Eton Pharmaceuticals Reports Third Quarter 2024 Financial Results
ETON 11.12.2024
Drug:Increlex-001 Increlex® (mecasermin injection)
Drug:ET-400-001 ET-400
Drug:ALKINDI-003 ALKINDI SPRINKLE®
Drug:Carglumic-002 Carglumic Acid
Date of Upcoming Event:2024-11-12
Name of Upcoming Event:Earnings Conference Call
About Gravity Analytica
Recent News
- 01.03.2025 - Eton Pharmaceuticals Advances Its Commitment to Rare Disease with the Acquisition of Galzin®
- 12.20.2024 - Eton Pharmaceuticals Closes Acquisition of Increlex® (mecasermin injection)
- 12.17.2024 - Eton Pharmaceuticals Announces Final Readout of PKU GOLIKE® Clinical Trial
Recent Filings
- Reported total revenue of
$10.3 million and GAAP Net Income of$0.6 million , or$0.02 per diluted share - Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection)
- Q3 2024 product sales increased 40% over Q3 2023, representing 15thstraight quarter of sequential product sales growth
- Produced positive quarterly GAAP net income from product sales for first time in company history
- Generated cash from operations of
$2.9 million in Q3 2024 - Granted additional patent for ET-400
- Management to hold conference call today at
4:30pm ET
“Our strong product revenue growth in the third quarter allowed us to achieve positive GAAP net income from product revenue for the first time in the Company’s history and we’re pleased to reach this important milestone one quarter ahead of our original goal. We are proud of our ability to continue delivering exceptional growth, as demonstrated by our 15thstraight quarter of sequential growth in product revenue, while managing the bottom line,” said
“This milestone is just the beginning of Eton’s growth story. With the upcoming close of the Increlex acquisition and our ET-400 PDUFA date approaching, 2025 is shaping up to be a transformational year for Eton. We are very excited about what we can achieve in the coming quarters and years,” concluded Brynjelsen.
Third Quarter and Recent Business Highlights
Delivered 15thstraight quarter of sequential growth in product sales and reported positive GAAP net income.Eton reported third quarter 2024 product sales of
Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A.The transaction, which was announced in October, will add a high-value biologic product to the Company’s commercial portfolio. The product is synergistic with Eton’s existing pediatric endocrinology call point, and the acquisition is expected to be accretive to 2025 earnings. The Company anticipates the transaction closing near year-end 2024.
New Drug Application (NDA) for ET-400 accepted by the
Granted additional patent for ET-400.On
Strong growth of ALKINDI SPRINKLE and the Company’s metabolic portfolio.ALKINDI SPRINKLE reported 55% year-over-year revenue growth in Q3 2024.Carglumic Acid also reported another quarter of strong sequential and year-over-year growth. The commercial availability of Betaine Anhydrous, Nitisinone, and PKU GOLIKE® has helped increase the frequency of the Company’s interactions with potential Carglumic Acid prescribers.
Initiation of ET-600 pivotal study.ET-600’s pivotal bioequivalence study has been initiated. ET-600 is under development for the treatment of the pediatric endocrinology condition diabetes insipidus. If the study results are positive, Eton anticipates submitting an NDA for the product in the first quarter of 2025.
Third Quarter Financial Results
Net Revenue:Net sales for the third quarter of 2024 were
Product sales and royalty revenue were
Gross Profit: Gross profit for the third quarter of 2024 was
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were
General and Administrative (G&A) Expenses:G&A expenses for the third quarter of 2024 were
Net Income:Net income for the third quarter of 2024 was
Cash Position: As of
Conference Call and Webcast Information
As previously announced,
| Date | ||
| Time | ||
| Dial in | Toll-free: 888-596-4144 | |
| Non-toll free: 646-968-2525 | ||
| Access Code: 1144771 | ||
| Webcast: | 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 also be accessed on the Investors section of Eton’s website athttps://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.
AboutEtonPharmaceuticals
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:
| Condensed Statements of Operations | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| For the three months ended | For the nine months ended | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | 500 | $ | — | $ | 500 | $ | 5,500 | ||||||||
| Product sales and royalties | 9,824 | 7,028 | 26,864 | 18,829 | ||||||||||||
| Total net revenues | 10,324 | 7,028 | 27,364 | 24,329 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | 270 | — | 270 | — | ||||||||||||
| Product sales and royalties | 3,752 | 2,625 | 10,159 | 6,898 | ||||||||||||
| Total cost of sales | 4,022 | 2,625 | 10,429 | 6,898 | ||||||||||||
| Gross profit | 6,302 | 4,403 | 16,935 | 17,431 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 505 | 615 | 4,126 | 2,275 | ||||||||||||
| General and administrative | 5,288 | 4,336 | 16,035 | 14,355 | ||||||||||||
| Total operating expenses | 5,793 | 4,951 | 20,161 | 16,630 | ||||||||||||
| Income (loss) from operations | 509 | (548 | ) | (3,226 | ) | 801 | ||||||||||
| Other income (expense): | ||||||||||||||||
| Other income | — | — | — | 800 | ||||||||||||
| Interest expense, net | (8 | ) | (31 | ) | (71 | ) | (281 | ) | ||||||||
| Total other income (expense) | (8 | ) | (31 | ) | (71 | ) | 519 | |||||||||
| Income (loss) before income tax expense | 501 | (579 | ) | (3,297 | ) | 1,320 | ||||||||||
| Income tax expense (benefit) | (126 | ) | — | (72 | ) | — | ||||||||||
| Net income (loss) | $ | 627 | $ | (579 | ) | $ | (3,225 | ) | $ | 1,320 | ||||||
| Net income (loss) per share, basic | $ | 0.02 | $ | (0.02 | ) | $ | (0.12 | ) | $ | 0.05 | ||||||
| Weighted average number of common shares outstanding, basic | 25,900 | 25,719 | 25,814 | 25,613 | ||||||||||||
| Net income (loss) per share, diluted | $ | 0.02 | $ | (0.02 | ) | $ | (0.12 | ) | $ | 0.05 | ||||||
| Weighted average number of common shares outstanding, diluted | 26,550 | 25,719 | 25,814 | 26,002 | ||||||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,261 | $ | 21,388 | ||||
| Accounts receivable, net | 5,591 | 3,411 | ||||||
| Inventories | 1,938 | 911 | ||||||
| Prepaid expenses and other current assets | 1,959 | 1,129 | ||||||
| Total current assets | 29,749 | 26,839 | ||||||
| Property and equipment, net | 33 | 58 | ||||||
| Intangible assets, net | 5,854 | 4,739 | ||||||
| Operating lease right-of-use assets, net | 193 | 92 | ||||||
| Other long-term assets, net | 12 | 12 | ||||||
| Total assets | $ | 35,841 | $ | 31,740 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,684 | $ | 1,848 | ||||
| Debt, net of unamortized discount | 4,125 | 5,380 | ||||||
| Accrued Medicaid rebates | 8,047 | 3,627 | ||||||
| Other accrued liabilities | 4,878 | 5,386 | ||||||
| Total current liabilities | 19,734 | 16,241 | ||||||
| Operating lease liabilities, net of current portion | 126 | 22 | ||||||
| Total liabilities | 19,860 | 16,263 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, | 26 | 26 | ||||||
| Additional paid-in capital | 123,250 | 119,521 | ||||||
| Accumulated deficit | (107,295 | ) | (104,070 | ) | ||||
| Total stockholders’ equity | 15,981 | 15,477 | ||||||
| Total liabilities and stockholders’ equity | $ | 35,841 | $ | 31,740 | ||||
| Condensed Statements of Cash Flows | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| Nine months ended | Nine months ended | |||||||
| Cash flows from operating activities | ||||||||
| Net Income (loss) | $ | (3,225 | ) | $ | 1,320 | |||
| Adjustments to reconcile net income (loss) to net cash from operating activities: | ||||||||
| Stock-based compensation | 2,383 | 2,387 | ||||||
| Depreciation and amortization | 791 | 576 | ||||||
| Non-cash lease expense | 53 | 50 | ||||||
| Debt discount amortization | 70 | 90 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (2,179 | ) | (1,643 | ) | ||||
| Inventories | (1,027 | ) | (494 | ) | ||||
| Prepaid expenses and other assets | 171 | 749 | ||||||
| Accounts payable | 836 | (52 | ) | |||||
| Accrued Medicaid rebates | 4,420 | 2,342 | ||||||
| Other accrued liabilities | (559 | ) | 1,103 | |||||
| Net cash from operating activities | 1,734 | 6,428 | ||||||
| Cash flows from investing activities | ||||||||
| Purchases of product license rights | (1,868 | ) | — | |||||
| Purchases of property and equipment | (14 | ) | — | |||||
| Net cash from investing activities | (1,882 | ) | — | |||||
| Cash flows from financing activities | ||||||||
| Repayment of long-term debt | (1,155 | ) | (770 | ) | ||||
| Proceeds from employee stock purchase plan and stock option exercises | 176 | 288 | ||||||
| Payment of tax withholding related to net share settlement of stock option exercises | — | (181 | ) | |||||
| Net cash from financing activities | (979 | ) | (663 | ) | ||||
| Change in cash and cash equivalents | (1,127 | ) | 5,765 | |||||
| Cash and cash equivalents at beginning of period | 21,388 | 16,305 | ||||||
| Cash and cash equivalents at end of period | $ | 20,261 | $ | 22,070 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 525 | $ | 638 | ||||
| Cash paid for income taxes | $ | 181 | $ | — | ||||
| Right-of-use assets and liabilities obtained due to lease renewal | $ | 153 | $ | 29 | ||||
| Supplemental disclosures of non-cash transactions in investing and financing activities | ||||||||
| Relative fair value of warrants issued in connection with debt | $ | 1,170 | $ | — | ||||
Source: Eton Pharmaceuticals