Full Press Release Details
Eton Pharmaceuticals Reports First Quarter 2022
DEER PARK, Ill., May 12, 2022 (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, 2022.
"We are proud to report our fifth straight
quarter of sequential growth in product sales. We expect this growth to continue for the foreseeable future as our commercial products
are still in the early stages of launch, and we expect many additional product launches later this year," said Sean Brynjelsen,
CEO of Eton Pharmaceuticals. "In addition to the strong commercial results, we have recently made significant progress
on the development side with the approval of cysteine injection and the FDA submission for our Biorphen vial product candidate,"
Major Business Highlights
| Reported a fifth straight quarter of sequential growth in product sales and royalty revenue. For the first quarter of 2022, Eton reported revenue of $2.2 million from product sales and royalties, representing a 100% increase from the fourth quarter of 2021. | ||
| Received final approval for cysteine injection. In April, the U.S. Food and Drug Administration (FDA) approved Eton's abbreviated new drug application for cysteine injection. The product-related Paragraph IV trial occurred in March 2022, and a judge's decision is expected by August 2022. If the outcome is successful, Eton plans to launch the product shortly after the judge's decision. | ||
| Submitted Prior Approval Supplement for Biorphen vial. The supplement to add the vial container system was submitted in April 2022. The FDA has assigned an August 2022 target action date for the submission. | ||
| Announcing development of Biorphen (phenylephrine) premix bag. Eton announced the development of a Biorphen premix bag. The product offering would address a significant unmet need in the market. Currently, many hospitals purchase premixed phenylephrine from compounding pharmacies. The product's New Drug Application (NDA) is expected to be submitted in the third quarter of 2022. |
Eton's carglumic acid product launched in late-December
2021 and has received a favorable reception from patients and physicians. Patients appreciate the product's room-temperature
stability compared to the competing product's refrigeration requirement. Numerous patients initiated treatment with carglumic acid
in the first quarter, and more have initiated since the quarter end. Eton continues to believe it can capture 25-35% market share before
the end of the year. The current market is estimated to be more than $50 million annually.
ALKINDI SPRINKLE continues to grow and reported
record quarterly revenue. More new patients initiated ALKINDI SPRINKLE in the first quarter than any other quarter since the launch
of the product. Eton's co-promotion agreement with Tolmar Pharmaceuticals was fully implemented in January, which positively impacted
product growth in the first quarter.
ALKINDI SPRINKLE and carglumic acid continue
to see strong growth and both posted record monthly revenue in April.The company expects 2022 revenue of at least $25 million, including
$10 million of milestone payments and $15 million of product sales and royalties.
Eton now has seven FDA-approved products, six of which
are being commercialized and are in launch phase. The company also has three additional products that have been submitted to the FDA,
which are expected to be approved and launched in the coming quarters.
Biorphen (phenylephrine) Premix for Injection.
Eton announced the development of a premix Biorphen bag product candidate. The company believes this product would address a significant
unmet need and large market opportunity. Currently, hospitals frequently purchase premixed bags from compounding pharmacies. Eton
expects the NDA for the product candidate to be submitted by the third quarter of 2022.
Zonisamide Oral Suspension. In April, the
product's contract manufacture received notice that the January 2022 FDA site inspection has been officially closed and
the facility was deemed ready for commercial manufacturing. As a result, Eton expects the application to be approved on its newly assigned
PDUFA date of July 18th.
Lamotrigine for Suspension. Eton's partner
submitted the product-related human factors study results to the FDA in the fourth quarter of 2021, and the application has been assigned
a PDUFA date of May 30th.
Biorphen Vial. The Prior Approval Supplement
for Biorphen vials has been submitted to the FDA and the application has been assigned a target action date of August 4, 2022.
Rezipres Vial. The Prior Approval Supplement
for Rezipres vials is expected to be submitted to the FDA later this month.
Dehydrated Alcohol Injection. Eton continues
to work on addressing the FDA's requests regarding the dehydrated alcohol injection product application. Eton had additional communications
with the agency earlier this month and remains confident that all requests received from the agency are addressable.
Zeneo Hydrocortisone Autoinjector. Development
activities are ongoing, and the product remains on pace for an expected New Drug Application submission in 2023.
Revenue: Eton reported product sales and royalty
revenue of $2.2 million for the first quarter of 2022, compared with $0.4 million in the prior year period. The revenue increase was primarily
due to growth in ALKINDI SPRINKLE and the launch of carglumic acid and Rezipres . Eton reported no licensing revenue in the first
quarter of 2022, compared with $11.5 million in the prior year period.
Research and Development (R&D) Expenses:
R&D expenses for the first quarter of 2022 were $1.6 million compared with $0.9 million in the prior year period. R&D
expenses in the first quarter of 2022 included a $0.5 million milestone related to the Zeneo hydrocortisone autoinjector.
Selling, General and Administrative (SG&A):
SG&A expenses were $4.9 million in the first quarter of 2022, compared to $4.1 million in the prior year quarter. The increased
expenses were driven by higher compensation expenses to support sales and quality assurance on commercial products as well as legal expenses
associated with the cysteine Paragraph IV trial.
Net Income: Eton reported a net loss of $5.3
million for the first quarter of 2022, compared with a net income of $5.1 million in the prior year period. Eton reported diluted
earnings per share (EPS) of ($0.21) in the first quarter of 2022, compared with $0.19 in the first quarter of 2021. The prior
year period included the benefit of $11.5 million in licensing revenue.
Cash Position: Cash and cash equivalents were
$15.2 million as of March 31, 2022.
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 9537298. 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
seven FDA-approved products, including ALKINDI SPRINKLE , Carglumic Acid, Biorphen , Alaway Preservative Free, Rezipres ,
Eprontia , and cysteine injection and has three additional products that have been submitted to the FDA for approval.
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, | March 31, | |||||||
| 2022 | 2021 | |||||||
| Revenues: | ||||||||
| Licensing revenue | $ | - | $ | 11,500 | ||||
| Product sales and royalties | 2,176 | 397 | ||||||
| Total net revenues | 2,176 | 11,897 | ||||||
| Cost of sales | ||||||||
| Licensing revenue | - | 1,500 | ||||||
| Product sales and royalties | 718 | 90 | ||||||
| Total cost of sales | 718 | 1,590 | ||||||
| Gross profit | 1,458 | 10,307 | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,618 | 886 | ||||||
| General and administrative | 4,927 | 4,058 | ||||||
| Total operating expenses | 6,545 | 4,944 | ||||||
| (Loss) income from operations | (5,087 | ) | 5,363 | |||||
| Other expense: | ||||||||
| Interest and other expense, net | (243 | ) | (247 | ) | ||||
| (Loss) income before income tax expense | (5,330 | ) | 5,116 | |||||
| Income tax expense | - | - | ||||||
| Net (loss) income | $ | (5,330 | ) | $ | 5,116 | |||
| Net (loss) income per share, basic | $ | (0.21 | ) | $ | 0.21 | |||
| Net (loss) income per share, diluted | $ | (0.21 | ) | $ | 0.19 | |||
| Weighted average number of common shares outstanding, basic | 25,301 | 24,453 | ||||||
| Weighted average number of common shares outstanding, diluted | 25,301 | 26,547 |
Eton Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
| March 31, 2022 | December 31, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,229 | $ | 14,406 | ||||
| Accounts receivable, net | 796 | 5,471 | ||||||
| Inventories | 510 | 550 | ||||||
| Prepaid expenses and other current assets | 2,216 | 3,177 | ||||||
| Total current assets | 18,751 | 23,604 | ||||||
| Property and equipment, net | 109 | 115 | ||||||
| Intangible assets, net | 4,240 | 3,621 | ||||||
| Operating lease right-of-use assets, net | 84 | 104 | ||||||
| Other long-term assets, net | 12 | 21 | ||||||
| Total assets | $ | 23,196 | $ | 27,465 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,131 | $ | 1,774 | ||||
| Current portion of long-term debt | - | 1,418 | ||||||
| Accrued liabilities | 1,351 | 1,366 | ||||||
| Total current liabilities | 3,482 | 4,558 | ||||||
| Long-term debt, net of discount and including accrued fees | 6,331 | 5,262 | ||||||
| Operating lease liabilities, net of current portion | - | 15 | ||||||
| Total liabilities | 9,813 | 9,835 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized; 24,626,004 shares issued and outstanding at March 31, 2022 and December 31, 2021 | 25 | 25 | ||||||
| Additional paid-in capital | 112,801 | 111,718 | ||||||
| Accumulated deficit | (99,443 | ) | (94,113 | ) | ||||
| Total stockholders' equity | 13,383 | 17,630 | ||||||
| Total liabilities and stockholders' equity | $ | 23,196 | $ | 27,465 |