Eton Pharmaceuticals(ETON) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION This part presents Eton Pharmaceuticals, Inc.'s unaudited condensed financial statements and management's discussion for the periods ended June 30, 2025 and 2024 Item 1. Financial Statements This section presents Eton Pharmaceuticals, Inc.'s unaudited condensed financial statements, including the Balance Sheet, Statements of Operations, Stockholders' Equity, and Cash Flows, with detailed notes on accounting policies, debt, and equity Condensed Balance Sheet This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $25,379 | $14,936 | | Total current assets | $68,443 | $41,021 | | Total assets | $101,676 | $76,123 | | Total current liabilities | $38,596 | $19,947 | | Total liabilities | $77,715 | $51,695 | | Total stockholders' equity | $23,961 | $24,428 | - Total assets increased by $25.55 million from December 31, 2024, to June 30, 2025, primarily driven by an increase in cash and cash equivalents and accounts receivable[11] - Total liabilities significantly increased by $26.02 million, mainly due to higher accounts payable, short-term debt, and accrued Medicaid rebates[11] Condensed Statements of Operations This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024, highlighting operational performance Condensed Statements of Operations Highlights (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total net revenues | $18,928 | $9,074 | $36,210 | $17,040 | | Gross profit | $11,924 | $5,626 | $21,785 | $10,633 | | Research and development | $3,712 | $2,970 | $4,873 | $3,621 | | General and administrative | $9,687 | $5,591 | $18,857 | $10,747 | | Loss from operations | $(1,475) | $(2,935) | $(1,945) | $(3,735) | | Net loss | $(2,585) | $(3,041) | $(4,157) | $(3,852) | | Net loss per share, basic and diluted | $(0.10) | $(0.12) | $(0.15) | $(0.15) | - Total net revenues for the six months ended June 30, 2025, increased by 112.5% to $36,210 thousand compared to $17,040 thousand in the prior year, driven by product sales and licensing revenue[13] - Gross profit for the six months ended June 30, 2025, increased by 104.9% to $21,785 thousand, while operating expenses also rose significantly, leading to a reduced operating loss[13] Condensed Statements of Stockholders' Equity This section outlines changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit, for the periods ended June 30, 2025 and 2024 Condensed Statements of Stockholders' Equity Highlights (in thousands) | Metric | Balances at Dec 31, 2024 | Stock-based Compensation | Stock Option Exercises & RSU Vesting | Net Loss | Balances at June 30, 2025 | | :-------------------------------- | :----------------------- | :----------------------- | :---------------------------------- | :------- | :------------------------ | | Common Stock (Amount) | $27 | — | — | — | $27 | | Additional Paid-in Capital | $132,294 | $3,296 | $394 | — | $135,984 | | Accumulated Deficit | $(107,893) | — | — | $(4,157) | $(112,050) | | Total Stockholders' Equity | $24,428 | $3,296 | $394 | $(4,157) | $23,961 | - Total stockholders' equity decreased slightly from $24,428 thousand at December 31, 2024, to $23,961 thousand at June 30, 2025, primarily due to the net loss, partially offset by stock-based compensation and stock option exercises[19] - Additional paid-in capital increased by $3,690 thousand for the six months ended June 30, 2025, mainly from stock-based compensation and stock option exercises[19] Condensed Statements of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Condensed Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash from (used in) operating activities | $10,049 | $(1,218) | | Net cash from (used in) investing activities | $0 | $(1,882) | | Net cash from (used in) financing activities | $394 | $(594) | | Change in cash and cash equivalents | $10,443 | $(3,694) | | Cash and cash equivalents at end of period | $25,379 | $17,694 | - Net cash from operating activities significantly improved to $10,049 thousand for the six months ended June 30, 2025, compared to a net cash outflow of $1,218 thousand in the prior year, driven by higher product sales and licensing milestone payments[22][154] - Cash and cash equivalents increased by $10,443 thousand, reaching $25,379 thousand at June 30, 2025, compared to a decrease of $3,694 thousand in the prior year[22] Notes to Condensed Financial Statements This section provides detailed explanations of the company's accounting policies, financial instruments, debt, equity, and commitments, supporting the condensed financial statements Note 1 — Company Overview This note provides an overview of Eton Pharmaceuticals, Inc., its focus on rare diseases, current commercial products, and late-stage product candidates - Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases[25] - The company currently markets eight commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, KHINDIVI™, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone[25] - Five additional product candidates are in late-stage development: ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector[25] Note 2 — Liquidity Considerations This note discusses the company's liquidity position, its ability to fund operations, and potential needs for additional capital, along with debt covenant limitations - The company believes its existing cash and cash equivalents of $25,379 thousand as of June 30, 2025, combined with product revenues, will be sufficient to fund operations and capital expenditures for at least the next twelve months[26] - There is a risk that capital resources could be used sooner than expected, potentially requiring additional capital through equity financings, debt issuance, or other arrangements[26] - Existing debt obligations contain covenants that limit the company's ability to pay dividends or make other distributions to stockholders[26] Note 3 — Summary of Significant Accounting Policies This note details the key accounting principles and methods used in preparing the financial statements, covering areas from revenue recognition to fair value measurements Basis of Presentation This section clarifies that the condensed financial statements are prepared in accordance with U.S. GAAP - The condensed financial statements are prepared in accordance with U.S. GAAP[27] Unaudited Interim Financial Information This section explains that interim financial statements are unaudited, prepared consistently with audited statements, and not necessarily indicative of full-year results - Interim financial statements are unaudited and prepared on the same basis as audited statements, reflecting all necessary adjustments for fair presentation[28] - Interim results are not necessarily indicative of full-year results[28] Use of Estimates This section highlights the necessity of management's significant estimates and assumptions in financial statement preparation, covering areas like rebates, inventory, and asset valuation - Preparation of financial statements requires management to make significant estimates and assumptions, including those for Medicaid rebates, inventory valuation, asset useful lives, deferred tax assets, and valuation of common stock and equity awards[29] Acquisitions This section outlines the accounting treatment for acquisitions, distinguishing between business combinations and asset acquisitions, and the application of the acquisition method - Acquisitions are evaluated under ASC 805 to determine if they are business combinations or asset acquisitions[30][31] - Business acquisitions are accounted for using the acquisition method, recording assets and liabilities at fair value, with any excess purchase price recognized as goodwill[32] Segment Information This section states that the company operates as a single reportable segment and highlights the high concentration of revenues and accounts receivable with a few key customers - The company operates as a single reportable segment, focusing on eight commercial rare disease products[36] - Revenues and accounts receivable are highly concentrated, with AnovoRx representing 92.0% of net product revenues for the six months ended June 30, 2025[37] Cash and Cash Equivalents This section defines cash equivalents as highly liquid investments with short original maturities, held in U.S. financial institutions or money market funds - Cash equivalents include highly liquid investments with original maturities of three months or less, held in U.S. financial institutions or high-grade money market funds[39] Accounts Receivable This section describes how accounts receivable are recorded net of allowances for discounts and chargebacks, with specific reserve amounts provided - Accounts receivable are recorded net of allowances for discounts and chargebacks, with reserves of $249 thousand and $238 thousand as of June 30, 2025, and December 31, 2024, respectively[40] Inventories This section details the valuation method for inventories (lower of cost or net realizable value using FIFO) and the recorded inventory reserve - Inventories are valued at the lower of cost or net realizable value using the first-in, first-out method[41] - An inventory reserve of $811 thousand was recorded at June 30, 2025, up from $605 thousand at December 31, 2024[41] Property and Equipment This section explains that property and equipment are stated at cost less accumulated depreciation, computed using the straight-line method over their estimated useful lives - Property and equipment are stated at cost less accumulated depreciation, computed using the straight-line method over estimated useful lives (3-5 years)[42] Intangible Assets This section describes the capitalization and amortization of intangible assets, primarily product license rights, over their estimated useful lives - Intangible assets, primarily product license rights, are capitalized upon FDA approval and amortized on a straight-line basis over their estimated useful lives (5-10 years)[43] Intangible Assets Amortization Expense (in thousands) | Period | Amortization Expense | | :----------------------- | :------------------- | | 6 Months Ended June 30, 2025 | $2,002 | | 6 Months Ended June 30, 2024 | $487 | Estimated Remaining Amortization Expense (in thousands) | Year | Amortization Expense | | :---------------- | :------------------- | | Remainder of 2025 | $2,002 | | 2026 | $4,004 | | 2027 | $3,880 | | 2028 | $3,546 | | 2029 | $3,449 | | Thereafter | $15,998 | | Total | $32,879 | Impairment of Long-Lived Assets This section outlines the policy for reviewing long-lived assets for impairment and confirms no impairment was recognized during the reported periods - Long-lived assets are reviewed for impairment when events indicate carrying amount may not be recoverable; no impairment was recognized for the six months ended June 30, 2025 or 2024[48] Deferred Financing Costs, Debt Discount and Detachable Debt-Related Warrants This section explains the accounting treatment for deferred financing costs and debt discounts related to warrants, amortized over the debt term - Costs incurred to issue debt and debt discounts related to warrants are deferred and recorded as a reduction to the debt balance, amortized over the debt term using the effective interest method[49] Leases This section details the company's accounting for leases under ASC Topic 842, recognizing right-of-use assets and lease liabilities for operating leases - The company accounts for leases under ASC Topic 842, recognizing right-of-use assets and lease liabilities for operating leases[50][52] - Operating lease expense is recognized on a straight-line basis over the lease term[53] Patent Costs This section states that all patent-related costs for filing and prosecuting applications are expensed as incurred due to inherent uncertainties - All patent-related costs for filing and prosecuting applications are expensed as incurred due to uncertainty of successful award and recovery[55] Concentrations of Credit Risk, Sources of Supply and Significant Customers This section addresses the company's exposure to credit risk from cash holdings, supply chain risks from third-party manufacturers, and customer concentration in accounts receivable - The company faces credit risk from cash and cash equivalents held with one major commercial bank, exceeding federally insured limits[57] - Dependence on a small number of third-party suppliers for manufacturing key chemicals and products poses supply chain risk[58] - Accounts receivable are highly concentrated with a few specialty pharmacies and wholesale distributors; no allowance for credit losses was recorded at June 30, 2025, or December 31, 2024[59] Revenue Recognition for Contracts with Customers This section details the company's revenue recognition policy under ASC 606, covering product sales, licensing revenues, and the impact of patient assistance and Medicaid reimbursements - Revenue is recognized in accordance with ASC 606 when customers obtain control of promised goods or services, reflecting the expected consideration[60] - Licensing revenues are recognized when the license is transferred or development milestones are achieved[64] - Product sales are subject to offsets for patient co-pay assistance and Medicaid reimbursements, recorded as a reduction of net revenues[70] Cost of Sales This section defines the components of cost of product sales, including profit-sharing, purchased product costs, freight, and amortization, as well as licensing cost of sales - Cost of product sales includes profit-sharing/royalty fees, purchased finished product costs, freight, and amortization of intangible assets[73] - Licensing cost of sales relates to supply and profit-sharing agreements, recognized upon achievement of development and commercial milestones[74] Research and Development Expenses This section explains that R&D expenses, including internal and external costs, are expensed as incurred, along with upfront and milestone payments for unapproved licensed technology - R&D expenses, including internal activities and external contracted services, are charged to operations as incurred[75] - Upfront and milestone payments for unapproved licensed technology are expensed as R&D[76] Income (Loss) Per Share This section describes the computation of basic and diluted net loss per common share, noting the exclusion of anti-dilutive common stock equivalents - Basic and diluted net loss per common share are computed using the weighted average number of common shares outstanding; common stock equivalents are excluded when anti-dilutive[77] Income Taxes This section outlines the company's accounting for income taxes under ASC 740, including the establishment of a 100% valuation reserve against deferred tax assets - The company accounts for income taxes under ASC 740, establishing a 100% valuation reserve against deferred tax assets as of June 30, 2025, and December 31, 2024[79] Stock-Based Compensation This section details the accounting for stock-based compensation under ASC 718, with fair value estimated using the Black-Scholes model and expensed over service periods - Stock-based compensation is accounted for under ASC 718, with fair value estimated using the Black-Scholes option-pricing model and expensed over the service periods[80][81] Fair Value Measurements This section describes the classification of fair value measurements into a three-level hierarchy based on input observability and notes that carrying amounts of many financial instruments approximate fair value - Fair value measurements are classified into a three-level hierarchy based on input observability (Level 1: quoted prices, Level 2: observable inputs, Level 3: unobservable inputs)[82][83] - The carrying amounts of financial instruments like cash, receivables, payables, and debt approximate their fair values due to short-term maturities or available borrowing rates[85] Impact of Recent Accounting Pronouncements This section discusses the company's evaluation of recent accounting pronouncements, including ASU 2023-09 (Income Taxes) and ASU 2024-03/2025-01 (Expense Disaggregation Disclosures) - The company is evaluating the effect of ASU 2023-09 (Income Taxes) effective January 1, 2025, and ASU 2024-03/2025-01 (Expense Disaggregation Disclosures) effective after December 15, 2026[87][88] Note 4 — Long-Term Debt This note details the amendment of the SWK Credit Agreement, including the expanded facility, extended maturity, reduced interest rate, and issuance of a common stock warrant - In September 2024, the company amended its SWK Credit Agreement, expanding the facility to $30,000 thousand, extending maturity to December 2027, and reducing the annual interest rate to SOFR plus 6.75%[92] - The amendment included issuing a warrant for 289,736 shares of common stock at $5.32 per share, with a fair value of $1,170 thousand[92] SWK Loan Future Payments (in thousands) as of June 30, 2025 | Year | Amount | | :----------------------- | :------- | | 2025 (Remainder) | $0 | | 2026 | $9,000 | | 2027 | $21,000 | | Total payments | $30,000 | | Less: unamortized discount | $(447) | | Plus: accrued exit fees | $625 | | Debt, net | $30,178 | Note 5 — Common Stock This note provides information on the company's authorized common stock and shares issued from stock option exercises during the reporting period - The company has 50,000,000 authorized shares of $0.001 par value common stock[97] - During the six months ended June 30, 2025, 108,451 shares of common stock were issued from stock option exercises[98] Note 6 — Common Stock Warrants This note details the company's outstanding common stock warrants, including their issuance dates, number of shares, exercise prices, and terms Outstanding Common Stock Warrants as of June 30, 2025 | Description | Warrant Issuance Date | No. of Shares | Exercise Price | | :-------------------------- | :-------------------- | :------------ | :------------- | | SWK Warrants – Debt – Tranche 1 | 11/13/2019 | 51,239 | $5.86 | | SWK Warrants – Debt – Tranche 2 | 8/11/2020 | 18,141 | $6.62 | | SWK Warrants – Debt – Tranche 3 | 9/30/2024 | 289,736 | $5.32 | | Total | | 359,116 | $5.46 (Weighted Average) | - The warrants are exercisable immediately and have a seven-year term from issuance, subject to cashless exercise and adjustments[91][101] Note 7 — Share-Based Payment Awards This note provides comprehensive details on the company's share-based payment awards, including stock options, restricted stock units, and the employee stock purchase plan - Total stock-based compensation expense for the six months ended June 30, 2025, was $3,296 thousand, compared to $1,661 thousand in the prior year[104] - As of June 30, 2025, there were 982,556 shares available for future issuance under the 2018 Equity Incentive Plan[102] Stock Options This section details the activity of stock options, including outstanding, issued, exercised, and forfeited options, along with related compensation expense and unrecognized costs Stock Option Activity (6 Months Ended June 30, 2025) | Metric | Shares | Weighted Average Exercise Price | | :-------------------------------- | :------- | :------------------------------ | | Outstanding as of Dec 31, 2024 | 5,918,616 | $4.65 | | Issued | 462,559 | $13.37 | | Exercised | (108,451) | $3.63 | | Forfeited/Cancelled | (227,114) | $4.99 | | Outstanding as of June 30, 2025 | 6,045,610 | $5.32 | | Options exercisable as of June 30, 2025 | 4,373,586 | $4.83 | | Aggregate Intrinsic Value (Outstanding) | | $54,036 | | Aggregate Intrinsic Value (Exercisable) | | $41,182 | - Stock-based compensation related to stock options was $1,756 thousand for the six months ended June 30, 2025, with $8,508 thousand of unrecognized costs remaining[110] Restricted Stock Units (RSUs) This section outlines the activity of restricted stock units, including outstanding, granted, vested, and forfeited units, along with related compensation expense and unrecognized expense Restricted Stock Unit Activity (6 Months Ended June 30, 2025) | Metric | Number of Units | Weighted Average Grant Date Fair Value Per Unit | | :-------------------------------- | :-------------- | :---------------------------------------------- | | Outstanding and unvested as of Dec 31, 2024 | 226,068 | $3.82 | | Granted | 184,412 | $13.11 | | Vested | (889) | $14.30 | | Forfeited | (30,940) | $6.30 | | Outstanding and unvested as of June 30, 2025 | 378,651 | $8.01 | - Stock-based compensation related to RSUs was $1,582 thousand for the six months ended June 30, 2025, with $2,981 thousand of unrecognized expense remaining[111] Employee Stock Purchase Plan This section provides information on the shares available under the ESPP and the recorded expense credit, noting no shares were issued due to specific filing requirements - The ESPP had 842,581 shares available for issuance as of June 30, 2025[112] - A credit to expense of ($42) thousand was recorded for the ESPP during the six months ended June 30, 2025, with no shares issued due to a requirement to file audited financial statements related to the INCRELEX® acquisition[115] Note 8 — Basic and Diluted Net Loss per Common Share This note presents the calculation of basic and diluted net loss per common share, including the weighted average shares outstanding and the impact of anti-dilutive equivalents Net Loss Per Common Share (in thousands, except per share amounts) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(2,585) | $(3,041) | $(4,157) | $(3,852) | | Weighted average common shares outstanding (basic and diluted) | 26,893,000 | 25,778,000 | 26,889,000 | 25,771,000 | | Net loss per share, basic and diluted | $(0.10) | $(0.12) | $(0.15) | $(0.15) | - Common stock equivalents were excluded from diluted net loss per share calculations for both periods as their inclusion would be anti-dilutive[117] Note 9 — Income Taxes This note details the company's income tax expense, effective tax rates, and the use of the discrete method for quarterly provision due to a full valuation allowance on deferred tax assets Income Tax Expense and Effective Tax Rates | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Loss before income taxes | $(2,519) | $(2,987) | $(4,017) | $(3,798) | | Income tax expense | $66 | $54 | $140 | $54 | | Effective tax rate | (2.6%) | (1.8%) | (3.5%) | (1.4%) | - The company uses the discrete method for quarterly income tax provision due to the inability to reliably estimate the annual effective tax rate, given a full valuation allowance on deferred tax assets[119] - New tax legislation (One Big Beautiful Bill Act, OBBBA) enacted July 4, 2025, is being evaluated for impact, but no material effect is anticipated in 2025[120] Note 10 — Related-Party Transactions This note discloses a related-party transaction involving licensing revenue and cost of sales from a development milestone related to the sale of DS-200 - The company recognized $1,500 thousand in licensing revenue and $675 thousand in cost of sales in March 2025 from a development milestone related to the sale of DS-200, with $675 thousand paid to Selenix, an entity affiliated with the CEO[122] Note 11 — Leases This note describes the amendment of the company's office lease in May 2025, resulting in increased ROU assets and operating lease liabilities - In May 2025, the company amended its office lease, expanding space and renewing the term through January 2031, resulting in $330 thousand in ROU assets and $519 thousand in operating lease liabilities[126] Lease-Related Assets and Liabilities (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Operating lease right-of-use assets, net | $324 | $175 | | Operating lease liabilities, current | $23 | $76 | | Operating lease liabilities, noncurrent | $492 | $107 | | Total operating lease liabilities | $515 | $183 | Note 12 — Commitments and Contingencies This note outlines the company's legal commitments, license and product development agreements, and indemnification policies Legal This section states that the company is not aware of any material pending or threatened litigation that would significantly impact its operations - The company is not aware of any pending or threatened litigation that would materially impact operations[130] License and product development agreements This section details various license and development agreements for the company's products, including recent acquisitions and out-licensing transactions - The company has various license and development agreements, including for ALKINDI SPRINKLE®, ZENEO® hydrocortisone, ET-600, PKU GOLIKE®, DS-200, Amglidia, GALZIN®, and INCRELEX®[132][134][135][137][138][139][140][141][142] - Key recent transactions include the acquisition of GALZIN® for $7,000 thousand and INCRELEX® for $22,500 thousand (plus $7,500 thousand for inventory) in December 2024[140][141] - In March 2025, the company out-licensed INCRELEX® commercial rights outside the U.S. to Esteve Pharmaceuticals for €4,000 upfront, recognizing $1,786 thousand in licensing revenues and $2,541 thousand in deferred revenues[142] Indemnification This section explains the company's indemnification of officers and directors, noting the minimal fair value and absence of recorded liabilities - The company indemnifies its officers and directors as permitted by Delaware law; the fair value of these rights is considered minimal, and no liabilities have been recorded[143] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and results for Q2 2025, highlighting revenue growth, operating expenses, liquidity, and non-GAAP measures Overview This section provides a brief overview of Eton Pharmaceuticals, Inc.'s business, focusing on its rare disease product portfolio and pipeline - Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases[147] - The company has eight commercial rare disease products and five additional product candidates in late-stage development[147] Results of Operations This section analyzes the company's revenue and gross profit performance for the three and six months ended June 30, 2025 and 2024 Revenue and Gross Profit (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total revenues | $18,928 | $9,074 | $36,210 | $17,040 | | Gross profit | $11,924 | $5,626 | $21,785 | $10,633 | | Product sales and royalties, net (6 months) | | | $32,924 | $17,040 | | Licensing revenue (6 months) | | | $3,286 | $0 | - Total revenues for the six months ended June 30, 2025, increased by $19,170 thousand, primarily due to increased sales of INCRELEX®, ALKINDI SPRINKLE®, and GALZIN®, and $3,286 thousand in licensing revenue[149][150] Research and Development Expenses This section examines the changes in R&D expenses, attributing increases to specific filing fees and development activities for product candidates Research and Development Expenses (in thousands) | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | R&D expenses | $3,712 | $2,970 | $4,873 | $3,621 | - R&D expenses increased by $1,252 thousand for the six months ended June 30, 2025, primarily due to a $2,155 thousand NDA filing fee for ET-600 and increased development activities for ET-700 and ET-800[151] General and Administrative Expenses This section analyzes the increase in G&A expenses, driven by higher advertising, promotional activities, stock-based compensation, and increased headcount-related costs General and Administrative Expenses (in thousands) | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | G&A expenses | $9,687 | $5,591 | $18,857 | $10,747 | - G&A expenses increased by $8,110 thousand for the six months ended June 30, 2025, mainly due to higher product advertising, promotional expenses, stock-based compensation, and increased compensation/benefit expenses from higher headcount[152] Liquidity and Capital Resources This section discusses the company's liquidity position, including total assets, cash, and working capital, and its ability to fund future operations - As of June 30, 2025, the company had total assets of $101.7 million, cash and cash equivalents of $25.4 million, and working capital of $29.8 million[153] - Management believes current cash and product revenues will be sufficient for at least the next twelve months, but acknowledges potential for earlier depletion of capital if estimates are inaccurate or growth is faster than expected[153] Cash Flows This section summarizes the company's cash flows from operating, investing, and financing activities, highlighting significant improvements in operating cash flow Summary of Cash Flows (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash from (used in) operating activities | $10,049 | $(1,218) | | Cash from (used in) investing activities | $0 | $(1,882) | | Cash from (used in) financing activities | $394 | $(594) | | Change in cash and cash equivalents | $10,443 | $(3,694) | - Operating cash flow improved significantly to $10,049 thousand in 2025, driven by higher product sales cash collections, an FDA filing fee refund, and a licensing milestone payment[154] - Investing activities showed no cash flow in 2025, compared to $1,882 thousand used in 2024 for the PKU GOLIKE® product license acquisition[154] Non-GAAP Financial Measures This section explains the company's use of non-GAAP financial measures like EBITDA and adjusted EBITDA to provide additional insights into performance and profitability - The company uses non-GAAP financial measures like EBITDA, adjusted EBITDA, non-GAAP net income, and non-GAAP EPS to provide additional insights into performance, operations, and profitability[155] Non-GAAP Financial Measures (in thousands, except per share amounts) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | GAAP net loss | $(2,585) | $(3,041) | $(4,157) | $(3,852) | | EBITDA | $(316) | $(2,489) | $362 | $(2,828) | | Adjusted EBITDA | $3,051 | $(1,649) | $6,726 | $(1,167) | | Non-GAAP Net Income (Loss) | $1,540 | $(1,871) | $3,935 | $(1,627) | | Non-GAAP earnings per share - Basic | $0.05 | $(0.08) | $0.15 | $(0.07) | | Non-GAAP earnings per share - Diluted | $0.03 | | $0.11 | | - Adjustments to GAAP figures include non-recurring acquisition/divestiture costs, refinancing fees, and non-cash items such as share-based compensation, inventory step-up expense, depreciation, amortization, and non-cash interest expense[155] Critical Accounting Policies This section outlines the critical accounting policies requiring significant management estimates and judgments, including revenue recognition, acquisitions, and stock-based compensation - The preparation of financial statements requires significant estimates and judgments, which are based on historical experience, known trends, and other reasonable factors[159] Revenue Recognition for Contracts with Customers This section details the five-step model for revenue recognition under ASC 606, covering point-in-time sales, milestone payments, and royalties - Revenue is recognized when customers obtain control of promised goods or services, following a five-step model under ASC 606[161] - For the six months ended June 30, 2025 and 2024, all revenues were recognized as point-in-time sales[163] - Milestone payments and royalties are recognized based on achievement probability and when related sales occur, respectively[164][166] Acquisitions This section explains the acquisition method of accounting for business combinations, emphasizing the significant estimates involved in valuing acquired assets and liabilities - Business acquisitions are accounted for using the acquisition method, requiring significant estimates and assumptions in valuing acquired assets and liabilities, including future cash flows, customer attrition, and discount rates[171][176] Stock-Based Compensation This section describes the estimation of stock-based compensation using the Black-Scholes model, highlighting the subjective assumptions required - Stock-based compensation is estimated using the Black-Scholes option-pricing model, requiring subjective assumptions for expected stock price volatility, expected term, forfeitures, and fair value of common stock[173] Off Balance Sheet Transactions This section confirms that the company does not engage in any off-balance sheet transactions - The company does not have any off-balance sheet transactions[174] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company manages market risks through capital preservation, with minimal exposure to interest rate and foreign currency risks - The company's investment activities focus on preserving capital, utilizing short-term, liquid, highly rated instruments[175] - As of June 30, 2025, cash equivalents included cash deposits and a high-grade money market fund[175] - The company believes it has minimal exposure to interest rate risk and no current exposure to foreign currency risk[175] Item 4. Controls and Procedures This section confirms the effectiveness of disclosure controls and procedures as of June 30, 2025, with no material changes in internal control Disclosure Controls and Procedures This section describes the design and effectiveness of disclosure controls and procedures, ensuring timely and accurate SEC reporting - Disclosure controls and procedures are designed to ensure information required for SEC reports is recorded, processed, summarized, and reported timely[177] - As of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures are effective[178] Changes in Internal Control over Financial Reporting This section confirms no material changes in internal control over financial reporting occurred during the six-month period ended June 30, 2025 - No changes in internal control over financial reporting occurred during the six-month period ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[180] PART II. OTHER INFORMATION This part covers other essential information including legal proceedings, risk factors, equity sales, defaults, mine safety, and exhibits Item 1. Legal Proceedings The company reports no material legal proceedings - There are no material pending or threatened legal proceedings[182] Item 1A. Risk Factors The company faces numerous risks and uncertainties; readers should review the comprehensive risk factors in the 2024 10-K - The company operates in a dynamic and rapidly changing environment with numerous risks and uncertainties[183] - Readers should carefully consider the risk factors discussed in Part I, Item 1A of the 2024 10-K, as they could materially affect the business[184] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This item is not applicable for the reporting period - This item is not applicable[185] Item 3. Defaults Upon Senior Securities This item is not applicable for the reporting period - This item is not applicable[186] Item 4. Mine Safety Disclosures This item is not applicable for the reporting period - This item is not applicable[187] Item 5. Other Information No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three-month period ended June 30, 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three-month period ended June 30, 2025[188] Item 6. Exhibits This section lists all exhibits, including offer letter agreements, SOX certifications, and iXBRL financial information - The exhibit index includes offer letter agreements, certifications pursuant to Section 302 and 906 of the Sarbanes-Oxley Act, and financial information in iXBRL format[192]