News Releases
“Our first product approval was a major milestone for Eton and a great accomplishment by our team,” said
Recent Business Milestones and Updates:
FDA approval of Biorphen. OnOctober 21 st, theFDA approved Biorphen, the first and onlyFDA -approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
- Executed debt transaction with
SWK Holdings . This week, Eton announced it has secured a$10 million debt facility fromSWK Holdings . The facility will give the company additional flexibility to pursue accretive business development activities while it invests in the commercial launch of Biorphen and the planned launch of ET-105 in early 2020.
- Licensed U.S marketing rights to ET-105. During the quarter, Eton closed the acquisition of U.S marketing rights to ET-105, which was executed upon the product’s NDA being accepted for review by the
FDA . ET-105 is an innovative formulation of lamotrigine that will be administered to patients as an oral liquid, and its NDA has been assigned a PDUFA date ofMarch 17, 2020 .
Biorphen Commercial Launch
Eton currently has a team of five hospital-focused sales representatives actively promoting Biorphen and expects to expand the team to more than ten representatives by the first quarter of 2020. Since approval, Eton’s team has promoted Biorphen and met with key opinion leaders at conferences including the
Eton estimates that the current phenylephrine injectable market is greater than 20 million Biorphen equivalent units per year. Over time, Eton expects to convert a significant share of the market to ready-to-use Biorphen, and in addition, expects to grow the market for phenylephrine as Biorphen’s three-year shelf life allows it to be stocked in additional locations throughout emergency rooms, crash carts, and in surgical centers where it previously was not feasible to stock ready-to-use phenylephrine due to the short expiry dating of compounded products.
Currently, ready-to-use phenylephrine injection is only available from 503B compounding pharmacies. Eton believes there is no longer a clinical need for 503B facilities to compound phenylephrine into ready-to-use formulations, and based on
Pipeline Update
Eton currently has eight product candidates in its late-stage pipeline, which the company defines as products that are expected to be submitted to the
Product (Molecule) | Dosage Form | Category | Expected Submission Timing |
Reference Product Market Size |
EM-100 (Ketotifen) | Ophthalmic | OTC** | Submitted | $50 million + |
ET-105 (Lamotrigine) | Oral Liquid | Neurology | Submitted | $700 million + |
DS-300 | Injectable | Hospital | 2019 | $75 million* + |
ET-203 | Injectable | Hospital | 2019 - 2020 | $90 million + |
ET-103 (Levothyroxine) | Oral Liquid | Endocrinology | 2020 | $2.5 billion + |
ET-104 | Oral Liquid | Neurology | 2020 | $75 million + |
DS-100 | Injectable | Hospital | 2020 | $100 million* + |
ET-101 | Oral Liquid | Neurology | 2020 | $800 million + |
Reference product market sizes based on IQVIA data unless noted. | ||||
*Based on management estimates | ||||
**Product will be marketed by Bausch Health | ||||
EM-100. Eton’s partner is finalizing an amendment to respond to the items addressed in the FDA’s Complete Response Letter, and the amendment is scheduled to be submitted before the end of November. Eton expects the amendment to be classified as a minor amendment, which would be assigned a three-month target action goal date by the
ET-105. The
DS-300. Eton expects to submit the ANDA for DS-300 before the end of this year.
ET-203. Eton’s partner has an
ET-103. Eton has submitted the ET-103 clinical protocol to the
ET-104. Eton is in active discussions with the
DS-100. Eton held a meeting with the
ET-101. Eton anticipates initiating ET-101’s bioequivalence study in the first quarter of 2020. If successful, Eton would anticipate submitting the product’s NDA in 2020.
Third Quarter Financial Results
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Eton reported a net loss for the third quarter of 2019 of
Cash Position: As of
Conference Call and Webcast Information:
About
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
Eton Pharmaceuticals, Inc. Condensed Statements of Operations (In thousands, except per share amounts) (Unaudited) |
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For the three months ended | For the nine months ended | |||||||||||||||
September 30, 2019 |
September 30, 2018 |
September 30, 2019 |
September 30, 2018 |
|||||||||||||
Revenue | $ | — | $ | — | $ | 500 | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 3,418 | 1,544 | 11,322 | 4,525 | ||||||||||||
General and administrative | 1,624 | 830 | 5,123 | 3,510 | ||||||||||||
Total operating expenses | 5,042 | 2,374 | 16,445 | 8,035 | ||||||||||||
Loss from operations | (5,042 | ) | (2,374 | ) | (15,945 | ) | (8,035 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest and other income, net | 77 | 25 | 321 | 82 | ||||||||||||
Change in fair value of warrant liability | — | (561 | ) | — | (1,057 | ) | ||||||||||
Loss before income tax expense | (4,965 | ) | (2,910 | ) | (15,624 | ) | (9,010 | ) | ||||||||
Income tax expense | — | — | — | — | ||||||||||||
Net loss | (4,965 | ) | (2,910 | ) | (15,624 | ) | (9,010 | ) | ||||||||
Accrued dividends on redeemable convertible preferred stock | — | (300 | ) | — | (900 | ) | ||||||||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | — | (429 | ) | — | (1,257 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (4,965 | ) | $ | (3,639 | ) | $ | (15,624 | ) | $ | (11,167 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.28 | ) | $ | (0.65 | ) | $ | (0.88 | ) | $ | (2.40 | ) | ||||
Weighted average number of common shares outstanding, basic and diluted | 17,878 | 5,615 | 17,706 | 4,658 |
Eton Pharmaceuticals, Inc. Condensed Balance Sheets (in thousands, except share and per share amounts) |
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September 30, 2019 |
December 31, 2018 |
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(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,777 | $ | 26,735 | ||||
Prepaid expenses and other current assets | 330 | 767 | ||||||
Total current assets | 12,107 | 27,502 | ||||||
Property and equipment, net | 1,169 | 773 | ||||||
Operating lease right-of-use assets, net | 191 | — | ||||||
Other long-term assets, net | 40 | 52 | ||||||
Total assets | $ | 13,507 | $ | 28,327 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 549 | $ | 1,421 | ||||
Accrued liabilities | 558 | 603 | ||||||
Total current liabilities | 1,107 | 2,024 | ||||||
Operating lease liabilities, net of current portion | 52 | — | ||||||
Total liabilities | 1,159 | 2,024 | ||||||
Commitments and contingencies (Note 13) | ||||||||
Stockholders’ equity | ||||||||
Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 17,807,167 and 17,607,928 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 18 | 18 | ||||||
Additional paid-in capital | 73,822 | 72,153 | ||||||
Accumulated deficit | (61,492 | ) | (45,868 | ) | ||||
Total stockholders’ equity | 12,348 | 26,303 | ||||||
Total liabilities and stockholders’ equity | $ | 13,507 | $ | 28,327 |
Eton Pharmaceuticals, Inc. Condensed Statements of Cash Flows (In thousands) (Unaudited) |
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Nine months ended September 30, 2019 |
Nine months ended September 30, 2018 |
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Cash flows from operating activities | ||||||||
Net loss | $ | (15,624 | ) | $ | (9,010 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 1,387 | 1,631 | ||||||
Depreciation and amortization | 299 | 40 | ||||||
Change in fair value of warrant liability | — | 1,057 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | 426 | (493 | ) | |||||
Accounts payable | (403 | ) | 254 | |||||
Accrued liabilities | (263 | ) | 150 | |||||
Net cash used in operating activities | (14,178 | ) | (6,371 | ) | ||||
Cash used in investing activities | ||||||||
Purchases of property and equipment | (1,062 | ) | (182 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from employee stock purchase plan and stock option exercises | 282 | — | ||||||
Net cash provided by financing activities | 282 | — | ||||||
Change in cash and cash equivalents | (14,958 | ) | (6,553 | ) | ||||
Cash and cash equivalents at beginning of period | 26,735 | 13,156 | ||||||
Cash and cash equivalents at end of period | $ | 11,777 | $ | 6,603 | ||||
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 | $ | — | $ | 900 | ||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | $ | — | $ | 1,257 | ||||
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Source: Eton Pharmaceuticals