Full Press Release Details
Pharmaceuticals Reports Third Quarter 2022 Financial Results
PARK, Ill., November 10, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or "the Company") (Nasdaq:
ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial
results for the quarter ended September 30, 2022.
third quarter results reflect the continued momentum we're seeing across our product portfolio. Product sales and royalties jumped
315% over the prior year period and 37% from the second quarter of 2022, marking the seventh straight quarter of sequential revenue
growth. Physicians and patients are responding positively to ALKINDI SPRINKLE and Carglumic Acid, and both products still have long
runways for growth ahead of them," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
the quarter, we added a third FDA-approved rare disease product. Betaine Anhydrous shares the same prescriber base as Carglumic
Acid and makes for an ideal fit for our metabolic genetics sales force. With two commercial products in the market,
the upcoming launch of Betaine, and the potential for additional product launches in 2023 and 2024, we are very
excited about what lies ahead for the Company," concluded Brynjelsen.
Quarter and Recent Business Highlights
seventh straight quarter of sequential growth in product sales and royalty revenue. Eton reported total third quarter 2022 revenue
of $3.2 million, comprised entirely of product sales and royalty revenue, representing growth of 315% over the prior year and 37% over
the second quarter of 2022.
strong growth in sales of ALKINDI SPRINKLE. Sales of ALKINDI SPRINKLE grew 183% over the prior year period and 19% over the second
quarter of 2022. Growth came from both new and existing prescribers.
adoption of Carglumic Acid. Now in its third full calendar quarter since launch, the product continues to see a strong reception
from prescribers and patients. Caglumic Acid sales grew 40% over the second quarter and the company believes it remains on track to reach
its goal of capturing 25-35% market share of the estimated $50 million market.
of a third FDA-approved rare disease product. During the quarter, Eton announced the acquisition of Betaine Anhydrous. The product
shares the same metabolic geneticist prescriber base as Carglumic Acid and is expected to be accretive to Eton's earnings in 2023.
Approval of Zonisade . The product is part of Eton's multi-product neurology oral solution agreement with Azurity
Pharmaceuticals. Azurity is solely responsible for commercializing the product; Eton is entitled to receive milestone payments and royalties
on net sales of the product. Zonisade was launched in October, triggering a $5 million milestone payment to Eton that will be recognized
in the fourth quarter.
Quarter Financial Results
Sales: Net sales for the third quarter of 2022 were $3.2 million compared with $0.8 million in the prior year period. In both periods,
revenue was comprised entirely of product sales and royalties, and the increase was primarily driven by growth in ALKINDI SPRINKLE and
the launch of Carglumic Acid in late 2021.
Profit: Gross profit for the third quarter of 2022 was $2.0 million compared with $0.1 million in the prior year period.
and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $0.7 million compared to $2.7 million in
the prior year period. The decrease was primarily due to a $1.1 million fee related to Biorphen and Rezipres conversion projects
in the prior year period, and decreased development costs for new product candidates.
and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $4.2 million compared to $3.3 million
in the prior year period. Cash G&A expenses for the third quarter of 2022 were $3.2 million, compared to $2.4 million in the prior
year period. The increase in G&A expenses was mainly due to incremental marketing and compensation to support product sales growth,
partially offset by lower legal and consulting expenses.
Income/Loss: Net loss for the third quarter of 2022 was $3.0 million or $0.12 per basic and diluted share compared to a net
loss of $6.1 million or $0.24 per diluted share in the prior year period.
Position: As of September 30, 2022, the company had cash and cash equivalents of $13.4 million. The Company will receive
a $5.0 million milestone payment for the launch of Zonisade during the fourth quarter.
Call and Webcast Information:
Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please register
here (audio only). The webcast can be accessed under "Events & Presentations" in the Investors section of the
company's website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company's
website approximately two hours after the call and will be available for 30 days.
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 were made.
Eton Pharmaceuticals
Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The Company currently has three FDA approved products in ALKINDI SPRINKLE , Carglumic Acid tablets, and Betaine Anhydrous for oral
solution, and three late-stage pipeline candidates under development with dehydrated alcohol injection, ZENEO hydrocortisone
autoinjector, and ET-400. In addition, the Company receives royalties on three FDA-approved products and is entitled to receive milestone
payments on other products. For more information, please visit our website at www.etonpharma.com.
Pharmaceuticals, Inc.
Statements of Operations
thousands, except per share amounts)
| For the three months ended | For the nine months ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | - | $ | - | $ | 5,000 | $ | 14,000 | ||||||||
| Product sales and royalties | 3,219 | 775 | 7,753 | 1,739 | ||||||||||||
| Total net revenues | 3,219 | 775 | 12,753 | 15,739 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | - | - | 990 | 1,500 | ||||||||||||
| Product sales and royalties | 1,201 | 654 | 3,805 | 955 | ||||||||||||
| Total cost of sales | 1,201 | 654 | 4,795 | 2,455 | ||||||||||||
| Gross profit | 2,018 | 121 | 7,958 | 13,284 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 744 | 2,678 | 3,052 | 5,554 | ||||||||||||
| General and administrative | 4,169 | 3,290 | 14,228 | 10,539 | ||||||||||||
| Total operating expenses | 4,913 | 5,968 | 17,280 | 16,093 | ||||||||||||
| (Loss) income from operations | (2,895 | ) | (5,847 | ) | (9,322 | ) | (2,809 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest and other expense, net | (150 | ) | (247 | ) | (611 | ) | (731 | ) | ||||||||
| Gain on PPP loan forgiveness | - | - | - | 365 | ||||||||||||
| Gain on equipment sale | - | - | - | 181 | ||||||||||||
| (Loss) income before income tax expense | (3,045 | ) | (6,094 | ) | (9,933 | ) | (2,994 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net (loss) income | $ | (3,045 | ) | $ | (6,094 | ) | $ | (9,933 | ) | $ | (2,994 | ) | ||||
| Net loss (income) per share, basic | $ | (0.12 | ) | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.12 | ) | ||||
| Net loss (income) per share, diluted | $ | (0.12 | ) | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.12 | ) | ||||
| Weighted average number of common shares outstanding, basic | 25,365 | 25,276 | 25,066 | 25,181 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 25,365 | 25,276 | 25,066 | 25,181 |
Pharmaceuticals, Inc.
thousands, except share and per share amounts)
| September 30, 2022 | December 31, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,378 | $ | 14,406 | ||||
| Accounts receivable, net | 1,498 | 5,471 | ||||||
| Inventories | 481 | 550 | ||||||
| Prepaid expenses and other current assets | 1,063 | 3,177 | ||||||
| Total current assets | 16,420 | 23,604 | ||||||
| Property and equipment, net | 73 | 115 | ||||||
| Intangible assets, net | 4,973 | 3,621 | ||||||
| Operating lease right-of-use assets, net | 42 | 104 | ||||||
| Other long-term assets, net | 12 | 21 | ||||||
| Total assets | $ | 21,520 | $ | 27,465 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,054 | $ | 1,774 | ||||
| Current portion of long-term debt | 708 | 1,418 | ||||||
| Accrued liabilities | 2,899 | 1,366 | ||||||
| Total current liabilities | 4,661 | 4,558 | ||||||
| Long-term debt, net of discount and including accrued fees | 5,678 | 5,262 | ||||||
| Operating lease liabilities, net of current portion | - | 15 | ||||||
| Total liabilities | 10,339 | 9,835 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized; 25,297,037 and 24,626,004 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 25 | 25 | ||||||
| Additional paid-in capital | 115,202 | 111,718 | ||||||
| Accumulated deficit | (104,046 | ) | (94,113 | ) | ||||
| Total stockholders' equity | 11,181 | 17,630 | ||||||
| Total liabilities and stockholders' equity | $ | 21,520 | $ | 27,465 |
Pharmaceuticals, Inc.
Statements of Cash Flows
| Nine months ended September 30, 2022 | Nine months ended September 30, 2021 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (9,933 | ) | $ | (2,994 | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Stock-based compensation | 3,332 | 2,518 | ||||||
| Depreciation and amortization | 1,522 | 325 | ||||||
| Debt discount amortization | 96 | 110 | ||||||
| Gain on forgiveness of debt | - | (365 | ) | |||||
| Gain on sale of equipment | - | (181 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 3,973 | (337 | ) | |||||
| Inventories | 69 | 908 | ||||||
| Prepaid expenses and other assets | 2,129 | (283 | ) | |||||
| Accounts payable | (720 | ) | 699 | |||||
| Accrued liabilities | 1,513 | (4 | ) | |||||
| Net cash provided by operating activities | 1,981 | 396 | ||||||
| Cash flows from investing activities | ||||||||
| Proceeds from sale of equipment | - | 700 | ||||||
| Purchase of product license rights | (2,750 | ) | - | |||||
| Purchases of property and equipment | (26 | ) | (5 | ) | ||||
| Net cash (used in) provided by investing activities | (2,776 | ) | 695 | |||||
| Cash flows from financing activities | ||||||||
| Repayment of long-term debt | (385 | ) | (150 | ) | ||||
| Proceeds from employee stock purchase plan and stock option exercises | 152 | 473 | ||||||
| Net cash (used in) provided by financing activities | (233 | ) | 323 | |||||
| Change in cash and cash equivalents | (1,028 | ) | 1,414 | |||||
| Cash and cash equivalents at beginning of period | 14,406 | 21,295 | ||||||
| Cash and cash equivalents at end of period | $ | 13,378 | $ | 22,709 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 545 | $ | 603 |
M. Wilson, In-Site Communications, Inc.