Darden Restaurants(DRI) - 2026 Q1 - Quarterly Results
2025-09-18 11:05
[Executive Summary](index=1&type=section&id=Executive%20Summary) Darden Restaurants reported strong Q1 2026 results with increased sales and EPS, alongside an updated positive fiscal 2026 outlook [Q1 2026 Performance Overview](index=1&type=section&id=Q1%202026%20Performance%20Overview) Darden reported a strong Q1 2026, with total sales up 10.4% to $3.0 billion and blended same-restaurant sales increasing by 4.7% | Metric | Q1 2026 Performance | | :-------------------------- | :------------------ | | Total Sales Increase | 10.4% | | Total Sales Value | $3.0 billion | | Blended Same-Restaurant Sales Increase | 4.7% | | Same-Restaurant Sales | Growth Rate | | :-------------------- | :---------- | | Consolidated Darden | 4.7% | | Olive Garden | 5.9% | | LongHorn Steakhouse | 5.5% | | Fine Dining | (0.2)% | | Other Business | 3.3% | - The strength of results is attributed to the company's strategy, focusing on "**being brilliant with the basics**" and leveraging **competitive advantages** to position brands for long-term success, enabling sales and market share growth while investing in the business and returning capital to shareholders[3](index=3&type=chunk) [Segment Performance](index=1&type=section&id=Segment%20Performance) Segment profit reporting was adjusted to exclude pre-opening costs, with 'Other Business' showing significant sales and profit growth - Segment profit reporting changed to exclude pre-opening costs, with fiscal 2025 figures recast for comparability. Segment profit is defined as sales less costs for food and beverage, restaurant labor, restaurant expenses, and marketing expenses, excluding non-cash real estate related expenses[4](index=4&type=chunk) | ($ in millions) | Q1 2026 Sales | Q1 2025 Sales | Q1 2026 Segment Profit | Q1 2025 Segment Profit | | :---------------- | :------------ | :------------ | :--------------------- | :--------------------- | | Consolidated Darden | $3,044.7 | $2,757.0 | | | | Olive Garden | $1,301.1 | $1,209.1 | $267.6 | $250.1 | | LongHorn Steakhouse | $776.4 | $713.5 | $134.9 | $128.4 | | Fine Dining | $286.5 | $278.9 | $38.7 | $38.9 | | Other Business | $680.7 | $555.5 | $109.3 | $84.3 | [Earnings Per Share & Shareholder Returns](index=1&type=section&id=Earnings%20Per%20Share%20%26%20Shareholder%20Returns) Diluted net EPS reached $2.19, with adjusted EPS up 12.6% to $1.97, alongside a $1.50 quarterly dividend and $183 million in share repurchases | Metric | Value | | :------------------------------------------------ | :---- | | Reported diluted net earnings per share (continuing operations) | $2.19 | | Adjusted diluted net earnings per share (continuing operations) | $1.97 | | Adjusted EPS Increase (YoY) | 12.6% | - The Board of Directors declared a quarterly cash dividend of **$1.50 per share**, payable on November 3, 2025, to shareholders of record on October 10, 2025[8](index=8&type=chunk) - The Company repurchased approximately **0.9 million shares** of its common stock for a total of **$183 million** during the quarter. As of the end of the fiscal first quarter, **$865 million** remained under the current **$1 billion** repurchase authorization[6](index=6&type=chunk)[9](index=9&type=chunk) [Fiscal 2026 Financial Outlook](index=3&type=section&id=Fiscal%202026%20Financial%20Outlook) Darden updated its fiscal 2026 outlook, projecting total sales growth of 7.5-8.5% and adjusted diluted net EPS of $10.50-$10.70 [Updated Outlook Details](index=3&type=section&id=Updated%20Outlook%20Details) The fiscal 2026 outlook projects total sales growth of 7.5-8.5%, same-restaurant sales growth of 2.5-3.5%, and adjusted diluted net EPS of $10.50-$10.70 | Metric | Fiscal 2026 Outlook | | :------------------------------------------------ | :------------------ | | Total sales growth | 7.5% to 8.5% | | Same-restaurant sales growth | 2.5% to 3.5% | | New restaurant openings | Approximately 65 | | Total capital spending | $700 to $750 million | | Total inflation | 3.0% to 3.5% | | Effective tax rate | Approximately 13% | | Adjusted diluted net earnings per share (continuing operations) | $10.50 to $10.70 | | Weighted average diluted shares outstanding | Approximately 117 million | - The total sales growth outlook includes approximately **2% growth** related to the 53rd week. The adjusted diluted net earnings per share outlook includes approximately **$0.20** related to the addition of the 53rd week[14](index=14&type=chunk) [Reconciliation of Adjusted Earnings Outlook](index=7&type=section&id=Reconciliation%20of%20Adjusted%20Earnings%20Outlook) A reconciliation details fiscal 2026 adjusted diluted net EPS outlook, accounting for Chuy's transaction costs, closed restaurant costs, and Olive Garden Canada sale gain | Reconciliation Item | 2026 Outlook Range | | :------------------------------------------------ | :----------------- | | Reported diluted net earnings per share from continuing operations | $10.64 to $10.84 | | Chuy's transaction and integration related costs | $0.06 | | Closed restaurants costs | $0.06 | | Gain on Olive Garden Canada sale | $(0.26) | | Adjusted diluted net earnings per share from continuing operations | $10.50 to $10.70 | [Company Information](index=3&type=section&id=Company%20Information) Darden Restaurants operates a diverse portfolio of restaurant brands and provides important disclosures regarding forward-looking statements [About Darden Restaurants](index=3&type=section&id=About%20Darden%20Restaurants) Darden Restaurants is a restaurant company with a diverse portfolio of differentiated brands, including well-known names like Olive Garden, LongHorn Steakhouse, and Ruth's Chris Steak House, among others - Darden's portfolio of differentiated brands includes Olive Garden, LongHorn Steakhouse, Yard House, Ruth's Chris Steak House, Cheddar's Scratch Kitchen, The Capital Grille, Chuy's, Seasons 52, Eddie V's, and Bahama Breeze[12](index=12&type=chunk) [Information About Forward-Looking Statements](index=5&type=section&id=Information%20About%20Forward-Looking%20Statements) Forward-looking statements are subject to risks and uncertainties, detailed in SEC filings, cautioning investors against undue reliance due to potential material differences - Forward-looking statements are made under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and speak only as of their initial date, with no obligation to update[13](index=13&type=chunk) - Risks and uncertainties include cost pressures, economic factors impacting the restaurant industry, labor challenges, increased costs, health concerns, cybersecurity risks, integration challenges (Chuy's), regulatory changes, intense competition, changing consumer preferences, climate change, supply chain disruptions, and litigation[13](index=13&type=chunk)[16](index=16&type=chunk) [Non-GAAP Financial Measures](index=5&type=section&id=Non-GAAP%20Financial%20Measures) Darden utilizes non-GAAP financial measures, such as adjusted diluted net EPS, to supplement GAAP results for performance analysis [Explanation of Non-GAAP Measures](index=5&type=section&id=Explanation%20of%20Non-GAAP%20Measures) Non-GAAP measures, like adjusted diluted net EPS, offer supplemental performance insights but are not GAAP substitutes and may not be comparable - Non-GAAP measures, like **adjusted diluted net earnings per share**, are used by management for performance analysis and provide useful supplemental information for understanding operating results[17](index=17&type=chunk) - These non-GAAP disclosures should not be viewed as a substitute for GAAP operating results and may not be comparable to non-GAAP measures presented by other companies[17](index=17&type=chunk) [Q1 Reported to Adjusted Earnings Reconciliation](index=5&type=section&id=Q1%20Reported%20to%20Adjusted%20Earnings%20Reconciliation) This reconciliation details Q1 2026 and Q1 2025 earnings adjustments, including acquisition costs, closed restaurant costs, and Olive Garden Canada sale gain | $ in millions, except per share amounts | Q1 2026 Reported | Q1 2026 Adjustments | Q1 2026 Adjusted | Q1 2025 Reported | Q1 2025 Adjustments | Q1 2025 Adjusted | | :-------------------------------------- | :--------------- | :------------------ | :--------------- | :--------------- | :------------------ | :--------------- | | Earnings Before Income Tax | $293.8 | $(35.3) | $258.5 | $232.1 | $1.5 | $233.6 | | Income Tax Expense | $35.9 | $(8.8) | $27.1 | $24.5 | $0.3 | $24.8 | | Net Earnings | $257.9 | $(26.5) | $231.4 | $207.6 | $1.2 | $208.8 | | Diluted Net Earnings Per Share | $2.19 | $(0.22) | $1.97 | $1.74 | $0.01 | $1.75 | | % Change vs Prior Year | 25.9% | | 12.6% | | | | | **Adjustments Detail:** | | | | | | | | Acquisition transaction and integration related costs | | $3.6 (EBIT) / $2.7 (Net) / $0.02 (EPS) | | | $1.5 (EBIT) / $1.2 (Net) / $0.01 (EPS) | | | Closed restaurants | | $3.1 (EBIT) / $2.3 (Net) / $0.02 (EPS) | | | — | | | Gain on Olive Garden Canada sale | | $(42.0) (EBIT) / $(31.5) (Net) / $(0.26) (EPS) | | | — | | [Restaurant Portfolio](index=7&type=section&id=Restaurant%20Portfolio) Darden's restaurant portfolio expanded, increasing total company-owned restaurants from 2,040 to 2,165 by August 2025 [Number of Company-Owned Restaurants](index=7&type=section&id=Number%20of%20Company-Owned%20Restaurants) Darden's restaurant portfolio shows an increase in total company-owned restaurants from 2,040 in August 2024 to 2,165 in August 2025, primarily driven by the addition of Chuy's restaurants and growth in Olive Garden and LongHorn Steakhouse | Brand | 8/24/2025 | 8/25/2024 | | :---------------------- | :-------- | :-------- | | Olive Garden | 933 | 923 | | LongHorn Steakhouse | 595 | 577 | | Cheddar's Scratch Kitchen | 182 | 181 | | Chuy's | 108 | — | | Yard House | 89 | 88 | | Ruth's Chris Steak House | 82 | 82 | | The Capital Grille | 73 | 68 | | Seasons 52 | 43 | 44 | | Eddie V's | 29 | 29 | | Bahama Breeze | 28 | 44 | | The Capital Burger | 3 | 4 | | **Darden Continuing Operations** | **2,165** | **2,040** | [Consolidated Financial Statements](index=8&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements reflect strong Q1 2026 performance with increased sales, operating income, and cash flow [Consolidated Statements of Earnings](index=8&type=section&id=Consolidated%20Statements%20of%20Earnings) The consolidated statements of earnings show a significant increase in sales and net earnings for the three months ended August 24, 2025, compared to the prior year. Operating income grew substantially, and diluted net earnings per share from continuing operations rose from $1.74 to $2.19 | (In millions, except per share data) | Three Months Ended 8/24/2025 | Three Months Ended 8/25/2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Sales | $3,044.7 | $2,757.0 | | Total operating costs and expenses | $2,705.5 | $2,487.8 | | Operating income | $339.2 | $269.2 | | Earnings before income taxes | $293.8 | $232.1 | | Income tax expense | $35.9 | $24.5 | | Earnings from continuing operations | $257.9 | $207.6 | | Net earnings | $257.8 | $207.2 | | Diluted net earnings per share (continuing operations) | $2.19 | $1.74 | [Consolidated Balance Sheets](index=9&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheet as of August 24, 2025, shows an increase in total assets to $12,759.6 million from $12,587.0 million at May 25, 2025. Total liabilities also increased, while total stockholders' equity saw a slight decrease | (In millions) | 8/24/2025 (Unaudited) | 5/25/2025 | | :-------------------------------- | :-------------------- | :-------- | | **ASSETS** | | | | Total current assets | $932.8 | $937.7 | | Land, buildings and equipment, net | $4,826.6 | $4,716.0 | | Operating lease right-of-use assets | $3,608.0 | $3,555.9 | | Goodwill | $1,658.2 | $1,659.4 | | Trademarks | $1,346.4 | $1,346.4 | | Other assets | $387.6 | $371.6 | | **Total assets** | **$12,759.6** | **$12,587.0** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $2,346.8 | $2,247.5 | | Long-term debt | $2,135.1 | $2,128.9 | | Operating lease liabilities - non-current | $3,878.3 | $3,816.9 | | Other liabilities | $1,840.8 | $1,803.6 | | **Total liabilities** | **$10,534.0** | **$10,275.7** | | Total stockholders' equity | $2,225.6 | $2,311.3 | | **Total liabilities and stockholders' equity** | **$12,759.6** | **$12,587.0** | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows indicate that net cash provided by operating activities of continuing operations increased to $342.5 million for the three months ended August 24, 2025. However, net cash used in financing activities also increased significantly, leading to a decrease in cash and cash equivalents | (In millions) | Three Months Ended 8/24/2025 | Three Months Ended 8/25/2024 | | :------------------------------------------------ | :--------------------------- | :--------------------------- | | Net cash provided by operating activities of continuing operations | $342.5 | $273.2 | | Net cash used in investing activities of continuing operations | $(159.3) | $(149.7) | | Net cash used in financing activities of continuing operations | $(212.2) | $(126.7) | | Increase (decrease) in cash, cash equivalents, and restricted cash | $(29.0) | $(3.2) | | Cash, cash equivalents, and restricted cash - end of period | $225.5 | $216.9 |
AirNet(ANTE) - 2025 Q2 - Quarterly Report
2025-09-18 10:43
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2025-09-18 00:00
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2025-09-17 22:19
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2025-09-17 21:09
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2025-09-17 21:01
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General Mills(GIS) - 2026 Q1 - Quarterly Report
2025-09-17 20:55
[PART I – Financial Information](index=4&type=section&id=PART%20I%20%E2%80%93%20Financial%20Information) This section presents General Mills' unaudited consolidated financial statements and management's discussion for Q1 FY26 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents General Mills' unaudited consolidated financial statements and notes for the quarter ended August 24, 2025 [Consolidated Statements of Earnings](index=4&type=section&id=Consolidated%20Statements%20of%20Earnings) The Consolidated Statements of Earnings show a significant increase in operating profit and net earnings for Q1 FY26, driven by a divestiture gain | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | Change (%) | | :--------------------------------------- | :------------------------------------- | :------------------------------------- | :--------- | | Net sales | $4,517.5 | $4,848.1 | -6.8% | | Operating profit | $1,725.8 | $831.5 | 107.6% | | Net earnings attributable to General Mills | $1,204.2 | $579.9 | 107.7% | | Earnings per share – diluted | $2.22 | $1.03 | 115.5% | - Operating profit and net earnings significantly increased due to a **$1,054.4 million divestitures gain** in the current quarter[12](index=12&type=chunk) [Consolidated Statements of Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income) Total comprehensive income for General Mills more than doubled year-over-year, driven by higher net earnings | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | Change (%) | | :------------------------------------- | :------------------------------------- | :------------------------------------- | :--------- | | Net earnings | $1,204.0 | $583.6 | 106.3% | | Other comprehensive loss, net of tax | $(55.0) | $(56.3) | -2.3% | | Total comprehensive income | $1,149.0 | $527.3 | 117.9% | | Comprehensive income attributable to General Mills | $1,148.7 | $523.1 | 119.6% | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows a slight decrease in total assets and liabilities, while total equity increased, driven by higher retained earnings | Metric | Aug. 24, 2025 (Millions) | May 25, 2025 (Millions) | Change (%) | | :--------------------------------- | :----------------------- | :---------------------- | :--------- | | Cash and cash equivalents | $952.9 | $363.9 | 161.8% | | Total current assets | $5,239.8 | $5,275.7 | -0.7% | | Total assets | $33,015.6 | $33,071.1 | -0.2% | | Total current liabilities | $7,959.6 | $7,857.3 | 1.3% | | Total liabilities | $23,496.7 | $23,859.9 | -1.5% | | Total equity | $9,518.9 | $9,211.2 | 3.3% | - Assets held for sale decreased from **$740.4 million** to **$0**, indicating the completion of divestitures[16](index=16&type=chunk) [Consolidated Statements of Total Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Total%20Equity) Total equity increased quarter-over-quarter, primarily due to net earnings, partially offset by cash dividends and share repurchases | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | Change (%) | | :--------------------------------------- | :------------------------------------- | :------------------------------------- | :--------- | | Total equity, beginning balance | $9,211.2 | $9,648.5 | -4.5% | | Net earnings attributable to General Mills | $1,204.2 | $579.9 | 107.7% | | Cash dividends declared | $(330.9) | $(337.8) | -2.0% | | Common stock in treasury, ending balance | $(11,866.6) | $(10,601.9) | 11.9% | | Total equity, ending balance | $9,518.9 | $9,526.6 | -0.1% | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash from operations decreased, while investing activities generated significant cash due to divestitures, and financing activities used more cash | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | Change (Millions) | | :------------------------------------- | :------------------------------------- | :------------------------------------- | :---------------- | | Net cash provided by operating activities | $397.0 | $624.2 | $(227.2) | | Net cash provided by (used by) investing activities | $1,694.8 | $(148.0) | $1,842.8 | | Net cash used by financing activities | $(1,507.2) | $(429.4) | $(1,077.8) | | Increase in cash and cash equivalents | $589.0 | $50.1 | $538.9 | | Cash and cash equivalents - end of period | $952.9 | $468.1 | $484.8 | - Investing activities were significantly boosted by **$1,803.4 million** in proceeds from divestitures in Q1 FY26[20](index=20&type=chunk) - Financing activities saw a substantial increase in cash used, primarily due to **$654.8 million** in net debt payments and **$500.0 million** in common stock repurchases[20](index=20&type=chunk) [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide essential context and detail for the financial statements, covering accounting policies, significant transactions, and segment performance [(1) Background](index=9&type=section&id=(1)%20Background) Interim financial statements are prepared under GAAP, and Q1 FY26 results are not indicative of the full fiscal year - Interim financial statements are prepared under GAAP, and Q1 FY26 results are not necessarily indicative of the full fiscal year[22](index=22&type=chunk) - Accounting policies are consistent with the Annual Report on Form 10-K for the fiscal year ended May 25, 2025[23](index=23&type=chunk) [(2) Acquisition and Divestitures](index=9&type=section&id=(2)%20Acquisition%20and%20Divestitures) General Mills completed the sale of its U.S. yogurt business in Q1 FY26, recording a significant pre-tax gain, and acquired Whitebridge Pet Brands - Completed the sale of the United States yogurt business in Q1 FY26, recording a pre-tax gain of **$1,046.5 million**[25](index=25&type=chunk) - Recorded a **$7.9 million** increase to the pre-tax gain from the sale of the Canada yogurt business in Q1 FY26[25](index=25&type=chunk) - Acquired NX Pet Holding, Inc. (Whitebridge Pet Brands) for **$1.4 billion** in Q3 FY25, adding **$1,086.7 million** in goodwill and **$289.0 million** for the Tiki Pets brand[26](index=26&type=chunk) [(3) Restructuring, Transformation, Impairment, and Other Exit Costs](index=9&type=section&id=(3)%20Restructuring,%20Transformation,%20Impairment,%20and%20Other%20Exit%20Costs) The company recorded **$18.3 million** in restructuring and transformation charges in Q1 FY26, an increase from the prior year | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :------------------------------------------------ | :------------------------------------- | :------------------------------------- | | Restructuring, transformation, impairment, and other exit costs | $16.3 | $2.2 | | Cost of sales (restructuring charges) | $2.0 | $0.7 | | Total restructuring, transformation, and impairment charges | $18.3 | $2.9 | - Net cash paid for restructuring and transformation actions increased from **$2.7 million** in Q1 FY25 to **$21.0 million** in Q1 FY26[28](index=28&type=chunk) Reserve Balance for Restructuring and Transformation Actions | Metric | Amount (Millions) | | :---------------------------------- | :---------------- | | Reserve balance as of May 25, 2025 | $77.1 | | Fiscal 2026 charges | $0.6 | | Utilized in fiscal 2026 | $(8.4) | | Reserve balance as of Aug. 24, 2025 | $69.3 | [(4) Goodwill and Other Intangible Assets](index=10&type=section&id=(4)%20Goodwill%20and%20Other%20Intangible%20Assets) Goodwill and other intangible assets saw minor changes in Q1 FY26, primarily due to foreign currency translation | Metric | Aug. 24, 2025 (Millions) | May 25, 2025 (Millions) | | :---------------------------------- | :----------------------- | :---------------------- | | Goodwill | $15,660.2 | $15,622.4 | | Other intangible assets | $7,087.3 | $7,081.4 | | Total | $22,747.5 | $22,703.8 | - Annual amortization expense for finite-lived intangible assets is estimated at approximately **$20 million** for each of the next five fiscal years[31](index=31&type=chunk) - The company monitors Progresso, Nudges, True Chews, and Kitano brand intangible assets for potential impairment[34](index=34&type=chunk) [(5) Inventories](index=11&type=section&id=(5)%20Inventories) Total inventories increased from May 25, 2025, to August 24, 2025, primarily driven by an increase in finished goods | Component | Aug. 24, 2025 (Millions) | May 25, 2025 (Millions) | | :-------------------------- | :----------------------- | :---------------------- | | Finished goods | $2,068.0 | $1,883.9 | | Raw materials and packaging | $496.0 | $460.0 | | Grain | $77.8 | $112.5 | | Excess of FIFO over LIFO cost | $(590.3) | $(545.6) | | Total | $2,051.5 | $1,910.8 | [(6) Risk Management Activities](index=11&type=section&id=(6)%20Risk%20Management%20Activities) General Mills uses derivatives to manage market price risks for commodities and foreign currency, aiming for price certainty - Derivatives are used to manage price risk for principal ingredients (grains, oils, dairy) and energy costs to achieve future price certainty[36](index=36&type=chunk) - Changes in derivative values are recorded in cost of sales, with gains/losses reclassified from unallocated corporate items to segment operating profit[37](index=37&type=chunk)[38](index=38&type=chunk) Net Loss on Mark-to-Market Valuation of Commodity Positions | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :---------------------------------------------------------------- | :------------------------------------- | :------------------------------------- | | Net loss on mark-to-market valuation of certain commodity positions | $(0.5) | $(37.7) | | Net mark-to-market valuation of certain commodity positions recognized in unallocated corporate items | $(8.5) | $(28.8) | [(7) Debt](index=12&type=section&id=(7)%20Debt) Notes payable significantly decreased, primarily due to the reduction in U.S. commercial paper, while maintaining substantial credit facilities Notes Payable | Metric | Aug. 24, 2025 (Millions) | May 25, 2025 (Millions) | Weighted Average Interest Rate (Aug. 24, 2025) | | :----------------------- | :----------------------- | :---------------------- | :--------------------------------------------- | | U.S. commercial paper | $- | $669.4 | -% | | Financial institutions | $22.1 | $7.6 | 6.0% | | Total notes payable | $22.1 | $677.0 | 6.0% | Credit Facilities | Credit Facility | Borrowing Capacity (Millions) | Borrowed Amount (Millions) | | :------------------------------------ | :---------------------------- | :------------------------- | | Committed credit facility expiring October 2029 | $2,700.0 | $- | | Uncommitted credit facilities and lines of credit | $774.8 | $22.1 | | Total | $3,474.8 | $22.1 | - The company was in compliance with all credit facility covenants, including maintaining a fixed charge coverage ratio of at least **2.5 times**, as of August 24, 2025[44](index=44&type=chunk)[49](index=49&type=chunk) [(8) Noncontrolling Interests](index=13&type=section&id=(8)%20Noncontrolling%20Interests) General Mills purchased the outstanding Class A limited membership interests of General Mills Cereals, LLC in Q4 FY25 for **$252.8 million** - In Q4 FY25, General Mills purchased the outstanding GMC Class A limited membership interests for **$252.8 million**, which represented its principal noncontrolling interest[50](index=50&type=chunk) [(9) Stockholders' Equity](index=13&type=section&id=(9)%20Stockholders'%20Equity) Stockholders' equity details the components of comprehensive income and accumulated other comprehensive loss, showing various impacts Comprehensive Income Attributable to General Mills | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :------------------------------------------------ | :------------------------------------- | :------------------------------------- | | Net earnings attributable to General Mills | $1,204.2 | $579.9 | | Other comprehensive (loss) income attributable to General Mills | $(55.5) | $(56.8) | | Total comprehensive income attributable to General Mills | $1,148.7 | $523.1 | Accumulated Other Comprehensive Loss (AOCI) | Component of AOCI | Aug. 24, 2025 (Millions) | May 25, 2025 (Millions) | | :------------------------------------------ | :----------------------- | :---------------------- | | Foreign currency translation adjustments | $(941.9) | $(876.7) | | Unrealized loss from hedge derivatives | $(1.6) | $(7.4) | | Pension, other postretirement, and postemployment benefits: Net actuarial loss | $(1,718.9) | $(1,726.8) | | Prior service credits | $61.9 | $65.9 | | Accumulated other comprehensive loss | $(2,600.5) | $(2,545.0) | [(10) Stock Plans](index=13&type=section&id=(10)%20Stock%20Plans) Compensation expense related to stock-based payments decreased in Q1 FY26, with fair value estimated using a Black-Scholes model Stock-Based Payments | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :------------------------------------------ | :------------------------------------- | :------------------------------------- | | Compensation expense related to stock-based payments | $15.1 | $20.3 | | (Shortfall) windfall tax impacts of stock-based payments | $(1.5) | $2.8 | - Unrecognized compensation expense for non-vested stock awards was **$181.6 million** as of August 24, 2025, to be recognized over an average of **28 months**[55](index=55&type=chunk) Stock Option Valuation Assumptions | Assumption | Quarter Ended Aug. 24, 2025 | Quarter Ended Aug. 25, 2024 | | :------------------------ | :-------------------------- | :-------------------------- | | Risk-free interest rate | 4.2% | 4.5% | | Expected term | 8.0 years | 8.5 years | | Expected volatility | 22.3% | 21.6% | | Dividend yield | 4.7% | 3.8% | [(11) Earnings Per Share](index=15&type=section&id=(11)%20Earnings%20Per%20Share) Basic and diluted EPS significantly increased in Q1 FY26, driven by higher net earnings and fewer diluted shares outstanding | Metric | Quarter Ended Aug. 24, 2025 | Quarter Ended Aug. 25, 2024 | | :------------------------------------------ | :-------------------------- | :-------------------------- | | Net earnings attributable to General Mills (Millions) | $1,204.2 | $579.9 | | Average number of common shares – basic EPS (Millions) | 541.3 | 560.5 | | Average number of common shares – diluted EPS (Millions) | 542.5 | 563.8 | | Earnings per share – basic | $2.22 | $1.03 | | Earnings per share – diluted | $2.22 | $1.03 | - Anti-dilutive stock options, restricted stock units, and performance share units increased from **4.4 million** in Q1 FY25 to **11.6 million** in Q1 FY26[58](index=58&type=chunk) [(12) Share Repurchases](index=15&type=section&id=(12)%20Share%20Repurchases) General Mills repurchased a higher number of shares for a greater aggregate price in Q1 FY26, primarily through ASR agreements Share Repurchase Activity | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :-------------------------- | :------------------------------------- | :------------------------------------- | | Shares of common stock | 8.7 | 4.5 | | Aggregate purchase price | $454.0 | $302.2 | - Entered into two ASR agreements totaling **$500.0 million** in Q1 FY26, receiving an initial delivery of **7.5 million shares**, funded by divestiture proceeds[59](index=59&type=chunk) - The delivery of **8.7 million shares** under ASR agreements reduced outstanding shares for EPS calculation in Q1 FY26[62](index=62&type=chunk) [(13) Statements of Cash Flows (Supplemental)](index=16&type=section&id=(13)%20Statements%20of%20Cash%20Flows%20(Supplemental)) Supplemental cash flow information shows an increase in both net cash interest payments and net income tax payments for Q1 FY26 | Metric | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :------------------------- | :------------------------------------- | :------------------------------------- | | Net cash interest payments | $125.9 | $83.7 | | Net income tax payments | $24.8 | $18.7 | [(14) Retirement and Postemployment Benefits](index=16&type=section&id=(14)%20Retirement%20and%20Postemployment%20Benefits) Net periodic benefit expense for defined benefit pension plans decreased, while other postretirement benefit plans generated net income | Benefit Plan | Quarter Ended Aug. 24, 2025 (Millions) | Quarter Ended Aug. 25, 2024 (Millions) | | :-------------------------------- | :------------------------------------- | :------------------------------------- | | Defined Benefit Pension Plans | $8.7 | $10.1 | | Other Postretirement Benefit Plans | $(15.4) | $(13.3) | | Postemployment Benefit Plans | $4.4 | $5.2 | [(15) Income Taxes](index=16&type=section&id=(15)%20Income%20Taxes) The effective tax rate increased in Q1 FY26, primarily due to unfavorable tax components related to the U.S. yogurt business sale - The effective tax rate for Q1 FY26 was **25.6%**, up from **21.8%** in Q1 FY25, primarily due to unfavorable tax components from the U.S. yogurt business sale and earnings mix[90](index=90&type=chunk) - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, with no material impact on income tax expense for Q1 FY26[65](index=65&type=chunk)[91](index=91&type=chunk) - OECD Pillar 2 rules, effective for fiscal 2025 in numerous countries, had no material impact on consolidated financial statements[66](index=66&type=chunk) [(16) Business Segment and Geographic Information](index=16&type=section&id=(16)%20Business%20Segment%20and%20Geographic%20Information) General Mills operates in four segments, with segment operating profit being the primary metric for performance assessment - Operating segments include North America Retail, International, North America Pet, and North America Foodservice[68](index=68&type=chunk) - Segment operating profit excludes unallocated corporate items, divestiture gains/losses, and restructuring costs, as these are centrally managed[74](index=74&type=chunk) Segment Net Sales and Operating Profit | Segment | Q1 FY26 Net Sales (Millions) | Q1 FY25 Net Sales (Millions) | Q1 FY26 Operating Profit (Millions) | Q1 FY25 Operating Profit (Millions) | | :------------------------ | :--------------------------- | :--------------------------- | :---------------------------------- | :---------------------------------- | | North America Retail | $2,625.5 | $3,016.6 | $564.2 | $745.7 | | International | $760.2 | $717.0 | $65.7 | $20.9 | | North America Pet | $610.0 | $576.1 | $112.9 | $119.4 | | North America Foodservice | $516.7 | $536.2 | $70.6 | $71.5 | | Total Segment | $4,512.4 | $4,845.9 | $813.4 | $957.5 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of General Mills' financial performance, liquidity, and critical accounting estimates for Q1 FY26 [Introduction](index=20&type=section&id=Introduction) General Mills' key priorities for fiscal 2026 include returning North America Retail to volume growth and accelerating North America Pet growth - Key priorities for fiscal 2026 are to return North America Retail to volume growth, accelerate North America Pet growth, and drive efficiencies for reinvestment[78](index=78&type=chunk) - Category growth is expected to be below long-term projections due to less benefit from net price realization and mix amid a challenging consumer backdrop[78](index=78&type=chunk) - Strategic investment includes launching Blue Buffalo into the U.S. fresh pet food sub-category in calendar 2025[78](index=78&type=chunk) - The net impact of North American yogurt divestitures and Whitebridge Pet Brands acquisition is expected to reduce adjusted operating profit growth by approximately **5 points** in fiscal 2026[78](index=78&type=chunk) [Consolidated Results of Operations](index=20&type=section&id=Consolidated%20Results%20of%20Operations) In Q1 FY26, net sales decreased **7%** (3% organic), while operating profit surged **108%** due to a divestiture gain Consolidated Financial Highlights | Metric | Q1 FY26 Value (Millions) | Q1 FY25 Value (Millions) | % Change | Constant Currency Growth (a) | | :--------------------------------------- | :----------------------- | :----------------------- | :------- | :--------------------------- | | Net sales | $4,517.5 | $4,848.1 | (7)% | | | Operating profit | $1,725.8 | $831.5 | 108% | | | Net earnings attributable to General Mills | $1,204.2 | $579.9 | 108% | | | Diluted earnings per share | $2.22 | $1.03 | 116% | | | Organic net sales growth rate | | | (3)% | | | Adjusted operating profit | $711.2 | $865.3 | (18)% | (18)% | | Adjusted diluted earnings per share | $0.86 | $1.07 | (20)% | (20)% | - The **108%** increase in operating profit was primarily driven by a **$1,054.4 million** divestiture gain from the sale of the U.S. yogurt business[79](index=79&type=chunk)[87](index=87&type=chunk) Net Sales Growth Components | Component of Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :---------------------------- | :------------------ | | Contributions from volume growth | (8) pts | | Net price realization and mix | 1 pt | | Foreign currency exchange | Flat | | Net sales growth | (7)% | Organic Net Sales Growth Components | Component of Organic Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :------------------------------------ | :------------------ | | Contributions from organic volume growth | (1) pt | | Organic net price realization and mix | (2) pts | | Organic net sales growth | (3) pts | [Segment Operating Results](index=22&type=section&id=Segment%20Operating%20Results) Segment results show varied performance, with North America Retail declining, International growing, and North America Pet sales up but profit down [North America Retail Segment Results](index=22&type=section&id=North%20America%20Retail%20Segment%20Results) North America Retail net sales decreased **13%** (5% organic) in Q1 FY26, primarily due to lower volume and divestitures North America Retail Financial Highlights | Metric | Q1 FY26 Net Sales (Millions) | Q1 FY25 Net Sales (Millions) | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | | Net sales | $2,625.5 | $3,016.6 | (13)% | | Segment operating profit | $564.2 | $745.7 | (24)% | North America Retail Net Sales Growth Components | Component of Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :---------------------------- | :------------------ | | Contributions from volume growth | (16) pts | | Net price realization and mix | 3 pts | | Divestitures | (8) pts | | Net sales growth | (13)% | - Organic net sales decreased **5%**, driven by unfavorable organic net price realization and mix and a decrease in organic volume growth[99](index=99&type=chunk) [International Segment Results](index=23&type=section&id=International%20Segment%20Results) International net sales increased **6%** (4% organic) in Q1 FY26, driven by favorable net price realization and foreign currency International Financial Highlights | Metric | Q1 FY26 Net Sales (Millions) | Q1 FY25 Net Sales (Millions) | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | | Net sales | $760.2 | $717.0 | 6% | | Segment operating profit | $65.7 | $20.9 | 214% | International Net Sales Growth Components | Component of Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :---------------------------- | :------------------ | | Contributions from volume growth | (2) pts | | Net price realization and mix | 6 pts | | Foreign currency exchange | 3 pts | | Net sales growth | 6% | - International organic net sales increased **4%**, driven by favorable organic net price realization and mix, partially offset by a decrease in organic volume growth[105](index=105&type=chunk) [North America Pet Segment Results](index=24&type=section&id=North%20America%20Pet%20Segment%20Results) North America Pet net sales increased **6%** in Q1 FY26, but segment operating profit decreased **5%** due to higher costs North America Pet Financial Highlights | Metric | Q1 FY26 Net Sales (Millions) | Q1 FY25 Net Sales (Millions) | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | | Net sales | $610.0 | $576.1 | 6% | | Segment operating profit | $112.9 | $119.4 | (5)% | North America Pet Net Sales Growth Components | Component of Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :---------------------------- | :------------------ | | Contributions from volume growth | 1 pt | | Net price realization and mix | 5 pts | | Acquisition | 11 pts | | Organic net sales growth | (5) pts | | Net sales growth | 6% | - Organic net sales for North America Pet decreased **5%**, driven by a decrease in contributions from organic volume growth[110](index=110&type=chunk) [North America Foodservice Segment Results](index=25&type=section&id=North%20America%20Foodservice%20Segment%20Results) North America Foodservice net sales decreased **4%** in Q1 FY26, primarily due to lower volume and unfavorable net price realization North America Foodservice Financial Highlights | Metric | Q1 FY26 Net Sales (Millions) | Q1 FY25 Net Sales (Millions) | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | | Net sales | $516.7 | $536.2 | (4)% | | Segment operating profit | $70.6 | $71.5 | (1)% | North America Foodservice Net Sales Growth Components | Component of Net Sales Growth | Q1 FY26 vs. Q1 FY25 | | :---------------------------- | :------------------ | | Contributions from volume growth | (2) pts | | Net price realization and mix | (2) pts | | Divestitures | (5) pts | | Organic net sales growth | 1 pt | | Net sales growth | (4)% | - Organic net sales for North America Foodservice increased **1%**, driven by an increase in contributions from organic volume growth[115](index=115&type=chunk) [Unallocated Corporate Items](index=25&type=section&id=Unallocated%20Corporate%20Items) Unallocated corporate expenses remained relatively stable in Q1 FY26, with transaction costs related to the U.S. yogurt business sale | Metric | Q1 FY26 (Millions) | Q1 FY25 (Millions) | | :---------------------------------------------------------------- | :----------------- | :----------------- | | Unallocated corporate expenses | $126 | $124 | | Transaction costs related to U.S. yogurt business sale | $12 | $- | | Net increase in expense from mark-to-market valuation of commodity positions and grain inventories | $8 | $29 | | Acquisition integration costs | $1 | $2 | [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Cash from operations decreased, while investing activities generated significant cash due to divestitures, and financing activities used more cash Cash Flow Activities | Cash Flow Activity | Q1 FY26 (Millions) | Q1 FY25 (Millions) | Change (Millions) | | :-------------------------------- | :----------------- | :----------------- | :---------------- | | Net cash provided by operating activities | $397 | $624 | $(227) | | Net cash provided by investing activities | $1,695 | $(148) | $1,843 | | Net cash used by financing activities | $(1,507) | $(429) | $(1,078) | - Investing activities were significantly boosted by **$1,798 million** cash from the sale of the U.S. yogurt business[119](index=119&type=chunk) - The company has **$2,166 million** of long-term debt maturing in the next **12 months** and expects adequate liquidity[124](index=124&type=chunk) [Critical Accounting Estimates](index=26&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates remain consistent with the prior annual report, with no impairment found in the fiscal 2025 annual test - Critical accounting estimates, such as revenue recognition and valuation of assets, use the same assumptions and methodologies as described in the FY25 Form 10-K[126](index=126&type=chunk) - No impairment was determined for goodwill and indefinite-lived intangible assets in the fiscal 2025 annual test, but certain brands are being monitored for potential impairment[127](index=127&type=chunk) [Recently Issued Accounting Pronouncements](index=27&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) General Mills is analyzing the impact of two recently issued FASB ASUs requiring additional income statement and income tax disclosures - FASB ASU 2024-03, requiring disaggregation of income statement expenses, is effective for annual periods beginning after December 15, 2026 (FY28)[128](index=128&type=chunk) - FASB ASU 2023-09, requiring enhanced income tax disclosures, is effective for annual periods beginning after December 15, 2024 (FY26)[129](index=129&type=chunk) [Non-GAAP Measures](index=27&type=section&id=Non-GAAP%20Measures) This section provides reconciliations and explanations for non-GAAP financial measures used by management to show underlying performance - Non-GAAP measures are used to provide useful information to investors and management by offering transparency to underlying performance[130](index=130&type=chunk)[131](index=131&type=chunk)[142](index=142&type=chunk) Reconciliation of Operating Profit to Adjusted Operating Profit | Metric | Q1 FY26 Value (Millions) | Q1 FY25 Value (Millions) | % of Net Sales (Q1 FY26) | % of Net Sales (Q1 FY25) | | :--------------------------------------- | :----------------------- | :----------------------- | :----------------------- | :----------------------- | | Operating profit as reported | $1,725.8 | $831.5 | 38.2% | 17.2% | | Divestitures gain | $(1,054.4) | $- | (23.3)% | -% | | Restructuring and transformation charges | $18.3 | $2.9 | 0.4% | 0.1% | | Transaction costs | $11.8 | $- | 0.3% | -% | | Mark-to-market effects | $8.5 | $28.8 | 0.2% | 0.6% | | Acquisition integration costs | $1.4 | $1.6 | -% | -% | | Adjusted operating profit | $711.2 | $865.3 | 15.7% | 17.8% | Reconciliation of Diluted Earnings Per Share to Adjusted Diluted Earnings Per Share | Metric | Q1 FY26 | Q1 FY25 | Change (%) | Constant-currency Growth (%) | | :------------------------------------------ | :------ | :------ | :--------- | :--------------------------- | | Diluted earnings per share, as reported | $2.22 | $1.03 | 116% | | | Divestitures gain | $(1.43) | $- | | | | Restructuring and transformation charges | $0.03 | $- | | | | CPW asset impairments and transaction costs | $0.02 | $- | | | | Transaction costs | $0.02 | $- | | | | Mark-to-market effects | $0.01 | $0.04 | | | | Adjusted diluted earnings per share | $0.86 | $1.07 | (20)% | (20)% | [Glossary](index=32&type=section&id=Glossary) This section defines key financial and operational terms used throughout the report, including GAAP and non-GAAP measures - Provides definitions for key terms such as 'Adjusted diluted EPS', 'Adjusted operating profit', 'Constant currency', 'Derivatives', 'Fair value hierarchy', 'Goodwill', 'Holistic Margin Management (HMM)', 'Organic net sales growth', and 'Strategic Revenue Management (SRM)'[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk)[173](index=173&type=chunk)[176](index=176&type=chunk) [CAUTIONARY STATEMENT RELEVANT TO FORWARD -LOOKING INFORMATION FOR THE PURPOSE OF "SAFE HARBOR" PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995](index=34&type=section&id=CAUTIONARY%20STATEMENT%20RELEVANT%20TO%20FORWARD%20-LOOKING%20INFORMATION%20FOR%20THE%20PURPOSE%20OF%20%22SAFE%20HARBOR%22%20PROVISIONS%20OF%20THE%20PRIVATE%20SECURITIES%20LITIGATION%20REFORM%20ACT%20OF%201995) This cautionary statement identifies various risks and uncertainties that could cause actual results to differ materially from forward-looking projections - Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from projections[179](index=179&type=chunk) - Key risk factors include tariffs, supply chain disruptions, competitive dynamics, economic conditions, and regulatory changes[181](index=181&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company provides a quantitative disclosure of its estimated maximum potential value-at-risk (VaR) for various market-risk-sensitive instruments Value-at-Risk (VaR) for Market-Risk-Sensitive Instruments | Instrument Type | One-day Risk of Loss (Millions) | Change During Quarter Ended Aug. 24, 2025 (Millions) | Analysis of Change | | :------------------------ | :------------------------------ | :--------------------------------------------------- | :----------------------- | | Interest rate instruments | $41 | $(5) | Decrease in interest rate volatility | | Foreign currency instruments | $54 | $3 | Immaterial | | Commodity instruments | $2 | $(1) | Immaterial | | Equity instruments | $3 | $- | Immaterial | [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of August 24, 2025 - Disclosure controls and procedures were evaluated and deemed effective as of August 24, 2025[184](index=184&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter ended August 24, 2025[185](index=185&type=chunk) [PART II – Other Information](index=35&type=section&id=PART%20II%20%E2%80%93%20Other%20Information) This section contains other required information, including equity security sales, market risk, controls, and exhibits [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) General Mills repurchased **8.7 million** shares for **$454.0 million** in Q1 FY26, primarily through ASR agreements Common Stock Repurchases | Period | Total Number of Shares Purchased (a) | Average Price Paid Per Share (b) | Total Number of Shares Purchased as Part of a Publicly Announced Program (c) | Maximum Number of Shares that may yet be Purchased Under the Program (c) | | :------------------------ | :----------------------------------- | :------------------------------- | :----------------------------------------------------------------------- | :----------------------------------------------------------------------- | | May 26, 2025 - June 29, 2025 | - | $- | - | 36,918,163 | | June 30, 2025 - July 27, 2025 | 7,520,212 | $49.92 | 7,520,212 | 29,397,951 | | July 28, 2025 - August 24, 2025 | 1,199,631 | $50.41 | 1,199,631 | 28,198,320 | | Total | 8,719,843 | $49.99 | 8,719,843 | 28,198,320 | - The company entered into two ASR agreements totaling **$500.0 million** in Q1 FY26, receiving an initial delivery of **7.5 million shares**[190](index=190&type=chunk) - The Board of Directors authorized the repurchase of up to **100,000,000 shares** of common stock on June 27, 2022, with no expiration date[189](index=189&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter[191](index=191&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including stock award agreements, CEO/CFO certifications, and iXBRL financial statements - Exhibits include forms of Performance Stock Unit, Stock Option, and Restricted Stock Unit Award Agreements[193](index=193&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included[193](index=193&type=chunk) - Financial Statements from the Quarterly Report on Form 10-Q are formatted in Inline Extensible Business Reporting Language (iXBRL)[193](index=193&type=chunk) [Signatures](index=37&type=section&id=Signatures) The report is duly signed on behalf of General Mills, Inc. by Mark A. Pallot, Vice President, Chief Accounting Officer - The report is signed by Mark A. Pallot, Vice President, Chief Accounting Officer, on September 17, 2025[196](index=196&type=chunk)
Rezolute(RZLT) - 2025 Q4 - Annual Report
2025-09-17 20:24
PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Rezolute, Inc. is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI) with its lead clinical asset, ersodetug. The company is advancing ersodetug through Phase 3 studies for congenital HI (sunRIZE study, topline results expected **Dec 2025**) and tumor HI (upLIFT study, topline results expected **H2 2026**), both of which have received Breakthrough Therapy Designation from the FDA. The company protects its intellectual property, faces competition, and operates under significant government regulation, with R&D expenses increasing in **FY2025** - Rezolute, Inc. is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI)[18](index=18&type=chunk) - Lead clinical asset, ersodetug, is an intravenously administered human monoclonal antibody that down-modulates insulin's binding, signaling, and action to counteract elevated insulin effects[19](index=19&type=chunk)[20](index=20&type=chunk) - The sunRIZE Phase 3 study for congenital HI completed enrollment in **May 2025**, with topline results anticipated in **December 2025**[21](index=21&type=chunk) - Ersodetug received Orphan Drug Designation (U.S., EU), Rare Pediatric Disease Designation (U.S.), PRIME designation (EMA), ILAP designation (UK), and Breakthrough Therapy Designation (FDA) for congenital HI[27](index=27&type=chunk) - The upLIFT Phase 3 study for tumor HI initiated in **mid-2025**, with topline results anticipated in the **second half of calendar 2026**. The study design was modified to a single-arm open-label trial with as few as **16 participants**[29](index=29&type=chunk)[30](index=30&type=chunk) - Ersodetug received Breakthrough Therapy Designation by the FDA in **May 2025** for tumor HI[28](index=28&type=chunk) [Summary of Clinical Assets](index=6&type=section&id=Summary%20of%20Clinical%20Assets) This section details the company's lead asset, ersodetug, and its development for congenital and tumor hyperinsulinism, with the sunRIZE Phase 3 study for congenital HI completing enrollment in **May 2025** and results expected in **December 2025**, and the upLIFT Phase 3 study for tumor HI starting in **mid-2025** with results expected in **H2 2026**, both indications having received significant regulatory designations - Ersodetug is a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism, acting by down-modulating insulin's effects[19](index=19&type=chunk)[20](index=20&type=chunk) - sunRIZE Phase 3 study for congenital HI completed enrollment in **May 2025**, exceeding its target of **56 participants** with **62 enrolled**. Topline results are expected in **December 2025**[21](index=21&type=chunk)[149](index=149&type=chunk) - Preliminary data from sunRIZE showed an average participant age of **3.4 years**, with **35% under 2**, **95% on standard treatments**, and an average of **15 hypoglycemia events** per week[23](index=23&type=chunk) - Ersodetug has received Orphan Drug, Rare Pediatric Disease, PRIME (EMA), ILAP (UK), and Breakthrough Therapy (FDA) designations for congenital HI[27](index=27&type=chunk) - upLIFT Phase 3 study for tumor HI initiated in **mid-2025**, with topline results expected in **H2 2026**. The FDA agreed to modify the study design to a single-arm open-label trial with as few as **16 participants**[29](index=29&type=chunk)[30](index=30&type=chunk)[150](index=150&type=chunk) - The addressable market for congenital HI and tumor HI in the U.S. is estimated at over **1,500 patients** each[26](index=26&type=chunk)[37](index=37&type=chunk) [Expanded Access Program ("EAP")](index=10&type=section&id=Expanded%20Access%20Program%20(%22EAP%22)) The EAP provides ersodetug on a compassionate use basis for severe, unmanageable hypoglycemia across various HI indications, showing substantial improvement and good tolerability in **13 tumor HI patients** and **5 congenital HI patients**, many of whom were refractory to standard care - The EAP makes ersodetug available for compassionate use when therapeutic options have failed and an individual's hypoglycemia is unmanageable[38](index=38&type=chunk) - **13 tumor HI patients** and **5 congenital HI patients** have received ersodetug through the EAP, demonstrating substantial improvement in hypoglycemia and good tolerability[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - Tumor HI patients in the EAP often required continuous intravenous dextrose and were hospitalized; ersodetug led to discontinuation or substantial reduction of IV dextrose and outpatient maintenance[38](index=38&type=chunk)[39](index=39&type=chunk) [Intellectual Property](index=12&type=section&id=Intellectual%20Property) Rezolute protects its intellectual property through patents, trade secrets, and trademarks, holding an exclusive worldwide license from XOMA for ersodetug, with patents expiring between **2030 and 2036**, and expects further data and marketing exclusivity - The company maintains and builds its patent portfolio through new filings, prosecution, and licensing, and protects know-how, trade secrets, and trademarks[42](index=42&type=chunk) - Holds a worldwide, exclusive license from XOMA for ersodetug, covering **38 issued patents** (**4 U.S.**) and pending applications, with patents expiring between **2030 and 2036**[44](index=44&type=chunk) - Expects further exclusivity for product candidates through data and marketing exclusivity under pharmaceutical regulatory laws, potentially up to **12 years** from BLA approval[44](index=44&type=chunk) [Competition](index=12&type=section&id=Competition) Rezolute faces competition from pharmaceutical and biotechnology companies, academic institutions, and governmental agencies in talent acquisition and technology development, with several companies, including Amylyx Pharmaceuticals, Hanmi Pharmaceuticals, and Zealand Pharma, developing therapies for HI that could compete with ersodetug - Competition exists from pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and private research organizations in personnel and technology[45](index=45&type=chunk) - Potential competitors for ersodetug in HI include Amylyx Pharmaceuticals, Hanmi Pharmaceuticals, and Zealand Pharma[45](index=45&type=chunk) [Government Regulation](index=12&type=section&id=Government%20Regulation) The company's products require extensive regulatory approval from governmental agencies like the FDA and foreign authorities, involving rigorous preclinical testing and clinical trials, and is also subject to various federal, state, and local laws regarding manufacturing, safety, and hazardous substance handling - All potential products require regulatory approval by governmental agencies (e.g., FDA, EMA) prior to commercialization, involving rigorous preclinical testing and clinical trials[46](index=46&type=chunk) - The company is subject to federal, state, and local laws and regulations concerning safe working conditions, laboratory practices, animal use, and hazardous substance handling[47](index=47&type=chunk)[48](index=48&type=chunk) [Research and Development](index=14&type=section&id=Research%20and%20Development) R&D expenses were **$61.5 million** in **FY2025**, an increase from **$55.7 million** in **FY2024**, primarily driven by increased clinical and manufacturing costs for ersodetug Research and Development Expenses | Fiscal Year Ended June 30 | 2025 (Millions) | 2024 (Millions) | | :------------------------ | :-------------- | :-------------- | | R&D Expenses | **$61.5** | **$55.7** | - The increase in R&D expenses was primarily due to a **$11.8 million** increase in ersodetug clinical and manufacturing costs, partially offset by a **$7.0 million** decrease in RZ402 costs[176](index=176&type=chunk) [Human Capital Management](index=14&type=section&id=Human%20Capital%20Management) As of **June 30, 2025**, Rezolute had **71 full-time employees**, with **52 in R&D**. The company prioritizes diversity and inclusion, and focuses on attracting, developing, and retaining talent through various programs and benefits, including equity compensation - As of **June 30, 2025**, the company had **71 full-time employees**, with **52 in research and development** and **19 in general and administrative functions**, all located in the United States[50](index=50&type=chunk) - The company adopted an equity and inclusion policy on **May 30, 2023**, and leverages formal and informal programs to identify, foster, and retain top talent, offering benefits and equity compensation[51](index=51&type=chunk)[52](index=52&type=chunk) [Corporate Information](index=14&type=section&id=Corporate%20Information) Rezolute, Inc. was incorporated in Delaware in **2010**, reincorporated in Nevada in **2021**, and maintains its executive office in Redwood City, CA. The company files reports with the SEC, which are available on www.sec.gov - Incorporated in Delaware in **2010**, reincorporated in Nevada in **June 2021**[54](index=54&type=chunk) - Maintains an executive office at 275 Shoreline Drive, Suite 500, Redwood City, CA 94065[54](index=54&type=chunk) - Files annual, quarterly, current reports, proxy statements, and other information with the Securities and Exchange Commission (SEC), available at www.sec.gov[54](index=54&type=chunk)[55](index=55&type=chunk) [Item 1A. Risk Factors](index=16&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could adversely affect Rezolute's business, financial condition, and results of operations, including potential delays or failures in clinical trials and regulatory approvals, product liability exposure, the need for substantial additional capital, and challenges in intellectual property protection, as well as risks related to its history of losses, potential loss of 'smaller reporting company' status, and global economic conditions - Delays or termination of clinical trials could increase costs, delay revenue generation, and adversely affect commercial prospects[57](index=57&type=chunk)[58](index=58&type=chunk) - Product candidates may produce serious adverse events, leading to trial interruptions, delays, or denial of regulatory approval[61](index=61&type=chunk) - The company has a history of losses (**$74.4 million** in **FY2025**, **$68.5 million** in **FY2024**) and will need substantial additional capital to fund operations and achieve profitability[87](index=87&type=chunk)[174](index=174&type=chunk) - Product liability claims from clinical studies or commercial sales could result in substantial liabilities, reputational damage, and financial losses, potentially exceeding insurance coverage[91](index=91&type=chunk)[92](index=92&type=chunk) - The company's intellectual property portfolio may not adequately protect product candidates, leading to direct competition, and patent litigation can be expensive and time-consuming[113](index=113&type=chunk)[117](index=117&type=chunk) - Federal and state laws impose substantial restrictions on the utilization of net operating loss (NOL) carryforwards due to ownership changes, potentially limiting future profitability[93](index=93&type=chunk)[345](index=345&type=chunk) [Risks Related to Our Product Development and Commercialization](index=16&type=section&id=Risks%20Related%20to%20Our%20Product%20Development%20and%20Commercialization) Significant risks include delays or termination of clinical trials due to regulatory disagreements, enrollment issues, adverse events, or manufacturing problems; failure to meet safety or efficacy requirements will prevent regulatory approval and commercialization, and reliance on third parties for trials and manufacturing introduces additional risks - Clinical testing is expensive, time-consuming, and uncertain; delays can arise from regulatory disagreements, investigator/site activation, IRB/EC approvals, protocol changes, manufacturing issues, patient enrollment/retention, funding, and adverse effects[58](index=58&type=chunk)[59](index=59&type=chunk) - Adverse events in clinical trials could force the company to stop development or prevent regulatory approval[61](index=61&type=chunk) - Failure to obtain regulatory approval for product candidates will prevent marketing and sales, hindering profitability[69](index=69&type=chunk) - Reliance on contract research organizations (CROs) and third-party suppliers for clinical trials and manufacturing means less control over timing, conduct, expense, and potential supply chain delays[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) [Risks Related to Our Business](index=23&type=section&id=Risks%20Related%20to%20Our%20Business) The company has a history of net losses (**$74.4 million** in **FY2025**) and an accumulated deficit of **$403.9 million**, requiring substantial additional capital; other risks include product liability exposure, limitations on net operating loss (NOL) carryforwards, potential future loss of "smaller reporting company" status, and adverse effects from global economic conditions and foreign operations Key Financial Metrics | Fiscal Year Ended June 30 | 2025 (Millions) | 2024 (Millions) | | :------------------------ | :-------------- | :-------------- | | Net Losses | **$(74.4)** | **$(68.5)** | | Accumulated Deficit | **$(403.9)** | **$(329.4)** | | Cash Used in Operating Activities | **$(69.1)** | **$(57.4)** | - As of **June 30, 2025**, cash and cash equivalents were **$94.1 million** and investments in marketable debt securities were **$73.8 million**, expected to provide adequate capital for at least **12 months**[87](index=87&type=chunk)[188](index=188&type=chunk) - Product liability claims could result in substantial liabilities, reputational damage, and financial losses, potentially exceeding insurance coverage[91](index=91&type=chunk)[92](index=92&type=chunk) - U.S. federal NOL carryforwards of **$201.4 million** are subject to significant limitations under IRC Section 382 due to ownership changes, with **$33.4 million** expiring without utilization[93](index=93&type=chunk)[346](index=346&type=chunk) - If market capitalization increases, the company may no longer qualify as a "smaller reporting company," leading to enhanced disclosure requirements and increased compliance costs[97](index=97&type=chunk) - Operations outside the U.S. are subject to different local politics, business factors, and regulatory requirements, including data privacy laws like HIPAA and GDPR[98](index=98&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Risks Related to Our Intellectual Property](index=30&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on its intellectual property, but current patent positions may not cover all necessary rights, and future licenses may not be available on reasonable terms; patents can be challenged, invalidated, or circumvented, and trade secrets are difficult to protect; litigation regarding intellectual property is expensive and could delay product commercialization - Current patent positions and license portfolio may not include all patent rights needed for full development and commercialization, and future necessary rights may not be available on commercially reasonable terms[107](index=107&type=chunk)[108](index=108&type=chunk)[110](index=110&type=chunk) - Patents may be challenged, deemed unenforceable, invalidated, or circumvented, and the coverage claimed in a patent application can be significantly reduced[114](index=114&type=chunk) - Reliance on trade secrets is risky as they are difficult to protect and may be independently discovered or disclosed despite confidentiality agreements[115](index=115&type=chunk) - Litigation regarding patents and other proprietary rights is expensive, time-consuming, and could cause delays in bringing product candidates to market[117](index=117&type=chunk)[118](index=118&type=chunk) [Risks Related to Our Common Stock](index=34&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The market price of common stock could decline due to the sale of a substantial number of shares (overhang) or changes in investor relations activities; changes in U.S. tax law, including the recent OBBBA, could also adversely affect the business - Offers or availability for sale of a substantial number of shares of common stock (overhang) could cause the price to decline and make additional financing more difficult[122](index=122&type=chunk)[124](index=124&type=chunk) - Investor relations activities and supply and demand factors may affect the price of common stock[125](index=125&type=chunk) - Changes in U.S. tax law, including the recent enactment of the One Big Beautiful Bill Act (OBBBA), could adversely affect the business[126](index=126&type=chunk)[127](index=127&type=chunk) [Item 1B. Unresolved Staff Comments.](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) As a smaller reporting company, Rezolute is not required to provide information on unresolved staff comments - The company is a smaller reporting company and is not required to provide information on unresolved staff comments[128](index=128&type=chunk) [Item 1C. Cybersecurity.](index=36&type=section&id=Item%201C.%20Cybersecurity.) Rezolute has established processes for assessing, identifying, and managing cybersecurity risks, including physical, procedural, and technical safeguards, response plans, regular tests, and employee training; external consultants are engaged, and the Audit Committee provides oversight; no material cybersecurity incidents occurred in **FY2025**, and management does not believe there are currently any known risks likely to materially affect the business - Established processes for assessing, identifying, and managing cybersecurity risks, including safeguards, response plans, regular tests, and policy reviews[129](index=129&type=chunk) - Engages external risk management consultants and computer security firms to enhance cybersecurity oversight and provides periodic employee training[130](index=130&type=chunk) - The Audit Committee of the Board of Directors provides direct cybersecurity risk oversight[132](index=132&type=chunk) - No known risks from cybersecurity threats are reasonably likely to materially affect the business, and no cybersecurity incidents occurred in **fiscal year 2025**[133](index=133&type=chunk) [Item 2. Properties.](index=38&type=section&id=Item%202.%20Properties.) Rezolute leases two office facilities: a corporate headquarters in Redwood City, CA (**9,300 sq ft**, lease until **Oct 2027**) and an office in Bend, OR (**5,000 sq ft**, lease until **Feb 2027**); the company believes its current properties are sufficient for its needs - Leases a **9,300 square feet** corporate headquarters facility in Redwood City, CA, with a lease term through **October 2027**[134](index=134&type=chunk) - Leases a **5,000 square feet** office space in Bend, OR, with a lease term through **February 2027**[135](index=135&type=chunk) - Believes current physical properties are sufficient and adequate to meet current and projected requirements[135](index=135&type=chunk) [Item 3. Legal Proceedings.](index=38&type=section&id=Item%203.%20Legal%20Proceedings.) For a discussion of the company's legal proceedings, refer to "Notes to Consolidated Financial Statements - Commitments and Contingencies" in Part II, Item 8 - For a discussion of the Company's legal proceedings, see "Notes to Consolidated Financial Statements - Commitments and Contingencies" in Part II. Item 8[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures.](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to Rezolute, Inc - This item is not applicable[137](index=137&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.](index=38&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) Rezolute's common stock has traded on Nasdaq under the symbol "RZLT" since **November 9, 2020**; as of **September 15, 2025**, there were **246 holders** of record; the company has never paid cash dividends and has no plans to do so in the foreseeable future, intending to reinvest all available funds into business development - Common stock has traded on Nasdaq under the symbol "RZLT" since **November 9, 2020**[140](index=140&type=chunk) - As of **September 15, 2025**, there were **246 holders** of record of the company's common stock[141](index=141&type=chunk) - The company has never paid cash dividends and intends to employ all available funds in the development of its business, with no plans to pay cash dividends in the foreseeable future[143](index=143&type=chunk) - No recent sales of unregistered securities[144](index=144&type=chunk) [Item 6. [Reserved]](index=40&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[146](index=146&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=40&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides an overview of Rezolute's financial condition and results of operations for the fiscal years ended **June 30, 2025** and **2024**; the company remains in a clinical stage with no meaningful revenue, focusing on advancing ersodetug through Phase 3 trials for congenital and tumor HI; it incurred net losses and relies on equity financings for liquidity, with management believing current resources are sufficient for at least **12 months**, but additional long-term financing will be needed - The company's priorities for **H2 2025** and **H1 2026** are to complete the sunRIZE study (topline data **Dec 2025**), continue enrollment in the tumor HI study, and submit a Biologics License Application (BLA) for ersodetug in **mid-2026**, assuming supportive data[148](index=148&type=chunk) - The company has not generated any meaningful revenues since inception and expects to incur operating losses for the foreseeable future, requiring additional capital[155](index=155&type=chunk)[156](index=156&type=chunk) Key Financial Metrics | Metric | FY2025 (Millions) | FY2024 (Millions) | | :----- | :---------------- | :---------------- | | Net loss | **$(74.4)** | **$(68.5)** | Cash Flow Summary | Cash Flow Type | FY2025 (Millions) | FY2024 (Millions) | | :------------- | :---------------- | :---------------- | | Operating activities | **$(69.1)** | **$(57.4)** | - The company raised **$107.0 million** in net proceeds from the issuance of equity securities in **FY2025** and **$62.6 million** in **FY2024**[185](index=185&type=chunk) [Executive Summary](index=40&type=section&id=Executive%20Summary) Rezolute's immediate priorities are to execute on two Phase 3 clinical trials for ersodetug: completing the sunRIZE study for congenital HI (topline data expected **Dec 2025**) and continuing enrollment in the upLIFT study for tumor HI (topline data expected **H2 2026**), with a goal to submit a Biologics License Application (BLA) in **mid-2026** - Priorities for **H2 2025** and **H1 2026** include completing the sunRIZE study for congenital HI (topline data **Dec 2025**), continuing enrollment in the tumor HI study, and submitting a BLA for ersodetug in **mid-2026**[148](index=148&type=chunk) [Clinical Development](index=40&type=section&id=Clinical%20Development) The company is focused on advancing ersodetug for all forms of HI; the pivotal Phase 3 sunRIZE study for congenital HI completed enrollment in **May 2025**, exceeding its target, with topline results expected in **December 2025**; the upLIFT study for tumor HI is enrolling in the U.S. and Europe, with its design modified to a single-arm open-label trial, and topline results expected in **H2 2026** - Completed enrollment in the pivotal Phase 3 sunRIZE clinical study of ersodetug for congenital HI in **May 2025**, exceeding the target with **62 participants**. Topline results are anticipated in **December 2025**[149](index=149&type=chunk) - The upLIFT study in tumor HI is currently enrolling in the U.S. and Europe. The FDA agreed to modifications to the study design, including removing the need for a double-blind randomized placebo-controlled trial, limiting it to a single-arm open-label portion with as few as **16 participants**. Topline results are anticipated in the **second half of 2026**[150](index=150&type=chunk)[151](index=151&type=chunk) [Recent Developments](index=42&type=section&id=Recent%20Developments) Recent developments include the appointment of Sunil Karnawat as Chief Commercial Officer in **August 2025**, with a compensation package including salary, bonus, and equity grants; the company also completed a private placement in **May 2025** (**$4.2 million** net proceeds) and an underwritten public offering in **April 2025** (**$96.8 million** net proceeds) - Sunil Karnawat was appointed Chief Commercial Officer on **August 18, 2025**, with an annual base salary of **$475,000**, a signing bonus of **$65,000**, and eligibility for an annual performance bonus target of **40%** of base salary[152](index=152&type=chunk) - Mr. Karnawat received an inducement grant of stock options to purchase **275,000 shares** and **25,000 shares** of RSUs[152](index=152&type=chunk) - Completed a private placement in **May 2025**, selling **1,295,383 shares** of common stock for net proceeds of **$4.2 million**[153](index=153&type=chunk) - Completed an underwritten public offering in **April 2025**, issuing **20,786,923 common shares** and **6,905,385 pre-funded warrants**, generating **$96.8 million** in net proceeds after deducting offering costs[154](index=154&type=chunk) [Factors Impacting our Results of Operations](index=42&type=section&id=Factors%20Impacting%20our%20Results%20of%20Operations) The company has not generated meaningful revenue since inception and expects continued operating losses due to the time required for clinical trials and regulatory approval; it anticipates needing additional capital from external sources to fund operations and product commercialization - The company has not generated any meaningful revenues since its inception and anticipates it will be some time before substantial revenues are generated, if ever, due to the time required for clinical trials and regulatory approval[155](index=155&type=chunk)[156](index=156&type=chunk) - Expects to generate operating losses for the foreseeable future and will need additional capital from external sources, which may be costly or require unfavorable terms[156](index=156&type=chunk) [Key Components of Consolidated Statements of Operations](index=42&type=section&id=Key%20Components%20of%20Consolidated%20Statements%20of%20Operations) This section defines the key components of the consolidated statements of operations: Research and Development (R&D) expenses, General and Administrative (G&A) expenses, Interest and other income, and Loss from change in fair value of derivative liabilities; R&D includes clinical trial costs, personnel, licensing, and consultants; G&A covers administrative personnel, legal, auditing, and investor relations - Research and development (R&D) expenses primarily consist of clinical trial costs, compensation and benefits for R&D personnel, licensing costs, and consultants and outside services[157](index=157&type=chunk) - General and administrative (G&A) expenses primarily include compensation and benefits for administrative, finance, accounting, and executive functions, as well as travel, legal, auditing, and investor relations costs[160](index=160&type=chunk) - Interest and other income primarily consists of interest income earned on marketable debt securities and temporary cash investments[161](index=161&type=chunk) - Loss from change in fair value of derivative liabilities reflects adjustments to fair value for warrant and embedded derivative liabilities[162](index=162&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The preparation of financial statements requires significant judgments and estimates, particularly for marketable debt securities (fair value, credit losses), derivative liabilities (fair value), share-based compensation (fair value, vesting), and clinical trial accruals (work completion estimates) - Significant accounting estimates include determining allowances for credit losses on marketable debt securities, fair value of derivative liabilities, fair value of share-based compensation, and estimates related to clinical trial accrued liabilities[163](index=163&type=chunk)[164](index=164&type=chunk)[238](index=238&type=chunk) - Investments in marketable debt securities are accounted for as available-for-sale, recorded at fair value, with unrealized gains and losses reported in shareholders' equity. Credit losses are recognized if declines in fair value are credit-related[165](index=165&type=chunk)[244](index=244&type=chunk) - Research and development costs are expensed as incurred, and clinical trial activities performed by third parties are accrued based on estimates of work completed[168](index=168&type=chunk)[169](index=169&type=chunk)[250](index=250&type=chunk) - Share-based compensation is measured at fair value using the Black-Scholes Merton option-pricing model for stock options and the closing market price for RSUs, recognized over the vesting period[170](index=170&type=chunk)[252](index=252&type=chunk) - Warrant and embedded derivative liabilities are adjusted to fair value at each reporting period, with changes recognized as gains and losses in the consolidated statements of operations[172](index=172&type=chunk)[256](index=256&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Rezolute reported net losses of **$74.4 million** in **FY2025**, an increase from **$68.5 million** in **FY2024**; R&D expenses increased by **10%** to **$61.5 million**, primarily due to ersodetug clinical and manufacturing costs; G&A expenses increased by **25%** to **$18.4 million**, driven by compensation and professional fees; interest income increased, while derivative liability losses decreased significantly as warrants were reclassified to equity Consolidated Results of Operations | Metric | FY2025 (Thousands) | FY2024 (Thousands) | Change (Amount) | Change (%) | | :------------------------------------------ | :----------------- | :----------------- | :-------------- | :--------- | | Operating expenses: | | | | | | Research and development | **$61,527** | **$55,743** | **$5,784** | **10%** | | General and administrative | **$18,367** | **$14,680** | **$3,687** | **25%** | | Total operating expenses | **$79,894** | **$70,423** | **$9,471** | **13%** | | Operating loss | **$(79,894)** | **$(70,423)** | **$(9,471)** | **13%** | | Non-operating income (expense): | | | | | | Interest and other income | **$5,482** | **$4,870** | **$612** | **13%** | | Loss from change in fair value of warrant derivative liability | **$0** | **$(2,850)** | **$2,850** | **100%** | | Loss from change in fair value of embedded derivative liabilities | **$0** | **$(56)** | **$56** | **100%** | | Total non-operating income (expense), net | **$5,482** | **$1,964** | **$3,518** | **179%** | | Net loss | **$(74,412)** | **$(68,459)** | **$(5,953)** | **9%** | - No revenue was generated for the fiscal years ended **June 30, 2025** and **2024**, as the company is in a clinical stage[175](index=175&type=chunk) - R&D expenses increased by **$5.8 million** (**10%**) in **FY2025**, primarily due to an **$11.8 million** increase in ersodetug clinical and manufacturing costs, partially offset by a **$7.0 million** decrease in RZ402 costs[176](index=176&type=chunk) - Ersodetug program costs increased by **$11.8 million**, driven by **$6.7 million** in manufacturing costs, **$3.2 million** for the tumor HI Phase 3 study, and **$1.9 million** for the sunRIZE clinical trial[177](index=177&type=chunk) - G&A expenses increased by **$3.7 million** (**25%**) in **FY2025**, mainly due to a **$1.8 million** increase in G&A compensation and benefits (due to more employees and higher bonuses) and a **$1.8 million** increase in professional fees for pre-commercial planning[180](index=180&type=chunk) - Interest and other income increased by **$0.6 million** (**13%**) in **FY2025** due to a higher average balance of investments in marketable debt securities[181](index=181&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) As of **June 30, 2025**, Rezolute had **$167.9 million** in total capital resources (**$94.1 million** cash, **$73.8 million** marketable debt securities) and **$159.2 million** in working capital; the company has incurred cumulative net losses of **$403.9 million** and relies on equity financings, having raised **$107.0 million** in **FY2025**; management believes current resources are sufficient for at least **12 months** but will need additional financing for long-term obligations, including significant milestone payments for license agreements Capital Resources and Working Capital | Metric | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | Cash and cash equivalents | **$94,107** | **$70,396** | | Investments in marketable debt securities | **$73,751** | **$56,478** | | Total Capital Resources | **$167,858** | **$126,874** | | Working Capital | **$159,233** | **$119,047** | | Cumulative Net Losses | **$(403,856)** | **$(329,444)** | - Primary source of liquidity has historically been from private placements and public offerings of equity securities, with net proceeds of **$107.0 million** in **FY2025** and **$62.6 million** in **FY2024**[185](index=185&type=chunk) - Management believes current capital resources are adequate to meet contractual obligations and fund planned activities for at least **12 months** from the issuance date of the consolidated financial statements[188](index=188&type=chunk)[273](index=273&type=chunk) - Significant long-term contractual obligations include a **$25.0 million** regulatory milestone payment to XOMA upon ersodetug approval and additional clinical and regulatory milestone payments up to **$25.0 million** to ActiveSite[189](index=189&type=chunk)[270](index=270&type=chunk) - Future commercialization of ersodetug and RZ402 could trigger additional milestone payments and royalties up to **$202.5 million** (**$185.0 million** to XOMA and **$17.5 million** to ActiveSite)[190](index=190&type=chunk) Cash Flow Summary | Cash Flow Type | FY2025 (Thousands) | FY2024 (Thousands) | Change (Thousands) | | :----------------------------- | :----------------- | :----------------- | :----------------- | | Operating activities | **$(69,075)** | **$(57,368)** | **$(11,707)** | | Investing activities | **$(14,541)** | **$48,699** | **$(63,240)** | | Financing activities | **$107,327** | **$63,029** | **$44,298** | [Off-Balance Sheet Arrangements](index=53&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements with unconsolidated organizations or financial partnerships during the fiscal years ended **June 30, 2025** and **2024** - The company did not have any relationships with unconsolidated organizations or financial partnerships for off-balance sheet arrangements during the fiscal years ended **June 30, 2025** and **2024**[205](index=205&type=chunk) [Recently Issued Accounting Pronouncements](index=53&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to Note 1 of the consolidated financial statements for the impact of recently issued accounting pronouncements - Information regarding the impact of certain recently issued accounting pronouncements on the consolidated financial statements is provided in Note 1[206](index=206&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk.](index=53&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Rezolute is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide the information under this item[207](index=207&type=chunk) [Item 8. Financial Statements and Supplementary Data.](index=54&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This item presents the audited consolidated financial statements for Rezolute, Inc. and its subsidiaries for the fiscal years ended **June 30, 2025** and **2024**, including the Report of Independent Registered Public Accounting Firm, balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, statements of cash flows, and comprehensive notes to the financial statements; the financial statements are prepared in conformity with GAAP and received an unqualified opinion from Grant Thornton LLP - Includes the Report of Independent Registered Public Accounting Firm, consolidated balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, and statements of cash flows for the fiscal years ended **June 30, 2025** and **2024**[210](index=210&type=chunk) - The consolidated financial statements present fairly, in all material respects, the financial position and results of operations in conformity with accounting principles generally accepted in the United States of America[213](index=213&type=chunk) - No critical audit matters were identified by the independent registered public accounting firm[217](index=217&type=chunk) [Report of Independent Registered Public Accounting Firm](index=55&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Grant Thornton LLP, the independent registered public accounting firm, issued an unqualified opinion on Rezolute's consolidated financial statements for the fiscal years ended **June 30, 2025** and **2024**, stating they present fairly the financial position and results of operations in conformity with GAAP; no critical audit matters were identified - Grant Thornton LLP provided an unqualified opinion on the consolidated financial statements for the fiscal years ended **June 30, 2025** and **2024**[213](index=213&type=chunk) - The audit was conducted in accordance with PCAOB standards, and no critical audit matters were identified[215](index=215&type=chunk)[217](index=217&type=chunk) [Consolidated Balance Sheets](index=57&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets show total assets increased to **$175.5 million** in **FY2025** from **$132.7 million** in **FY2024**, driven by increases in cash and marketable debt securities; total liabilities increased to **$13.4 million** from **$11.7 million**, while total shareholders' equity increased to **$162.1 million** from **$121.0 million** Consolidated Balance Sheet Summary | Asset/Liability/Equity | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | **Assets:** | | | | Cash and cash equivalents | **$94,107** | **$70,396** | | Investments in marketable debt securities | **$73,751** | **$56,478** | | Total current assets | **$171,145** | **$128,653** | | Total assets | **$175,490** | **$132,737** | | **Liabilities:** | | | | Total current liabilities | **$11,912** | **$9,606** | | Total liabilities | **$13,363** | **$11,734** | | **Shareholders' Equity:** | | | | Additional paid-in capital | **$565,903** | **$450,473** | | Accumulated deficit | **$(403,856)** | **$(329,444)** | | Total shareholders' equity | **$162,127** | **$121,003** | - Total assets increased by **$42.7 million**, primarily due to increases in cash and cash equivalents (**$23.7 million**) and marketable debt securities (**$17.3 million**)[221](index=221&type=chunk) - Accumulated deficit increased by **$74.4 million** to **$403.9 million**, reflecting ongoing net losses[221](index=221&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=58&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$74.4 million** in **FY2025**, an increase from **$68.5 million** in **FY2024**; operating expenses rose by **13%** to **$79.9 million**, driven by R&D and G&A increases; interest and other income increased, while losses from derivative liabilities were zero in **FY2025** compared to **$2.9 million** in **FY2024**; basic and diluted net loss per common share was **$(0.98)** in **FY2025**, an improvement from **$(1.33)** in **FY2024** due to a higher weighted average share count Consolidated Statements of Operations Summary | Metric | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------------------------ | :----------------- | :----------------- | | Research and development | **$61,527** | **$55,743** | | General and administrative | **$18,367** | **$14,680** | | Total operating expenses | **$79,894** | **$70,423** | | Operating loss | **$(79,894)** | **$(70,423)** | | Interest and other income, net | **$5,482** | **$4,870** | | Loss from change in fair value of embedded derivative liability | **$0** | **$(56)** | | Loss from change in fair value of warrant derivative liability | **$0** | **$(2,850)** | | Net loss | **$(74,412)** | **$(68,459)** | | Comprehensive loss | **$(74,340)** | **$(68,187)** | | Net loss per common share: Basic and diluted | **$(0.98)** | **$(1.33)** | | Weighted average number of common shares outstanding: Basic and diluted | **75,999,290** | **51,466,150** | - Net loss increased by **$5.9 million** (**9%**) in **FY2025** compared to **FY2024**[174](index=174&type=chunk)[223](index=223&type=chunk) - Basic and diluted net loss per common share improved from **$(1.33)** in **FY2024** to **$(0.98)** in **FY2025**, despite a higher net loss, due to a significant increase in weighted average shares outstanding[223](index=223&type=chunk) [Consolidated Statements of Shareholders' Equity](index=59&type=section&id=Consolidated%20Statements%20of%20Shareholders'%20Equity) Total shareholders' equity increased to **$162.1 million** in **FY2025** from **$121.0 million** in **FY2024**; this increase was primarily driven by **$107.5 million** in proceeds from equity issuances (underwritten offerings and private placements) and **$7.1 million** in share-based compensation, partially offset by a net loss of **$74.4 million** Shareholders' Equity Changes | Metric | June 30, 2024 (Thousands) | Equity Changes in FY2025 (Thousands) | June 30, 2025 (Thousands) | | :-------------------------------- | :------------------------ | :--------------------------- | :------------------------ | | Common Stock | **$53** | **$33** | **$87** | | Additional Paid-in Capital | **$450,473** | **$115,430** | **$565,903** | | Accumulated Other Comprehensive Loss | **$(79)** | **$72** | **$(7)** | | Accumulated Deficit | **$(329,444)** | **$(74,412)** | **$(403,856)** | | Total Shareholders' Equity | **$121,003** | **$41,124** | **$162,127** | - Proceeds from equity securities in the **2025** Underwritten Offering (net of underwriting discounts) contributed **$76.194 million** to additional paid-in capital[227](index=227&type=chunk) - Proceeds from **2025** Pre-Funded Warrants contributed **$21.089 million** to additional paid-in capital[227](index=227&type=chunk) - Gross proceeds from the **2024** and **2025** Private Placements contributed **$6.0 million** and **$4.210 million**, respectively[227](index=227&type=chunk) - Share-based compensation added **$7.121 million** to additional paid-in capital in **FY2025**[227](index=227&type=chunk) - Net loss of **$74.412 million** reduced accumulated deficit[227](index=227&type=chunk) [Consolidated Statements of Cash Flows](index=60&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$69.1 million** in **FY2025** from **$57.4 million** in **FY2024**, primarily due to higher net losses; net cash used in investing activities was **$14.5 million** in **FY2025**, a shift from **$48.7 million** provided in **FY2024**, reflecting increased purchases of marketable debt securities; net cash provided by financing activities significantly increased to **$107.3 million** in **FY2025** from **$63.0 million** in **FY2024**, driven by proceeds from equity offerings Cash Flow Summary | Cash Flow Type | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------------------------ | :----------------- | :----------------- | | Net Cash Used in Operating Activities | **$(69,075)** | **$(57,368)** | | Net Cash Provided by (Used in) Investing Activities | **$(14,541)** | **$48,699** | | Net Cash Provided by Financing Activities | **$107,327** | **$63,029** | | Net increase in cash and cash equivalents | **$23,711** | **$54,360** | | Cash and cash equivalents at end of fiscal year | **$94,107** | **$70,396** | - The increase in cash used in operating activities was mainly due to a higher net loss (**$74.4 million** in **FY2025** vs. **$68.5 million** in **FY2024**)[197](index=197&type=chunk) - Investing activities shifted from providing cash to using cash, primarily due to increased purchases of marketable debt securities (**$128.1 million** in **FY2025** vs. **$66.4 million** in **FY2024**)[202](index=202&type=chunk) - Financing activities were significantly boosted by proceeds from the **2025** Underwritten Offering (**$97.3 million**) and private placements (**$10.2 million**)[203](index=203&type=chunk) [Notes to Consolidated Financial Statements](index=62&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the company's accounting policies, liquidity, investments, leases, license agreements, derivative liabilities, shareholders' equity, share-based compensation, income taxes, commitments, related party transactions, supplemental financial information, net loss per share, financial instruments, and segment disclosures; it also includes information on recently adopted and future accounting pronouncements and subsequent events - The company is a clinical stage biopharmaceutical company operating as a single reportable segment[233](index=233&type=chunk)[237](index=237&type=chunk)[392](index=392&type=chunk) - Management believes current capital resources are adequate for at least **12 months**, but additional financing will be needed for long-term obligations[273](index=273&type=chunk)[191](index=191&type=chunk) - Investments in marketable debt securities totaled **$73.8 million** as of **June 30, 2025**, all maturing within **12 months**[274](index=274&type=chunk) - Lease obligations include a corporate headquarters in Redwood City, CA, and an office in Bend, OR, with total lease payments of **$1.744 million** through **FY2028**[281](index=281&type=chunk)[286](index=286&type=chunk) - License agreements with XOMA and ActiveSite involve significant milestone payments, including **$25.0 million** to XOMA upon ersodetug regulatory approval and up to **$25.0 million** to ActiveSite for clinical/regulatory milestones[288](index=288&type=chunk)[291](index=291&type=chunk) - As of **June 30, 2025**, the company had U.S. federal NOL carryforwards of **$201.4 million**, subject to IRC Section 382 limitations[346](index=346&type=chunk) [NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=62&type=section&id=NOTE%201%20%E2%80%94%20NATURE%20OF%20OPERATIONS%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Rezolute, Inc. is a clinical-stage rare disease company focused on hyperinsulinism; its financial statements are consolidated and prepared under GAAP, requiring significant estimates for areas like marketable debt securities, derivative liabilities, share-based compensation, and clinical trial accruals; the company operates as a single reportable segment; recently adopted ASU 2023-07 on segment reporting had no material impact, and ASU 2023-09 on income tax disclosures will be adopted in **FY2026** - Rezolute, Inc. is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, with ersodetug as its primary clinical asset[233](index=233&type=chunk) - Consolidated financial statements are prepared in accordance with GAAP, requiring management judgments, estimates, and assumptions for various financial items[235](index=235&type=chunk)[238](index=238&type=chunk) - The company operates as a single reportable operating segment, with its Chief Executive Officer serving as the chief operating decision maker[237](index=237&type=chunk)[392](index=392&type=chunk) - Investments in marketable debt securities are classified as available-for-sale and recorded at fair value, with credit risk assessment for declines in fair value[244](index=244&type=chunk) - Research and development costs are expensed as incurred, and clinical trial activities performed by third parties are accrued based on estimates of work completed[250](index=250&type=chunk)[251](index=251&type=chunk) - Share-based compensation is measured at fair value using the Black-Scholes-Merton model for stock options and the closing market price for RSUs[252](index=252&type=chunk) [NOTE 2 — LIQUIDITY](index=68&type=section&id=NOTE%202%20%E2%80%94%20LIQUIDITY) Rezolute is a clinical-stage company with no revenue, incurring a **$74.4 million** net loss in **FY2025** and an accumulated deficit of **$403.9 million**; as of **June 30, 2025**, it had **$167.9 million** in cash and marketable debt securities, primarily from equity financings (**$107.0 million** in **FY2025**); management believes these resources are sufficient for at least **12 months**, but significant future milestone payments under license agreements will require additional long-term financing - Incurred a net loss of **$74.4 million** and used **$69.1 million** in operating activities in **FY2025**, with an accumulated deficit of **$403.9 million**[268](index=268&type=chunk) - Total capital resources (cash, cash equivalents, and marketable debt securities) were **$167.9 million** as of **June 30, 2025**[268](index=268&type=chunk) - Primary source of liquidity has historically been from private placements and public offerings of equity securities, with **$107.0 million** net proceeds in **FY2025**[269](index=269&type=chunk) - Management believes the company's cash and cash equivalents and investments in marketable debt securities will be adequate to meet contractual obligations and carry out planned activities for at least **12 months**[273](index=273&type=chunk) - A **$25.0 million** milestone payment to XOMA is due upon regulatory approval of ersodetug, not expected to be recognized as a liability within the next **12 months**[270](index=270&type=chunk) [NOTE 3 — INVESTMENTS IN MARKETABLE DEBT SECURITIES](index=70&type=section&id=NOTE%203%20%E2%80%94%20INVESTMENTS%20IN%20MARKETABLE%20DEBT%20SECURITIES) As of **June 30, 2025**, total investments in marketable debt securities were **$73.8 million**, all classified as short-term and maturing within **12 months**; the company invests in liquid, high-quality debt securities with maturities generally **two years or less**; no sales prior to maturity or credit loss allowances were recognized in **FY2025** or **FY2024** Marketable Debt Securities Summary | Investment Type | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :------------------------------ | :------------------------ | :------------------------ | | Short-term investments | **$73,751** | **$56,478** | | Long-term investments | **$0** | **$263** | | Total investments | **$73,751** | **$56,741** | - All marketable debt securities (**$73.8 million**) as of **June 30, 2025**, are scheduled to mature during the **12-month period** ending **June 30, 2026**[274](index=274&type=chunk) - No marketable debt securities were sold prior to maturity, and no allowance for credit losses or other-than-temporary impairment was recognized for the fiscal years ended **June 30, 2025** and **2024**[275](index=275&type=chunk)[276](index=276&type=chunk) Marketable Debt Securities Details | Investment Type | Amortized Cost (Thousands) | Gross Unrealized Gains (Thousands) | Gross Unrealized Losses (Thousands) | Fair Value (Thousands) | | :------------------------------ | :------------------------- | :------------------------- | :-------------------------- | :--------------------- | | Corporate commercial paper | **$16,595** | **$1** | **$(8)** | **$16,588** | | Obligations of U.S. government agencies | **$5,447** | **$0** | **$(2)** | **$5,445** | | U.S. Treasury obligations | **$1,485** | **$0** | **$(1)** | **$1,484** | | Corporate notes and bonds | **$50,231** | **$18** | **$(15)** | **$50,234** | | Total | **$73,758** | **$19** | **$(26)** | **$73,751** | [NOTE 4 — LEASES](index=71&type=section&id=NOTE%204%20%E2%80%94%20LEASES) Rezolute has operating leases for its Redwood City, CA headquarters (**9,300 sq ft**, **$48,000/month** average base rent, expires **Nov 2027**) and Bend, OR office (**5,000 sq ft**, **$9,000/month** average base rent, expires **Feb 2027**); total operating lease liabilities were **$1.6 million** as of **June 30, 2025**, with a weighted-average remaining lease term of **2.3 years**; lease expense was **$0.7 million** in **FY2025** - The lease for the Bend, Oregon office was extended to **February 2027**, with an average base rent of approximately **$9,000 per month**[280](index=280&type=chunk) - The corporate headquarters in Redwood City, California, has a lease through **November 2027**, with an average base rent of approximately **$48,000 per month**[281](index=281&type=chunk) Lease Liabilities and Right-of-Use Assets | Metric | June 30, 2025 (Thousands) | June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------ | :------------------------ | | Right-of-use assets | **$1,348** | **$1,880** | | Current operating lease liabilities | **$632** | **$568** | | Long-term operating lease liabilities | **$983** | **$1,660** | | Total operating lease liabilities | **$1,615** | **$2,228** | Lease Expense | Expense Type | FY2025 (Thousands) | FY2024 (Thousands) | | :------------------------ | :----------------- | :----------------- | | Research and development | **$489** | **$484** | | General and administrative | **$178** | **$196** | | Total | **$667** | **$680** | - As of **June 30, 2025**, the weighted-average remaining lease term was **2.3 years**, and the weighted-average discount rate used was **7.1%**[285](index=285&type=chunk) Future Lease Payments | Fiscal Year Ending June 30 | Amount (Thousands) | | :------------------------- | :----------------- | | 2026 | **$770** | | 2027 | **$750** | | 2028 | **$224** | | Total lease payments | **$1,744** | | Less imputed interest | **$(129)** | | Present value of operating lease liabilities | **$1,615** | [NOTE 5 — LICENSE AGREEMENTS](index=72&type=section&id=NOTE%205%20%E2%80%94%20LICENSE%20AGREEMENTS) Rezolute has license agreements with XOMA and ActiveSite; under the XOMA License Agreement for ersodetug, milestone payments totaling **$12.0 million** have been made, with a **$25.0 million** payment due upon first regulatory approval; additional sales-based milestones up to **$185.0 million** and royalties are also due; under the ActiveSite License Agreement for the PKI Portfolio (including RZ402), **$4.0 million** in milestone payments have been made, with **$5.0 million** due upon first dosing in a Phase 3 trial, and up to **$17.5 million** for commercial success/alternative indications, plus **2.0%** royalties on sales - The XOMA License Agreement grants an exclusive global license to develop and commercialize ersodetug. Milestone payments made to date include **$2.0 million** (Phase 2 last patient), **$5.0 million** (Phase 3 first patient), and **$5.0 million** (Phase 3 last patient dosed)[288](index=288&type=chunk) - A **$25.0 million** milestone payment to XOMA will be due upon the first regulatory approval of ersodetug by any regulatory authority[288](index=288&type=chunk) - Upon future commercialization of ersodetug, royalties based on net sales and additional milestone payments up to **$185.0 million** related to annual net sales targets will be required[288](index=288&type=chunk) - The ActiveSite License Agreement for the PKI Portfolio (RZ402) requires various milestone payments up to **$46.5 million**. **$1.0 million** was paid (IND clearance) and **$3.0 million** was paid (Phase 2 first patient)[291](index=291&type=chunk) - The next milestone payment to ActiveSite is **$5.0 million** upon the first dosing of a patient in a Phase 3 clinical trial[291](index=291&type=chunk) - The company is also required to pay royalties equal to **2.0%** of any sales of products that use the PKI Portfolio and additional milestone payments up to **$17.5 million** for commercial success or alternative indication approvals[291](index=291&type=chunk) [NOTE 6 — EMBEDDED DERIVATIVE LIABILITY](index=73&type=section&id=NOTE%206%20%E2%80%94%20EMBEDDED%20DERIVATIVE%20LIABILITY) The company accounts for an exit fee agreement from a terminated **$30.0 million** loan as an embedded derivative liability; this fee of **4.00%** (**$0.6 million**) is triggered by certain "Exit Events" before **April 13, 2031**; the estimated fair value of this liability was **$0.5 million** as of **June 30, 2025** and **2024** - An exit fee agreement from a terminated **$30.0 million** Loan and Security Agreement is accounted for as an embedded derivative liability[293](index=293&type=chunk) - The exit fee is **4.00%** of the funded principal balance (**$0.6 million**) and is triggered by certain "Exit Events" occurring prior to **April 13, 2031**[293](index=293&type=chunk) - The estimated fair value of the embedded derivative liability was **$0.5 million** as of **June 30, 2025** and **2024**[293](index=293&type=chunk) [NOTE 7 — SHAREHOLDERS' EQUITY](index=73&type=section&id=NOTE%207%20%E2%80%94%20SHAREHOLDERS'%20EQUITY) Shareholders approved an increase in authorized common shares to **165.0 million** in **December 2024**; the company issued fully vested pre-funded warrants (PFWs) for **28.2 million shares** between **Oct 2021** and **Apr 2025**, all classified as equity; recent equity financings include the **2025** Private Placement (**$4.2 million** net proceeds) and the **2025** Underwritten Offering (**$96.8 million** net proceeds); an Exchange Agreement in **March 2024** involved purchasing **3.0 million common shares** and issuing Exchange PFWs, which were reclassified from derivative liability to equity in **May 2024** - On **December 5, 2024**, shareholders approved an increase in the authorized number of common shares from **100.0 million** to **165.0 million shares**[294](index=294&type=chunk) - Between **October 2021** and **April 2025**, the company issued fully vested pre-funded warrants (PFWs) exercisable to purchase an aggregate of **28.2 million shares** of common stock, all classified in shareholders' equity[295](index=295&type=chunk) Pre-Funded Warrants Activity | PFW Type | Outstanding, June 30, 2024 (Shares) | Issuance in FY2025 (Shares) | Cashless Exercise in FY2025 (Shares) | Outstanding, June 30, 2025 (Shares) | | :---------------- | :---------------------------------- | :-------------------------- | :----------------------------------- | :---------------------------------- | | 2021 PFWs | **123,000** | — | — | **123,000** | | 2022 PFWs | **8,147,371** | — | **(2,526,318)** | **5,621,053** | | Exchange PFWs | **3,000,000** | — | **(3,000,000)** | — | | 2024 PFWs | **3,750,000** | — | — | **3,750,000** | | 2025 PFWs | — | **6,905,385** | — | **6,905,385** | | Total | **15,020,3
Pluri (PLUR) - 2025 Q4 - Annual Report
2025-09-17 20:22
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Cracker Barrel(CBRL) - 2025 Q4 - Annual Results
2025-09-17 20:21
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