Eton Pharmaceuticals Announces Fourth Quarter and Full Year 2019 Financial Results
“2019 was an important year for Eton. Our team achieved a number of major milestones in the advancement of our pipeline, the most significant of which was the approval and launch of Biorphen, our first commercial product,” said
Fourth Quarter Milestones
- FDA approval and commercial Launch of Biorphen. Biorphen, Eton’s first commercial product, was launched in December. More than 100 different institutions have already placed orders for Biorphen.
- DS-300 ANDA filing. In December, Eton submitted an ANDA for DS-300. The application was accepted for review and was confirmed to be the first-to-file ANDA against the innovator product. The innovator product represents an estimated market size of more than
$60 million . - EM-100 amendment submitted. In December, Eton’s licensing partner submitted an amendment to the EM-100 application in response to the Complete Response Letter received in
July 2019 . Eton believes the amendment fully addressed all issues raised by the FDA and expects EM-100 to be approved in 2020.
Biorphen Commercial Launch Update
During the fourth quarter, Eton launched Biorphen, the first and only FDA-approved ready-to-use formulation of phenylephrine injection. The product was approved in October and launched in December. Initial customer demand for the product has resulted in more than 100 different institutions purchasing the product. Customers have specifically cited Biorphen’s lack of dilution, three-year shelf-life, and FDA-approved status as significant benefits that led to their institutions’ conversion to the product.
Eton recently announced that it entered into a co-promotion arrangement with
Ongoing phenylephrine supply disruptions from 503B compounding facilities, including the announced shutdown of compounding industry leader PharMedium in January, have highlighted the critical need for Biorphen. During the quarter, Eton sent 503B facilities notices referencing that FDA-approved Biorphen is now commercially available and as a result, there is no longer a clinical need for compounded phenylephrine injection. Eton believes that selling compounded phenylephrine after the introduction of Biorphen is a violation of FDA regulations, and Eton is actively engaged in communications with the FDA to discuss the enforcement of the existing compounding regulations.
The overall market opportunity for ready-to-use phenylephrine is estimated to be more than 20 million units of Biorphen annually, and Eton’s long-term goal is to capture at least four million units per year.
Eton has also initiated the development of line extensions to convert Biorphen into vial and pre-filled syringe container systems to address the needs and preferences of certain customer segments. The line extension products are expected to launch as early as next year.
Pipeline Update
Eton currently has eight product candidates in its late-stage pipeline, including three products under review with the FDA:
Product (Molecule) | Dosage Form | Category | Expected Submission Timing |
Reference Product Market Size |
EM-100 (Ketotifen) | Ophthalmic | OTC** | Submitted | |
ET-105 (Lamotrigine) | Oral Liquid | Pediatric | Submitted | |
DS-300 | Injectable | Hospital | Submitted | |
ET-104 | Oral Liquid | Pediatric | 2020 | |
ET-103 (Levothyroxine) | Oral Liquid | Pediatric | 2020 | |
ET-203 | Injectable | Hospital | 2020 | |
DS-100 | Injectable | Hospital | 2020 | |
ET-101 | Oral Liquid | Pediatric | 2020 | |
Note: Pipeline only includes product candidates that Eton expects to submit within twelve months. Reference product market sizes based on IQVIA data unless noted. |
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*Based on management estimates | ||||
**Product will be marketed by Bausch Health | ||||
EM-100. In December, the company’s licensing partner, Bausch Health, submitted an amendment to the EM-100 product application, and Eton believes the amendment fully addresses all issues raised by the FDA in the
ET-105. As previously disclosed, Eton received comments from the FDA requesting changes to the Dosage and Administration section of the product’s Prescribing Information to simplify the dosing information for intended users, and the FDA requested a human factors validation study with the revised labeling to demonstrate that the intended users can accurately prepare and administer the oral suspension. As a result, Eton expects to receive a CRL on its PDUFA date of
DS-300. Eton submitted the ANDA for DS-300 in December. The application was accepted for review and assigned a GDUFA target action date in
ET-104. Eton is awaiting final FDA acceptance of its pediatric study protocol (PSP) for ET-104. The product’s NDA is expected to be submitted once agreement is reached on the PSP.
ET-103. Eton is in discussions with the FDA regarding the product’s bioequivalence data results to ensure compliance with FDA requirements prior to submission of the NDA. If Eton receives agreement from the FDA, it expects the product’s NDA to be submitted in the first half of 2020.
ET-203. Eton’s development partner,
DS-100. NDA compilation is under way and Eton expects to submit the NDA in 2020.
ET-101. The product’s bioequivalence study is ongoing, and Eton is in discussions with the FDA regarding the application’s Pediatric Study Plan. If successful, Eton expects to submit the product’s NDA in the second half of 2020.
Fourth Quarter and Full Year 2019 Financial Results
Revenue: Revenue for the fourth quarter of 2019 was
Cost of Product Sales: Cost of product sales for the fourth quarter of 2019 was
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2019 totaled
For the full year 2019, R&D expenses were
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2019 were
For the full year 2019, SG&A expenses were
Net Loss: Net loss for the fourth quarter of 2019 was
For the full year 2019, net loss was
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
Statements of Operations
(In thousands, except per share amounts)
Three months ended (Unaudited) |
For the years ended |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales | $ | 459 | $ | — | $ | 459 | $ | — | ||||||||
Licensing revenue | — | — | 500 | — | ||||||||||||
Total revenues | 459 | — | 959 | — | ||||||||||||
Cost of product sales | 453 | — | 453 | — | ||||||||||||
Gross Profit | 6 | — | 506 | — | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 233 | 1,102 | 11,555 | 5,627 | ||||||||||||
General and administrative | 2,429 | 1,184 | 7,552 | 4,694 | ||||||||||||
Total operating expenses | 2,662 | 2,286 | 19,107 | 10,321 | ||||||||||||
Loss from operations | (2,656 | ) | (2,286 | ) | (18,601 | ) | (10,321 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest and other income (expense), net | (40 | ) | 82 | 281 | 164 | |||||||||||
Change in fair value of warrant liability | — | (1,526 | ) | — | (2,583 | ) | ||||||||||
Loss before income tax expense | (2,696 | ) | (3,730 | ) | (18,320 | ) | (12,740 | ) | ||||||||
Income tax expense | — | — | — | — | ||||||||||||
Net loss | (2,696 | ) | (3,730 | ) | (18,320 | ) | (12,740 | ) | ||||||||
Accrued dividends on redeemable convertible preferred stock | — | (148 | ) | — | (1,048 | ) | ||||||||||
Deemed dividends for accretion of redeemable convertible preferred stock issuance costs | — | (437 | ) | — | (1,694 | ) | ||||||||||
Deemed dividends for beneficial conversion feature of redeemable convertible preferred stock | — | (21,747 | ) | — | (21,747 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (2,696 | ) | $ | (26,062 | ) | $ | (18,320 | ) | $ | (37,229 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.15 | ) | $ | (2.24 | ) | $ | (1.03 | ) | $ | (5.80 | ) | ||||
Weighted-average number of common shares outstanding, basic and diluted | 17,924 | 11,640 | 17,761 | 6,418 | ||||||||||||
BALANCE SHEETS
(in thousands, except share and per share amounts)
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 12,066 | $ | 26,735 | |||||
Accounts receivables, net | 473 | — | |||||||
Inventory | 380 | — | |||||||
Prepaid expenses and other current assets | 2,090 | 767 | |||||||
Total current assets | 15,009 | 27,502 | |||||||
Property and equipment, net | 1,117 | 773 | |||||||
Intangible assets, net | 725 | — | |||||||
Operating lease right-of-use assets, net | 160 | — | |||||||
Other long-term assets, net | 61 | 52 | |||||||
Total assets | $ | 17,072 | $ | 28,327 | |||||
Liabilities and stockholders’ equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 575 | $ | 1,421 | |||||
Accrued liabilities | 1,388 | 603 | |||||||
Total current liabilities | 1,963 | 2,024 | |||||||
Long-term debt, net of discount and including accrued fees | 4,540 | — | |||||||
Operating lease liabilities, net of current portion | 19 | — | |||||||
Total liabilities | 6,522 | 2,024 | |||||||
Commitments and contingencies (Note 16) | |||||||||
Stockholders’ equity | |||||||||
Common stock, |
18 | 18 | |||||||
Additional paid-in capital | 74,720 | 72,153 | |||||||
Accumulated deficit | (64,188 | ) | (45,868 | ) | |||||
Total stockholders’ equity | 10,550 | 26,303 | |||||||
Total liabilities and stockholders’ equity | $ | 17,072 | $ | 28,327 | |||||
STATEMENTS OF CASH FLOWS
(In thousands)
For the years ended |
||||||||
2019 | 2018 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (18,320 | ) | $ | (12,740 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 1,888 | 1,850 | ||||||
Depreciation and amortization | 447 | 63 | ||||||
Debt discount amortization | 16 | — | ||||||
Change in fair value of warrant liability | — | 2,583 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | (473 | ) | — | |||||
Inventory | (380 | ) | — | |||||
Prepaid expenses and other assets | (1,361 | ) | (663 | ) | ||||
Accounts payable | (377 | ) | 413 | |||||
Accrued liabilities | 534 | 349 | ||||||
Net cash used in operating activities | (18,026 | ) | (8,145 | ) |
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Cash used in investing activities | ||||||||
Purchases of property and equipment | (1,096 | ) | (236 | ) | ||||
Purchase of product licensing rights | (750 | ) | — | |||||
Net cash used in investing activities | (1,846 | ) | (236 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of long-term debt, net of issuance costs | 4,750 | — | ||||||
Proceeds from initial public offering, net of underwriting discounts and commissions | — | 22,803 | ||||||
Payments of initial public offering costs | — | (843 | ) | |||||
Proceeds from employee stock purchase plan and stock option exercises | 453 | — | ||||||
|
5,203 | 21,960 | ||||||
Change in cash and cash equivalents | (14,669 | ) | 13,579 | |||||
Cash and cash equivalents at beginning of period | 26,735 | 13,156 | ||||||
Cash and cash equivalents at end of period | $ | 12,066 | $ | 26,735 | ||||
Supplemental disclosures of cash flow information | ||||||||
Cash paid for interest | $ | — | $ | — | ||||
Cash paid for income taxes | $ | — | $ | — | ||||
Investor Contact:
dkrempa@etonpharma.com
847-805-1077
Source: Eton Pharmaceuticals