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.
“Our 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.
“During 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.
Third Quarter and Recent Business
Highlights
Reported 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.
Continued 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.
Increasing 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. Carglumic 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.
Acquisition 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.
FDA 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.
Third Quarter Financial Results
Net 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.
Gross Profit: Gross profit for the third
quarter of 2022 was $2.0 million compared with $0.1 million in the
prior year period.
Research 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 $1.1 million in expenses related to Biorphen® and
Rezipres® conversion projects in the prior year period, and
decreased development costs for new product candidates.
General 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.
Net 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.
Cash Position: As of September 30, 2022, the
company had cash and cash equivalents of $13.4 million. The Company
expects to receive a $5.0 million milestone payment for the launch
of Zonisade during the fourth quarter.
Conference Call and Webcast Information
As previously announced, Eton Pharmaceuticals will host a its
third quarter 2022 conference call as follows:
Date |
November 10,
2022 |
Time |
4:30 p.m. ET (3:30 p.m. CT) |
Register (audio only): |
Click Here |
Webcast (live and replay): |
Click here |
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.
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.About Eton
Pharmaceuticals
Eton 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.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
Eton Pharmaceuticals, Inc. |
Condensed Statements of Operations |
(In thousands, except per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eton Pharmaceuticals, Inc. |
Condensed Balance Sheets |
(in 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eton Pharmaceuticals, Inc. |
Condensed Statements of Cash Flows |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
Nine months ended |
September 30, 2022 |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Mar 2024 to Apr 2024
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Apr 2023 to Apr 2024