ETON Eton Pharmaceuticals Inc

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 December 31, 2024.

“The fourth quarter of 2024 was the most transformational in Eton’s history. We closed the pivotal acquisition of Increlex, acquired another high-value rare disease product in Galzin, and boosted our product pipeline with the license of Amglidia and initiation of two exciting new internal development projects, ET-700 and ET-800. We completed all this while continuing to execute on our base business, delivering record product sales and our 16th straight quarter of sequential revenue growth,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“We are poised for an acceleration of growth in 2025. Increlex was relaunched in January with our now fully dedicated pediatric endocrinology sales force and is already adding new patients at a pace well ahead of our expectations. Galzin was relaunched in March with our newly deployed metabolic sales force and has been well received by the Wilson disease community. Launch inventory for ET-400 has been manufactured and our team stands ready to launch the product within days of its PDUFA goal date of May 28, if approved. Finally, ET-600’s successful pivotal study results allow us to file an additional high-value NDA in the coming weeks.” concluded Brynjelsen.

Fourth Quarter and Recent Business Highlights

Delivered 16th straight quarter of sequential growth in product sales. Eton reported fourth quarter 2024 net sales of $11.6 million, an increase of 59% over the prior year period, driven primarily by strong growth of ALKINDI SPRINKLE® and Carglumic Acid. The company expects sequential growth in quarterly product revenue to continue through 2025 and beyond.

Relaunched Increlex, which is tracking ahead of expectations. Increlex is a highly durable, complex biologic used for the treatment of an ultra-rare pediatric endocrinology condition that is estimated to impact approximately 200 children in the U.S. Eton closed the acquisition in late December and relaunched the product in the United States in January. The Company intends to leverage its existing sales team and relationships in the pediatric endocrinology community to promote the product and increase awareness of this underdiagnosed and undertreated condition. The launch has seen strong initial results, with numerous new patients added in January, February, and the first half of March.

Awarded second patent for ET-400 and preparing for potential launch. During the fourth quarter, Eton was granted an additional patent for ET-400 by the United States Patent & Trademark Office (USPTO). The patent, which expires in 2043, covers hydrocortisone oral liquid formulations and is expected to be listed in the FDA’s Orange Book upon approval. The Company has successfully manufactured launch quantities for the product and its sales and promotional campaigns are ready to go live. If approved on its May 28 Prescription Drug User Fee Act (PDUFA) goal date, the Company anticipates being in position to quickly launch the product.

Acquired and re-launched Galzin. In January, Eton added the ultra-rare disease commercial product Galzin to its metabolic portfolio. Seeing the need for improved patient experience, increased awareness, and broader access and affordability, the Company relaunched Galzin on March 3 with its newly deployed metabolic sales force and robust Eton Cares patient support service. The Eton Cares patient support program ensures patients can access Galzin with $0 co-pays, patient assistance, reimbursement support, and overnight shipments.

Announced positive pivotal study results for ET-600 and the issuance of a patent. ET-600 passed its pivotal bioequivalence study, successfully demonstrating pharmacokinetic equivalence to the reference product. In addition, the Company was issued a patent covering the product’s proprietary formulation of desmopressin oral solution. The patent expires in 2044 and is expected to be listed in the FDA’s Orange Book upon the product’s approval. Eton is preparing to submit an NDA for ET-600 in April, which could allow for approval in the first quarter of 2026.

Disclosed two new internal development programs, ET-700 and ET-800. The Company has two new, high-value product candidates under development internally. More details regarding these previously undisclosed programs will be shared during Eton’s Investor Day conference call.

Acquired U.S. rights to Amglidia (glyburide oral suspension). Amglidia, which has been approved in the E.U. since 2018, is under development in the U.S. for the treatment of neonatal diabetes mellitus and has been granted Orphan Drug Designation by the FDA. Amglidia is a strong strategic fit with Eton’s existing pediatric endocrinology portfolio, and the Company is scheduled to meet with the FDA in April 2025 to discuss the product’s clinical pathway.

Fourth Quarter Financial Results

Net Revenue: Total net revenues for the fourth quarter of 2024 increased 59% to $11.6 million compared to $7.3 million in the prior year period, driven primarily by growth in ALKINDI SPRINKLE and Carglumic Acid. The Increlex and Galzin acquisitions closed in late December and contributed less than $0.2 million of revenue during the fourth quarter.

Gross Profit: Gross profit for the fourth quarter of 2024 was $6.5 million, compared to gross profit of $3.6 million for the fourth quarter of 2023. The increase was primarily due to increased product sales. In addition, fourth quarter 2023 gross profit was negatively impacted by $1.0 million as a result of ALKINDI SPRINKLE net sales triggering a one-time commercial success-based milestone under the terms of the product’s licensing agreement.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $(0.9) million compared to $1.0 million in the prior year period. During the fourth quarter of 2024, Eton’s ET-400 product was granted Orphan Drug Designation by the FDA, which resulted in Eton receiving a refund of the NDA filing fee that was paid and expensed in the second quarter of 2024.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were $6.7 million compared to $4.6 million in the prior year period. The increase was primarily due to personnel additions and increased sales and marketing investments that were initiated in the fourth quarter of 2024 to support the 2025 launches of Increlex, Galzin, and ET-400, as well as Increlex related transaction costs.

Net Loss: Net loss for the fourth quarter of 2024 was $0.6 million or $0.02 per basic and diluted share compared to a net loss of $2.3 million or $0.09 per basic and diluted share in the prior year period.

Cash Position: As of December 31, 2024, Eton had cash and cash equivalents of $14.9 million.

Conference Call and Webcast InformationAs previously announced, Eton Pharmaceuticals will hold a virtual Investor Day and report fourth quarter 2024 financial results on Tuesday, March 18, 2025, beginning at 10:00 a.m. ET (9:00 a.m. CT).To participate, please click here to register. An archived webcast will be available on the Investors section of Eton’s website approximately two hours after the completion of the event and for 30 days thereafter.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.

About Eton PharmaceuticalsEton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

Forward-Looking StatementsStatements 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: 212-452-2793E: lwilson@insitecony.com

Eton Pharmaceuticals, Inc.STATEMENTS OF OPERATIONS(In thousands, except per share amounts)
		For the three months ended									For the years ended
		(Unaudited)
		December 31,				December 31,					December 31,				December 31,
		2024				2023					2024				2023
Revenues:
Licensing revenue		$	—			$	—				$	500			$	5,500
Product sales and royalties, net			11,647				7,313					38,511				26,142
Total net revenues			11,647				7,313					39,011				31,642
Cost of sales:
Licensing revenue			—				1,000					270				1,000
Product sales and royalties			5,171				2,683					15,330				9,581
Total cost of sales			5,171				3,683					15,600				10,581
Gross profit			6,476				3,630					23,411				21,061
Operating expenses:
Research and development			(871	)			1,047					3,255				3,322
General and administrative			6,718				4,575					22,753				18,931
Total operating expenses			5,847				5,622					26,008				22,253
Income (loss) from operations			629				(1,992	)				(2,597	)			(1,192	)
Other (expense) income:
Interest and other (expense) income, net			(1,140	)			(17	)				(1,211	)			503
Loss before income tax expense			(511	)			(2,009	)				(3,808	)			(689	)
Income tax expense			87				247					15				247
Net loss		$	(598	)		$	(2,256	)			$	(3,823	)		$	(936	)
Net loss per share, basic and diluted		$	(0.02	)		$	(0.09	)			$	(0.15	)		$	(0.04	)
Weighted average number of common shares outstanding, basic and diluted			26,136				25,741					25,895				25,645

Eton Pharmaceuticals, Inc.BALANCE SHEETS(in thousands, except share and per share amounts)
		December 31,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	14,936			$	21,388
Accounts receivable, net			5,361				3,411
Inventories, net			15,232				911
Prepaid expenses and other current assets			5,492				1,129
Total current assets			41,021				26,839
Property and equipment, net			34				58
Intangible assets, net			34,881				4,739
Operating lease right-of-use assets, net			175				92
Other long-term assets, net			12				12
Total assets		$	76,123			$	31,740
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	4,167			$	1,848
Current portion of long-term debt, net of discount			—				5,380
Accrued Medicaid rebates			6,866				3,627
Accrued liabilities			8,914				5,386
Total current liabilities			19,947				16,241
Long-term debt, net of discount and including accrued fees			29,811				—
Operating lease liabilities, net of current portion			107				22
Other long-term liabilities			1,830				—
Total liabilities			51,695				16,263
Commitments and contingencies
Stockholders’ equity
Common stock, $0.001 par value; 50,000,000 shares authorized; 26,709,084 and 25,688,062 shares issued and outstanding at December 31, 2024 and 2023, respectively			27				26
Additional paid-in capital			132,294				119,521
Accumulated deficit			(107,893	)			(104,070	)
Total stockholders’ equity			24,428				15,477
Total liabilities and stockholders’ equity		$	76,123			$	31,740

Eton Pharmaceuticals, Inc.STATEMENTS OF CASH FLOWS(In thousands)
		For the three months ended								For the years ended
		(Unaudited)
		December 31,				December 31,				December 31,				December 31,
		2024				2023				2024				2023
Cash flows from operating activities
Net loss		$	(598	)		$	(2,256	)		$	(3,823	)		$	(936	)
Adjustments to reconcile net loss to net cash from operating activities:
Stock-based compensation			782				750				3,165				3,137
Depreciation and amortization			355				325				1,146				901
Non-cash lease expense			17				17				70				67
Debt discount amortization			1,039				27				1,109				117
Changes in operating assets and liabilities, net of impact of product acquisitions:											—				—
Accounts receivable			(939	)			84				(3,118	)			(1,559	)
Inventories			(34	)			140				(1,061	)			(354	)
Prepaid expenses and other assets			(3,520	)			(655	)			(3,349	)			94
Accounts payable			1,482				105				2,318				53
Accrued Medicaid rebates			(1,181	)			476				3,239				2,818
Accrued liabilities			2,043				1,374				1,484				2,477
Other non-current assets and liabilities			38				—				38				—
Net cash from operating activities			(516	)			387				1,218				6,815
Cash from investing activities
Purchases of property and equipment			(12	)			—				(26	)			—
Acquisition of business			(30,000	)			—				(30,000	)			—
Purchase of product licensing rights			(8,369	)			(775	)			(10,237	)			(775	)
Net cash from investing activities			(38,381	)			(775	)			(40,263	)			(775	)
Cash flows from financing activities
Net proceeds from the issuance of long-term debt			25,309				—				25,309				—
Repayment of long-term debt			—				(385	)			(1,155	)			(1,155	)
Common stock issued in private placement offering			7,000				—				7,000				—
Proceeds from stock option exercises			1,015				—				1,191				148
Payment of tax withholding related to net share settlement of stock option exercises			—				—				—				(180	)
Employee stock purchase plan			108				91				248				229
Stock warrant exercises			—				—				—				—
Net cash from financing activities			33,432				(294	)			32,593				(958	)
Change in cash and cash equivalents			(5,465	)			(682	)			(6,452	)			5,082
Cash and cash equivalents at beginning of period			20,401				22,070				21,388				16,305
Cash and cash equivalents at end of period		$	14,936			$	21,388			$	14,936			$	21,388
Supplemental disclosures of cash flow information
Cash paid for interest		$	140			$	204			$	665			$	842
Cash paid for income taxes		$	(99	)		$	247			$	82			$	247
Supplemental disclosures of non-cash investing and financing activities:
Debt issuance costs		$	386			$	—			$	386			$	—
Fair value of warrants issued in connection with debt agreement		$	—			$	—			$	1,171			$	—
Right-of-use assets obtained in exchange for lease liabilities		$	66			$	—			$	219			$	29