false 0001710340 0001710340 2025-03-18 2025-03-18
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
 
FORM 8-K
 
 
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
March 18, 2025
 
Date of Report (Date of earliest event reported)
 
 
 
ETON PHARMACEUTICALS, INC.
 
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-38738
 
37-1858472
(State
 
(Commission
 
(I.R.S. Employer
of incorporation)
 
File Number)
 
Identification Number)
 
 
21925 W. Field Parkway, Suite 235
 
 
Deer Park, Illinois 60010-7208
 
 
(Address of principal executive offices) (Zip code)
 
 
(847) 787-7361
 
 
(Registrants telephone number, including area code)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.001 per share
 
ETON
 
NASDAQ Global Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
 
 

 
 
Item 2.02 Results of Operations and Financial Condition.
 
On March 18, 2025, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
 
The information in this Item 2.02 and the attached Exhibit 99.1 are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this Item 2.02 and the attached exhibit shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
 
Item 9.01 Financial Statements and Exhibits
 
Exhibit 99.1
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
2

 
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: March 18, 2025
By:  
/s/ James R. Gruber                                      
   
James R. Gruber
   
Chief Financial Officer and Secretary
   
(Principal Financial Officer)
 
3

Exhibit 99.1

 

Eton Pharmaceuticals Reports Fourth Quarter 2024 Financial Results

Management to Hold Investor Day Conference Call Today at 10:00am ET

 

 

Reported record product revenue of $11.6 million in Q4 2024, an increase of 59% over Q4 2023, representing the 16th straight quarter of sequential product sales growth

 

Closed the transformational acquisition of pediatric endocrinology biologic Increlex® and relaunched the product in January

 

Acquired and relaunched ultra rare disease product Galzin® 

 

Licensed U.S. rights to late-stage pipeline candidate Amglidia®, further boosting the Company’s pediatric endocrinology pipeline

 

Announced positive pivotal clinical study results for ET-600; preparing for an April 2025 NDA submission

 

Manufactured ET-400 launch inventory in preparation for a potential approval on its PDUFA goal date of May 28  

 

Management to hold Investor Day conference call today at 10:00am ET to discuss its recent acquisitions and review its product portfolio, market opportunities, and 2025 and long-term financial outlook

 

DEER PARK, Ill., March 18, 2025 (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 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 the 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 has a meeting scheduled 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 in the 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 Information

 

As 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 Etons 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 Pharmaceuticals

 

Eton 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 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.

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 business acquisition:

                           

Accounts receivable

    (939 )     84       (3,118 )     (1,559 )

Inventories

    (283 )     140       (1,310 )     (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

    (765 )     387       969       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

    (8,120 )     (775 )     (9,988 )     (775 )

Net cash from investing activities

    (38,132 )     (775 )     (40,014 )     (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  
                                 
 
v3.25.1
Document And Entity Information
Mar. 18, 2025
Document Information [Line Items]  
Entity, Registrant Name ETON PHARMACEUTICALS, INC.
Document, Type 8-K
Document, Period End Date Mar. 18, 2025
Entity, Incorporation, State or Country Code DE
Entity, File Number 001-38738
Entity, Tax Identification Number 37-1858472
Entity, Address, Address Line One 21925 W. Field Parkway
Entity, Address, Address Line Two Suite 235
Entity, Address, City or Town Deer Park
Entity, Address, State or Province IL
Entity, Address, Postal Zip Code 60010
City Area Code 847
Local Phone Number 787-7361
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol ETON
Security Exchange Name NASDAQ
Entity, Emerging Growth Company false
Amendment Flag false
Entity, Central Index Key 0001710340

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