Full Press Release Details
Eton Pharmaceuticals Reports Record Revenue
DEER PARK, Ill., May 13, 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 first quarter ended March 31, 2021 and provided an update
on business progress.
"We are proud to report record revenue
and the first profitable quarter in Eton's history," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We have
begun seeing the results of the years of hard work developing our product candidates. We now have three approved and revenue generating
products, and we expect to have a number of additional products launched later this year as a result of the four upcoming PDUFA
dates over the next three months," added Brynjelsen.
Q1 Business Highlights
First quarter revenue of $11.9
million and operating income of $5.4 million. Revenue included sales or royalties received on three commercial products plus
payments related to the sale of Eton's neurology oral liquids products.
Launch of Alaway Preservative
Free. In February, Bausch Health launched Alaway Preservative Free in major U.S. retailers. Eton collected a $1.5 million launch
milestone plus a royalty on the product's sales in the first quarter.
Completed sale of neurology oral
liquid products. Eton completed the sale of its neurology portfolio to Azurity Pharmaceuticals. Eton will receive milestone
payments of up to $45 million, $9.5 million of which was received in the first quarter, and a single digit royalty on product sales.
Eton remains focused on the commercial launch
of ALKINDI SPRINKLE in the United States. The first quarter of 2021 was the first full quarter of the product's launch. The
company's sales representatives have already engaged with more than 90% of their initial targets in the pediatric endocrinology
community, and sales representatives have been met with a positive reception from physicians, nurses, and caretakers.
Although Initial sales force communications
have largely been virtual due to COVID-19 related restrictions, certain physicians' offices and hospitals have recently begun
accepting in-person meetings. Given the expectation for higher conversion rates on in-person meetings, Eton has adopted a sales
force strategy that focuses resources most heavily in states where in-person meetings are taking place, rather than the traditional
regional allocation of territories. The new strategy will allow all sales representatives to focus on maximizing in-person meetings,
even if their previously assigned geography comprises states that are not accepting in-person visits. Eton will continue to refine
the resource allocation in the coming weeks and months as additional states begin accepting in-person visits.
In April, Eton presented virtually at the Pediatric
Endocrinology Nursing Society national conference and the Pediatric Endocrinology Society annual meeting, the first two conferences
since the product's launch.
The company has seen strong adoption of ALKINDI
SPRINKLE, and prescriptions continue to grow month over month. Over 100 new patient prescriptions have been written this year,
and the company continues to work towards its goal of more than 400 new patient prescriptions by the end of the year.
Eton owns or has economic interests in six
pipeline products that are currently under review with the FDA, four of which have been assigned Prescription Drug User Fee Act
Eton expects these products to be approved
and launched later this year. In addition, given the company's strong financial position, it remains actively pursuing business
development opportunities to add high-value late-stage orphan product candidates to its portfolio.
| Current Product Portfolio & Pipeline | ||
| Product | Status | |
| ALKINDI SPRINKLE | Commercial | |
| Alaway Preservative Free | Commercial | |
| Biorphen | Commercial | |
| Dehydrated Alcohol Injection | Filed | |
| Zonisamide Oral Suspension | Filed | |
| Topiramate Oral Solution | Filed | |
| Lamotrigine for Suspension | Filed | |
| RTU Ephedrine Injection | Filed | |
| Cysteine Injection | Filed | |
| ALKINDI SPRINKLE - Canada | Pre-Filing |
Revenue: Eton reported revenue of $11.9
million for the first quarter of 2021, which included $9.5 million from the sale of its neurology oral liquid products and a $1.5
million milestone payment from Bausch Health for the launch of Alaway Preservative Free. In the prior-year period, the company
reported revenue of $0.1 million.
General and Administrative (G&A) Expenses:
G&A expenses for the first quarter of 2021 were $4.1 million compared to $2.6 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 first quarter
of 2021 included $0.7 million of non-cash expenses.
Research and Development (R&D) Expenses:
R&D expenses for the first quarter of 2021 were $0.9 million compared to $6.3 million in the prior-year period. The prior-year
period included $4.8 million of one-time licensing payments for the acquisition of marketing rights to ALKINDI SPRINKLE. Absent
any new business development transaction, the company expects full year 2021 R&D expenses to be substantially below 2020 levels.
Net Income: Eton reported net income
of $5.1 million for the first quarter of 2021, compared to a net loss of $9.0 million in the prior-year period. Eton reported diluted
earnings per share (EPS) of $0.19 in the first quarter of 2021, compared to a loss of $0.50 per share in the prior year period.
Cash Position: Eton reported cash and
cash equivalents of $25.1 million as of March 31, 2021.
Conference 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 5847989. 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.
About 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 three FDA-approved products, including ALKINDI SPRINKLE, Biorphen , and Alaway Preservative Free,
and has six additional products that have been submitted to the FDA.
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 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, Inc.
Condensed Statements of Operations
(In thousands, except per share amounts)
| For the three months ended | ||||||||
| March 31, 2021 | March 31, 2020 | |||||||
| Revenues: | ||||||||
| Licensing revenue | $ | 11,500 | $ | - | ||||
| Product sales and royalties | 397 | 99 | ||||||
| Total net revenues | 11,897 | 99 | ||||||
| Cost of sales | ||||||||
| Licensing revenue | 1,500 | - | ||||||
| Product sales and royalties | 90 | 102 | ||||||
| Total cost of sales | 1,590 | 102 | ||||||
| Gross profit (loss) | 10,307 | (3 | ) | |||||
| Operating expenses: | ||||||||
| Research and development | 886 | 6,268 | ||||||
| General and administrative | 4,058 | 2,610 | ||||||
| Total operating expenses | 4,944 | 8,878 | ||||||
| Income (loss) from operations | 5,363 | (8,881 | ) | |||||
| Other expense: | ||||||||
| Interest and other expense, net | (247 | ) | (168 | ) | ||||
| Income (loss) before income tax expense | 5,116 | (9,049 | ) | |||||
| Income tax expense | - | - | ||||||
| Net income (loss) | $ | 5,116 | $ | (9,049 | ) | |||
| Net income (loss) per share, basic | $ | 0.21 | $ | (0.50 | ) | |||
| Net income (loss) per share, diluted | $ | 0.19 | $ | (0.50 | ) | |||
| Weighted average number of common shares outstanding, basic | 24,453 | 18,143 | ||||||
| Weighted average number of common shares outstanding, diluted | 26,547 | 18,143 |
Eton Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share
| March 31, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,113 | $ | 21,295 | ||||
| Accounts receivable, net | 300 | 48 | ||||||
| Inventories | 1,348 | 1,242 | ||||||
| Equipment held-for-sale | 551 | - | ||||||
| Prepaid expenses and other current assets | 2,962 | 2,116 | ||||||
| Total current assets | 30,274 | 24,701 | ||||||
| Property and equipment, net | 176 | 811 | ||||||
| Intangible assets, net | 537 | 575 | ||||||
| Operating lease right-of-use assets, net | 163 | 192 | ||||||
| Other long-term assets, net | 36 | 40 | ||||||
| Total assets | $ | 31,186 | $ | 26,319 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,761 | $ | 2,344 | ||||
| Current portion of long-term debt | 385 | - | ||||||
| PPP loan, current portion | 341 | 280 | ||||||
| Accrued liabilities | 712 | 1,170 | ||||||
| Total current liabilities | 3,199 | 3,794 | ||||||
| Long-term debt, net of discount and including accrued fees | 6,183 | 6,532 | ||||||
| Long-term portion of PPP and EIDL loans | 170 | 231 | ||||||
| Operating lease liabilities, net of current portion | 79 | 99 | ||||||
| Total liabilities | 9,631 | 10,656 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 24,482,616 and 24,312,808 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 24 | 24 | ||||||
| Additional paid-in capital | 108,573 | 107,797 | ||||||
| Accumulated deficit | (87,042 | ) | (92,158 | ) | ||||
| Total stockholders' equity | 21,555 | 15,663 | ||||||
| Total liabilities and stockholders' equity | $ | 31,186 | $ | 26,319 |
Eton Pharmaceuticals, Inc.
Condensed Statements of Cash Flows