Full Press Release Details
Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Highlights Business Progress
NDA filing for ET-202 Accepted for Review and Assigned PDUFA Date of October 21, 2019 -
PARK, III., Mar. 25, 2019 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc. (NASDAQ: ETON), a specialty pharmaceutical company
focused on developing and commercializing innovative drug products, reported financial results for the fourth quarter and full
year ended December 31, 2018 and provided a business update.
was an important year in Eton's history as we made tremendous progress both clinically and operationally, including the
successful completion of our IPO. The momentum has continued into 2019, as we have already executed three significant transactions
this year, including Bausch Health's acquisition of EM-100, and we now have a total of four product candidates filed with
the FDA," said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. "As we move further into 2019, we
look forward to continuing with the advancement of our pipeline and preparing to become a commercial revenue company."
| NDA filing for ET-202 accepted for review by FDA . The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ET-202. The product candidate has been assigned a PDUFA target action date of October 21, 2019. Eton has begun preparing for a commercial launch internally. | ||
| First patient dosed for ET-103 clinical study . Eton dosed the first patient in its clinical study for ET-103. Results are expected in the third quarter of 2019, and, if successful, Eton anticipates an NDA submission before year end 2019. | ||
| Patent application filed for ET-104 . A patent application was filed for ET-104, Eton's recently acquired innovative oral liquid product candidate for the treatment of a neurological condition. A clinical study of ET-104 is expected to initiate in the second quarter of 2019. If successful, Eton anticipates an NDA submission before year end 2019. | ||
| Established Internal R&D laboratory. Eton has begun testing in its new, state of the art Research and Development (R&D) laboratory in Lake Zurich, Illinois. The addition of this facility provides Eton with internal capabilities for analytical testing activities and product development. |
Quarter and Full Year 2018 Financial Results
Position: As of December 31, 2018, Eton reported cash and cash equivalents of $26.7 million compared to $13.2 million at December
31, 2017. The increase in the company's cash position was primarily attributable to the $22.0 million in net proceeds from
the initial public offering (IPO), which closed in November 2018.
and Development (R&D) Expenses: R&D expenses were $1.1 million for the fourth quarter of 2018 compared to $0.9 million
for the same period in 2017. The increase was primarily driven by increased R&D headcount and the addition of laboratory related
expenses in 2018. R&D expenses for the full year 2018 were $5.6 million compared to $3.9 million for the full year 2017. The
increase was primarily driven by increased headcount and higher product development spending in 2018 and 2017 including only a
partial year since the company's inception in April 2017.
& Administrative (G&A) Expenses: G&A expenses were $1.2 million for the fourth quarter of 2018, compared to $1.3
million for the same period in 2017. The decrease was primarily driven by a decline in stock-based compensation partially offset
by increased employee compensation costs and public company expenses. G&A expenses for the full year 2018 were $4.7 million,
compared to $3.2 million for the full year 2017. The increase was primarily driven by higher employee compensation expenses due
to increased headcount and a full year of operations in 2018, partially offset by lower stock-based compensation expenses.
Loss: Eton reported a net loss for the fourth quarter of 2018 of $3.7 million compared to a net loss of $2.2 million for the
same period of 2017. Fourth quarter 2018 results included a $1.5 million non-cash expense due to change in fair value of warrant
liability. For the full year 2018, Eton reported a net loss of $12.7 million compared to $7.2 million for 2017. The increase was
primarily driven by higher operating expenses due to increased headcount and our expenses reflecting only a partial year for 2017.
Full year 2018 results included a $2.6 million non-cash expense due to change in fair value of warrant liability.
Eton Pharmaceuticals
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products utilizing
the FDA's 505(b)(2) regulatory pathway. Eton is primarily focused on liquid dosage forms including injectables, oral liquids
and ophthalmics. Eton has a diversified pipeline of high-value product candidates in various stages of development and therapeutic
areas, including multiple product candidates currently pending regulatory approval with the FDA.
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
Pharmaceuticals, Inc.
thousands, except per share amounts)
| Three months ended December 31, (Unaudited) | Year ended December 31, | Period from April 27, 2017 (Inception) to December 31, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,102 | $ | 863 | $ | 5,627 | $ | 3,930 | ||||||||
| General and administrative | 1,184 | 1,333 | 4,694 | 3,220 | ||||||||||||
| Total operating expenses | 2,286 | 2,196 | 10,321 | 7,150 | ||||||||||||
| Loss from operations | (2,286 | ) | (2,196 | ) | (10,321 | ) | (7,150 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 82 | 26 | 164 | 35 | ||||||||||||
| Change in fair value of warrant liability | (1,526 | ) | - | (2,583 | ) | (41 | ) | |||||||||
| Loss before income tax expense | (3,730 | ) | (2,170 | ) | (12,740 | ) | (7,156 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net loss | (3,730 | ) | (2,170 | ) | (12,740 | ) | (7,156 | ) | ||||||||
| Accrued dividends on redeemable convertible preferred stock | (148 | ) | (300 | ) | (1,048 | ) | (643 | ) | ||||||||
| Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | (437 | ) | (401 | ) | (1,694 | ) | (840 | ) | ||||||||
| Deemed dividends for beneficial conversion feature of redeemable convertible preferred stock | (21,747 | ) | - | (21,747 | ) | - | ||||||||||
| Net loss attributable to common stockholders | $ | (26,062 | ) | $ | (2,871 | ) | $ | (37,229 | ) | $ | (8,639 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.24 | ) | $ | (0.81 | ) | $ | (5.80 | ) | $ | (2.50 | ) | ||||
| Weighted-average number of common shares outstanding, basic and diluted | 11,640 | 3,525 | 6,418 | 3,453 |
Pharmaceuticals, Inc.
thousands, except share and per share amounts)
| December 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 26,735 | $ | 13,156 | ||||
| Prepaid expenses | 767 | 136 | ||||||
| Total current assets | 27,502 | 13,292 | ||||||
| Property and equipment, net | 773 | 119 | ||||||
| Other long-term assets, net | 52 | 32 | ||||||
| Total assets | $ | 28,327 | $ | 13,443 | ||||
| Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,421 | $ | 539 | ||||
| Accrued liabilities | 603 | 254 | ||||||
| Total current liabilities | 2,024 | 793 | ||||||
| Warrant liability | - | 520 | ||||||
| Total liabilities | 2,024 | 1,313 | ||||||
| Commitments and contingencies | ||||||||
| Redeemable convertible preferred stock - Series A | ||||||||
| $0.001 par value, 10,000,000 shares authorized as of December 31, 2018 and 2017; no shares and 6,685,082 shares issued and outstanding as of December 31, 2018 and 2017, respectively; aggregate liquidation preference of $0 and $20,698 as of December 31, 2018 and 2017, respectively | - | 19,004 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized as of December 31, 2018 and 2017; 17,607,928 and 6,000,000 shares issued and outstanding at December 31, 2018 and 2017, respectively | 18 | 6 | ||||||
| Additional paid-in capital | 72,153 | 1,759 | ||||||
| Accumulated deficit | (45,868 | ) | (8,639 | ) | ||||
| Total stockholders' equity (deficit) | 26,303 | (6,874 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and Stockholders' equity (deficit) | $ | 28,327 | $ | 13,443 |
Pharmaceuticals, Inc.
Statements of Cash Flows
| Year ended December 31, 2018 | Period from April 27, 2017 (Inception) to December 31, 2017 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (12,740 | ) | $ | (7,156 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,850 | 1,761 | ||||||
| Depreciation and amortization | 63 | 13 | ||||||
| Change in fair value of warrant liability | 2,583 | 41 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (663 | ) | (170 | ) | ||||
| Accounts payable | 413 | 539 | ||||||
| Accrued liabilities | 349 | 254 | ||||||
| Net cash used in operating activities | (8,145 | ) | (4,718 | ) | ||||
| Cash used in investing activities | ||||||||
| Purchases of property and equipment | (236 | ) | (130 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from initial public offering, net of underwriting discounts and commissions | 22,803 | - | ||||||
| Payments of initial public offering costs | (843 | ) | - | |||||
| Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs | - | 18,000 | ||||||
| Proceeds from sale of common stock, net of issuance costs | - | 4 | ||||||
| Net cash provided by financing activities | 21,960 | 18,004 | ||||||
| Change in cash and cash equivalents | 13,579 | 13,156 | ||||||
| Cash and cash equivalents at beginning of period | 13,156 | - | ||||||
| Cash and cash equivalents at end of period | $ | 26,735 | $ | 13,156 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | - | $ | - | ||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Supplemental disclosures of non-cash investing and financing activities: | ||||||||
| Accrued dividends on redeemable convertible preferred stock | $ | 1,048 | $ | 643 | ||||
| Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | $ | 1,694 | $ | 840 | ||||
| Common stock warrant liability issued with redeemable convertible preferred stock financing | $ | - | $ | 479 | ||||
| Purchase of equipment included in accounts payable | $ | 469 | $ | - | ||||
| Beneficial conversion feature on redeemable convertible preferred stock | $ | 21,747 | $ | - | ||||
| Reclassification of common stock warrants from liability to additional paid in capital | $ | 3,103 | $ | - |
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