Eton Pharmaceuticals Reports Fourth Quarter 2021 Financial Results
- Fourth Quarter 2021 Revenue of
$6.1 million - Fourth Quarter 2021 Net Income of
$1.0 million and EPS of$0.04
“Our business has never been stronger. The carglumic acid launch is tracking ahead of our initial expectations, the recently implemented co-promotion partnership with Tolmar has accelerated growth of ALKINDI SPRINKLE®, and just this week we launched another new product, Rezipres,” said
Major Business Updates
- Launch of Carglumic Acid tablets. In late December, Eton launched the first and only generic alternative to Carbaglu®. Initial adoption of the product is ahead of Eton’s original expectations.
- Implementation of ALKINDI SPRINKLE® co-promotion partnership with
Tolmar Pharmaceuticals . By the end of January, Tolmar’s 62-person commercial sales force was fully trained and promoting ALKINDI SPRINKLE. Eton has already seen an increase in new ALKINDI SPRINKLE prescriptions, and March is on pace to be the company’s best month ever for new patient adds. - Launch of EPRONTIA™ (topiramate) oral solution. In December,
Azurity Pharmaceuticals launched EPRONTIA, the first and only liquid formulation of topiramate. The launch of the product triggered a$5 million milestone payment from Azurity to Eton. - Launch of Rezipres® (ready-to-use ephedrine injection). The market for ephedrine injection in
the United States was$86 million in 2021 according to IQVIA. Rezipres will be promoted by XGen Pharmaceutical DJB's hospital sales force.
Commercial Update
Eton launched carglumic acid in late
During the fourth quarter, Eton announced that it had entered into a co-promotion agreement with
Portfolio Update
Eton now has six FDA-approved commercial products in launch phase. The company also has four additional products that have been submitted to the FDA, which are expected to be approved and launched in the coming quarters.
Biorphen & Rezipres Vial Conversions. Biorphen and Rezipres registration batches have successfully been manufactured in vials. Eton plans to submit the supplement applications for both products to the FDA in the second quarter of 2022, which should allow for a launch of vial presentations of both products in 2022.
Dehydrated Alcohol Injection. Eton is actively working to prepare a resubmission to the FDA that addresses all of the FDA’s questions from the Complete Response Letter and items discussed during its meeting with the FDA that took place in the fourth quarter. Eton is confident that it will be able to fully address all of the FDA’s requests and expects to have the response submitted in the coming weeks.
Zonisamide Oral Suspension. The
Lamotrigine for Suspension. Eton’s partner submitted results of the product’s human factor study to the FDA in the fourth quarter of 2021 and the application has been assigned a target action date in
Cysteine Hydrochloride Injection. Eton’s paragraph IV bench trial is taking place this week in
Zeneo Hydrocortisone Autoinjector. Development activities are ongoing and the product remains on pace for an expected New Drug Application submission in 2023.
Financial Results
Revenue: Eton reported revenue of
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were moderate at
Selling, General and Administrative (SG&A): SG&A expenses were
Net Income: Eton reported net income of
Cash Position: Cash and cash equivalents were
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)
| For the three months ended | For the years ended | |||||||||||||||
| (Unaudited) | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | 5,000 | $ | — | $ | 19,000 | $ | — | ||||||||
| Product sales and royalties, net | 1,093 | 81 | 2,832 | 39 | ||||||||||||
| Total net revenues | 6,093 | 81 | 21,832 | 39 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | — | — | 1,500 | — | ||||||||||||
| Product sales and royalties | 280 | 300 | 1,123 | 286 | ||||||||||||
| Total cost of sales | 280 | 300 | 2,623 | 286 | ||||||||||||
| Gross profit (loss) | 5,813 | (219 | ) | 19,209 | (247 | ) | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 681 | 3,401 | 6,235 | 14,104 | ||||||||||||
| General and administrative | 3,818 | 3,800 | 14,469 | 12,760 | ||||||||||||
| Total operating expenses | 4,499 | 7,201 | 20,704 | 26,864 | ||||||||||||
| Income (loss) from operations | 1,314 | (7,420 | ) | (1,495 | ) | (27,111 | ) | |||||||||
| Other (expense) income: | ||||||||||||||||
| Interest and other expense, net | (275 | ) | (267 | ) | (1,006 | ) | (859 | ) | ||||||||
| Gain on PPP loan forgiveness | — | — | 365 | — | ||||||||||||
| Gain on equipment sale | — | — | 181 | — | ||||||||||||
| Income (loss) before income tax expense | 1,039 | (7,687 | ) | (1,955 | ) | (27,970 | ) | |||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net income (loss) | $ | 1,039 | $ | (7,687 | ) | $ | (1,955 | ) | $ | (27,970 | ) | |||||
| Net income (loss) per share, basic | $ | 0.04 | $ | (0.32 | ) | $ | (0.08 | ) | $ | (1.33 | ) | |||||
| Net income (loss) per share, diluted | $ | 0.04 | $ | (0.32 | ) | $ | (0.08 | ) | $ | (1.33 | ) | |||||
| Weighted average number of common shares outstanding, basic | 25,285 | 23,809 | 25,207 | 21,010 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 25,957 | 23,809 | 25,207 | 21,010 | ||||||||||||
Balance Sheets
(In thousands, except share and per share amounts)
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,406 | $ | 21,295 | ||||
| Accounts receivable, net | 5,471 | 48 | ||||||
| Inventories | 550 | 1,242 | ||||||
| Prepaid expenses and other current assets | 3,177 | 2,116 | ||||||
| Total current assets | 23,604 | 24,701 | ||||||
| Property and equipment, net | 115 | 811 | ||||||
| Intangible assets, net | 3,621 | 575 | ||||||
| Operating lease right-of-use assets, net | 104 | 192 | ||||||
| Other long-term assets, net | 21 | 40 | ||||||
| Total assets | $ | 27,465 | $ | 26,319 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,774 | $ | 2,344 | ||||
| Current portion of long-term debt | 1,418 | — | ||||||
| PPP loan, current portion | — | 280 | ||||||
| Accrued liabilities | 1,366 | 1,170 | ||||||
| Total current liabilities | 4,558 | 3,794 | ||||||
| Long-term debt, net of discount and including accrued fees | 5,262 | 6,532 | ||||||
| Long-term portion of PPP and EIDL loans | — | 231 | ||||||
| Operating lease liabilities, net of current portion | 15 | 99 | ||||||
| Total liabilities | 9,835 | 10,656 | ||||||
| Stockholders’ equity | ||||||||
| Common stock, |
25 | 24 | ||||||
| Additional paid-in capital | 111,718 | 107,797 | ||||||
| Accumulated deficit | (94,113 | ) | (92,158 | ) | ||||
| Total stockholders’ equity | 17,630 | 15,663 | ||||||
| Total liabilities and stockholders’ equity | $ | 27,465 | $ | 26,319 | ||||
Statements of Cash Flows
(In thousands)
| Year ended |
Year ended |
|||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (1,955 | ) | $ | (27,970 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 3,381 | 2,576 | ||||||
| Common stock issued for product candidate licensing rights | — | 1,264 | ||||||
| Depreciation and amortization | 462 | 651 | ||||||
| Debt discount amortization | 148 | 121 | ||||||
| Gain on forgiveness of PPP loan | (365 | ) | — | |||||
| Gain on sale of equipment | (181 | ) | — | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (5,423 | ) | 425 | |||||
| Inventories | 692 | (862 | ) | |||||
| Prepaid expenses and other assets | (1,026 | ) | (20 | ) | ||||
| Accounts payable | (570 | ) | 1,769 | |||||
| Accrued liabilities | 116 | (300 | ) | |||||
| Net cash used in operating activities | (4,721 | ) | (22,346 | ) | ||||
| Cash used in investing activities | ||||||||
| Proceeds from sale of equipment | 700 | — | ||||||
| Purchases of property and equipment | (9 | ) | (50 | ) | ||||
| Purchase of product licensing rights | (3,250 | ) | — | |||||
| Net cash used in financing activities | (2,559 | ) | (50 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from sales of common stock, net of offering costs | — | 28,782 | ||||||
| Proceeds from issuance of long-term debt, net of issuance costs | — | 1,965 | ||||||
| EIDL loan payoff | (150 | ) | — | |||||
| Proceeds from PPP and EIDL loans | — | 511 | ||||||
| Proceeds from employee stock purchase plan and stock option exercises | 541 | 367 | ||||||
| Net cash provided by financing activities | 391 | 31,625 | ||||||
| Change in cash and cash equivalents | (6,889 | ) | 9,229 | |||||
| Cash and cash equivalents at beginning of period | 21,295 | 12,066 | ||||||
| Cash and cash equivalents at end of period | $ | 14,406 | $ | 21,295 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 815 | $ | 797 | ||||
| Cash paid for income taxes | $ | — | $ | — | ||||
| Supplemental disclosure of non-cash investing and financing activity | ||||||||
| Relative fair value of common stock warrants issued in connection with debt | $ | — | $ | 94 | ||||
| Right-of-use assets obtained in exchange for lease liabilities | $ | — | $ | 195 | ||||
Investor Contact:
dkrempa@etonpharma.com
612-387-3740
Source: Eton Pharmaceuticals