Eton Pharmaceuticals Reports Third Quarter 2024 Financial Results
Eton Pharmaceuticals reported strong Q3 2024 financial results with total revenue of $10.3 million and GAAP Net Income of $0.6 million ($0.02 per share). Product sales increased 40% year-over-year, marking the 15th consecutive quarter of sequential growth. The company generated $2.9 million in operating cash flow and achieved positive quarterly GAAP net income from product sales for the first time. Key highlights include an agreement to acquire Increlex, FDA acceptance of the ET-400 NDA with a PDUFA date of February 28, 2025, and strong growth in ALKINDI SPRINKLE (55% YoY) and Carglumic Acid sales.
Eton Pharmaceuticals ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un fatturato totale di 10,3 milioni di dollari e un reddito netto GAAP di 0,6 milioni di dollari (0,02 dollari per azione). Le vendite di prodotti sono aumentate del 40% rispetto all'anno precedente, segnando il 15° trimestre consecutivo di crescita sequenziale. L'azienda ha generato 2,9 milioni di dollari in flusso di cassa operativo e ha raggiunto un reddito netto GAAP positivo trimestrale dalle vendite di prodotti per la prima volta. I punti salienti includono un accordo per acquisire Increlex, l'accettazione da parte della FDA della NDA ET-400 con una data PDUFA fissata per il 28 febbraio 2025 e una forte crescita nelle vendite di ALKINDI SPRINKLE (55% anno su anno) e Acido Carglumico.
Eton Pharmaceuticals informó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos totales de $10.3 millones y un ingreso neto GAAP de $0.6 millones ($0.02 por acción). Las ventas de productos aumentaron un 40% interanual, marcando el 15º trimestre consecutivo de crecimiento secuencial. La compañía generó $2.9 millones en flujo de caja operativo y logró un ingreso neto GAAP trimestral positivo de las ventas de productos por primera vez. Los aspectos destacados incluyen un acuerdo para adquirir Increlex, la aceptación por parte de la FDA de la NDA ET-400 con fecha PDUFA del 28 de febrero de 2025, y un fuerte crecimiento en las ventas de ALKINDI SPRINKLE (55% interanual) y Ácido Carglumico.
에톤 제약은 2024년 3분기 재무 결과를 발표하며 총 수익이 1,030만 달러이고 GAAP 순이익이 60만 달러(주당 0.02 달러)에 달했다고 밝혔습니다. 제품 판매는 작년 대비 40% 증가하여 15분기 연속으로 성장세를 유지했습니다. 회사는 290만 달러의 운영 현금 흐름을 생성했고, 제품 판매로 인한 GAAP 순이익을 분기 단위로 처음으로 기록했습니다. 주요 하이라이트에는 인크렐렉스 인수 협정, FDA가 ET-400 NDA를 수용한 것과 PDUFA 날짜가 2025년 2월 28일인 것, ALKINDI SPRINKLE(전년 대비 55%) 및 카르글루믹산 판매의 강력한 성장 등이 포함되어 있습니다.
Eton Pharmaceuticals a rapporté des résultats financiers solides pour le troisième trimestre 2024, avec un chiffre d'affaires total de 10,3 millions de dollars et un bénéfice net GAAP de 0,6 million de dollars (0,02 dollar par action). Les ventes de produits ont augmenté de 40 % d'une année sur l'autre, marquant le 15e trimestre consécutif de croissance séquentielle. L'entreprise a généré 2,9 millions de dollars de flux de trésorerie d'exploitation et a atteint un bénéfice net GAAP trimestriel positif provenant des ventes de produits pour la première fois. Les faits saillants incluent un accord pour acquérir Increlex, l'acceptation par la FDA de la NDA ET-400 avec une date PDUFA fixée au 28 février 2025, ainsi qu'une forte croissance des ventes d'ALKINDI SPRINKLE (55 % d'une année sur l'autre) et de l'Acide Carglumique.
Eton Pharmaceuticals meldete für das dritte Quartal 2024 starke Finanzzahlen mit einem Gesamtumsatz von 10,3 Millionen Dollar und einem GAAP-Nettoeinkommen von 0,6 Millionen Dollar (0,02 Dollar pro Aktie). Die Produktverkäufe stiegen im Jahresvergleich um 40%, was das 15. aufeinanderfolgende Quartal mit sequenzieller Wachstumssteigerung markiert. Das Unternehmen erwirtschaftete 2,9 Millionen Dollar an operativem Cashflow und erzielte zum ersten Mal ein positives vierteljährliches GAAP-Nettoeinkommen aus Produktverkäufen. Zu den wichtigsten Highlights gehören eine Vereinbarung zur Übernahme von Increlex, die Akzeptanz des ET-400 NDA durch die FDA mit einem PDUFA-Datum vom 28. Februar 2025 sowie ein starkes Wachstum bei den Verkaufszahlen von ALKINDI SPRINKLE (55% im Jahresvergleich) und Cargluminsäure.
- First-ever positive GAAP net income of $0.6 million ($0.02 per share)
- 40% YoY increase in product sales to $9.8 million
- 15 consecutive quarters of sequential product sales growth
- Generated $2.9 million in operating cash flow
- ALKINDI SPRINKLE achieved 55% year-over-year revenue growth
- Strong cash position of $20.3 million as of September 30, 2024
- Increased G&A expenses from $4.3M to $5.3M year-over-year
Insights
Strong financial performance with
The expansion of Eton's rare disease portfolio through strategic moves is noteworthy. The Increlex acquisition adds a valuable biologic product complementing their pediatric endocrinology focus. ET-400's new patent protection until 2043 strengthens their market position in oral hydrocortisone formulations. The initiation of ET-600's pivotal study for diabetes insipidus demonstrates continued pipeline progression. The company's strategy of focusing on rare diseases while building a synergistic portfolio around pediatric endocrinology shows strong commercial logic and potential for sustained growth.
- Reported total revenue of
$10.3 million and GAAP Net Income of$0.6 million , or$0.02 per diluted share - Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection)
- Q3 2024 product sales increased
40% over Q3 2023, representing 15th straight quarter of sequential product sales growth - Produced positive quarterly GAAP net income from product sales for first time in company history
- Generated cash from operations of
$2.9 million in Q3 2024 - Granted additional patent for ET-400
- Management to hold conference call today at 4:30pm ET
DEER PARK, Ill., Nov. 12, 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 September 30, 2024.
“Our strong product revenue growth in the third quarter allowed us to achieve positive GAAP net income from product revenue for the first time in the Company’s history and we’re pleased to reach this important milestone one quarter ahead of our original goal. We are proud of our ability to continue delivering exceptional growth, as demonstrated by our 15th straight quarter of sequential growth in product revenue, while managing the bottom line,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
“This milestone is just the beginning of Eton’s growth story. With the upcoming close of the Increlex acquisition and our ET-400 PDUFA date approaching, 2025 is shaping up to be a transformational year for Eton. We are very excited about what we can achieve in the coming quarters and years,” concluded Brynjelsen.
Third Quarter and Recent Business Highlights
Delivered 15th straight quarter of sequential growth in product sales and reported positive GAAP net income. Eton reported third quarter 2024 product sales of
Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. The transaction, which was announced in October, will add a high-value biologic product to the Company’s commercial portfolio. The product is synergistic with Eton’s existing pediatric endocrinology call point, and the acquisition is expected to be accretive to 2025 earnings. The Company anticipates the transaction closing near year-end 2024.
New Drug Application (NDA) for ET-400 accepted by the U.S. Food and Drug Administration (FDA). In July, the FDA accepted Eton’s NDA for ET-400, its proprietary patented formulation of hydrocortisone oral solution and assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025. Eton expects to manufacture product inventory in the fourth quarter of 2024 to enable a commercial launch promptly after the expected approval in 2025. The Company believes the introduction of ET-400 will enable it to capture a greater percentage of the oral hydrocortisone market and, together with ALKINDI SPRINKLE, the two products are expected to achieve combined peak sales of more than
Granted additional patent for ET-400. On November 5, Eton was granted an additional patent for ET-400 by the United States Patent & Trademark Office (USPTO), further strengthening the IP protection for the product. The patent, which expires in 2043, covers hydrocortisone oral liquid formulations and is expected to be listed in the FDA’s Orange Book upon ET-400’s approval.
Strong growth of ALKINDI SPRINKLE and the Company’s metabolic portfolio. ALKINDI SPRINKLE reported
Initiation of ET-600 pivotal study. ET-600’s pivotal bioequivalence study has been initiated. ET-600 is under development for the treatment of the pediatric endocrinology condition diabetes insipidus. If the study results are positive, Eton anticipates submitting an NDA for the product in the first quarter of 2025.
Third Quarter Financial Results
Net Revenue: Net sales for the third quarter of 2024 were
Product sales and royalty revenue were
Gross Profit: Gross profit for the third quarter of 2024 was
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2024 were
Net Income: Net income for the third quarter of 2024 was
Cash Position: As of September 30, 2024, Eton had cash and cash equivalents of
Conference Call and Webcast Information
As previously announced, Eton Pharmaceuticals will host a its third quarter 2024 conference call as follows:
| Date | November 12, 2024 | |
| Time | 4:30 p.m. ET (3:30 p.m. CT) | |
| Dial in | Toll-free: 888-596-4144 | |
| Non-toll free: 646-968-2525 | ||
| Access Code: 1144771 | ||
| Webcast: | Click Here |
In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com.
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
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
| Eton Pharmaceuticals, Inc. | ||||||||||||||||
| Condensed Statements of Operations | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| For the three months ended | For the nine months ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | 500 | $ | — | $ | 500 | $ | 5,500 | ||||||||
| Product sales and royalties | 9,824 | 7,028 | 26,864 | 18,829 | ||||||||||||
| Total net revenues | 10,324 | 7,028 | 27,364 | 24,329 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | 270 | — | 270 | — | ||||||||||||
| Product sales and royalties | 3,752 | 2,625 | 10,159 | 6,898 | ||||||||||||
| Total cost of sales | 4,022 | 2,625 | 10,429 | 6,898 | ||||||||||||
| Gross profit | 6,302 | 4,403 | 16,935 | 17,431 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 505 | 615 | 4,126 | 2,275 | ||||||||||||
| General and administrative | 5,288 | 4,336 | 16,035 | 14,355 | ||||||||||||
| Total operating expenses | 5,793 | 4,951 | 20,161 | 16,630 | ||||||||||||
| Income (loss) from operations | 509 | (548 | ) | (3,226 | ) | 801 | ||||||||||
| Other income (expense): | ||||||||||||||||
| Other income | — | — | — | 800 | ||||||||||||
| Interest expense, net | (8 | ) | (31 | ) | (71 | ) | (281 | ) | ||||||||
| Total other income (expense) | (8 | ) | (31 | ) | (71 | ) | 519 | |||||||||
| Income (loss) before income tax expense | 501 | (579 | ) | (3,297 | ) | 1,320 | ||||||||||
| Income tax expense (benefit) | (126 | ) | — | (72 | ) | — | ||||||||||
| Net income (loss) | $ | 627 | $ | (579 | ) | $ | (3,225 | ) | $ | 1,320 | ||||||
| Net income (loss) per share, basic | $ | 0.02 | $ | (0.02 | ) | $ | (0.12 | ) | $ | 0.05 | ||||||
| Weighted average number of common shares outstanding, basic | 25,900 | 25,719 | 25,814 | 25,613 | ||||||||||||
| Net income (loss) per share, diluted | $ | 0.02 | $ | (0.02 | ) | $ | (0.12 | ) | $ | 0.05 | ||||||
| Weighted average number of common shares outstanding, diluted | 26,550 | 25,719 | 25,814 | 26,002 | ||||||||||||
| Eton Pharmaceuticals, Inc. | ||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,261 | $ | 21,388 | ||||
| Accounts receivable, net | 5,591 | 3,411 | ||||||
| Inventories | 1,938 | 911 | ||||||
| Prepaid expenses and other current assets | 1,959 | 1,129 | ||||||
| Total current assets | 29,749 | 26,839 | ||||||
| Property and equipment, net | 33 | 58 | ||||||
| Intangible assets, net | 5,854 | 4,739 | ||||||
| Operating lease right-of-use assets, net | 193 | 92 | ||||||
| Other long-term assets, net | 12 | 12 | ||||||
| Total assets | $ | 35,841 | $ | 31,740 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,684 | $ | 1,848 | ||||
| Debt, net of unamortized discount | 4,125 | 5,380 | ||||||
| Accrued Medicaid rebates | 8,047 | 3,627 | ||||||
| Other accrued liabilities | 4,878 | 5,386 | ||||||
| Total current liabilities | 19,734 | 16,241 | ||||||
| Operating lease liabilities, net of current portion | 126 | 22 | ||||||
| Total liabilities | 19,860 | 16,263 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, | 26 | 26 | ||||||
| Additional paid-in capital | 123,250 | 119,521 | ||||||
| Accumulated deficit | (107,295 | ) | (104,070 | ) | ||||
| Total stockholders’ equity | 15,981 | 15,477 | ||||||
| Total liabilities and stockholders’ equity | $ | 35,841 | $ | 31,740 | ||||
| Eton Pharmaceuticals, Inc. | ||||||||
| Condensed Statements of Cash Flows | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| Nine months ended | Nine months ended | |||||||
| September 30, 2024 | September 30, 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net Income (loss) | $ | (3,225 | ) | $ | 1,320 | |||
| Adjustments to reconcile net income (loss) to net cash from operating activities: | ||||||||
| Stock-based compensation | 2,383 | 2,387 | ||||||
| Depreciation and amortization | 791 | 576 | ||||||
| Non-cash lease expense | 53 | 50 | ||||||
| Debt discount amortization | 70 | 90 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (2,179 | ) | (1,643 | ) | ||||
| Inventories | (1,027 | ) | (494 | ) | ||||
| Prepaid expenses and other assets | 171 | 749 | ||||||
| Accounts payable | 836 | (52 | ) | |||||
| Accrued Medicaid rebates | 4,420 | 2,342 | ||||||
| Other accrued liabilities | (559 | ) | 1,103 | |||||
| Net cash from operating activities | 1,734 | 6,428 | ||||||
| Cash flows from investing activities | ||||||||
| Purchases of product license rights | (1,868 | ) | — | |||||
| Purchases of property and equipment | (14 | ) | — | |||||
| Net cash from investing activities | (1,882 | ) | — | |||||
| Cash flows from financing activities | ||||||||
| Repayment of long-term debt | (1,155 | ) | (770 | ) | ||||
| Proceeds from employee stock purchase plan and stock option exercises | 176 | 288 | ||||||
| Payment of tax withholding related to net share settlement of stock option exercises | — | (181 | ) | |||||
| Net cash from financing activities | (979 | ) | (663 | ) | ||||
| Change in cash and cash equivalents | (1,127 | ) | 5,765 | |||||
| Cash and cash equivalents at beginning of period | 21,388 | 16,305 | ||||||
| Cash and cash equivalents at end of period | $ | 20,261 | $ | 22,070 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 525 | $ | 638 | ||||
| Cash paid for income taxes | $ | 181 | $ | — | ||||
| Right-of-use assets and liabilities obtained due to lease renewal | $ | 153 | $ | 29 | ||||
| Supplemental disclosures of non-cash transactions in investing and financing activities | ||||||||
| Relative fair value of warrants issued in connection with debt | $ | 1,170 | $ | — | ||||
FAQ
What was Eton Pharmaceuticals (ETON) revenue in Q3 2024?
When is the PDUFA date for Eton's (ETON) ET-400 drug?
How much cash did Eton Pharmaceuticals (ETON) have as of September 30, 2024?
What was ALKINDI SPRINKLE's growth rate for Eton (ETON) in Q3 2024?
