Eton Pharmaceuticals Reports Second Quarter 2025 Financial Results
- Q2 2025 product sales of
$18.9 million , representing 108% growth over Q2 2024 and the 18th straight quarter of sequential product sales growth - Q2 2025 basic and fully diluted GAAP EPS of
$(0.10) , non-GAAP fully diluted EPS of$0.03 , and Adjusted EBITDA of$3.1 million - Launched KHINDIVI™ (hydrocortisone) Oral Solution
- Reached 100 active INCRELEX® patients, ahead of previous guidance of year end
- Company projects reaching an annual revenue run rate of
$80 million in Q3, one quarter ahead of previous guidance - Management to hold conference call today at
4:30pm ET
“Eton continues to execute on all fronts. During the second quarter, we received FDA approval for and subsequently launched KHINDIVI, marking our third commercial launch in 2025. As the first and only FDA-approved oral solution of hydrocortisone, KHINDIVI is a game changer for many pediatric patients. We were excited to finally bring this important treatment to the market and look forward to continuing to raise awareness of its availability,” said
“Our strong commercial execution helped us deliver an impressive 108% revenue growth in the quarter, driven primarily by ongoing growth from ALKINDI SPRINKLE and the relaunches of INCRELEX and GALZIN. INCRELEX continues to track well ahead of our original expectations with 100 active patients at the end of July. We previously expected to reach this mark at the end of the year, so we are proud of the team’s hard work to hit this milestone well ahead of schedule. With these recent successes and the ongoing strength of our entire portfolio, we now expect to achieve an
“In addition to executing on these three product launches and driving significant revenue growth, we continue to advance our pipeline programs, evaluate new business development opportunities and prepare for the potential approval and launch of ET-600 in the first quarter of 2026,” concluded Brynjelsen.
Second Quarter and Recent Business Highlights
18th straight quarter of sequential growth in product sales and 108% growth over prior year quarter. Eton reported second quarter 2025 product sales of
INCRELEX relaunch outperforming expectations; reached 100 active patients at the end of July. Eton’s ongoing engagement with the pediatric endocrinology community has helped drive awareness and clinical adoption of INCRELEX. The Company had a robust presence at key scientific conferences during the quarter, including
FDA approval and commercial launch of KHINDIVI, Eton’s 8th commercial product. On
Continued growth of ALKINDI SPRINKLE. In the second quarter, ALKINDI SPRINKLE delivered strong sequential and year-over-year growth in revenue and patients on treatment. Through the second quarter, year-to-date new patient prescriptions exceeded the first two quarters of all prior years. In recent months, Eton had a prominent footprint at major healthcare professional congresses such as PENS, PES, ENDO, and
Strong initial trajectory for GALZIN commercial relaunch. Eton relaunched GALZIN in March and believes it has now successfully transitioned most existing users to Eton’s distribution network. The Company’s launch has been well received by the Wilson disease community, which has expressed excitement about Eton’s efforts to broaden access to treatment with its
NDA for ET-600 accepted by the FDA and second patent received. In July, ET-600's NDA was accepted for review by the FDA and assigned a Target Action Date of
Second Quarter Financial Results
Net Revenue: Net revenues for the second quarter of 2025 were
The company now expects to achieve an approximately
Gross Profit: Gross profit for the second quarter of 2025 was
Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were
Adjusted G&A expense, which removes share-based compensation, transaction related costs, and other one-time expenses, was
Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA): Adjusted EBITDA for the second quarter of 2025 was
Net Income/Loss: Net loss for the second quarter of 2025 was
On a non-GAAP basis, the Company reported net income of
For a reconciliation of GAAP net loss to Earnings Before Interest, Taxes, Depreciation and Amortization EBITDA (“EBITDA”), Adjusted EBITDA and adjusted Non-GAAP basic and fully diluted earnings per share to the most directly comparable GAAP financial measure, please see the tables below.
Cash Position: As of
Conference Call and Webcast Information
As previously announced,
| Date: | |
| Time: | |
| Dial In: | (800) 715-9871 or (646) 307-1963; Conference ID: 5899895 |
| 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 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.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI™, INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia®, 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
Non-GAAP Financial Measures
In addition to the Company’s results of operations determined in accordance with
Adjusted EBITDA
The Company defines Adjusted EBITDA as net loss, excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, investment loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net loss. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net loss as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.
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 |
For the six months ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | — | $ | — | $ | 3,286 | $ | — | ||||||||
| Product sales and royalties, net | 18,928 | 9,074 | 32,924 | 17,040 | ||||||||||||
| Total net revenues | 18,928 | 9,074 | 36,210 | 17,040 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | — | — | 825 | — | ||||||||||||
| Product sales and royalties | 7,004 | 3,448 | 13,600 | 6,407 | ||||||||||||
| Total cost of sales | 7,004 | 3,448 | 14,425 | 6,407 | ||||||||||||
| Gross profit | 11,924 | 5,626 | 21,785 | 10,633 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,712 | 2,970 | 4,873 | 3,621 | ||||||||||||
| General and administrative | 9,687 | 5,591 | 18,857 | 10,747 | ||||||||||||
| Total operating expenses | 13,399 | 8,561 | 23,730 | 14,368 | ||||||||||||
| Loss from operations | (1,475 | ) | (2,935 | ) | (1,945 | ) | (3,735 | ) | ||||||||
| Other expense: | ||||||||||||||||
| Interest and other expense, net | (1,044 | ) | (52 | ) | (2,072 | ) | (63 | ) | ||||||||
| Loss before income tax expense | (2,519 | ) | (2,987 | ) | (4,017 | ) | (3,798 | ) | ||||||||
| Income tax expense | 66 | 54 | 140 | 54 | ||||||||||||
| Net loss | $ | (2,585 | ) | $ | (3,041 | ) | $ | (4,157 | ) | $ | (3,852 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.15 | ) | $ | (0.15 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 26,893 | 25,778 | 26,889 | 25,771 | ||||||||||||
Balance Sheets (In thousands, except share and per share amounts) |
||||||||
2024 |
||||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,379 | $ | 14,936 | ||||
| Accounts receivable, net | 14,453 | 5,361 | ||||||
| Inventories, net | 23,791 | 15,232 | ||||||
| Prepaid expenses and other current assets | 4,820 | 5,492 | ||||||
| Total current assets | 68,443 | 41,021 | ||||||
| Property and equipment, net | 18 | 34 | ||||||
| Intangible assets, net | 32,879 | 34,881 | ||||||
| Operating lease right-of-use assets, net | 324 | 175 | ||||||
| Other long-term assets, net | 12 | 12 | ||||||
| Total assets | $ | 101,676 | $ | 76,123 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,142 | $ | 4,167 | ||||
| Short-term debt, net of discount | 2,769 | — | ||||||
| Accrued Medicaid rebates | 16,226 | 6,866 | ||||||
| Accrued liabilities | 7,459 | 8,914 | ||||||
| Total current liabilities | 38,596 | 19,947 | ||||||
| Long-term debt, net of discount and including accrued fees | 27,409 | 29,811 | ||||||
| Operating lease liabilities, net of current portion | 492 | 107 | ||||||
| Long-term inventory payable | 6,949 | — | ||||||
| Other long-term liabilities | 4,269 | 1,830 | ||||||
| Total liabilities | 77,715 | 51,695 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, |
27 | 27 | ||||||
| Additional paid-in capital | 135,984 | 132,294 | ||||||
| Accumulated deficit | (112,050 | ) | (107,893 | ) | ||||
| Total stockholders’ equity | 23,961 | 24,428 | ||||||
| Total liabilities and stockholders’ equity | $ | 101,676 | $ | 76,123 | ||||
Statements of Cash Flows (In thousands) (Unaudited) |
||||||||
| Six months ended |
Six months ended |
|||||||
| Cash flows from (used in) operating activities | ||||||||
| Net loss | $ | (4,157 | ) | $ | (3,852 | ) | ||
| Adjustments to reconcile net loss to net cash from operating activities: | ||||||||
| Stock-based compensation | 3,296 | 1,661 | ||||||
| Depreciation and amortization | 2,018 | 513 | ||||||
| Inventory step-up | 2,349 | — | ||||||
| Non-cash lease expense | 30 | 36 | ||||||
| Debt discount amortization and non-cash interest expenses | 342 | 48 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (9,092 | ) | (1,462 | ) | ||||
| Inventories | (10,909 | ) | (1,157 | ) | ||||
| Prepaid expenses and other assets | 672 | 330 | ||||||
| Accounts payable | 7,970 | 284 | ||||||
| Accrued Medicaid rebates | 9,359 | 3,514 | ||||||
| Accrued liabilities | (1,201 | ) | (1,133 | ) | ||||
| Other non-current assets and liabilities | 9,372 | — | ||||||
| Net cash from (used in) operating activities | 10,049 | (1,218 | ) | |||||
| Cash flows from (used in) investing activities | ||||||||
| Purchases of product license rights | — | (1,868 | ) | |||||
| Purchases of property and equipment | — | (14 | ) | |||||
| Net cash from (used in) investing activities | — | (1,882 | ) | |||||
| Cash flows from (used in) financing activities | ||||||||
| Repayment of long-term debt | — | (770 | ) | |||||
| Proceeds from stock option exercises | 394 | 176 | ||||||
| Net cash from (used in) financing activities | 394 | (594 | ) | |||||
| Change in cash and cash equivalents | 10,443 | (3,694 | ) | |||||
| Cash and cash equivalents at beginning of period | 14,936 | 21,388 | ||||||
| Cash and cash equivalents at end of period | $ | 25,379 | $ | 17,694 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 852 | $ | 362 | ||||
| Cash paid for income taxes | $ | 89 | $ | — | ||||
Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (in thousands, except per share amounts) (Unaudited) |
||||||||||||||||
| For the three months ended | For the six months ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| GAAP net loss | $ | (2,585 | ) | $ | (3,041 | ) | $ | (4,157 | ) | $ | (3,852 | ) | ||||
| Depreciation (1) | 4 | 9 | 16 | 23 | ||||||||||||
| Intangible amortization expense (2) | 1,001 | 267 | 2,002 | 487 | ||||||||||||
| Interest expense (including debt discount amortization and non-cash interest expenses) | 1,198 | 222 | 2,361 | 460 | ||||||||||||
| Income tax expense | 66 | 54 | 140 | 54 | ||||||||||||
| EBITDA | $ | (316 | ) | $ | (2,489 | ) | $ | 362 | $ | (2,828 | ) | |||||
| Other non-GAAP adjustments: | ||||||||||||||||
| Inventory step-up expense (3) | 1,207 | — | 2,349 | — | ||||||||||||
| Stock-based compensation (4) | 2,096 | 840 | 3,296 | 1,661 | ||||||||||||
| Severance expense (5) | — | — | 335 | — | ||||||||||||
| Divestiture-related costs (6) | 64 | — | 384 | — | ||||||||||||
| Total of Other non-GAAP adjustments | 3,367 | 840 | 6,364 | 1,661 | ||||||||||||
| Adjusted EBITDA | $ | 3,051 | $ | (1,649 | ) | $ | 6,726 | $ | (1,167 | ) | ||||||
| GAAP loss before income tax | $ | (2,519 | ) | $ | (2,987 | ) | $ | (4,017 | ) | $ | (3,798 | ) | ||||
| Non-GAAP adjustments: | ||||||||||||||||
| Depreciation (1) | 4 | 9 | 16 | 23 | ||||||||||||
| Intangible amortization expense (2) | 1,001 | 267 | 2,002 | 487 | ||||||||||||
| Inventory step-up expense (3) | 1,207 | — | 2,349 | — | ||||||||||||
| Share-based compensation (4) | 2,096 | 840 | 3,296 | 1,661 | ||||||||||||
| Severance expense (5) | — | — | 335 | — | ||||||||||||
| Divestiture-related costs (6) | 64 | — | 384 | — | ||||||||||||
| Total pre-tax non-GAAP adjustments | 4,372 | 1,116 | 8,382 | 2,171 | ||||||||||||
| Income tax effect of pre-tax non-GAAP adjustments (7) | 313 | — | 430 | — | ||||||||||||
| Total non-GAAP adjustments | 4,059 | 1,116 | 7,952 | 2,171 | ||||||||||||
| Non-GAAP Net Income | $ | 1,540 | $ | (1,871 | ) | $ | 3,935 | $ | (1,627 | ) | ||||||
| Weighted average number of common shares outstanding, basic | 26,893 | 25,778 | 26,889 | 25,771 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 31,141 | 25,778 | 31,066 | 25,771 | ||||||||||||
| GAAP loss per share - Basic | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.15 | ) | $ | (0.15 | ) | ||||
| Non-GAAP adjustments | 0.15 | 0.04 | 0.30 | 0.08 | ||||||||||||
| Non-GAAP earnings per share - Basic | $ | 0.05 | $ | (0.08 | ) | $ | 0.15 | $ | (0.07 | ) | ||||||
| GAAP loss per share - Basic | $ | (0.10 | ) | $ | (0.15 | ) | ||||||||||
| Non-GAAP adjustments | 0.13 | 0.26 | ||||||||||||||
| Non-GAAP earnings per share - Diluted | $ | 0.03 | $ | 0.11 | ||||||||||||
| (1 | ) | Represents depreciation expense related to our property and equipment. |
| (2 | ) | Intangible amortization expenses are associated with our intellectual property rights related to INCRELEX®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. |
| (3 | ) | During the three and six months ended |
| (4 | ) | Represents share-based compensation expense associated with our stock option and restricted stock unit stock unit grants to our employees and non-employee directors and our employee share purchase plan. |
| (5 | ) | Represents severance and benefit expenses associated with role redundancy within commercial operations during the first quarter of 2025. |
| (6 | ) | Represents legal expense and other divestiture-related costs associated with the out-licensing of the INCRELEX® commercial rights in territories outside of the U.S. |
| (7 | ) | Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the effective income tax rate for the period as the Company is in a full income tax valuation allowance position and the income tax adjustments on pre-tax non-GAAP adjustment is commensurate with the performance measure. |
Second Quarter 2025 GAAP to Non-GAAP Net Income (Loss) Reconciliation (in thousands, except per share amounts) (Unaudited) |
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| GAAP | Depreciation and Intangible Amortization |
Inventory Step-Up Expense |
Stock Based Compensation |
Divestiture Related Costs |
Non-GAAP |
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| Revenues: | ||||||||||||||||||||||||
| Licensing revenue | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
| Product sales and royalties | 18,928 | — | — | — | — | 18,928 | ||||||||||||||||||
| Total net revenues | 18,928 | — | — | — | — | 18,928 | ||||||||||||||||||
| Cost of sales: | ||||||||||||||||||||||||
| Licensing revenue | — | — | — | — | — | — | ||||||||||||||||||
| Product sales and royalties | 7,004 | (1,001 | ) | (1,207 | ) | — | — | 4,796 | ||||||||||||||||
| Total cost of sales | 7,004 | (1,001 | ) | (1,207 | ) | — | — | 4,796 | ||||||||||||||||
| Gross profit | 11,924 | 1,001 | 1,207 | — | — | 14,132 | ||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Research and development | 3,712 | — | — | (43 | ) | — | 3,669 | |||||||||||||||||
| General and administrative | 9,687 | (4 | ) | — | (2,053 | ) | (64 | ) | 7,566 | |||||||||||||||
| Total operating expenses | 13,399 | (4 | ) | — | (2,096 | ) | (64 | ) | 11,235 | |||||||||||||||
| (Loss) income from operations | (1,475 | ) | 1,005 | 1,207 | 2,096 | 64 | 2,897 | |||||||||||||||||
| Other expense: | ||||||||||||||||||||||||
| Interest and other expense, net | (1,044 | ) | — | — | — | — | (1,044 | ) | ||||||||||||||||
| (Loss) income before income tax expense | (2,519 | ) | 1,005 | 1,207 | 2,096 | 64 | 1,853 | |||||||||||||||||
| Income tax expense | 66 | 57 | 68 | 118 | 4 | 313 | ||||||||||||||||||
| Net (loss) income | $ | (2,585 | ) | $ | 948 | $ | 1,139 | $ | 1,978 | $ | 60 | $ | 1,540 | |||||||||||
| Net (loss) income per share, basic | $ | (0.10 | ) | $ | 0.04 | $ | 0.04 | $ | 0.07 | $ | 0.00 | $ | 0.05 | |||||||||||
| Net (loss) income per share, diluted | $ | (0.10 | ) | $ | 0.03 | $ | 0.04 | $ | 0.06 | $ | 0.00 | $ | 0.03 | |||||||||||
| Weighted average number of common shares outstanding, basic | 26,893 | |||||||||||||||||||||||
| Weighted average number of common shares outstanding, diluted | 31,141 | |||||||||||||||||||||||
YTD 2025 GAAP to Non-GAAP Net Income (Loss) Reconciliation (in thousands, except per share amounts) (Unaudited) |
||||||||||||||||||||||||||||
| GAAP |
Depreciation and Intangible Amortization |
Inventory Step-Up Expense |
Stock Based Compensation |
Severance Expense |
Divestiture Related Costs |
Non-GAAP |
||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||||
| Licensing revenue | $ | 3,286 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 3,286 | ||||||||||||||
| Product sales and royalties | 32,924 | — | — | — | — | — | 32,924 | |||||||||||||||||||||
| Total net revenues | 36,210 | — | — | — | — | — | 36,210 | |||||||||||||||||||||
| Cost of sales: | ||||||||||||||||||||||||||||
| Licensing revenue | 825 | — | — | — | — | — | 825 | |||||||||||||||||||||
| Product sales and royalties | 13,600 | (2,002 | ) | (2,349 | ) | — | — | — | 9,249 | |||||||||||||||||||
| Total cost of sales | 14,425 | (2,002 | ) | (2,349 | ) | — | — | — | 10,074 | |||||||||||||||||||
| Gross profit | 21,785 | 2,002 | 2,349 | — | — | — | 26,136 | |||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||
| Research and development | 4,873 | — | — | (82 | ) | — | — | 4,791 | ||||||||||||||||||||
| General and administrative | 18,857 | (16 | ) | — | (3,214 | ) | (335 | ) | (384 | ) | 14,908 | |||||||||||||||||
| Total operating expenses | 23,730 | (16 | ) | — | (3,296 | ) | (335 | ) | (384 | ) | 19,699 | |||||||||||||||||
| (Loss) income from operations | (1,945 | ) | 2,018 | 2,349 | 3,296 | 335 | 384 | 6,437 | ||||||||||||||||||||
| Other expense: | ||||||||||||||||||||||||||||
| Interest and other expense, net | (2,072 | ) | — | — | — | — | — | (2,072 | ) | |||||||||||||||||||
| (Loss) income before income tax expense | (4,017 | ) | 2,018 | 2,349 | 3,296 | 335 | 384 | 4,365 | ||||||||||||||||||||
| Income tax expense | 140 | 70 | 81 | 114 | 12 | 13 | 430 | |||||||||||||||||||||
| Net (loss) income | $ | (4,157 | ) | $ | 1,948 | $ | 2,268 | $ | 3,182 | $ | 323 | $ | 371 | $ | 3,935 | |||||||||||||
| Net (loss) income per share, basic | $ | (0.15 | ) | $ | 0.07 | $ | 0.08 | $ | 0.12 | $ | 0.01 | $ | 0.01 | $ | 0.15 | |||||||||||||
| Net (loss) income per share, diluted | $ | (0.15 | ) | $ | 0.06 | $ | 0.07 | $ | 0.10 | $ | 0.01 | $ | 0.01 | $ | 0.11 | |||||||||||||
| Weighted average number of common shares outstanding, basic | 26,889 | |||||||||||||||||||||||||||
| Weighted average number of common shares outstanding, diluted | 31,066 | |||||||||||||||||||||||||||
Source: Eton Pharmaceuticals
