UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s
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)) |
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.
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
Item 2.02. Results of Operations and Financial Condition
On November 10, 2022, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2022. 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.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release issued by Eton Pharmaceuticals, Inc. on November 10, 2022 relating to financial results | |
| 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Eton Pharmaceuticals, Inc. | |
| Date: November 10, 2022 | /s/ James R. Gruber |
| James R. Gruber | |
| Chief Financial Officer and Secretary |
| 3 |
Exhibit 99.1
Eton Pharmaceuticals Reports Third Quarter 2022 Financial Results
DEER PARK, Ill., November 10, 2022 (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, 2022.
“Our third quarter results reflect the continued momentum we’re seeing across our product portfolio. Product sales and royalties jumped 315% over the prior year period and 37% from the second quarter of 2022, marking the seventh straight quarter of sequential revenue growth. Physicians and patients are responding positively to ALKINDI SPRINKLE and Carglumic Acid, and both products still have long runways for growth ahead of them,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
“During the quarter, we added a third FDA-approved rare disease product. Betaine Anhydrous shares the same prescriber base as Carglumic Acid and makes for an ideal fit for our metabolic genetics sales force. With two commercial products in the market, the upcoming launch of Betaine, and the potential for additional product launches in 2023 and 2024, we are very excited about what lies ahead for the Company,” concluded Brynjelsen.
Third Quarter and Recent Business Highlights
Reported seventh straight quarter of sequential growth in product sales and royalty revenue. Eton reported total third quarter 2022 revenue of $3.2 million, comprised entirely of product sales and royalty revenue, representing growth of 315% over the prior year and 37% over the second quarter of 2022.
Continued strong growth in sales of ALKINDI SPRINKLE. Sales of ALKINDI SPRINKLE grew 183% over the prior year period and 19% over the second quarter of 2022. Growth came from both new and existing prescribers.
Increasing adoption of Carglumic Acid. Now in its third full calendar quarter since launch, the product continues to see a strong reception from prescribers and patients. Caglumic Acid sales grew 40% over the second quarter and the company believes it remains on track to reach its goal of capturing 25-35% market share of the estimated $50 million market.
Acquisition of a third FDA-approved rare disease product. During the quarter, Eton announced the acquisition of Betaine Anhydrous. The product shares the same metabolic geneticist prescriber base as Carglumic Acid and is expected to be accretive to Eton’s earnings in 2023.
FDA Approval of Zonisade™. The product is part of Eton’s multi-product neurology oral solution agreement with Azurity Pharmaceuticals. Azurity is solely responsible for commercializing the product; Eton is entitled to receive milestone payments and royalties on net sales of the product. Zonisade was launched in October, triggering a $5 million milestone payment to Eton that will be recognized in the fourth quarter.
Third Quarter Financial Results
Net Sales: Net sales for the third quarter of 2022 were $3.2 million compared with $0.8 million in the prior year period. In both periods, revenue was comprised entirely of product sales and royalties, and the increase was primarily driven by growth in ALKINDI SPRINKLE and the launch of Carglumic Acid in late 2021.
Gross Profit: Gross profit for the third quarter of 2022 was $2.0 million compared with $0.1 million in the prior year period.
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $0.7 million compared to $2.7 million in the prior year period. The decrease was primarily due to a $1.1 million fee related to Biorphen and Rezipres conversion projects in the prior year period, and decreased development costs for new product candidates.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $4.2 million compared to $3.3 million in the prior year period. Cash G&A expenses for the third quarter of 2022 were $3.2 million, compared to $2.4 million in the prior year period. The increase in G&A expenses was mainly due to incremental marketing and compensation to support product sales growth, partially offset by lower legal and consulting expenses.
Net Income/Loss: Net loss for the third quarter of 2022 was $3.0 million or $0.12 per basic and diluted share compared to a net loss of $6.1 million or $0.24 per diluted share in the prior year period.
Cash Position: As of September 30, 2022, the company had cash and cash equivalents of $13.4 million. The Company will receive a $5.0 million milestone payment for the launch of Zonisade during the fourth quarter.
Conference Call and Webcast Information:
Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please register here (audio only). The webcast can be accessed under “Events & Presentations” in the Investors section of the company’s website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.
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 Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has three FDA approved products in ALKINDI SPRINKLE®, Carglumic Acid tablets, and Betaine Anhydrous for oral solution, and three late-stage pipeline candidates under development with dehydrated alcohol injection, ZENEO® hydrocortisone autoinjector, and ET-400. In addition, the Company receives royalties on three FDA-approved products and is entitled to receive milestone payments on other products. For more information, please visit our website at www.etonpharma.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, | |||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | — | $ | — | $ | 5,000 | $ | 14,000 | ||||||||
| Product sales and royalties | 3,219 | 775 | 7,753 | 1,739 | ||||||||||||
| Total net revenues | 3,219 | 775 | 12,753 | 15,739 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | — | — | 990 | 1,500 | ||||||||||||
| Product sales and royalties | 1,201 | 654 | 3,805 | 955 | ||||||||||||
| Total cost of sales | 1,201 | 654 | 4,795 | 2,455 | ||||||||||||
| Gross profit | 2,018 | 121 | 7,958 | 13,284 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 744 | 2,678 | 3,052 | 5,554 | ||||||||||||
| General and administrative | 4,169 | 3,290 | 14,228 | 10,539 | ||||||||||||
| Total operating expenses | 4,913 | 5,968 | 17,280 | 16,093 | ||||||||||||
| (Loss) income from operations | (2,895 | ) | (5,847 | ) | (9,322 | ) | (2,809 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest and other expense, net | (150 | ) | (247 | ) | (611 | ) | (731 | ) | ||||||||
| Gain on PPP loan forgiveness | — | — | — | 365 | ||||||||||||
| Gain on equipment sale | — | — | — | 181 | ||||||||||||
| (Loss) income before income tax expense | (3,045 | ) | (6,094 | ) | (9,933 | ) | (2,994 | ) | ||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net (loss) income | $ | (3,045 | ) | $ | (6,094 | ) | $ | (9,933 | ) | $ | (2,994 | ) | ||||
| Net loss (income) per share, basic | $ | (0.12 | ) | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.12 | ) | ||||
| Net loss (income) per share, diluted | $ | (0.12 | ) | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.12 | ) | ||||
| Weighted average number of common shares outstanding, basic | 25,365 | 25,276 | 25,066 | 25,181 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 25,365 | 25,276 | 25,066 | 25,181 | ||||||||||||
Eton Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
| September 30, 2022 | December 31, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,378 | $ | 14,406 | ||||
| Accounts receivable, net | 1,498 | 5,471 | ||||||
| Inventories | 481 | 550 | ||||||
| Prepaid expenses and other current assets | 1,063 | 3,177 | ||||||
| Total current assets | 16,420 | 23,604 | ||||||
| Property and equipment, net | 73 | 115 | ||||||
| Intangible assets, net | 4,973 | 3,621 | ||||||
| Operating lease right-of-use assets, net | 42 | 104 | ||||||
| Other long-term assets, net | 12 | 21 | ||||||
| Total assets | $ | 21,520 | $ | 27,465 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,054 | $ | 1,774 | ||||
| Current portion of long-term debt | 708 | 1,418 | ||||||
| Accrued liabilities | 2,899 | 1,366 | ||||||
| Total current liabilities | 4,661 | 4,558 | ||||||
| Long-term debt, net of discount and including accrued fees | 5,678 | 5,262 | ||||||
| Operating lease liabilities, net of current portion | — | 15 | ||||||
| Total liabilities | 10,339 | 9,835 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized; 25,297,037 and 24,626,004 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 25 | 25 | ||||||
| Additional paid-in capital | 115,202 | 111,718 | ||||||
| Accumulated deficit | (104,046 | ) | (94,113 | ) | ||||
| Total stockholders’ equity | 11,181 | 17,630 | ||||||
| Total liabilities and stockholders’ equity | $ | 21,520 | $ | 27,465 | ||||
Eton Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
Nine months ended September 30, 2022 | Nine months ended September 30, 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (9,933 | ) | $ | (2,994 | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Stock-based compensation | 3,332 | 2,518 | ||||||
| Depreciation and amortization | 1,522 | 325 | ||||||
| Debt discount amortization | 96 | 110 | ||||||
| Gain on forgiveness of debt | — | (365 | ) | |||||
| Gain on sale of equipment | — | (181 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 3,973 | (337 | ) | |||||
| Inventories | 69 | 908 | ||||||
| Prepaid expenses and other assets | 2,129 | (283 | ) | |||||
| Accounts payable | (720 | ) | 699 | |||||
| Accrued liabilities | 1,513 | (4 | ) | |||||
| Net cash provided by operating activities | 1,981 | 396 | ||||||
| Cash flows from investing activities | ||||||||
| Proceeds from sale of equipment | — | 700 | ||||||
| Purchase of product license rights | (2,750 | ) | — | |||||
| Purchases of property and equipment | (26 | ) | (5 | ) | ||||
| Net cash (used in) provided by investing activities | (2,776 | ) | 695 | |||||
| Cash flows from financing activities | ||||||||
| Repayment of long-term debt | (385 | ) | (150 | ) | ||||
| Proceeds from employee stock purchase plan and stock option exercises | 152 | 473 | ||||||
| Net cash (used in) provided by financing activities | (233 | ) | 323 | |||||
| Change in cash and cash equivalents | (1,028 | ) | 1,414 | |||||
| Cash and cash equivalents at beginning of period | 14,406 | 21,295 | ||||||
| Cash and cash equivalents at end of period | $ | 13,378 | $ | 22,709 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 545 | $ | 603 | ||||
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com