Company Performance - Xeris Biopharma's shares have increased by 32.4% over the past month, reaching a new 52-week high of $7.61 [1] - The stock has gained 112.4% since the beginning of the year, outperforming the Zacks Medical sector, which declined by 7.5%, and the Zacks Medical - Drugs industry, which returned 5.3% [1] Earnings and Revenue Expectations - Xeris Biopharma has consistently beaten earnings estimates, with the latest EPS reported at -$0.01 against a consensus estimate of -$0.03 [2] - For the current fiscal year, the company is expected to post earnings of -$0.05 per share on revenues of $285.65 million, reflecting an 84.85% change in EPS and a 40.67% change in revenues [3] - For the next fiscal year, earnings are projected to be $0.20 per share on revenues of $346.4 million, indicating a year-over-year change of 485% in EPS and 21.27% in revenues [3] Valuation Metrics - Xeris Biopharma currently has a Value Score of D, while its Growth and Momentum Scores are both A, resulting in a combined VGM Score of A [6] - The stock holds a Zacks Rank of 2 (Buy) due to rising earnings estimates, suggesting potential for further growth [7][8] Industry Comparison - The Medical - Drugs industry is positioned in the top 35% of all industries, indicating favorable conditions for both Xeris Biopharma and its peer, Rigel Pharmaceuticals [11] - Rigel Pharmaceuticals has a Zacks Rank of 1 (Strong Buy) and has shown strong earnings performance, beating consensus estimates by 66.50% [9][10]

PART I. FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements and accompanying notes for the periods ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,285 | $71,621 | | Total current assets | $185,578 | $167,662 | | Total assets | $334,686 | $323,060 | | **Liabilities** | | | | Total current liabilities | $95,171 | $100,443 | | Long-term debt, net | $218,626 | $217,006 | | Total liabilities | $353,990 | $352,675 | | **Stockholders' Equity (deficit)** | | | | Total stockholders' equity (deficit) | $(19,304) | $(29,615) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $67,708 | $46,512 | $125,510 | $86,775 | | Total revenue | $71,539 | $48,065 | $131,658 | $88,703 | | Total costs and expenses | $67,057 | $56,252 | $130,266 | $111,135 | | Income (loss) from operations | $4,482 | $(8,187) | $1,392 | $(22,432) | | Net loss | $(1,928) | $(15,005) | $(11,148) | $(33,985) | | Net loss per common share - basic and diluted | $(0.01) | $(0.10) | $(0.07) | $(0.24) | | Weighted average common shares outstanding - basic and diluted | 159,459,413 | 148,345,549 | 155,972,048 | 144,372,512 | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Stockholders' Equity (Deficit) (in thousands) | Item | December 31, 2024 | March 31, 2025 | June 30, 2025 | | :--- | :--- | :--- | :--- | | Common Stock (Shares) | 149,429,410 | 156,014,050 | 161,224,762 | | Common Stock (Amount) | $15 | $16 | $16 | | Additional Paid In Capital | $642,256 | $645,962 | $663,713 | | Accumulated Deficit | $(671,861) | $(681,081) | $(683,009) | | Total Stockholders' Equity (Deficit) | $(29,615) | $(35,128) | $(19,304) | [Condensed Consolidated Statements of Cash Flow](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flow%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,849) | $(30,651) | | Net cash used in investing activities | $(292) | $(15,047) | | Net cash provided by (used in) financing activities | $(2,195) | $35,853 | | Decrease in cash, cash equivalents and restricted cash | $(12,336) | $(9,845) | | Cash, cash equivalents and restricted cash, end of quarter | $63,408 | $61,829 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for the condensed consolidated financial statements [Note 1. Organization and Business](index=8&type=section&id=Note%201.%20Organization%20and%20Business) - Xeris Biopharma Holdings, Inc is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for chronic endocrine and neurological diseases in the United States[18](index=18&type=chunk) - The company's commercial products include Recorlev for Cushing's syndrome, Gvoke for severe hypoglycemia, and Keveyis for Primary Periodic Paralysis (PPP)[18](index=18&type=chunk) - Xeris leverages its proprietary formulation technologies (XeriSol and XeriJect) for new product creation (e.g, XP-8121) and development partnerships[18](index=18&type=chunk) - The company has incurred operating losses since inception, with an **accumulated deficit of $683.0 million** as of June 30, 2025[21](index=21&type=chunk) - Cash resources are believed to be **sufficient for at least the next 12 months**, but the company may seek additional equity or debt financing, subject to market conditions and potential dilution or restrictions[21](index=21&type=chunk)[22](index=22&type=chunk) [Note 2. Basis of presentation and summary of significant accounting policies and estimates](index=8&type=section&id=Note%202.%20Basis%20of%20presentation%20and%20summary%20of%20significant%20accounting%20policies%20and%20estimates) - The condensed consolidated financial statements are unaudited and prepared in accordance with GAAP for interim financial information and SEC regulations[23](index=23&type=chunk)[25](index=25&type=chunk) - Revenue is recognized when the customer obtains control of promised goods or services, recorded at net product sales price, including estimated allowances for discounts, rebates, and returns[32](index=32&type=chunk)[33](index=33&type=chunk) - For the three and six months ended June 30, 2025, **four customers accounted for 96% of gross product revenue**, and 86% of trade accounts receivable as of June 30, 2025[36](index=36&type=chunk) - New accounting pronouncements include ASU 2023-09 (Income Tax Disclosures, effective FY2025), ASU 2024-03 (Expense Disaggregation Disclosures, effective FY2026), and ASU 2024-04 (Induced Conversions of Convertible Debt, effective FY2025)[37](index=37&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) [Note 3. Disaggregated Revenue](index=10&type=section&id=Note%203.%20Disaggregated%20Revenue) Disaggregated Revenue by Product (in thousands) | Product | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Recorlev | $31,444 | $13,338 | $56,974 | $23,937 | | Gvoke | $23,467 | $20,046 | $44,312 | $36,625 | | Keveyis | $11,485 | $13,128 | $22,912 | $26,213 | | Other product revenue | $1,312 | $0 | $1,312 | $0 | | **Product revenue, net** | **$67,708** | **$46,512** | **$125,510** | **$86,775** | | Royalty, contract and other revenue | $3,831 | $1,553 | $6,148 | $1,928 | | **Total revenue** | **$71,539** | **$48,065** | **$131,658** | **$88,703** | [Note 4. Inventory](index=10&type=section&id=Note%204.%20Inventory) Inventory Components (in thousands) | Component | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Raw materials | $35,685 | $31,732 | | Work in process | $10,516 | $10,991 | | Finished goods | $21,081 | $5,452 | | **Inventory, net** | **$67,282** | **$48,175** | | Inventory reserves | $10,100 | $7,700 | [Note 5. Property and Equipment](index=11&type=section&id=Note%205.%20Property%20and%20Equipment) Property and Equipment, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total property and equipment (gross) | $12,788 | $12,825 | | Less: accumulated depreciation and amortization | $(7,504) | $(7,263) | | **Property and equipment, net** | **$5,284** | **$5,562** | | Depreciation and amortization expense (Q2) | $0.3 million | $0.3 million | | Depreciation and amortization expense (YTD) | $0.6 million | $0.6 million | [Note 6. Intangible Assets](index=12&type=section&id=Note%206.%20Intangible%20Assets) Identified Intangible Assets (in thousands) | Asset | Life (Years) | Gross Assets | Accumulated Amortization (June 30, 2025) | Net (June 30, 2025) | Net (December 31, 2024) | | :--- | :--- | :--- | :--- | :--- | :--- | | Keveyis | 5 | $11,000 | $(8,250) | $2,750 | $3,850 | | Recorlev | 14 | $121,000 | $(30,250) | $90,750 | $95,071 | | **Total intangible assets** | | **$132,000** | **$(38,500)** | **$93,500** | **$98,921** | Expected Amortization Expense (in thousands) | Year | Amount | | :--- | :--- | | 2025 | $5,422 | | 2026 | $10,293 | | 2027 | $8,643 | | 2028 | $8,643 | | 2029 | $8,643 | | Thereafter | $51,856 | | **Total** | **$93,500** | [Note 7. Other Accrued Liabilities](index=12&type=section&id=Note%207.%20Other%20Accrued%20Liabilities) Other Accrued Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued employee costs | $15,043 | $19,577 | | Accrued interest expense | $1,724 | $2,123 | | Accrued supply chain costs | $783 | $871 | | Accrued marketing costs | $2,166 | $1,506 | | Accrued research and development costs | $2,508 | $766 | | Accrued other costs | $2,745 | $2,873 | | **Total other accrued liabilities** | **$24,969** | **$27,716** | [Note 8. Debt](index=12&type=section&id=Note%208.%20Debt) Debt Components (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Convertible senior notes | $33,950 | $49,204 | | Loan agreement | $187,342 | $185,995 | | **Debt, net of unamortized debt issuance costs** | **$218,626** | **$232,108** | | Current portion | $0 | $15,102 | | Non-current portion | $218,626 | $217,006 | - In March and April 2025, **$15.2 million of 2025 Convertible Senior Notes were converted** into 4,978,151 shares of common stock, leaving an outstanding balance of $33.6 million for the 2028 Convertible Notes as of June 30, 2025[54](index=54&type=chunk) - The 2028 Convertible Notes have an **effective interest rate of 8.9%** and a fair value of approximately $57.9 million as of June 30, 2025[54](index=54&type=chunk)[56](index=56&type=chunk) - The Amended and Restated Credit Agreement (2029 Loans) provides **$200.0 million in term loans**, maturing on March 5, 2029 (or January 15, 2028, under certain conditions related to the 2028 Convertible Notes)[57](index=57&type=chunk)[58](index=58&type=chunk) - The 2029 Loans incur interest at a floating rate of 6.95% plus the greater of SOFR (three-month tenor) or 2.00% per annum, with an **effective interest rate of approximately 11.4%**[59](index=59&type=chunk) Future Minimum Principal Payments (in thousands) | Year | Amount | | :--- | :--- | | 2025 remaining | $0 | | 2026 | $0 | | 2027 | $0 | | 2028 | $33,574 | | 2029 | $200,000 | | Thereafter | $0 | | **Total** | **$233,574** | - Interest expense for the three months ended June 30, 2025, was **$7.4 million** (down from $8.0 million in 2024), and for the six months ended June 30, 2025, was **$14.7 million** (down from $15.0 million in 2024), primarily due to a lower principal amount of debt outstanding[64](index=64&type=chunk) [Note 9. Warrants](index=14&type=section&id=Note%209.%20Warrants) Outstanding Warrants as of June 30, 2025 | Classification | Warrants Outstanding | Exercise Price per Warrant | Expiration Date | | :--- | :--- | :--- | :--- | | **Warrants classified as liabilities:** | | | | | 2018 Term B Warrants | 40,292 | $11.169 | September 2025 | | **Warrants classified as equities:** | | | | | Avenue Capital loan agreement | 209,633 | $2.390 | December 2025 | | Horizon and Oxford loan agreement | 125,999 | $3.130 | December 2026 | | Armistice securities purchase agreement | 5,119,454 | $3.223 | February 2027 | | Hayfin Amended and Restated Credit Agreement | 263,158 | $2.280 | March 2029 | | **Total Equity Warrants** | **5,718,244** | | | - In August 2025, Armistice Capital exercised warrants for 1,706,485 shares of common stock for $5.5 million, leaving 3,412,969 outstanding warrants[66](index=66&type=chunk) [Note 10. Fair Value Measurements](index=15&type=section&id=Note%2010.%20Fair%20Value%20Measurements) - Fair value measurements are classified into Level 1 (unadjusted quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (significant unobservable inputs)[68](index=68&type=chunk)[69](index=69&type=chunk) Fair Value Hierarchy (in thousands) | Item | Total as of June 30, 2025 | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | Cash and money market funds | $59,285 | $59,285 | $0 | $0 | | Restricted cash | $4,123 | $4,123 | $0 | $0 | | **Total Assets** | **$63,408** | **$63,408** | **$0** | **$0** | | Item | Total as of December 31, 2024 | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | Cash and money market funds | $71,621 | $71,621 | $0 | $0 | | Restricted cash | $4,123 | $4,123 | $0 | $0 | | **Total Assets** | **$75,744** | **$75,744** | **$0** | **$0** | [Note 11. Stock Compensation Plan](index=15&type=section&id=Note%2011.%20Stock%20Compensation%20Plan) - The company operates several stock compensation plans: 2011 Plan, 2018 Plan (6.1 million shares available), 2018 Employee Stock Purchase Plan (ESPP) (6.1 million shares available), Inducement Plan (0.9 million shares available), and Assumed Plans (0.2 million shares available)[72](index=72&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) Stock Option Activity (Six Months Ended June 30, 2025) | Item | Number of Options | Weighted Average Exercise Price Per Share | | :--- | :--- | :--- | | Outstanding - December 31, 2024 | 8,832,170 | $5.31 | | Exercised | (1,682,222) | $3.63 | | Forfeited | (22) | $5.29 | | Expired | (72,414) | $9.00 | | **Outstanding - June 30, 2025** | **7,077,512** | **$5.66** | | Vested and expected to vest | 7,077,512 | $5.66 | | Exercisable | 7,077,470 | $5.66 | | Total intrinsic value (June 30, 2025) | | $5.7 million | | Unrecognized stock-based compensation expense | | < $0.1 million | Restricted Stock Unit (RSU) Activity (Six Months Ended June 30, 2025) | Item | Number of Units | Weighted Average Grant Date Fair Value Per Share | | :--- | :--- | :--- | | Unvested balance - December 31, 2024 | 16,420,640 | $2.12 | | Granted | 5,468,000 | $3.71 | | Vested | (6,827,525) | $2.09 | | Forfeited | (592,812) | $2.30 | | **Unvested balance - June 30, 2025** | **14,468,303** | **$2.73** | | Total fair value of RSUs vested (YTD) | | $25.5 million | | Unrecognized stock-based compensation expense | | $29.1 million | | Weighted-average remaining vesting period | | 1.8 years | - As of June 30, 2025, there was **$4.0 million of unrecognized stock-based compensation expense** related to Stock Appreciation Rights (SARs), expected to be recognized over a weighted-average remaining vesting period of 1.5 years[85](index=85&type=chunk) Total Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $444 | $382 | $768 | $719 | | Selling, general and administrative | $4,564 | $3,851 | $8,683 | $7,281 | | **Total stock-based compensation expense** | **$5,008** | **$4,233** | **$9,451** | **$8,000** | [Note 12. Leases](index=17&type=section&id=Note%2012.%20Leases) - The company has non-cancellable operating leases for office and laboratory space, expiring between 2031 and 2036[86](index=86&type=chunk) - As of June 30, 2025, operating leases had a **weighted-average remaining lease term of 10.2 years** and a weighted-average discount rate of 11.9%[90](index=90&type=chunk) Lease Expense (in thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Operating lease expense | $1,272 | $1,340 | $2,567 | $2,680 | | Variable lease expense | $974 | $325 | $1,949 | $566 | | Sublease income | $(291) | $(52) | $(584) | $(105) | | **Total lease expense** | **$1,955** | **$1,613** | **$3,932** | **$3,141** | Maturities of Lease Liabilities (in thousands) as of June 30, 2025 | Year | Amount | | :--- | :--- | | 2025 remaining | $3,063 | | 2026 | $6,232 | | 2027 | $6,389 | | 2028 | $6,549 | | 2029 | $6,714 | | Thereafter | $38,727 | | **Total lease payments** | **$67,674** | | Less: Effect of discounting | $(29,077) | | **Present value of lease liabilities** | **$38,597** | | Current operating lease liabilities | $6,156 | | Non-current operating lease liabilities | $32,441 | [Note 13. Commitments and Contingencies](index=19&type=section&id=Note%2013.%20Commitments%20and%20Contingencies) - The company has a supply agreement with Taro Pharmaceuticals for Keveyis, extended until March 2027, with annual minimum marketing spend and purchase order quantity requirements[96](index=96&type=chunk) - As of June 30, 2025, the company had **$4.1 million in unused letters of credit**, collateralized by restricted cash, primarily for leases[97](index=97&type=chunk) - Management is not aware of any existing, pending, or threatened legal actions that would have a material impact on the company's financial position or results of operations[98](index=98&type=chunk) - The 2029 Loans may mature earlier (January 15, 2028) if the 2028 Convertible Notes are outstanding and certain conditions regarding their extension or redemption are not met[99](index=99&type=chunk)[101](index=101&type=chunk) [Note 14. Net Loss Per Common Share](index=20&type=section&id=Note%2014.%20Net%20Loss%20Per%20Common%20Share) - Basic and diluted net loss per common share are the same for all periods presented due to the anti-dilutive effect of potentially dilutive securities[102](index=102&type=chunk) Anti-Dilutive Securities Excluded from EPS Computation | Security Type | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Shares to be issued upon conversion of Convertible Notes | 10,971,895 | 15,939,216 | | Vested and unvested stock options | 7,077,512 | 8,943,175 | | Restricted stock units | 14,468,303 | 16,765,889 | | Warrants | 5,758,536 | 8,362,270 | | **Total anti-dilutive securities** | **38,276,246** | **50,010,550** | [Note 15. Segment Reporting](index=20&type=section&id=Note%2015.%20Segment%20Reporting) - The company operates as a **single operating and reporting segment**, focused on developing and commercializing therapies for chronic endocrine and neurological diseases[104](index=104&type=chunk) - The Chief Executive Officer (CODM) reviews consolidated financial information, including net loss, budget vs actual results, and revenue trends, to assess performance and allocate resources[105](index=105&type=chunk)[106](index=106&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition, operational results, and cash flows for the reported periods [Cautionary statements for forward-looking information](index=21&type=section&id=Cautionary%20statements%20for%20forward-looking%20information) - The discussion contains forward-looking statements subject to various important factors and risks, including regulatory approvals, macroeconomic conditions, market volatility, and the ability to market products[108](index=108&type=chunk) - The company disclaims any obligation to update forward-looking statements[108](index=108&type=chunk) [Business Overview and Strategy](index=21&type=section&id=Business%20Overview%20and%20Strategy) Xeris Biopharma focuses on chronic diseases using proprietary technologies to grow commercial products and develop new therapies [Commercial Products](index=21&type=section&id=Commercial%20Products) - Recorlev is approved for endogenous hypercortisolemia in adult Cushing's syndrome patients[112](index=112&type=chunk) - Gvoke is a ready-to-use, liquid-stable glucagon for severe hypoglycemia in pediatric and adult patients (age 2+)[112](index=112&type=chunk) - Keveyis is the first approved therapy in the U.S for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis (PPP)[112](index=112&type=chunk) [Our Pipeline](index=21&type=section&id=Our%20Pipeline) - XP-8121 is a once-weekly, subcutaneous injection of levothyroxine in development for hypothyroidism, with plans to initiate a Phase 3 clinical trial[112](index=112&type=chunk) - The company is pursuing formulation and development partnerships to apply its XeriSol and XeriJect technologies to enhance other companies' proprietary drugs[112](index=112&type=chunk) [Our Strategy](index=22&type=section&id=Our%20Strategy) - The strategy is to build a profitable biopharmaceutical company by growing its three commercial products and investing in therapies for unmet medical needs[113](index=113&type=chunk) [Patent Rights](index=22&type=section&id=Patent%20Rights) - As of July 31, 2025, the company owned **180 patents globally**, including composition of matter patents for its ready-to-use glucagon formulation expiring in 2036[114](index=114&type=chunk) - Patents related to Recorlev's proprietary formulations provide protection through 2040[114](index=114&type=chunk) [Financing](index=22&type=section&id=Financing) - Operations have been funded primarily through stock sales and debt financing, resulting in an **accumulated deficit of $683.0 million** as of June 30, 2025[115](index=115&type=chunk) - The company expects to incur net losses for at least the next 12 months due to continued marketing, R&D, public company operations, and increased borrowing costs[115](index=115&type=chunk)[120](index=120&type=chunk) - Future capital requirements may necessitate additional public equity or debt financing, which may not be available on acceptable terms or at all[115](index=115&type=chunk) [Components of our Results of Operations](index=22&type=section&id=Components%20of%20our%20Results%20of%20Operations) Explains the accounting policies and components that make up the company's revenue and expense lines [Product revenue, net](index=22&type=section&id=Product%20revenue%2C%20net) - Net product revenue represents gross sales less estimated allowances for patient copay assistance, prompt payment discounts, payor rebates, chargebacks, service fees, and product returns[117](index=117&type=chunk) [Royalty, contract and other revenue](index=22&type=section&id=Royalty%2C%20contract%20and%20other%20revenue) - Royalty and contract revenue is recognized as earned in accordance with contract terms when reasonably estimable and collectability is assured, including revenue from collaboration and technology partnerships[118](index=118&type=chunk) [Cost of goods sold](index=22&type=section&id=Cost%20of%20goods%20sold) - Cost of goods sold primarily includes product costs (raw materials, manufacturing, overhead), shipping, distribution, and losses from excess or obsolete inventory[119](index=119&type=chunk) [Research and development expenses](index=23&type=section&id=Research%20and%20development%20expenses) - R&D expenses are recognized as incurred and include costs for preclinical studies, clinical trials, personnel, lab supplies, outsourced development, regulatory activities, and facility costs[121](index=121&type=chunk) - The company expects to incur significant R&D expenses as it advances pipeline candidates, plans clinical trials, and prepares regulatory filings[122](index=122&type=chunk) [Selling, general and administrative expenses](index=23&type=section&id=Selling%2C%20general%20and%20administrative%20expenses) - SG&A expenses primarily consist of compensation, marketing, selling, professional fees, and facility costs not included in R&D[124](index=124&type=chunk) [Amortization of intangible assets](index=23&type=section&id=Amortization%20of%20intangible%20assets) - Amortization of intangible assets relates to Recorlev (14-year period) and Keveyis (5-year period), using the straight-line method[125](index=125&type=chunk) [Other income (expense)](index=23&type=section&id=Other%20income%20(expense)) - Other income (expense) includes interest expense on debt, interest income, debt refinancing costs, and changes in fair value of Contingent Value Rights (CVRs)[126](index=126&type=chunk) [Results of Operations Analysis](index=23&type=section&id=Results%20of%20Operations%20Analysis) Analyzes financial performance, highlighting significant changes in revenue, costs, and net loss compared to the prior year Summary of Results of Operations (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total revenue | $71,539 | $48,065 | $23,474 | 48.8% | $131,658 | $88,703 | $42,955 | 48.4% | | Total cost and expenses | $67,057 | $56,252 | $10,805 | 19.2% | $130,266 | $111,135 | $19,131 | 17.2% | | Income (loss) from operations | $4,482 | $(8,187) | $12,669 | (154.7)% | $1,392 | $(22,432) | $23,824 | (106.2)% | | Net loss | $(1,928) | $(15,005) | $13,077 | (87.2)% | $(11,148) | $(33,985) | $22,837 | (67.2)% | [Product Revenue, Net](index=24&type=section&id=Product%20Revenue%2C%20Net) Overall product revenue increased significantly, driven by strong growth in Recorlev and Gvoke [Recorlev Revenue](index=24&type=section&id=Recorlev%20Revenue) - Recorlev net revenue **increased by $18.1 million (135.7%)** for Q2 2025 YoY, primarily due to higher volume (141.3%) offset by unfavorable net pricing (5.6%)[129](index=129&type=chunk) - Recorlev net revenue **increased by $33.0 million (138.0%)** for YTD 2025 YoY, driven by higher volume (148.1%) offset by unfavorable net pricing (10.1%)[130](index=130&type=chunk) [Gvoke Revenue](index=24&type=section&id=Gvoke%20Revenue) - Gvoke net revenue **increased by $3.4 million (17.1%)** for Q2 2025 YoY, due to higher volume (4.0%) and favorable net pricing (13.1%)[131](index=131&type=chunk) - Gvoke net revenue **increased by $7.7 million (21.0%)** for YTD 2025 YoY, due to higher volume (9.0%) and favorable net pricing (12.0%)[131](index=131&type=chunk) [Keveyis Revenue](index=24&type=section&id=Keveyis%20Revenue) - Keveyis net revenue **decreased by $1.6 million (12.5%)** for Q2 2025 YoY, due to lower volume (20.5%) partially offset by favorable net pricing (8.0%)[132](index=132&type=chunk) - Keveyis net revenue **decreased by $3.3 million (12.6%)** for YTD 2025 YoY, due to lower volume (20.5%) partially offset by favorable net pricing (7.9%)[133](index=133&type=chunk) [Other Product Revenue](index=25&type=section&id=Other%20Product%20Revenue) - Other product revenue **increased by $1.3 million** for both Q2 and YTD 2025, including the sale of VialDx to American Regent[134](index=134&type=chunk) [Cost of Goods Sold](index=25&type=section&id=Cost%20of%20Goods%20Sold) - Cost of goods sold **increased by $4.1 million (52.7%)** for Q2 2025 YoY and **$6.9 million (49.9%)** for YTD 2025 YoY[135](index=135&type=chunk) - COGS as a percent of total product revenue increased to **17.6% for Q2 2025** (from 16.7%), primarily due to higher write-offs of Gvoke components ($1.5 million or 2.2%) offset by higher sales of lower COGS products (1.4%)[136](index=136&type=chunk) - COGS as a percent of total product revenue increased to **16.4% for YTD 2025** (from 15.9%), primarily due to a one-time credit for Keveyis in 2024 (1.9%) offset by higher sales of lower COGS products (1.3%)[137](index=137&type=chunk) [Research and Development Expenses](index=25&type=section&id=Research%20and%20Development%20Expenses) - R&D expenses **increased by $2.3 million (39.9%)** for Q2 2025 YoY and **$2.2 million (16.4%)** for YTD 2025 YoY[138](index=138&type=chunk) Research and Development Expenses by Type (in thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Pipeline | $2,444 | $941 | $5,030 | $4,071 | | Technology development | $529 | $301 | $815 | $840 | | Personnel related expenses | $4,325 | $3,579 | $8,552 | $7,007 | | Lab supplies and equipment depreciation | $434 | $384 | $776 | $764 | | Other | $323 | $554 | $635 | $898 | | **Total** | **$8,055** | **$5,759** | **$15,808** | **$13,580** | [Selling, General and Administrative Expenses](index=25&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) - SG&A expenses **increased by $4.4 million (11.0%)** for Q2 2025 YoY and **$10.0 million (12.8%)** for YTD 2025 YoY, primarily due to higher personnel-related expenses from investments in the Recorlev commercial organization[139](index=139&type=chunk)[140](index=140&type=chunk) [Amortization of Intangible Assets](index=25&type=section&id=Amortization%20of%20Intangible%20Assets) - Amortization of intangible assets remained consistent at **$2.7 million for Q2 2025** and **$5.4 million for YTD 2025**, compared to the same periods in 2024[141](index=141&type=chunk) [Other Income (Expense)](index=25&type=section&id=Other%20Income%20(Expense)) - Interest expense **decreased by $0.6 million (7.6%)** for Q2 2025 YoY and **$0.3 million (2.2%)** for YTD 2025 YoY, primarily due to a lower principal amount of debt outstanding[142](index=142&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses cash flow activities, funding sources, and future capital requirements [Financing Transactions](index=27&type=section&id=Financing%20Transactions) - The company has an Open Market Sale Agreement with Jefferies LLC for up to **$75.0 million of common stock**, with no shares sold to date[145](index=145&type=chunk) - In September 2023, **$32.0 million of 2025 Convertible Notes were exchanged** for $33.6 million of 2028 Convertible Notes[146](index=146&type=chunk) - In March 2024, an Amended and Restated Credit Agreement provided **$200.0 million in term loans** and up to an additional $15.2 million for redeeming 2025 Convertible Notes[147](index=147&type=chunk) - In March and April 2025, **$15.2 million of 2025 Convertible Senior Notes were converted** into 4,978,152 shares of common stock, leaving $33.6 million of 2028 Convertible Notes outstanding as of June 30, 2025[148](index=148&type=chunk) [Capital Resources and Funding Requirements](index=27&type=section&id=Capital%20Resources%20and%20Funding%20Requirements) - The company has an **accumulated deficit of $683.0 million** as of June 30, 2025, but believes current cash resources are sufficient for at least the next twelve months[149](index=149&type=chunk) - Substantial additional expenditures are expected for marketing, sales, and R&D, leading to anticipated net losses for at least the next twelve months[149](index=149&type=chunk) - Future capital requirements depend on commercialization success, R&D costs, regulatory actions, competition, and intellectual property defense, potentially requiring additional financing[149](index=149&type=chunk)[150](index=150&type=chunk) [Cash Flows Analysis](index=27&type=section&id=Cash%20Flows%20Analysis) Provides a detailed breakdown of cash flows from operating, investing, and financing activities Summary of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,849) | $(30,651) | | Net cash used in investing activities | $(292) | $(15,047) | | Net cash provided by/(used in) financing activities | $(2,195) | $35,853 | [Operating Activities](index=29&type=section&id=Operating%20Activities) - Net cash used in operating activities **decreased to $9.8 million** for YTD 2025, from $30.7 million for YTD 2024, primarily driven by higher sales[152](index=152&type=chunk) [Investing Activities](index=29&type=section&id=Investing%20Activities) - Net cash used in investing activities **decreased to $292.0 thousand** for YTD 2025, from $15.0 million for YTD 2024, due to fewer purchases of short-term investments[153](index=153&type=chunk) [Financing Activities](index=29&type=section&id=Financing%20Activities) - Net cash used in financing activities was **$2.2 million for YTD 2025**, a shift from $35.9 million provided in YTD 2024[154](index=154&type=chunk) - The cash used in YTD 2025 was driven by repurchases of common stock for taxes and proceeds from stock awards, while YTD 2024 was primarily from **$38.2 million net proceeds from a term loan**[154](index=154&type=chunk) [CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES AND ASSUMPTIONS](index=29&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20USE%20OF%20ESTIMATES%20AND%20ASSUMPTIONS) - There have been **no significant changes** to the company's critical accounting policies since December 31, 2024[155](index=155&type=chunk) [NEW ACCOUNTING STANDARDS](index=29&type=section&id=NEW%20ACCOUNTING%20STANDARDS) - Refer to Note 2 for a description of recent accounting pronouncements applicable to the financial statements[156](index=156&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses the company's exposure to interest rate and foreign currency exchange rate fluctuations [Interest Rate Risk](index=29&type=section&id=Interest%20Rate%20Risk) - A hypothetical **one-percentage point change in interest rates** would increase or decrease annual interest income on cash, cash equivalents, restricted cash, and investments by approximately **$0.6 million**[158](index=158&type=chunk) - The company is exposed to interest rate risk on its **SOFR-indexed borrowings** under the Amended and Restated Credit Agreement, which has a floating rate[159](index=159&type=chunk) - The 2028 Convertible Notes have a **fixed interest rate of 8.0% annually**, thus not subjecting the company to interest rate risk[159](index=159&type=chunk) [Foreign Currency Exchange Risk](index=29&type=section&id=Foreign%20Currency%20Exchange%20Risk) - The company may be subject to foreign currency exchange rate fluctuations from international contracts, but net foreign currency gains and losses did not materially affect results for the three and six months ended June 30, 2025[160](index=160&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Details management's evaluation of disclosure controls and procedures, concluding they were effective as of June 30, 2025 [Evaluation of Disclosure Controls and Procedures](index=30&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[161](index=161&type=chunk) [Changes in Internal Control Over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - **No changes in internal control over financial reporting** occurred during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[162](index=162&type=chunk) PART II. OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS](index=31&type=section&id=Item%201.%20Legal%20Proceedings) Reports no material legal proceedings that would adversely affect the company's financial position or operations - The company is not currently subject to any **material legal proceedings**[164](index=164&type=chunk) - Management does not believe any existing claims would individually or in aggregate have a **material adverse effect** on the company's business, financial position, or results of operations[164](index=164&type=chunk) [ITEM 1A. RISK FACTORS](index=32&type=section&id=Item%201A.%20Risk%20Factors) Refers to the comprehensive risk factors discussed in the Annual Report on Form 10-K for the year ended December 31, 2024 - **No material changes** to the company's risk factors have occurred since the filing of its Annual Report on Form 10-K for the year ended December 31, 2024[166](index=166&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or issuer purchases of equity securities during the reporting period - There were **no recent sales of unregistered securities**[167](index=167&type=chunk) - The section on use of proceeds from initial public offering is not applicable[168](index=168&type=chunk) - There were **no issuer purchases of equity securities**[169](index=169&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reports that there are no defaults upon senior securities to disclose for the reporting period - This item is **not applicable**[170](index=170&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Reports that there are no mine safety disclosures required for the reporting period - This item is **not applicable**[171](index=171&type=chunk) [ITEM 5. OTHER INFORMATION](index=32&type=section&id=Item%205.%20Other%20Information) Details a Rule 10b5-1 trading plan adopted by the Chairperson of the board for selling shares to cover tax obligations - On June 12, 2025, Marla Persky, Chairperson of the board, adopted a **Rule 10b5-1 trading plan** to sell up to 31,000 shares of common stock to satisfy tax withholding obligations from RSU vesting, effective until June 30, 2026[172](index=172&type=chunk) - No other directors or officers adopted, materially modified, or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025[173](index=173&type=chunk) [ITEM 6. EXHIBITS](index=33&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed as part of the Quarterly Report on Form 10-Q - The exhibits filed include Amended and Restated Certificate of Incorporation and By-laws, certifications of Principal Executive and Financial Officers (31.1, 31.2, 32.1), and various Inline XBRL Taxonomy Extension Documents[176](index=176&type=chunk) [SIGNATURES](index=34&type=section&id=Signatures) Formally concludes the Quarterly Report on Form 10-Q with the required signatures from executive officers - The report is signed by John Shannon, Chief Executive Officer and Director, and Steven M Pieper, Chief Financial Officer, on August 7, 2025[181](index=181&type=chunk)

Financial Data and Key Metrics Changes - Total revenue grew 49% year over year to a record of almost $72 million in Q2 2025, driven by strong demand across the product portfolio [5][14] - Net product revenue increased 46% to approximately $67.7 million, with RECORLEV leading the growth [14][15] - Adjusted EBITDA was positive at $12.5 million, reflecting an improvement of nearly $13 million year over year [19] Performance by Product Line - RECORLEV revenue reached over $31 million, a 136% increase year over year, with a 122% increase in the average number of patients on therapy [7][14] - Gvoke generated $23.5 million in revenue, a 17% increase compared to the previous year, supported by a 5% growth in total prescriptions [15][10] - KEVEYIS revenue was over $11.5 million, showing a modest increase in the average number of patients on therapy [10][15] Market Data and Key Metrics Changes - The company anticipates total revenue for 2025 to be in the range of $280 million to $290 million, representing a year-over-year growth of 40% at the midpoint [6][20] - The hypercortisolism market is expanding, with increased attention on cortisol testing, which is expected to benefit all players in the market [29] Company Strategy and Development Direction - The company is focused on strategic investments to drive sustained growth, particularly in RECORLEV and the pipeline asset XP-8121 [12][21] - The company plans to expand its commercial footprint and increase investments to support the dynamic growth in the hypercortisolism market [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance and growth opportunities ahead, citing the positive trajectory of commercial products [6][13] - The company remains committed to delivering continued positive adjusted EBITDA while making deliberate value-driven investments [22] Other Important Information - The company celebrated the ten-year anniversary of KEVEYIS' FDA approval, highlighting its importance in treating patients with primary periodic paralysis [10] - The company is leveraging proprietary technology to develop a novel formulation for XP-8121, targeting a significant unmet medical need in hypothyroidism [12] Q&A Session Summary Question: Can you talk about the gross to net benefit for Gvoke? - Management anticipates that the favorability will continue for the balance of the year [23] Question: How do you see the script growth for Gvoke in the back half of the year? - Management expects an increase in script growth in Q3, typically a stronger quarter due to back-to-school movements [26] Question: Where are RECORLEV prescriptions coming from? - The majority of prescriptions are from endocrinologists, with over half of patients being new to therapy [27] Question: How will the competitive environment change with a new drug launch? - Management believes that more players in the market will generate more awareness and growth opportunities for all [29] Question: What are the plans for long-term spending to support RECORLEV? - The company plans to increase its commercial footprint and make significant investments in the RECORLEV brand [34] Question: Will there be further clinical data generated for RECORLEV? - Management confirmed plans to generate more data to solidify RECORLEV's value proposition [37] Question: How do you see the treatment landscape for Gvoke evolving? - There is significant opportunity to reach patients who currently do not have access to rescue glucagon, with a large number of patients still unprotected [41]

Financial Outlook & Growth Strategy - Xeris expects total revenue of approximately $260 million to $275 million in 2025 and to maintain positive adjusted EBITDA [21] - The company anticipates total revenue to reach approximately $750 million by 2030, driven by Recorlev and the launch of XP-8121 [20, 127] - Xeris projects Recorlev to achieve peak net revenue between $1 billion and $3 billion, with XP-8121 also expected to reach $1 billion to $3 billion in peak net revenue [23, 99, 132] Recorlev Growth Opportunities - Recorlev is expected to approach $1 billion in annual net revenue [26, 40] - The U S addressable market for hypercortisolism is estimated at 3 to 5 million patients [23] - Recorlev inhibits cortisol production at multiple points in the cortisol production pathway [32] XP-8121 Hypothyroidism Treatment - XP-8121 is designed to improve patient experience and clinical outcomes in hypothyroidism [91] - XP-8121 targets a U S addressable market of 3 to 5 million treated patients with inconsistent TSH levels [23, 100] - XP-8121 has a multi-billion dollar peak revenue potential [98] Operational & Commercial Strengths - Xeris has a management team with experience in promoting pharmaceutical products and expertise in market preparedness [114] - The company has in-house capabilities across rare, ultra-rare, and retail markets, with dedicated sales, patient support, and medical education [114] - Xeris' commercial model is designed to drive continuous rapid growth [115]

Group 1 - Xeris Biopharma Holdings, Inc. is a biotechnology company with three commercial products generating sales and proprietary formulation modification technologies [1] - The company's revenue is accelerating due to the sales of its products, indicating a positive growth trajectory [1] Group 2 - The company is listed on NASDAQ under the ticker symbol XERS, which may attract investor interest [1]

Summary of Xeris Biopharma Holdings (XERS) Conference Call Company Overview - Xeris Biopharma is a unique biopharma company with three commercial products: Gvoke, KEVEYIS, and Recorlev [6][7] - The company has achieved 13 to 14 consecutive quarters of over 20% growth, projecting $268 million in revenue for the current year, representing a 32% growth rate year-over-year [7][11] Financial Performance - The company has reached adjusted EBITDA positive status and aims to maintain this going forward, allowing for self-funding of growth and pipeline development [7] - Long-term revenue guidance includes $750 million by 2030 and $1 billion in net revenue for Recorlev by 2035 [11][12] Product Pipeline and Market Opportunities - Recorlev is positioned as a significant growth driver, with a large emerging market opportunity in hypercortisolism and Cushing syndrome [13][14] - The company anticipates that its Phase III ready product, XP 8,001.21, could generate $1 billion to $3 billion in peak sales [12] Competitive Landscape - Recorlev is differentiated in the market for treating Cushing's syndrome, focusing on normalizing cortisol synthesis, which is crucial for patients with resistant diabetes and other conditions [15][19] - The company views the entry of new competitors as an opportunity to raise awareness about cortisol testing and treatment options rather than a threat [26][28] Gvoke and KEVEYIS - Gvoke is a rescue medication for diabetes, with a significant market opportunity as only about 1 million of the estimated 15 million eligible patients currently have access to it [30][31] - The company is focused on educating the medical community to increase compliance with guidelines recommending rescue medications for insulin users [41] XP 8,001.21 Development - XP 8,001.21 targets a large unmet medical need in the thyroid space, with an estimated 3 to 5 million patients unable to achieve consistent control with current oral therapies [44][45] - The company plans to initiate Phase III trials in 2026, with potential market entry by 2030, estimating a market opportunity of $1 billion to $3 billion [48][67] Clinical Trial Insights - Phase II data demonstrated the ability to normalize thyroid levels with 40% less drug compared to traditional therapies [51] - The primary endpoint for the upcoming Phase III trial will focus on the percentage of patients achieving normal TSH levels after one year [56][62] Conclusion - Xeris Biopharma is positioned for significant growth with its current products and pipeline, particularly in addressing unmet medical needs in diabetes and thyroid disorders. The company is actively working to educate healthcare providers and expand market access for its therapies.

Summary of Xeris Biopharma Holdings (XERS) 2025 Investor Day Company Overview - Xeris Biopharma Holdings is positioned for significant transformation and growth, focusing on three commercial products: Gvoke, KEVEYIS, and Recorlev, which address critical unmet medical needs in patients with diabetes, primary periodic paralysis, and hypercortisolism respectively [9][10] - The company is preparing to launch a new product, XP-8121, targeting hypothyroidism, which is expected to meet a significant unmet need in the market [11][15] Financial Performance - Xeris anticipates total revenue between $260 million to $275 million, with a positive adjusted EBITDA and 85% gross margins, indicating financial stability and self-sustainability [14][17] - Recorlev is projected to reach $1 billion in annual net revenue within the next ten years, serving as a growth engine for the company [19][15] Product Insights Recorlev - Recorlev is designed for treating hypercortisolism in patients with Cushing's syndrome, with a unique mechanism that normalizes cortisol levels [20][32] - The product is expected to address significant unmet needs and is positioned to generate sustainable long-term cash flow [21][19] - Clinical studies have shown that Recorlev can improve various health markers, including blood glucose levels, BMI, and cholesterol levels [34][33] XP-8121 - XP-8121 is a new formulation for hypothyroidism, utilizing proprietary XEROSOL technology for a once-weekly subcutaneous injection, which aims to provide consistent control of thyroid hormone levels [63][74] - The product addresses challenges associated with oral levothyroxine therapy, such as absorption issues and the need for frequent monitoring [70][72] Market Dynamics - The market for hypercortisolism is evolving, with increased awareness and screening for Cushing's syndrome, which is expected to drive demand for Recorlev [26][41] - The hypothyroidism market has not seen significant innovation in nearly fifty years, creating a substantial opportunity for XP-8121 [63][64] Clinical Perspectives - Experts highlighted the complexities of diagnosing and treating Cushing's syndrome, emphasizing the need for a comprehensive approach to patient care [47][50] - The burden of managing hypothyroidism is significant, with many patients experiencing inconsistent control due to various factors, including dietary influences and medication interactions [70][89] Strategic Initiatives - Xeris plans to expand its sales force and invest in market education to enhance the understanding of hypercortisolism and the value of Recorlev [36][39] - The company aims to partner with healthcare professionals to improve screening and treatment guidelines for both hypercortisolism and hypothyroidism [39][38] Conclusion - Xeris Biopharma is on a growth trajectory with a strong product pipeline and a commitment to addressing unmet medical needs in endocrinology, positioning itself as a leader in the biopharmaceutical space [18][15]

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Xeris reported strong Q1 2025 revenue growth, a narrowed net loss, and improved operating cash flow [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets slightly decreased, liabilities marginally declined, and the stockholders' deficit widened due to the quarterly net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $58,440 | $71,621 | | Total current assets | $163,494 | $167,662 | | Total assets | $315,453 | $323,060 | | Total current liabilities | $95,072 | $100,443 | | Long-term debt, net | $217,805 | $217,006 | | Total liabilities | $350,581 | $352,675 | | Total stockholders' equity (deficit) | $(35,128) | $(29,615) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 total revenue increased 47.9% to $60.1 million, significantly reducing the operating loss to $3.1 million and narrowing the net loss to $9.2 million Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $60,119 | $40,638 | | Total costs and expenses | $63,209 | $54,883 | | Loss from operations | $(3,090) | $(14,245) | | Net loss | $(9,220) | $(18,980) | | Net loss per common share | $(0.06) | $(0.14) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to $10.0 million in Q1 2025, while investing activities remained minimal and financing activities shifted to a net use Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,031) | $(20,303) | | Net cash used in investing activities | $(13) | $(19,650) | | Net cash provided by (used in) financing activities | $(3,137) | $35,194 | | **Decrease in cash** | **$(13,181)** | **$(4,759)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes provide details on business operations, accounting policies, product revenue growth, debt obligations, and confirm sufficient cash resources for the next 12 months despite a cumulative deficit - The company is a commercial-stage biopharmaceutical firm focused on endocrine and neurological diseases, with key products being **Recorlev**, **Gvoke**, and **Keveyis**[19](index=19&type=chunk) - Despite an accumulated deficit of **$681.1 million** as of March 31, 2025, management believes current cash resources are sufficient to sustain operations for at least the next 12 months[22](index=22&type=chunk) Disaggregated Revenue by Product (in thousands) | Product | Q1 2025 Revenue | Q1 2024 Revenue | | :--- | :--- | :--- | | Recorlev | $25,530 | $10,599 | | Gvoke | $20,845 | $16,579 | | Keveyis | $11,427 | $13,085 | | **Total Product Revenue, net** | **$57,802** | **$40,263** | - In March 2025, **$3.2 million** of 2025 Convertible Notes were converted into common stock, with the remaining **$12.0 million** converted in April 2025[59](index=59&type=chunk)[60](index=60&type=chunk) - Total stock-based compensation expense was **$4.4 million** in Q1 2025, compared to **$3.8 million** in Q1 2024[97](index=97&type=chunk) - Due to the net loss, **43.2 million** potentially dilutive securities were excluded from the diluted EPS calculation for Q1 2025[111](index=111&type=chunk)[112](index=112&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong Q1 2025 revenue growth driven by commercial products, significantly narrowed net loss, and sufficient capital resources for the next twelve months [Overview and Strategy](index=22&type=section&id=Overview%20and%20Strategy) The company's strategy focuses on maximizing commercial product potential, advancing its pipeline including XP-8121, and leveraging proprietary formulation technologies to achieve profitability - The company's top priority is maximizing the potential of its three commercial products: **Recorlev**, **Gvoke**, and **Keveyis**[121](index=121&type=chunk) - The pipeline is led by **XP-8121**, a once-weekly subcutaneous injection of levothyroxine for hypothyroidism, with plans to initiate a Phase 3 trial[122](index=122&type=chunk) - The core strategy is to achieve profitability by growing commercial product sales, funding new therapies for unmet medical needs[124](index=124&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Q1 2025 total revenue grew 47.9% to $60.1 million, primarily driven by strong Recorlev and Gvoke sales, leading to a significant reduction in operating loss Q1 2025 vs Q1 2024 Results of Operations (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $60,119 | $40,638 | $19,481 | 47.9% | | Cost of goods sold | $8,728 | $5,971 | $2,757 | 46.2% | | Research and development | $7,753 | $7,821 | $(68) | (0.9%) | | Selling, general and administrative | $44,018 | $38,380 | $5,638 | 14.7% | | Loss from operations | $(3,090) | $(14,245) | $11,155 | (78.3%) | | Net loss | $(9,220) | $(18,980) | $9,760 | (51.4%) | - **Recorlev** revenue increased by **$14.9 million (140.9%)**, primarily driven by a **156.6%** increase in volume[141](index=141&type=chunk) - **Gvoke** revenue increased by **$4.3 million (25.7%)**, driven by both higher volume (**14.9%**) and favorable net pricing (**10.8%**)[142](index=142&type=chunk) - **Keveyis** revenue decreased by **$1.7 million (12.7%)** due to unfavorable net pricing, offsetting a slight increase in volume[143](index=143&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains sufficient liquidity for the next 12 months, supported by improved operating cash flow and recent financing activities, despite a cumulative deficit - The company believes its cash resources as of March 31, 2025, are sufficient to sustain operations and capital needs for at least the next twelve months[154](index=154&type=chunk) - Net cash used in operating activities decreased from **$20.3 million** in Q1 2024 to **$10.0 million** in Q1 2025, primarily due to higher sales[157](index=157&type=chunk) - In March 2024, the company entered into an Amended and Restated Credit Agreement for **$200.0 million** in term loans[152](index=152&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations affecting cash and SOFR-indexed debt, with foreign currency exchange risk deemed immaterial - The company is exposed to interest rate risk on its cash, cash equivalents, and **SOFR-indexed** long-term debt[165](index=165&type=chunk)[167](index=167&type=chunk) - A hypothetical **1%** change in interest rates would impact annual interest income by approximately **$0.6 million**[166](index=166&type=chunk) - Foreign currency exchange risk is not considered material[168](index=168&type=chunk) [Controls and Procedures](index=28&type=section&id=Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, following the Q1 2025 implementation of a new ERP system and related control updates - The CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2025[169](index=169&type=chunk) - A new Enterprise Resource Planning (**ERP**) system was implemented in Q1 2025, leading to updates in internal controls over financial reporting[170](index=170&type=chunk) [Part II. Other Information](index=29&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings expected to have an adverse effect on its business - As of the report date, the company is not a party to any legal proceedings expected to have a material adverse effect on its business[172](index=172&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred in the company's risk factors since the filing of its Annual Report on Form 10-K for FY2024 - No material changes have occurred in the company's risk factors since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024[174](index=174&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no sales of unregistered equity securities during the period - There were no sales of unregistered securities in the reported period[175](index=175&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q1 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan during the three months ended March 31, 2025[180](index=180&type=chunk)

Financial Data and Key Metrics Changes - Total revenue grew by 48% year-over-year to $60.1 million, while net product revenue increased by 44% to $57.8 million, marking the fourteenth consecutive quarter of over 20% product revenue growth [20][24] - Adjusted EBITDA for the quarter was positive at $4.4 million, supporting the commitment to delivering positive adjusted EBITDA going forward [23][24] - Gross margin improved to 85%, reflecting a 200 basis point increase driven by a favorable product mix [22] Business Line Data and Key Metrics Changes - RECORLEV revenue surged by 141% to $25.5 million, with the average number of patients on therapy increasing by 124% compared to the same period in 2024 [20][21] - Gvoke revenue reached nearly $21 million, reflecting a 26% increase year-over-year, supported by an 8% rise in total prescriptions [10][21] - KEVEYIS revenue was over $11 million, showing slight growth compared to Q4 2024, indicating resilience in the brand [11][21] Market Data and Key Metrics Changes - The glucagon market grew by approximately 5%, with the company achieving an 8% growth in prescriptions, indicating a strong competitive position [49] - The company anticipates no material impact from potential sector-specific tariffs, as the majority of operations are U.S.-based [25][55] Company Strategy and Development Direction - The company is focused on three strategic priorities: driving rapid growth of commercial products, maintaining financial discipline, and enhancing communication with stakeholders [16] - The upcoming Analyst and Investor Day on June 3 is expected to provide deeper insights into the strategic vision and initiatives for the future [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth momentum, particularly with RECORLEV, and indicated that the market for hypercortisolism is expanding [32] - The company plans to provide more detailed guidance on peak sales potential for RECORLEV during the Analyst and Investor Day [31] Other Important Information - The FDA approved the supplemental new drug application for Gvoke VialDx, which will expand its use and is expected to enhance market reach through a partnership with American Regent [12][13] - The company has accelerated the redemption of convertible notes, reducing total debt by $15 million, which will generate interest expense savings [24] Q&A Session Summary Question: What is the peak sales potential for RECORLEV? - Management has not updated guidance on peak sales potential but will provide more details at the Analyst and Investor Day [31][32] Question: What are the primary drivers behind operational efficiency? - The company has maintained financial discipline, with significant growth primarily from RECORLEV and controlled expenses contributing to operational efficiency [38][39] Question: Can you provide details on the pivotal study design for XP-8121? - Management prefers to wait for the Analyst and Investor Day to provide comprehensive details on XP-8121 [44][45] Question: What is the competitive landscape for the glucagon market? - The company is driving market growth, having outperformed the overall market growth rate [49] Question: Any updates on KEVEYIS and formulary changes? - There were no significant formulary changes or competitive impacts noted for KEVEYIS, which is expected to maintain its performance [51][52] Question: Where are your drugs manufactured in relation to potential tariffs? - Most manufacturing operations are U.S.-based, and the company does not expect any material impact from tariffs [55][56]

Financial Data and Key Metrics Changes - Total revenue grew by 48% year-over-year to $60.1 million, while net product revenue increased by 44% to $57.8 million, marking the fourteenth consecutive quarter of over 20% product revenue growth [19][20] - Gross margin improved to 85%, up by 200 basis points sequentially due to a favorable product mix [21] - Adjusted EBITDA was positive at $4.4 million, supporting the commitment to deliver positive adjusted EBITDA going forward [22][24] Business Line Data and Key Metrics Changes - RECORLEV revenue surged by 141% to $25.5 million, with the average number of patients on therapy increasing by 124% compared to the same period last year [19][20] - Gvoke revenue reached nearly $21 million, reflecting an 8% increase in prescriptions year-over-year [9][20] - KEVEYIS revenue was over $11 million, showing slight growth compared to the previous quarter [11][20] Market Data and Key Metrics Changes - The glucagon market grew by approximately 5%, while Gvoke outperformed this growth with an 8% increase in prescriptions [50] - The company anticipates no material impact from potential sector-specific tariffs, as the majority of operations are U.S.-based [24][54] Company Strategy and Development Direction - The company is focused on three strategic priorities: driving growth of commercial products, managing financial discipline, and enhancing communication with stakeholders [16] - A key achievement includes the FDA approval of Gvoke VialDx, which expands its use as an IV administration [12][13] - The company plans to provide a comprehensive update on XP-8121 at the upcoming Analyst and Investor Day scheduled for June 3 [15][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth momentum, particularly with RECORLEV and Gvoke, and highlighted the importance of strategic investments made in the previous year [6][8] - The company raised the bottom end of its revenue guidance for the year from $255 million to $260 million, indicating an expected total revenue growth of nearly 32% [24][25] Other Important Information - The company has accelerated the redemption of its 2025 convertible notes, reducing total debt by $15 million [23] - The upcoming Analyst and Investor Day is expected to provide deeper insights into the company's strategic vision and initiatives [17][58] Q&A Session Summary Question: What is the peak sales potential for RECORLEV given market expansion? - Management indicated that they will provide more guidance on peak sales potential at the Analyst and Investor Day in June, acknowledging significant market expansion opportunities [28][32] Question: What are the primary drivers behind operational efficiency and profitability improvement? - Management attributed operational efficiency to top-line growth, particularly from RECORLEV, and disciplined expense management [36][38] Question: Can you provide details on the pivotal study design for XP-8121? - Management declined to provide details at this time, preferring to wait for the Analyst and Investor Day to present a comprehensive overview [44][45] Question: What is the competitive landscape in the glucagon market? - Management noted that they are driving market growth, with Gvoke prescriptions growing faster than the overall market [50] Question: Any updates on KEVEYIS and its competitive position? - Management reported no significant changes in formulary or competitive landscape for KEVEYIS, maintaining a steady performance [51][52] Question: How are potential sector-specific tariffs expected to impact operations? - Management stated that most manufacturing operations are U.S.-based, and they do not expect any material impact from tariffs [54][56]