Eton Pharmaceuticals(ETON) - 2023 Q4 - Annual Results

Business Highlights and Outlook Eton achieved its twelfth consecutive quarter of product sales growth, driven by ALKINDI SPRINKLE and Carglumic Acid, reported positive operating cash flow, and advanced its pipeline with positive study results for ET-400 and ET-600, positioning for future NDA submissions and growth - Achieved its twelfth consecutive quarter of sequential growth in product sales, with Q4 2023 product sales and royalty revenue reaching $7.3 million, a 109% year-over-year increase[4] - Generated $0.4 million in positive operating cash flow during Q4 2023, ending the year with a cash and cash equivalents balance of $21.4 million[5][14] - Advanced its product pipeline with key developments: * ET-400: Passed its pivotal bioequivalence study, with an NDA submission planned for Q2 2024 and a potential FDA approval in Q1 2025. A new U.S. patent was awarded, expiring in 2043 * ET-600: Passed its pilot bioequivalence study, with a pivotal study planned for the second half of 2024 and a potential NDA submission in early 2025[3][6][7] - Launched new commercial initiatives to drive growth, including an ALKINDI SPRINKLE sampling program and the launch of Nitisinone capsules, targeting a $50 million market[8][9] Financial Performance For the full year 2023, total net revenues grew to $31.6 million, driven by a 132% increase in product sales and royalties, resulting in a narrowed net loss of $0.9 million, an improvement from the prior year's $9.0 million loss Fourth Quarter 2023 Financial Results In Q4 2023, total net revenues decreased to $7.3 million due to the absence of a prior-year licensing milestone, while product sales and royalty revenue grew 109%, resulting in a net loss of $2.3 million Q4 2023 vs. Q4 2022 Financial Highlights (in millions, except per share data) | Metric | Q4 2023 | Q4 2022 | Change | | :--- | :--- | :--- | :--- | | Product Sales & Royalties | $7.3 | $3.5 | +109% | | Licensing Revenue | $0.0 | $5.0 | -100% | | Total Net Revenues | $7.3 | $8.5 | -14% | | Gross Profit | $3.6 | $6.4 | -44% | | R&D Expenses | $1.0 | $0.9 | +11% | | G&A Expenses | $4.6 | $4.4 | +5% | | Net Income (Loss) | ($2.3) | $0.9 | N/A | | EPS (Diluted) | ($0.09) | $0.04 | N/A | - Gross profit was negatively impacted by a $1.0 million one-time commercial success-based milestone payment to Diurnal PLC related to ALKINDI SPRINKLE sales[11][12] Full Year 2023 Financial Results Total net revenues for full year 2023 increased to $31.6 million, driven by a 132% surge in product sales and royalties, significantly narrowing the net loss to $0.9 million from $9.0 million in 2022 Full Year 2023 vs. 2022 Financial Highlights (in millions, except per share data) | Metric | FY 2023 | FY 2022 | Change | | :--- | :--- | :--- | :--- | | Product Sales & Royalties | $26.1 | $11.3 | +132% | | Licensing Revenue | $5.5 | $10.0 | -45% | | Total Net Revenues | $31.6 | $21.3 | +49% | | Gross Profit | $21.1 | $14.3 | +47% | | Total Operating Expenses | $22.3 | $22.6 | -1% | | Net Loss | ($0.9) | ($9.0) | -90% | | EPS (Diluted) | ($0.04) | ($0.36) | -89% | Financial Position and Cash Flow As of December 31, 2023, cash and cash equivalents increased to $21.4 million, with the company generating $6.8 million in net cash from operating activities for the full year - Cash and cash equivalents increased to $21.4 million as of December 31, 2023, up from $16.3 million at the end of 2022[14][23] - Net cash provided by operating activities was $6.8 million for the full year 2023, a significant improvement from $4.8 million in 2022[25] Balance Sheet Summary (in thousands) | Metric | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total Current Assets | $26,839 | $20,004 | | Total Assets | $31,740 | $25,030 | | Total Current Liabilities | $16,241 | $6,461 | | Total Liabilities | $16,263 | $11,952 | | Total Stockholders' Equity | $15,477 | $13,078 | Financial Statements This section presents the detailed, unaudited financial statements for Eton Pharmaceuticals, Inc. for the periods ended December 31, 2023, and 2022, including Statements of Operations, Balance Sheets, and Statements of Cash Flows Statements of Operations The Statements of Operations detail the company's revenues, costs, and expenses for Q4 and full year 2023 compared to 2022, culminating in net income or loss Eton Pharmaceuticals, Inc. STATEMENTS OF OPERATIONS (In thousands, except per share amounts) | | For the three months ended (Unaudited) | For the years ended | | | :--- | :--- | :--- | :--- | | | Dec 31, 2023 | Dec 31, 2022 | Dec 31, 2023 | Dec 31, 2022 | | Total net revenues | $7,313 | $8,498 | $31,642 | $21,251 | | Gross profit (loss) | $3,630 | $6,360 | $21,061 | $14,318 | | Total operating expenses | $5,622 | $5,298 | $22,253 | $22,578 | | Income (loss) from operations | ($1,992) | $1,062 | ($1,192) | ($8,260) | | Net income (loss) | ($2,256) | $912 | ($936) | ($9,021) | | Net loss per share, basic | ($0.09) | $0.04 | ($0.04) | ($0.36) | | Net loss per share, diluted | ($0.09) | $0.04 | ($0.04) | ($0.36) | Balance Sheets The Balance Sheets provide a snapshot of the company's financial position at the end of 2023 and 2022, listing assets, liabilities, and stockholders' equity Eton Pharmaceuticals, Inc. BALANCE SHEETS (in thousands) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $21,388 | $16,305 | | Total current assets | $26,839 | $20,004 | | Total assets | $31,740 | $25,030 | | Liabilities and stockholders' equity | | | | Total current liabilities | $16,241 | $6,461 | | Total liabilities | $16,263 | $11,952 | | Total stockholders' equity | $15,477 | $13,078 | | Total liabilities and stockholders' equity | $31,740 | $25,030 | Statements of Cash Flows The Statements of Cash Flows illustrate how cash was generated and used by operating, investing, and financing activities during 2023 and 2022, reconciling beginning and ending cash balances Eton Pharmaceuticals, Inc. STATEMENTS OF CASH FLOWS (In thousands) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $6,815 | $4,821 | | Net cash used in investing activities | ($775) | ($2,788) | | Net cash (used in) provided by financing activities | ($957) | ($134) | | Change in cash and cash equivalents | $5,083 | $1,899 | | Cash and cash equivalents at beginning of year | $16,305 | $14,406 | | Cash and cash equivalents at end of year | $21,388 | $16,305 | Conference Call and Company Information This section provides details for the Q4 2023 conference call and webcast, along with an overview of Eton Pharmaceuticals' focus on rare diseases, its approved product portfolio, and late-stage development pipeline - A conference call and webcast were scheduled for March 14, 2024, at 4:30 p.m. ET to discuss the financial results[15][16] - Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases[17] - The company's portfolio includes four FDA-approved products (ALKINDI SPRINKLE®, Carglumic Acid, Betaine Anhydrous, Nitisinone) and three late-stage candidates (ET-400, ET-600, ZENEO® hydrocortisone autoinjector)[17]