Eton Pharmaceuticals Reports First Quarter 2024 Financial Results
• Q1 2024 revenue of
• Acquired PKU GOLIKE®, launched Nitisinone, and submitted a new drug application (NDA) for product candidate ET-400
• Management to hold conference call today at
“We have had a very productive start to 2024. In addition to reporting record product sales and our 13th straight quarter of sequential product sales growth, we acquired PKU GOLIKE which adds a compelling new commercial growth asset to our metabolic portfolio. We also launched Nitisinone and submitted an NDA for our highly anticipated ET-400 product candidate,” said
“It’s an exciting time for Eton as we continue to execute on our vision. With strong growth expected from our existing products, plus the additions of PKU GOLIKE and Nitisinone, we are positioned for a very strong 2024 as we gear up for the potential launch of ET-400 in early 2025,” concluded Brynjelsen.
First quarter and Recent Business Highlights
13th straight quarter of sequential growth in product sales and royalty revenue. Eton reported first quarter 2024 product sales of
Acquired
Submitted NDA to the
Continued growth in ALKINDI SPRINKLE and Carglumic Acid. In the first quarter, the Company launched an ALKINDI SPRINKLE sampling program, which allows physicians to hold product and immediately start a patient on treatment. The Company estimates that Carglumic Acid has now captured over 50% of the patient population and continues to see new patient additions. The launches of Betaine and Nitisinone have further strengthened Eton’s relationships with the metabolic community and have helped increase the frequency of interactions with Carglumic Acid prescribers.
Launched rare disease product Nitisinone. The product was launched in
First Quarter Financial Results
Net Revenue: Net revenues for the first quarter of 2024 were
Gross Profit: Gross profit for the first quarter of 2024 was
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2024 were
Net Income: Net loss for the first quarter of 2024 was
Cash Position: As of
Conference Call and Webcast Information
As previously announced,
| Date | |
| Time | |
| 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 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.
* Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.
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-
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
Investor Relations:
T: 212-452-2793
E: lwilson@insitecony.com
Statements of Operations (In thousands, except per share amounts) (Unaudited) |
||||||||
| For the three months ended | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Licensing revenue | $ | — | $ | — | ||||
| Product sales and royalties | 7,966 | 5,304 | ||||||
| Total net revenues | 7,966 | 5,304 | ||||||
| Cost of sales: | ||||||||
| Licensing revenue | — | — | ||||||
| Product sales and royalties | 2,959 | 1,958 | ||||||
| Total cost of sales | 2,959 | 1,958 | ||||||
| Gross profit | 5,007 | 3,346 | ||||||
| Operating expenses: | ||||||||
| Research and development | 651 | 535 | ||||||
| General and administrative | 5,156 | 5,345 | ||||||
| Total operating expenses | 5,807 | 5,880 | ||||||
| Loss from operations | (800 | ) | (2,534 | ) | ||||
| Other income (expense): | ||||||||
| Other income | — | — | ||||||
| Interest expense, net | (11 | ) | (126 | ) | ||||
| Total other income (expense) | (11 | ) | (126 | ) | ||||
| Loss before income tax expense | (811 | ) | (2,660 | ) | ||||
| Income tax expense | — | — | ||||||
| Net loss | $ | (811 | ) | $ | (2,660 | ) | ||
| Net loss per share, basic | $ | (0.03 | ) | $ | (0.10 | ) | ||
| Weighted average number of common shares outstanding, basic | 25,763 | 25,525 | ||||||
| Net loss per share, diluted | $ | (0.03 | ) | $ | (0.10 | ) | ||
| Weighted average number of common shares outstanding, diluted | 25,763 | 25,525 | ||||||
Balance Sheets (In thousands, except share and per share amounts) |
||||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,655 | $ | 21,388 | ||||
| Accounts receivable, net | 4,240 | 3,411 | ||||||
| Inventories | 2,318 | 911 | ||||||
| Prepaid expenses and other current assets | 1,050 | 1,129 | ||||||
| Total current assets | 24,263 | 26,839 | ||||||
| Property and equipment, net | 57 | 58 | ||||||
| Intangible assets, net | 6,388 | 4,739 | ||||||
| Operating lease right-of-use assets, net | 74 | 92 | ||||||
| Other long-term assets, net | 12 | 12 | ||||||
| Total assets | $ | 30,794 | $ | 31,740 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,263 | $ | 1,848 | ||||
| Current portion of debt, net of discount | 5,020 | 5,380 | ||||||
| Accrued liabilities | 8,017 | 9,013 | ||||||
| Total current liabilities | 15,300 | 16,241 | ||||||
| Operating lease liabilities, net of current portion | — | 22 | ||||||
| Total liabilities | 15,300 | 16,263 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, |
26 | 26 | ||||||
| Additional paid-in capital | 120,349 | 119,521 | ||||||
| Accumulated deficit | (104,881 | ) | (104,070 | ) | ||||
| Total stockholders’ equity | 15,494 | 15,477 | ||||||
| Total liabilities and stockholders’ equity | $ | 30,794 | $ | 31,740 | ||||
Statements of Cash Flows (In thousands) (Unaudited) |
||||||||
| Three months ended | Three months ended | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (811 | ) | $ | (2,660 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 821 | 872 | ||||||
| Depreciation and amortization | 252 | 213 | ||||||
| Debt discount amortization | 25 | 29 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (829 | ) | (1,022 | ) | ||||
| Inventories | (1,407 | ) | 120 | |||||
| Prepaid expenses and other assets | 79 | 191 | ||||||
| Accounts payable | 414 | (530 | ) | |||||
| Accrued liabilities | (1,017 | ) | 1,239 | |||||
| Net cash used in operating activities | (2,473 | ) | (1,548 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of product license rights | (1,868 | ) | — | |||||
| Purchases of property and equipment | (14 | ) | — | |||||
| Net cash used in investing activities | (1,882 | ) | — | |||||
| Cash flows from financing activities | ||||||||
| Repayment of long-term debt | (385 | ) | — | |||||
| Proceeds from stock option exercises | 7 | 132 | ||||||
| Payment of tax withholding related to net share settlement of stock option exercises | — | (181 | ) | |||||
| Net cash used in financing activities | (378 | ) | (49 | ) | ||||
| Change in cash and cash equivalents | (4,733 | ) | (1,597 | ) | ||||
| Cash and cash equivalents at beginning of period | 21,388 | 16,305 | ||||||
| Cash and cash equivalents at end of period | $ | 16,655 | $ | 14,708 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 190 | $ | 216 | ||||
| Cash paid for income taxes | $ | — | $ | — | ||||
Source: Eton Pharmaceuticals