eton20231107c_8k.htm
false 0001710340 0001710340 2023-11-09 2023-11-09
 
 
 
 
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
 
November 9, 2023
 
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 November 9, 2023, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2023. 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: November 9, 2023
By:  
/s/ James R. Gruber                                      
   
James R. Gruber
   
Chief Financial Officer and Secretary
   
(Principal Financial Officer)
 
3
ex_593047.htm

Exhibit 99.1

 

Eton Pharmaceuticals Reports Third Quarter 2023 Financial Results

 

 

Product sales and royalty revenue of $7.0 million up 118% from Q3 2022, representing the eleventh straight quarter of sequential product sales and royalty revenue growth

 

Generated $0.9 million in positive cash flow from operations; ended quarter with $22.1 million of cash on hand

 

Acquired ultra-rare disease product Nitisinone Capsules

 

Management to hold conference call today at 4:30pm ET

 

DEER PARK, Ill., November 9, 2023 (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, 2023.

 

“The momentum continues for Eton, and we’re proud to report our eleventh straight quarter of product sales and royalty revenue growth, which has allowed us to reach cash flow break-even ahead of schedule. Sales of ALKINDI SPRINKLE® and Carglumic Acid remain strong, and we recently added a fourth commercial rare disease product to our portfolio, Nitisinone Capsules, which we expect to launch in early 2024,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

 

“Reaching cash flow break-even is an important milestone on our journey to becoming a highly profitable and industry leading rare disease company. I am proud of the hard work and dedication from our employees that made it possible. With strong organic growth prospects for our existing commercial products, the potential near-term launches of Nitisinone and ET-400, plus a strong balance sheet and favorable M&A environment, I couldn’t be more excited about Eton’s outlook for 2024 and beyond,” concluded Brynjelsen.

 

Third Quarter and Recent Business Highlights

 

Eleventh straight quarter of sequential growth in product sales and royalty revenue. Eton reported third quarter 2023 product sales and royalty revenue of $7.0 million, representing 118% growth over the prior year period and 8% growth over the second quarter of 2023.

 

Recorded positive cash flow from operations solely from product sales and royalty revenue. During the quarter, cash on hand increased from $21.6 million to $22.1 million.

 

Strong growth in product sales driven by ALKINDI SPRINKLE and Carglumic Acid. Both products posted strong year-over-year and quarter-over-quarter sales growth. The Company expects to launch an ALKINDI SPRINKLE physician sampling program in the coming weeks, which is expected to further accelerate the product’s growth.

 

Acquired FDA-approved ultra-rare disease product Nitisinone. In October, Eton acquired Nitisinone capsules which will be Eton’s fourth commercial product, moving the company closer to its goal of reaching ten commercial products by the end of 2025. Eton expects to launch the product during the first quarter of 2024.

 

First full quarter of commercial availability for Betaine Anhydrous. The launch of Betaine resulted in a significant increase in the company’s interactions with metabolic geneticists, which is expected to help drive Betaine revenue as well as potentially benefit Carglumic Acid and the company’s soon-to-be-launched Nitisinone product.

 

Held pre-NDA meeting with FDA regarding product candidate ET-400. Last week, Eton held a pre-NDA meeting with the FDA regarding ET-400. Based on feedback from the meeting, the company plans to run an additional bioequivalence study and submit the NDA in the middle of 2024. ET-400 is a proprietary liquid formulation of hydrocortisone that, if approved, would complement ALKINDI SPRINKLE by providing patients with an additional treatment option. The Company believes that the combined peak sales of ET-400 and ALKINDI SPRINKLE could exceed $50 million annually.

 

Third Quarter Financial Results

 

Net Revenue: Net sales for the third quarter of 2023 were $7.0 million compared with $3.2 million in the prior year period, an increase of 118%. Net sales were comprised entirely of product sales and royalties in both periods. The year-over-year increase was primarily driven by growth in ALKINDI SPRINKLE and Carglumic Acid tablets. Product sales and royalty revenue for the third quarter of 2023 were up 8% over the second quarter of 2023.

 

Gross Profit: Gross profit for the third quarter of 2023 was $4.4 million compared with $2.0 million in the prior year period.

 

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $0.6 million compared to $0.7 million in the prior year period. The decrease was primarily due to decreased expenses associated with products sold to Dr. Reddy's in 2022.

 

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2023 were $4.3 million compared to $4.2 million in the prior year period. The slight increase in G&A expenses was mainly due to increased employee-related expenses related to sales force expansion offset by decreased sales and marketing expenses associated with third party sales commissions.

 

Net Loss: Net loss for the third quarter of 2023 was $0.6 million or $0.02 per basic and diluted share compared to a net loss of $3.0 million, or $0.12 per basic and diluted share, in the prior year period.

 

Cash Position: As of September 30, 2023, the Company had cash and cash equivalents of $22.1 million.

 

 

 

Conference Call and Webcast Information

 

As previously announced, Eton will host its third quarter 2023 conference call as follows:

 

Date:                           Thursday, November 9, 2023

Time:                           4:30 p.m. ET (3:30 p.m .CT)

Register* (Audio Only)          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 be accessed on the Investors section of Eton’s website at 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.

 

* Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.

 

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.

About Eton Pharmaceuticals

 

Eton is an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases. The Company currently has four FDA-approved rare disease products, ALKINDI SPRINKLE® for the treatment of pediatric adrenocortical insufficiency, Carglumic Acid for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, Betaine Anhydrous for the treatment of homocystinuria, and Nitisinone for the treatment of hereditary tyrosinemia type 1. The Company has three additional product candidates in late-stage development: ET-400 for the treatment of adrenocortical insufficiency, ET-600 for the treatment of diabetes insipidus, and ZENEO® hydrocortisone autoinjector for the treatment of adrenal crisis. For more information, please visit our website at www.etonpharma.com.

 

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,

 
   

2023

   

2022

   

2023

   

2022

 

Revenues:

                               

Licensing revenue

 

$

   

$

   

$

5,500

   

$

5,000

 

Product sales and royalties

   

7,028

     

3,219

     

18,829

     

7,753

 

Total net revenues

   

7,028

     

3,219

     

24,329

     

12,753

 
                                 

Cost of sales:

                               

Licensing revenue

   

     

     

     

990

 

Product sales and royalties

   

2,625

     

1,201

     

6,898

     

3,805

 

Total cost of sales

   

2,625

     

1,201

     

6,898

     

4,795

 
                                 

Gross profit

   

4,403

     

2,018

     

17,431

     

7,958

 
                                 

Operating expenses:

                               

Research and development

   

615

     

744

     

2,275

     

3,052

 

General and administrative

   

4,336

     

4,169

     

14,355

     

14,228

 

Total operating expenses

   

4,951

     

4,913

     

16,630

     

17,280

 
                                 

Income (loss) from operations

   

(548

)

   

(2,895

)

   

801

     

(9,322

)

                                 

Other income (expense):

                               

Other income

   

     

     

800

     

 

Interest and other expense, net

   

(31

)

   

(150

)

   

(281

)

   

(611

)

Total other income (expense)

   

(31

)

   

(150

)

   

519

     

(611

)

                                 

Income (loss) before income tax expense

   

(579

)

   

(3,045

)

   

1,320

     

(9,933

)

                                 

Income tax expense

   

     

     

     

 
                                 

Net income (loss)

 

$

(579

)

 

$

(3,045

)

 

$

1,320

   

$

(9,933

)

Net income (loss) per share, basic

 

$

(0.02

)

 

$

(0.12

)

 

$

0.05

   

$

(0.40

)

Weighted average number of common shares outstanding, basic

   

25,719

     

25,365

     

25,613

     

25,066

 

Net income (loss) per share, diluted

 

$

(0.02

)

 

$

(0.12

)

 

$

0.05

   

$

(0.40

)

Weighted average number of common shares outstanding, diluted

   

25,719

     

25,365

     

26,012

     

25,066

 

 

 

 

 

 

Eton Pharmaceuticals, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

 

 

   

September 30, 2023

   

December 31, 2022

 
   

(Unaudited)

         

Assets

               

Current assets:

               

Cash and cash equivalents

 

$

22,070

   

$

16,305

 

Accounts receivable, net

   

3,495

     

1,852

 

Inventories

   

1,051

     

557

 

Prepaid expenses and other current assets

   

541

     

1,290

 

Total current assets

   

27,157

     

20,004

 
                 

Property and equipment, net

   

38

     

72

 

Intangible assets, net

   

4,210

     

4,754

 

Operating lease right-of-use assets, net

   

109

     

188

 

Other long-term assets, net

   

12

     

12

 

Total assets

 

$

31,526

   

$

25,030

 
                 

Liabilities and stockholders equity

               

Current liabilities:

               

Accounts payable

 

$

1,712

   

$

1,766

 

Current portion of long-term debt

   

1,540

     

1,033

 

Accrued liabilities

   

7,141

     

3,662

 

Total current liabilities

   

10,393

     

6,461

 
                 

Long-term debt, net of discount and including accrued fees

   

4,197

     

5,384

 

Operating lease liabilities, net of current portion

   

44

     

107

 
                 

Total liabilities

   

14,634

     

11,952

 
                 

Commitments and contingencies (Note 11)

               
                 

Stockholders equity

               

Common stock, $0.001 par value; 50,000,000 shares authorized; 25,658,396 and 25,353,119 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

   

26

     

25

 

Additional paid-in capital

   

118,680

     

116,187

 

Accumulated deficit

   

(101,814

)

   

(103,134

)

Total stockholders equity

   

16,892

     

13,078

 
                 

Total liabilities and stockholders equity

 

$

31,526

   

$

25,030

 

 

 

 

 

 

 

Eton Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

   

Nine months ended

   

Nine months ended

 
   

September 30, 2023

   

September 30, 2022

 

Cash flows from operating activities

               

Net income (loss)

 

$

1,320

   

$

(9,933

)

                 

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

               

Stock-based compensation

   

2,387

     

3,332

 

Depreciation and amortization

   

626

     

1,522

 

Debt discount amortization

   

90

     

96

 

Changes in operating assets and liabilities:

               

Accounts receivable

   

(1,643

)

   

3,973

 

Inventories

   

(494

)

   

69

 

Prepaid expenses and other assets

   

749

     

2,129

 

Accounts payable

   

(52

)

   

(720

)

Accrued liabilities

   

3,445

     

1,513

 

Net cash provided by operating activities

   

6,428

     

1,981

 
                 

Cash flows from investing activities

               

Purchases of product license rights

   

     

(2,750

)

Purchases of property and equipment

   

     

(26

)

Net cash used in investing activities

   

     

(2,776

)

                 

Cash flows from financing activities

               

Repayment of long-term debt

   

(770

)

   

(385

)

Proceeds from employee stock purchase plan and stock option exercises

   

288

     

152

 

Payment of tax withholding related to net share settlement of stock option exercises

   

(181

)

   

 

Net cash used in financing activities

   

(663

)

   

(233

)

                 

Change in cash and cash equivalents

   

5,765

     

(1,028

)

Cash and cash equivalents at beginning of period

   

16,305

     

14,406

 

Cash and cash equivalents at end of period

 

$

22,070

   

$

13,378

 
                 

Supplemental disclosures of cash flow information

               

Cash paid for interest

 

$

638

   

$

545

 

Cash paid for income taxes

 

$

   

$

 
                 

Supplemental disclosures of non-cash transactions

               

Adjustment of operating lease right-of-use assets and liabilities due to tenant allowance

 

$

29

   

$