitors in the glucagon market, with the company investing in sales team expansion to maintain momentum [8][9] - Recorlev is gaining traction as a first-line treatment for Cushing's syndrome, with healthcare professionals valuing its multipronged approach to cortisol suppression [12] Management Commentary on Operating Environment and Future Outlook - Management expects total net revenue to grow from 2023 levels in 2024, with operating expenses remaining flat and continued reduction in cash burn [19][38] - The company is optimistic about the large market opportunity for Gvoke, with less than 10% of at-risk patients currently having a ready-to-use glucagon product [9][10] - The XeriJect technology platform is seen as a key differentiator, with successful formulation of TEPEZZA and ongoing collaborations with Amgen and Regeneron [15][17] Other Important Information - The company successfully formulated the ultra-concentrated subcutaneous version of XeriJect TEPEZZA, triggering a $6 million success payment from Amgen [15][23] - The Phase 2 study for XeriSol levothyroxine is over 80% enrolled, with data expected mid-2024 to inform the Phase 3 program [14] - The company exchanged approximately two-thirds of its 2025 convertible senior notes for 2028 notes, reducing near-term debt obligations [22] Q&A Session Summary Questions on Recorlev - Management discussed Recorlev's patient footprint and competitive landscape, noting strong referral growth and low discontinuation rates [40][44][46] - The company views Corcept's relacorilant as a potential competitor but believes Recorlev's superior product performance will maintain its market position [42] Questions on Gvoke - Management highlighted Gvoke's strong growth in the glucagon market, with a 50% increase in prescriptions year-to-date [59] - The company sees Amphastar's Baqsimi as a positive addition to the market, helping to increase awareness and adoption of ready-to-use glucagon products [41] Questions on Financials and Strategy - The company is committed to achieving cash flow breakeven in Q4 2023 and does not anticipate shareholder dilution [50] - Operating expenses are growing at a slower rate than revenue, with SG&A expenses expected to decrease further in Q4 2023 [52][54] - Management is focused on maintaining a self-sustaining business model and investing in growth opportunities rather than pursuing share buybacks [56] Questions on XeriJect Technology - The XeriJect platform offers competitive advantages in delivering ultra-high concentrated subcutaneous injections, with potential to move IV-administered drugs to self-administration [69] - Partnerships with Amgen and Regeneron are progressing well, but timelines for further development and commercialization depend on partner decisions [67][68] Questions on Future Plans - The company is actively evaluating potential acquisitions and pipeline additions but remains disciplined in resource allocation [65][76] - Management is committed to building a growth-oriented biopharmaceutical company and improving patient lives across its range of therapies [79]