Full Press Release Details
Pharmaceuticals Reports Fourth Quarter 2021 Financial Results
| - | Fourth Quarter 2021 Revenue of $6.1 million | |
| - | Fourth Quarter 2021 Net Income of $1.0 million and EPS of $0.04 |
PARK, Ill., Mar. 16, 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 fourth quarter ended December
business has never been stronger. The carglumic acid launch is tracking ahead of our initial expectations, the recently implemented co-promotion
partnership with Tolmar has accelerated growth of ALKINDI SPRINKLE , and just this week we launched another new product,
Rezipres," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "In addition, we continue to make progress with our four additional
products that have been submitted to the FDA, which should lead to even more product launches in the coming quarters," added Brynjelsen.
| Launch of Carglumic Acid tablets . In late December, Eton launched the first and only generic alternative to Carbaglu . Initial adoption of the product is ahead of Eton's original expectations. | ||
| Implementation of ALKINDI SPRINKLE co-promotion partnership with Tolmar Pharmaceuticals. By the end of January, Tolmar's 62-person commercial sales force was fully trained and promoting ALKINDI SPRINKLE. Eton has already seen an increase in new ALKINDI SPRINKLE prescriptions, and March is on pace to be the company's best month ever for new patient adds. | ||
| Launch of EPRONTIA (topiramate) oral solution. In December, Azurity Pharmaceuticals launched EPRONTIA , the first and only liquid formulation of topiramate. The launch of the product triggered a $5 million milestone payment from Azurity to Eton. | ||
| Launch of Rezipres (ready-to-use ephedrine injection). The market for ephedrine injection in the United States was $86 million in 2021 according to IQVIA. Rezipres will be promoted by XGen Pharmaceutical DJB's hospital sales force. |
launched carglumic acid in late December 2021. The product is the first and only generic version of Carbaglu .
Eton's product has been awarded Competitive Generic Therapy (CGT) designation by the U.S. Food and Drug Administration (FDA) which
provides additional market exclusivity. The company's sales force is actively promoting the product to physicians and will be exhibiting
in the coming weeks at the annual meetings for the American College of Medical Genetics and Genomics (ACMG) and the Society for Inherited
Metabolic Disorders. Initial interest in the product has been strong, with patients, physicians, and payers expressing excitement about
carglumic acid's lower price and more convenient room temperature storage. Current adoption of the product has exceeded the company's
the fourth quarter, Eton announced that it had entered into a co-promotion agreement with Tolmar Pharmaceuticals, under which Tolmar's
62-person pediatric endocrinology sales force would promote ALKINDI SPRINKLE. Tolmar's sales force became fully trained and started
promoting ALKINDI SPRINKLE in the second half of January. Tolmar's sales force has greatly increased the number of in-person physician
visits taking place, and Eton has already seen a significant increase in new patient prescriptions for the product. The company
expects the month of March to produce the highest number of monthly new patient prescriptions since the launch of ALKINDI SPRINKLE.
now has six FDA-approved commercial products in launch phase. The company also has four additional products that have been submitted
to the FDA which are expected to be approved and launched in the coming quarters.
& Rezipres Vial Conversions. Biorphen and Rezipres registration batches have successfully been manufactured in vials. Eton plans
to submit the supplement applications for both products to the FDA in the second quarter of 2022, which should allow for a launch
of vial presentations of both products in 2022.
Alcohol Injection. Eton is actively working to prepare a resubmission to the FDA that addresses all of the FDA's questions
from the Complete Response Letter and items discussed during its meeting with the FDA that took place in the fourth quarter. Eton is
confident that it will be able to fully address all of the FDA's requests and expects to have the response submitted in the coming
Oral Suspension. The UK-based contract manufacturing site was inspected by the FDA at the end of January. Eton believes the inspection
was successful and should allow for the approval of the application, however no decision timeline has been communicated to Eton. Eton
will receive a $5 million milestone payment upon the approval and launch of zonisamide.
for Suspension. Eton's partner submitted results of the product's human factor study to the FDA in the fourth
quarter of 2021 and the application has been assigned a target action date in May 2022. Eton will receive a $5 million
milestone payment upon the approval and launch of lamotrigine.
Hydrochloride Injection. Eton's paragraph IV bench trial is taking place this week in Delaware. While no timeline has been
provided for the judge's ruling, Eton expects to have a decision later this year. The 30-month stay for Eton's application
expires in August 2022.
Hydrocortisone Autoinjector. Development activities are ongoing and the product remains on pace for an expected New Drug Application
Eton reported revenue of $6.1 million for the fourth quarter of 2021. Revenue in the quarter included a $5.0 million milestone payment
from Azurity Pharmaceuticals triggered by the commercial launch of EPRONTIA. Eton reported no material revenue in the fourth quarter
and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were moderate at $0.7 million compared
to $3.4 million in the prior-year period. R&D expenses in the fourth quarter of 2020 were elevated due to a $1.4 million FDA filing
fee for topiramate oral solution, a milestone fee for the FDA filing acceptance of Rezipres, and expenses related to the Biorphen
vial and other products in development.
General and Administrative (SG&A): SG&A expenses were $3.8 million in both the fourth quarters of 2021 and 2020. Fourth
quarter 2021 expenses were slightly higher for increased compensation expenses and market research consulting along with FDA product
fees for Rezipres, offset by lower sales & marketing expenses associated with the fourth quarter 2020 launch of ALKINDI
SPRINKLE. SG&A expenses for the fourth quarter of 2021 included $0.8 million of non-cash expenses.
Income: Eton reported net income of $1.0 million for the fourth quarter of 2021, compared to a net loss of $7.7 million in
the prior-year period. Eton reported diluted earnings per share (EPS) of $0.04 in the fourth quarter of 2021, compared to ($0.32) in
the prior year period.
Position: Cash and cash equivalents were $14.4 million as of December 31, 2021. Eton received the $5.0 million EPRONTIA commercial
launch milestone payment in early January.
Call and Webcast Information:
Pharmaceuticals will host a conference call and webcast today at 7:00 p.m. ET (6:00 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 1318317. 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
Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE , Carglumic
Acid, Biorphen , Alaway Preservative Free, Rezipres , and Eprontia , and has four
additional products that have been submitted to the FDA for approval.
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.
thousands, except per share amounts)
| For the three months ended | For the years ended | |||||||||||||||
| (Unaudited) | ||||||||||||||||
| December 31, | December 31, | December 31, | December 31, | |||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Licensing revenue | $ | 5,000 | $ | - | $ | 19,000 | $ | - | ||||||||
| Product sales and royalties, net | 1,093 | 81 | 2,832 | 39 | ||||||||||||
| Total net revenues | 6,093 | 81 | 21,832 | 39 | ||||||||||||
| Cost of sales: | ||||||||||||||||
| Licensing revenue | - | - | 1,500 | - | ||||||||||||
| Product sales and royalties | 280 | 300 | 1,123 | 286 | ||||||||||||
| Total cost of sales | 280 | 300 | 2,623 | 286 | ||||||||||||
| Gross profit (loss) | 5,813 | (219 | ) | 19,209 | (247 | ) | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 681 | 3,401 | 6,235 | 14,104 | ||||||||||||
| General and administrative | 3,818 | 3,800 | 14,469 | 12,760 | ||||||||||||
| Total operating expenses | 4,499 | 7,201 | 20,704 | 26,864 | ||||||||||||
| Income (loss) from operations | 1,314 | (7,420 | ) | (1,495 | ) | (27,111 | ) | |||||||||
| Other (expense) income: | ||||||||||||||||
| Interest and other expense, net | (275 | ) | (267 | ) | (1,006 | ) | (859 | ) | ||||||||
| Gain on PPP loan forgiveness | - | - | 365 | - | ||||||||||||
| Gain on equipment sale | - | - | 181 | - | ||||||||||||
| Income (loss) before income tax expense | 1,039 | (7,687 | ) | (1,955 | ) | (27,970 | ) | |||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net income (loss) | $ | 1,039 | $ | (7,687 | ) | $ | (1,955 | ) | $ | (27,970 | ) | |||||
| Net income (loss) per share, basic | $ | 0.04 | $ | (0.32 | ) | $ | (0.08 | ) | $ | (1.33 | ) | |||||
| Net income (loss) per share, diluted | $ | 0.04 | $ | (0.32 | ) | $ | (0.08 | ) | $ | (1.33 | ) | |||||
| Weighted average number of common shares outstanding, basic | 25,285 | 23,809 | 25,207 | 21,010 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 25,957 | 23,809 | 25,207 | 21,010 |
Pharmaceuticals, Inc.
thousands, except share and per share amounts)
| December 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,406 | $ | 21,295 | ||||
| Accounts receivable, net | 5,471 | 48 | ||||||
| Inventories | 550 | 1,242 | ||||||
| Prepaid expenses and other current assets | 3,177 | 2,116 | ||||||
| Total current assets | 23,604 | 24,701 | ||||||
| Property and equipment, net | 115 | 811 | ||||||
| Intangible assets, net | 3,621 | 575 | ||||||
| Operating lease right-of-use assets, net | 104 | 192 | ||||||
| Other long-term assets, net | 21 | 40 | ||||||
| Total assets | $ | 27,465 | $ | 26,319 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,774 | $ | 2,344 | ||||
| Current portion of long-term debt | 1,418 | - | ||||||
| PPP loan, current portion | - | 280 | ||||||
| Accrued liabilities | 1,366 | 1,170 | ||||||
| Total current liabilities | 4,558 | 3,794 | ||||||
| Long-term debt, net of discount and including accrued fees | 5,262 | 6,532 | ||||||
| Long-term portion of PPP and EIDL loans | - | 231 | ||||||
| Operating lease liabilities, net of current portion | 15 | 99 | ||||||
| Total liabilities | 9,835 | 10,656 | ||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value; 50,000,000 shares authorized; 24,626,004 and 24,312,808 shares issued and outstanding at December 31, 2021 and 2020, respectively | 25 | 24 | ||||||
| Additional paid-in capital | 111,718 | 107,797 | ||||||
| Accumulated deficit | (94,113 | ) | (92,158 | ) | ||||
| Total stockholders' equity | 17,630 | 15,663 | ||||||
| Total liabilities and stockholders' equity | $ | 27,465 | $ | 26,319 |
Pharmaceuticals, Inc.
| Year ended December 31, 2021 | Year ended December 31, 2020 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (1,955 | ) | $ | (27,970 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 3,381 | 2,576 | ||||||
| Common stock issued for product candidate licensing rights | - | 1,264 | ||||||
| Depreciation and amortization | 462 | 651 | ||||||
| Debt discount amortization | 148 | 121 | ||||||
| Gain on forgiveness of PPP loan | (365 | ) | - | |||||
| Gain on sale of equipment | (181 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (5,423 | ) | 425 | |||||
| Inventories | 692 | (862 | ) | |||||
| Prepaid expenses and other assets | (1,026 | ) | (20 | ) | ||||
| Accounts payable | (570 | ) | 1,769 | |||||
| Accrued liabilities | 116 | (300 | ) | |||||
| Net cash used in operating activities | (4,721 | ) | (22,346 | ) | ||||
| Cash used in investing activities | ||||||||
| Proceeds from sale of equipment | 700 | - | ||||||
| Purchases of property and equipment | (9 | ) | (50 | ) | ||||
| Purchase of product licensing rights | (3,250 | ) | - | |||||
| Net cash used in financing activities | (2,559 | ) | (50 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from sales of common stock, net of offering costs | - | 28,782 | ||||||
| Proceeds from issuance of long-term debt, net of issuance costs | - | 1,965 | ||||||
| EIDL loan payoff | (150 | ) | - | |||||
| Proceeds from PPP and EIDL loans | - | 511 | ||||||
| Proceeds from employee stock purchase plan and stock option exercises | 541 | 367 | ||||||
| Net cash provided by financing activities | 391 | 31,625 | ||||||
| Change in cash and cash equivalents | (6,889 | ) | 9,229 | |||||
| Cash and cash equivalents at beginning of period | 21,295 | 12,066 | ||||||
| Cash and cash equivalents at end of period | $ | 14,406 | $ | 21,295 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Cash paid for interest | $ | 815 | $ | 797 | ||||
| Cash paid for income taxes | $ | - | $ | - | ||||
| Supplemental disclosure of non-cash investing and financing activity | ||||||||
| Relative fair value of common stock warrants issued in connection with debt | $ | - | $ | 94 | ||||
| Right-of-use assets obtained in exchange for lease liabilities | $ | - | $ | 195 |