Eton Pharmaceuticals Reports Third Quarter 2022 Financial Results
- Q3 2022 revenue of
$3.2 million , product sales and royalty revenue up 315% from prior year and 37% from Q2 2022 - Strong sales growth of ALKINDI SPRINKLE® and Carglumic Acid
- Third commercial product, Betaine Anhydrous, added to rare disease portfolio
“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
“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
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. Carglumic 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
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
Third Quarter Financial Results
Gross Profit: Gross profit for the third quarter of 2022 was
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were
Net Income/Loss: Net loss for the third quarter of 2022 was
Cash Position: As of
Conference Call and Webcast Information
As previously announced,
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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
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| Condensed Statements of Operations | ||||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| For the three months ended | For the nine months ended | |||||||||||||||||
| 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 | ||||||||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| (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, 25,297,037 and 24,626,004 shares issued and outstanding at 2022 and |
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 | ||||
| Condensed Statements of Cash Flows | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| Nine months ended |
Nine months ended |
|||||||
| 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 | ||||
Source: Eton Pharmaceuticals