Eton Pharmaceuticals(ETON)

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Eton Pharmaceuticals to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024
GlobeNewswire News Room· 2024-07-30 21:30
The live webcast can also be accessed on the Investors section of Eton's website at https://ir.etonpharma.com/. An archived webcast will be available on Eton's website approximately two hours after the completion of the event and for 30 days thereafter. About Eton Pharmaceuticals Investor Relations: Source: Eton Pharmaceuticals DEER PARK, Ill., July 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. ("Eton" or the "Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and ...
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Newsfilter· 2024-07-15 20:05
- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 - DEER PARK, Ill., July 15, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or the "Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company's New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA) ...
Eton Pharmaceuticals(ETON) - 2024 Q1 - Quarterly Report
2024-05-09 20:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _______________________ Commission file number: 001-38738 ETON PHARMACEUTICALS, INC. (Exact name of registrant as speci ...
Eton Pharmaceuticals(ETON) - 2024 Q1 - Quarterly Results
2024-05-09 20:17
Exhibit 99.1 Eton Pharmaceuticals Reports First Quarter 2024 Financial Results DEER PARK, Ill., MAY 9, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or "the Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended March 31, 2024. "We have had a very productive start to 2024. In addition to reporting record product sales and our 13th straight quarter of sequential ...
Eton Pharmaceuticals to Present at the Citizens JMP Life Sciences Conference
Globenewswire· 2024-05-01 20:05
DEER PARK, Ill., May 01, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that Sean Brynjelsen, Chief Executive Officer, and James Gruber, Chief Financial Officer, will present at the Citizens JMP Life Sciences Conference in New York as follows: Date:Monday, May 13, 2024 Time: 10:00am ET Webcast: Click Here To schedule a 1x1 meeting with the Company, please c ...
Eton Pharmaceuticals to Report First Quarter 2024 Financial Results on Thursday, May 9, 2024
Newsfilter· 2024-04-29 20:30
DEER PARK, Ill., April 29, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. ("Eton" or the "Company") (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2024 financial results on Thursday, May 9, 2024. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET (3:30 p.m. CT). In addition to taking live questions from participants on the confe ...
Eton Pharmaceuticals Announces Acquisition of PKU GOLIKE® for Phenylketonuria
Newsfilter· 2024-03-22 06:00
PKU GOLIKE® is a commercial ultra-rare disease medical formula complementary to Eton's existing metabolic franchise and specialty call pointTransaction is expected to be accretive to 2024 earningsEstimated peak sales of more than $10 million annuallyU.S. phenylketonuria ("PKU") medical formula market estimated to be $100 million annually DEER PARK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or the "Company") (NASDAQ:ETON), an innovative pharmaceutical company focused on deve ...
Eton Pharmaceuticals, Inc. (ETON) Reports Q4 Loss, Lags Revenue Estimates
Zacks Investment Research· 2024-03-14 22:16
Eton Pharmaceuticals, Inc. (ETON) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to earnings of $0.04 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -125%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.02, delivering a surprise of 80%.Over the last four quarters, the company h ...
Eton Pharmaceuticals(ETON) - 2023 Q4 - Annual Results
2024-03-13 16:00
[Business Highlights and Outlook](index=1&type=section&id=Business%20Highlights%20and%20Outlook) 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](index=4&type=chunk) - 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](index=5&type=chunk)[14](index=14&type=chunk) - 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](index=3&type=chunk)[6](index=6&type=chunk)[7](index=7&type=chunk) - 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](index=8&type=chunk)[9](index=9&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) 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](index=1&type=section&id=Fourth%20Quarter%202023%20Financial%20Results) 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](index=11&type=chunk)[12](index=12&type=chunk) [Full Year 2023 Financial Results](index=4&type=section&id=Full%20Year%202023%20Financial%20Results) 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](index=2&type=section&id=Financial%20Position%20and%20Cash%20Flow) 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](index=14&type=chunk)[23](index=23&type=chunk) - 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](index=25&type=chunk) 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](index=4&type=section&id=Financial%20Statements) 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](index=4&type=section&id=Statements%20of%20Operations) 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](index=5&type=section&id=Balance%20Sheets) 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](index=6&type=section&id=Statements%20of%20Cash%20Flows) 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](index=3&type=section&id=Conference%20Call%20and%20Company%20Information) 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](index=15&type=chunk)[16](index=16&type=chunk) - Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases[17](index=17&type=chunk) - 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](index=17&type=chunk)
Eton Pharmaceuticals(ETON) - 2023 Q4 - Annual Report
2024-03-13 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______ TO ______ Title of each class Trading Symbol Name of each exchange on which registered Common Stock, $0.001 par value ETON The Nasdaq Glob ...