Company Overview - Xeris is a fast-growing commercial biopharma company with three commercial products on the market [1] - The products include Gvoke for hypoglycemia, Keveyis for primary periodic paralysis, and Recorlev for hypercortisolemia and Cushing's syndrome [2] Product Portfolio - Gvoke is a rescue pen for hypoglycemia, similar to an EpiPen for diabetics [1] - Keveyis treats an ultra-rare hereditary genetic disorder known as primary periodic paralysis [2] - Recorlev is focused on hypercortisolemia and Cushing's syndrome, identified as a significant growth driver for the company [2] - The company is also developing XP-8121, a once-weekly subcutaneous levothyroxine for hypothyroidism, which is ready for Phase III trials [2]

Summary of Xeris Biopharma FY Conference Call (March 11, 2026) Company Overview - **Company**: Xeris Biopharma (NasdaqGS:XERS) - **CEO**: John Shannon - **CFO**: Steve Pieper - **Business Model**: Fast-growing commercial biopharma company with three commercial products: - **Gvoke**: Rescue pen for hypoglycemia - **KEVEYIS**: Treatment for primary periodic paralysis - **Recorlev**: Treatment for hypercortisolemia and Cushing's syndrome, identified as the primary growth driver - **Pipeline**: XP-8121, a once-weekly SubQ levothyroxine for hypothyroidism, is phase 3-ready and expected to start trials in 2026 [5][6][8] Financial Performance - **2025 Revenue**: $292 million, exceeding expectations with a 44% growth year-over-year [8] - **Adjusted EBITDA**: $60 million, marking a transition to positive EBITDA [8] - **Net Income**: Achieved for the full year, indicating the ability to self-fund strategy and pipeline [8] Product Performance Recorlev - **Growth**: Over 100% growth for the past two years, with significant acceleration noted in late 2024 [10][14] - **Market Dynamics**: Increased patient screening and diagnosis in hypercortisolemia led to a larger patient base [14] - **Sales Organization Expansion**: Increased from 28 to 42 sales personnel to capture market opportunities [14] - **Future Guidance**: Majority of growth expected in 2026 will come from Recorlev, with confidence in meeting or exceeding guidance [28][30] Gvoke - **Steady Growth**: Consistent growth since launch, targeting insulin users who need protection from hypoglycemia [20] - **Market Penetration**: Approximately 15 million potential users, with only 1 million currently using Gvoke [20] - **Revenue Growth Expectation**: Anticipated growth in the high single digits to low double digits for the foreseeable future [21] KEVEYIS - **Resilience**: Despite generic competition, KEVEYIS returned to growth in Q4 2025 after initial declines [24] - **Patient Support Services**: Additional services around the product have contributed to its resilience [25] Competitive Landscape - **Market Dynamics**: Increased competition in the hypercortisolemia space is viewed positively, as it helps identify and treat more patients [34] - **RECORLEV Differentiation**: Unique mechanism of action that normalizes cortisol levels, distinguishing it from competitors that only block cortisol at the receptor level [42][43] Future Outlook - **Peak Sales Target for Recorlev**: $1 billion by 2035, with ongoing investments required to support growth [45][46] - **XP-8121 Potential**: Positioned as a blockbuster with a significant unmet medical need, targeting 3-5 million patients who struggle with GI absorption issues [81] - **Balance Sheet Strength**: Ended the year with over $110 million in cash, allowing for continued investment in key products [84] Conclusion - **Market Positioning**: Xeris Biopharma is focused on executing its strategy and believes that continued performance will lead to rational market movements and stock appreciation [86]

Cash Flow - Net cash provided by operating activities increased to $28.6 million for the year ended December 31, 2025, compared to a cash outflow of $37.0 million in 2024, primarily driven by higher product sales [477]. - Net cash used in investing activities was $696.0 thousand for the year ended December 31, 2025, a significant decrease from $4.9 million in cash provided in 2024, due to fewer purchases of short-term investments [478]. - Net cash provided by financing activities was $11.4 million for the year ended December 31, 2025, down from $36.2 million in 2024, influenced by proceeds from stock awards and common shares issuance [479]. - The company reported a net cash inflow of $20.7 million from warrants, offset by a $10.9 million repurchase of common stock for tax withholding [481]. Revenue Recognition - The company recognizes revenue when control of goods is obtained by customers, with revenues recorded at net product sales price after accounting for allowances [486]. - The company participates in federal and state government rebate programs, accruing estimated rebates based on actual average amounts and expected prescriptions [488]. Interest and Debt - Interest income from cash and investments could increase or decrease by approximately $1.0 million annually with a hypothetical one-percentage point change in interest rates [493]. - The company’s long-term debt incurs interest at a floating rate of 6.95%, with a fixed rate of 8.0% on the 2028 Convertible Notes, limiting exposure to interest rate risk [494]. Foreign Currency Impact - Foreign currency exchange rates did not materially affect the company's results for the year ended December 31, 2025 [495].

Core Insights - Xeris Biopharma Holdings, Inc. has demonstrated significant growth with record financial performance for Q4 and the full year of 2025, and has provided optimistic financial guidance for 2026 [1] Financial Performance - On March 2, 2026, the company reported earnings per share of $0.06, surpassing the estimated $0.03, indicating strong performance against market expectations [2][5] - The revenue generated was $85.8 million, slightly below the estimated $86 million, yet the company's strategic focus remains evident [2][5] Valuation Metrics - The price-to-sales ratio stands at 3.48, indicating that investors are willing to pay $3.48 for every dollar of sales, reflecting positive market sentiment [3] - The enterprise value to sales ratio is 3.23, showing the company's total valuation compared to its revenue [3] - However, the enterprise value to operating cash flow ratio of 109.77 suggests that the company is generating less cash flow relative to its valuation, which may raise concerns for cash flow-focused investors [3] Financial Stability - The debt-to-equity ratio is 2.76, indicating that the company has more than twice as much debt as equity [4] - Despite the high debt levels, the current ratio of 2.19 suggests that Xeris Biopharma has a strong ability to cover its short-term liabilities with its short-term assets, providing a cushion for financial stability [4]

Core Insights - The company experienced significant growth in 2025, with total revenue increasing by 44% year-over-year to approximately $292 million, driven by strong demand across all three commercial products: Recorlev, Gvoke, and Keveyis [3][14][18] - Recorlev was identified as the primary growth engine, with revenue reaching $139.3 million for the full year, reflecting over 100% growth [14][18] - The company achieved financial self-sustainability in 2025, allowing for continued investment in its pipeline and commercial strategy [4][18] Revenue Performance - Total revenue for Q4 2025 was $85.8 million, representing a 43% increase year-over-year [13][14] - For the full year, Recorlev revenue was $139.3 million, Gvoke revenue was $94.1 million, and Keveyis revenue was $47.6 million [14][15] - The company expects total revenue for 2026 to be between $375 million and $390 million, indicating over 30% growth at the midpoint compared to 2025 [12][19] Product Development and Pipeline - The company plans to initiate a Phase III study for XP-8121 in the second half of 2026, which is anticipated to be a significant value creation inflection point [8][11] - XP-8121 is projected to address a significant unmet medical need and has the potential to generate $1 billion to $3 billion in peak revenue [10][11] - The company has a strong intellectual property foundation for Recorlev, with four Orange Book-listed patents running until March 2040 [6][5] Operational Strategy - The company has expanded its commercial team to enhance sales and patient support, nearly doubling its footprint in January 2025 [1][5] - Adjusted EBITDA for 2025 was $59.4 million, reflecting continued operating leverage and disciplined expense management [18][21] - The company plans to increase R&D expenses by approximately $25 million in 2026 to support the XP-8121 program [20][21] Market Position and Competitive Landscape - The company remains confident in its ability to defend Recorlev against patent infringement lawsuits, having filed against two ANDA filers [5][48] - The market for Recorlev is expected to continue expanding, with the company positioned to capture a larger share due to increased prescriber awareness and patient demand [1][39] - Gvoke and Keveyis are also expected to contribute steadily to revenue, with Gvoke anticipated to grow in the high single-digit to low double-digit range [36][37]

Core Insights - Xeris Biopharma reported significant revenue growth in Q4 and full year 2025, achieving financial self-sustainability and a strong operational foundation [6][5][18] Financial Performance - Fourth quarter revenue reached $85.8 million, a 43% year-over-year increase, while full-year revenue was $291.8 million, up 44% [5] - Adjusted EBITDA for the year was nearly $60 million, with a gross margin of 87% in Q4 and 85% for the full year, reflecting improvements driven by product mix [4][7] - Gvoke generated $24.6 million in Q4 and $94.1 million for the full year, with a 14% growth attributed to broad access and alignment with treatment guidelines [2] - Recorlev's revenue was $45.3 million in Q4 and $139.3 million for the full year, representing over 100% growth, with the patient base expanding to approximately 700 by year-end 2025 [3] Strategic Outlook - For 2026, Xeris projects total revenue between $375 million and $390 million, indicating over 30% growth at the midpoint, while maintaining adjusted EBITDA positivity despite increased R&D and SG&A investments [9][11] - The company plans to initiate phase III studies for its key pipeline program, XP-8121, in the second half of 2026, targeting a market of over 20 million patients [16][17] Product Development and Market Position - Recorlev is expected to be the primary growth driver, with ongoing investments in commercial expansion and patient support [12][10] - Xeris is confident in its intellectual property for Recorlev, holding four Orange Book-listed patents until March 2040 and orphan drug exclusivity through the end of 2028 [14] Competitive Landscape - The company anticipates typical seasonality in Q1, with payer and co-pay resets potentially slowing January sales before a rebound in February and March [13]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 grew 43% year-over-year to nearly $86 million, while full-year revenue increased by 44% to $292 million [5][6][15] - Adjusted EBITDA for Q4 was $25.1 million, an improvement of $16.8 million compared to the previous year, with full-year adjusted EBITDA at $59.4 million [18][19] - The company achieved net income for the first time on a full-year basis in 2025, marking a significant milestone in financial performance [19] Business Line Data and Key Metrics Changes - Recorlev revenue was $45.3 million in Q4 and $139.3 million for the full year, reflecting over 100% growth for both periods, driven by an expanding patient base [16][17] - Gvoke generated $24.6 million in Q4 and $94.1 million for the year, with steady prescription growth and broad access contributing to its performance [16][17] - Keveyis revenue was $12.8 million in Q4 and $47.6 million for the year, supported by an increase in the average number of patients on therapy [17] Market Data and Key Metrics Changes - The patient base for Recorlev nearly doubled to approximately 700 patients by the end of 2025, reflecting increased prescriber awareness and confidence [7] - Gvoke remains a life-saving product for diabetes patients, with continued alignment with treatment guidelines supporting its growth [9] - Keveyis continues to serve a small, underserved patient community, aligning with the company's mission to make a meaningful difference in rare diseases [10] Company Strategy and Development Direction - The company aims for rapid revenue growth and plans to invest in sales, patient support, and commercial infrastructure [12][20] - XP-8121 is expected to enter Phase 3 trials in the second half of 2026, with potential peak sales of $1 billion to $3 billion [11][12] - The company is committed to maintaining a strong balance sheet while making disciplined investments to support growth [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and momentum entering 2026, expecting total revenue between $375 million and $390 million, representing over 30% growth at the midpoint compared to 2025 [13][20] - The company anticipates remaining adjusted EBITDA positive while significantly increasing R&D and commercial investments [20][22] - Management highlighted the importance of a strong operating foundation and the potential for sustained long-term growth [19][70] Other Important Information - The company filed a patent infringement lawsuit against two ANDA filers to protect Recorlev, with confidence in its intellectual property [8][62] - Management emphasized the need for ongoing investments in data studies and patient support to drive Recorlev's growth [26] Q&A Session Summary Question: Insights on Recorlev expansion and operating leverage - Management noted the doubling of the commercial footprint and the need for additional resources to manage patient loads effectively [26][27] Question: Impact of IP litigation on business development - Management stated that the strategy for Recorlev remains unchanged and they are prepared for the litigation [31][32] Question: Guidance on capital deployment beyond 2026 - Management indicated a strong balance sheet and the potential for business development opportunities while remaining disciplined [33][34] Question: Revenue guidance by product for 2026 - Management expects Keveyis to flatten out, Gvoke to grow in the high single-digit to low double-digit range, and Recorlev to be the primary growth driver [40][41] Question: Concerns about generic competition for Recorlev - Management does not see generic Korlym as a risk, emphasizing the different approaches required for prescribing [50] Question: Updates on XP-8121 and FDA interactions - Management confirmed alignment with the FDA and readiness to initiate Phase 3 trials without regulatory gating issues [53]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 grew 43% year-over-year to nearly $86 million, while full-year revenue increased by 44% to $292 million [5][6][15] - Adjusted EBITDA for Q4 was $25.1 million, an improvement of $16.8 million compared to the previous year, and for the full year, it was $59.4 million [18][19] - The company achieved net income on a full-year basis for the first time in 2025, marking a significant milestone in financial performance [19] Business Line Data and Key Metrics Changes - Recorlev revenue was $45.3 million in Q4 and $139.3 million for the full year, reflecting growth of over 100% for both periods, driven by an expanding patient base [16][17] - Gvoke generated $24.6 million in Q4 and $94.1 million for the full year, with steady prescription growth and broad access contributing to its performance [16][17] - Keveyis revenue was $12.8 million in Q4 and $47.6 million for the year, supported by an increase in the average number of patients on therapy [17] Market Data and Key Metrics Changes - Recorlev ended the year with approximately 700 patients, nearly doubling the number from year-end 2024, indicating strong demand and prescriber awareness [7][8] - Gvoke's growth was supported by strong prescriber awareness and alignment with treatment guidelines, reinforcing its role as a reliable contributor [9] - Keveyis continues to serve a small, underserved patient community, aligning with the company's mission to make a meaningful difference in rare diseases [10] Company Strategy and Development Direction - The company aims to drive rapid revenue growth, advance its pipeline, and maintain a strong balance sheet while making targeted investments [12][19] - The strategic focus includes preparing for the phase III clinical trial of XP-8121, which is expected to be a significant value creation inflection point [10][12] - The company remains committed to achieving $1 billion in peak sales for Recorlev by 2035, with a strong intellectual property foundation supporting this goal [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's long-term strategy and highlighted the successful execution of strategic priorities in 2025 [4][6] - The outlook for 2026 anticipates total revenue between $375 million and $390 million, representing over 30% growth at the midpoint compared to 2025 [13][20] - Management emphasized the importance of maintaining disciplined investment prioritization to enhance operating leverage and support sustained performance [19][22] Other Important Information - The company filed a patent infringement lawsuit against two ANDA filers to protect its rights regarding Recorlev, reinforcing its confidence in its intellectual property [8][64] - The company plans to significantly increase R&D and SG&A expenses in 2026 to support growth initiatives and the upcoming phase III study for XP-8121 [21][22] Q&A Session Summary Question: Insights on Recorlev expansion and operating leverage - Management indicated that they have doubled their commercial footprint and will continue to invest in resources to manage patient loads effectively [26][27] Question: Thoughts on IP litigation and potential acquisitions - Management stated that their strategy remains unchanged and they are prepared for the IP litigation, with confidence in achieving $1 billion in sales for Recorlev by 2035 [28][32] Question: Guidance on capital deployment and gross margin evolution - Management noted that the strong balance sheet allows for disciplined business development and that gross margins are expected to improve due to favorable product mix [34][35] Question: Revenue guidance by product for 2026 - Management expects Keveyis to stabilize, Gvoke to grow in the high single-digit to low double-digit range, and Recorlev to be the primary growth driver [41][42] Question: Updates on XP-8121 and FDA interactions - Management confirmed alignment with the FDA and emphasized the importance of entering the phase III trial with a scaled-up go-to-market device [54][56]

Financial Data and Key Metrics Changes - In Q4 2025, total revenue grew 43% year-over-year to nearly $86 million, with full-year revenue increasing by 44% to $292 million [5][14] - Adjusted EBITDA for Q4 was $25.1 million, an improvement of $16.8 million compared to the previous year, with full-year adjusted EBITDA at $59.4 million [17][18] - The company reported net income for the first time on a full-year basis in 2025, reflecting improved financial health [18] Business Line Data and Key Metrics Changes - Recorlev revenue was $45.3 million in Q4 and $139.3 million for the full year, reflecting over 100% growth for both periods, driven by an expanding patient base [15][16] - Gvoke generated $24.6 million in Q4 and $94.1 million for the full year, with steady prescription growth and broad access [15][16] - Keveyis revenue was $12.8 million in Q4 and $47.6 million for the year, supported by an increase in the average number of patients on therapy [16] Market Data and Key Metrics Changes - Recorlev ended 2025 with approximately 700 patients, nearly doubling from year-end 2024, indicating strong market demand [6] - Gvoke remains a life-saving product for diabetes patients, with continued alignment with treatment guidelines contributing to its growth [8] - The company anticipates a significant market opportunity for XP-8121, targeting a peak revenue potential of $1 billion to $3 billion [11] Company Strategy and Development Direction - The company aims to drive rapid revenue growth, advance its pipeline, and maintain a strong balance sheet for future investments [11][18] - The strategic focus includes expanding the commercial team for Recorlev and preparing for the Phase 3 study of XP-8121 [10][11] - The company is committed to maintaining disciplined investment prioritization while enhancing operating leverage [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial self-sustainability and the ability to fund its strategy and pipeline [4][5] - The outlook for 2026 includes expected total revenue between $375 million and $390 million, representing over 30% growth at the midpoint compared to 2025 [11][19] - Management highlighted the importance of continued investment in R&D and commercial infrastructure to support growth [20] Other Important Information - The company filed a patent infringement lawsuit against two ANDA filers to protect its rights regarding Recorlev [7] - The company has four Orange Book-listed patents for Recorlev that run until March 2040, providing a strong IP foundation [7] Q&A Session Summary Question: Insights on Recorlev expansion and operating leverage - Management noted the recent doubling of the commercial footprint and the need for additional resources to manage patient loads effectively [25][26] Question: Impact of IP litigation on business development - Management reiterated that their strategy for Recorlev remains unchanged and they are prepared for the ongoing litigation [30][31] Question: Guidance on capital deployment beyond 2026 - Management indicated a strong balance sheet and the potential for business development opportunities, while emphasizing the strength of existing assets [32] Question: Revenue guidance by product for 2026 - Management expects steady contributions from Keveyis and Gvoke, with Recorlev being the primary growth driver [40] Question: Updates on XP-8121 and FDA interactions - Management confirmed alignment with the FDA and emphasized the importance of entering Phase 3 with a scaled-up commercial device [52] Question: Openness to settlement regarding Recorlev litigation - Management declined to comment on legal strategy but expressed confidence in their patent position [66]

分组1 - Xeris Biopharma reported quarterly earnings of $0.06 per share, exceeding the Zacks Consensus Estimate of $0.03 per share, compared to a loss of $0.03 per share a year ago, representing an earnings surprise of +84.62% [1] - The company achieved revenues of $85.81 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 5.38%, and showing an increase from year-ago revenues of $60.1 million [2] - Xeris Biopharma has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates four times during the same period [2] 分组2 - The stock has underperformed the market, losing about 22% since the beginning of the year, while the S&P 500 has gained 0.5% [3] - The current consensus EPS estimate for the coming quarter is $0.02 on revenues of $84.8 million, and for the current fiscal year, it is $0.24 on revenues of $373.85 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the bottom 43% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]