Full Press Release Details
Pharmaceuticals Reports Second Quarter Financial Results
PARK, Ill., Aug 16, 2021 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused
on developing and commercializing treatments for rare diseases, today reported financial results for the second quarter ended June 30,
the second quarter we received FDA-approval for Rezipres , which is now the fourth FDA-approved product in our portfolio,"
said Sean Brynjelsen CEO of Eton Pharmaceuticals. "We look forward to launching Rezipres in the coming months. We also expanded
our pediatric endocrinology portfolio with the acquisition of U.S. and Canadian rights to the ZENEO Hydrocortisone autoinjector.
ZENEO Hydrocortisone is a terrific strategic fit with ALKINDI SPRINKLE, and we look forward to working with Crossject to bring it to
market as quickly as possible."
Quarter Business Highlights
| - | Received U.S. Food and Drug Administration (FDA) approval of Rezipres , a ready-to-use formulation of ephedrine injection. Eton expects the product to be commercially available in the coming months. | |
| - | Acquired U.S. and Canadian rights to ZENEO Hydrocortisone autoinjector. The product candidate is expected to be the first needle-free autoinjector for the treatment of adrenal crisis. Eton expects the product to be submitted to the FDA in 2023. | |
| - | Progressed ALKINDI SPRINKLE commercial launch. ALKINDI SPRINKE launch activities expanded in the quarter as the company was able to shift from virtual meetings to in-person meetings with physicians and industry leaders. The product continues to receive a favorable reception from physicians, patients, and payers. |
second quarter of 2021 was ALKINDI SPRINKLE's second full quarter of commercial launch. Eton continues to see increasing adoption
of the product, and the number of patients on treatment has grown month over month. As a result of fewer COVID-19 restrictions during
the quarter, the ALKINDI SPRINKLE sales force was able to prioritize in-person meetings for the first time since the product's
launch. In-person meetings are now the primary method of engagement, surpassing telephone and video calls in the quarter. As a result
of favorable feedback from the in-person meetings, Eton expects to expand its sales force to drive more frequent engagement with physicians
and potentially faster patient conversion.
SPRINKLE has received favorable support from payers that recognize the importance of precision dosing in the treatment of adrenal insufficiency.
The company has seen a very high rate of new patients converting from initial quick starts to commercial reimbursement. Currently more
than 90% of patients on treatment are being reimbursed.
the quarter Eton expanded its active engagement with the adrenal insufficiency community. The company sponsored continuing medical education
programs for healthcare professionals to raise awareness of the significant risks and lifelong side effects associated with over or
under-dosing when treating adrenal insufficiency in pediatric patients. Eton continues to work with key advocacy partners to help raise
awareness of adrenal insufficiency and is hosting an advisory panel with key opinion leaders in the adrenal insufficiency community in
| Current Product Portfolio & Pipeline | ||
| Product | Status | |
| ALKINDI SPRINKLE | Commercial | |
| Alaway Preservative Free | Commercial | |
| Biorphen | Commercial | |
| Rezipres | Approved | |
| Topiramate Oral Solution | Filed | |
| Dehydrated Alcohol Injection | Filed | |
| Zonisamide Oral Solution | Filed | |
| Lamotrigine for Suspension | Filed | |
| Cysteine Injection | Filed | |
| ALKINDI (Canada) | Under Development | |
| ZENEO Hydrocortisone Autoinjector | Under Development |
Oral Solution. The topiramate product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible
for all regulatory activities. During the quarter, Azurity submitted responses to the FDA's review questions which the FDA deemed
to be an amendment to the application and resulted in the FDA extending the application's PDUFA date to November 6, 2021. Eton
believes all FDA requests have been responded to and expects the application to be approved on or before the new PDUFA date. The product's
U.S. manufacturing site was successfully inspected by the FDA in August 2020, so Eton does not expect a pre-approval inspection to be
required for the application review.
Alcohol Injection. Eton expects to submit an application amendment to the FDA in the coming months that fully addresses the agency's
complete response letter and could allow for FDA approval in early 2022.
Oral Solution. The zonisamide product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible
for all regulatory activities. Azurity has submitted a formal response to the FDA's complete response letter; however, the potential
timing of an inspection of the product's foreign manufacturing site remains unknown.
for Suspension. The lamotrigine product candidate was sold to Azurity Pharmaceuticals in February 2021. Azurity is now responsible
for all regulatory activities. The third and final arm of the human factor study has now been enrolled. The study is expected
to be completed and submitted to the FDA before the end of 2021.
Injection. The product's paragraph IV litigation remains ongoing and the company remains confident in a successful outcome.
Eton reported revenue of $3.1 million for the second quarter of 2021. Revenue included $2.5 million of licensing revenue related to the
company's previously announced transaction with Azurity. In the prior-year period, the company did not have any material revenue.
and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2021 were $3.3 million compared to $2.9 million
in the prior-year period. The increase was largely due to increased costs related to the commercialization of ALKINDI SPRINKLE. G&A
expenses for the second quarter of 2021 included $0.7 million of non-cash expenses.
and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were $2.0 million compared to $1.6 million in
the prior-year period. R&D expenses included $0.5 million related to the acquisition of U.S. and Canadian rights to ZENEO Hydrocortisone
Income: Eton reported a net loss of $2.0 million for the second quarter of 2021, compared to a net loss of $4.7 million in the prior-year
period. Eton reported diluted earnings per share (EPS) of ($0.08) in the second quarter of 2021, compared to ($0.23) in the prior year
Position: Cash and cash equivalents were $25.8 million as of June 30, 2021.
Call and Webcast Information:
Eton 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
dial 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 2454465. 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
Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The company currently owns or receives royalties from four FDA-approved products, including ALKINDI SPRINKLE, Biorphen , Alaway
Preservative Free, and Rezipres and has five additional products that have been submitted to the FDA.
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 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.
Pharmaceuticals, Inc.
Statements of Operations
thousands, except per share amounts)
| For the three months ended | For the six month s ended | |||||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | 2,500 | $ | - | $ | 14,000 | $ | - | ||||||||
| Product sales and royalties | 567 | 20 | 964 | 119 | ||||||||||||
| Total net revenues | 3,067 | 20 | 14,964 | 119 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | - | - | 1,500 | - | ||||||||||||
| Product sales and royalties | 136 | 28 | 226 | 130 | ||||||||||||
| Total cost of sales | 136 | 28 | 1,726 | 130 | ||||||||||||
| Gross profit (loss) | 2,931 | (8 | ) | 13,238 | (11 | ) | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,990 | 1,609 | 2,876 | 7,877 | ||||||||||||
| General and administrative | 3,266 | 2,921 | 7,324 | 5,531 | ||||||||||||
| Total operating expenses | 5,256 | 4,530 | 10,200 | 13,408 | ||||||||||||
| (Loss) income from operations | (2,325 | ) | (4,538 | ) | 3,038 | (13,419 | ) | |||||||||
| Other (expense) income: | ||||||||||||||||
| Interest and other expense, net | (237 | ) | (192 | ) | (484 | ) | (360 | ) | ||||||||
| Gain on PPP loan forgiveness | 365 | - | 365 | - | ||||||||||||
| Gain on equipment sale | 181 | - | 181 | - | ||||||||||||
| (Loss) income before income tax expense | (2,016 | ) | (4,730 | ) | 3,100 | (13,779 | ) | |||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net (loss) income | $ | (2,016 | ) | $ | (4,730 | ) | $ | 3,100 | $ | (13,779 | ) | |||||
| Net loss (income) per share, basic | $ | (0.08 | ) | $ | (0.23 | ) | $ | 0.12 | $ | (0.70 | ) | |||||
| Net loss (income) per share, diluted | $ | (0.08 | ) | $ | (0.23 | ) | $ | 0.12 | $ | (0.70 | ) | |||||
| Weighted average number of common shares outstanding, basic | 25,211 | 21,005 | 25,133 | 19,574 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 25,211 | 21,005 | 26,486 | 19,574 |
Pharmaceuticals, Inc.
thousands, except share and per share amounts)
| June 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,802 | $ | 21,295 | ||||
| Accounts receivable, net | 303 | 48 | ||||||
| Inventories | 1,242 | 1,242 | ||||||
| Prepaid expenses and other current assets | 1,728 | 2,116 | ||||||
| Total current assets | 29,075 | 24,701 | ||||||
| Property and equipment, net | 156 | 811 | ||||||
| Intangible assets, net | 500 | 575 | ||||||
| Operating lease right-of-use assets, net | 143 | 192 | ||||||
| Other long-term assets, net | 32 | 40 | ||||||
| Total assets | $ | 29,906 | $ | 26,319 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,522 | $ | 2,344 | ||||
| Current portion of long-term debt | 749 | - | ||||||
| PPP loan, current portion | - | 280 | ||||||
| Accrued liabilities | 835 | 1,170 | ||||||
| Total current liabilities | 3,106 | 3,794 | ||||||
| Long-term debt, net of discount and including accrued fees | 5,856 | 6,532 | ||||||
| Long-term portion of PPP and EIDL loans | 150 | 231 | ||||||
| Operating lease liabilities, net of current portion | 58 | 99 | ||||||
| Total liabilities | 9,170 | 10,656 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 24,600,175 and 24,312,808 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 25 | 24 | ||||||
| Additional paid-in capital | 109,769 | 107,797 | ||||||
| Accumulated deficit | (89,058 | ) | (92,158 | ) | ||||
| Total stockholders' equity | 20,736 | 15,663 | ||||||
| Total liabilities and stockholders' equity | $ | 29,906 | $ | 26,319 |
Pharmaceuticals, Inc.
Statements of Cash Flows
| Six months ended June 30, 2021 | Six months ended June 30, 2020 | |||||||
| Cash flows from operating activities | ||||||||
| Net income (loss) | $ | 3,100 | $ | (13,779 | ) | |||
| Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||
| Stock-based compensation | 1,509 | 1,079 | ||||||
| Common stock issued for product candidate licensing rights | - | 1,264 | ||||||
| Depreciation and amortization | 240 | 326 | ||||||
| Debt discount amortization | 73 | 50 | ||||||
| Gain on forgiveness of debt | (365 | ) | - | |||||
| Gain on sale of equipment | (181 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (255 | ) | 473 | |||||
| Inventories | - | (1,329 | ) | |||||
| Prepaid expenses and other assets | 419 | 1,251 | ||||||
| Accounts payable | (822 | ) | 1,378 | |||||
| Accrued liabilities | (372 | ) | (783 | ) | ||||
| Net cash provided by (used in) operating activities | 3,346 | (10,070 | ) | |||||
| Cash provided by (used in) investing activities | ||||||||
| Proceeds from sale of equipment | 700 | - | ||||||
| Purchases of property and equipment | (3 | ) | (4 | ) | ||||
| Net cash provided by (used in) financing activities | 697 | (4 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from sales of common stock, net of offering costs | - | 7,756 | ||||||
| Proceeds from PPP loan | - | 361 | ||||||
| Proceeds from employee stock purchase plan and stock option exercises | 464 | 161 | ||||||
| Net cash provided by financing activities | 464 | 8,278 | ||||||
| Change in cash and cash equivalents | 4,507 | (1,796 | ) | |||||
| Cash and cash equivalents at beginning of period | 21,295 | 12,066 | ||||||
| Cash and cash equivalents at end of period | $ | 25,802 | $ | 10,270 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 424 | $ | 358 | ||||
| Cash paid for income taxes | $ | - | $ | - |