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Eton Pharmaceuticals Reports First Quarter 2022 Financial Results

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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,” added Brynjelsen.

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.

Commercial Update

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.

Portfolio Update

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.


Financial Results

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)
(Unaudited)
 
  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 


Eton Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
      
  Three months ended
March 31, 2022
 Three months ended
March 31, 2021
 
Cash flows from operating activities       
Net (loss) income $(5,330) $5,116 
        
Adjustments to reconcile net (loss) income to net cash provided by
operating activities:
       
Stock-based compensation  1,083   673 
Depreciation and amortization  181   155 
Debt discount amortization  36   36 
Changes in operating assets and liabilities:       
Accounts receivable  4,675   (252)
Inventories  40   (106)
Prepaid expenses and other assets  961   (846)
Accounts payable  (393)  (583)
Accrued liabilities  (30)  (478)
Net cash provided by operating activities  1,223   3,715 
        
Cash used in investing activities       
Purchases of property and equipment  (15)   
Net cash used in investing activities  (15)   
        
Cash flows from financing activities       
Repayment of long-term debt  (385)   
Proceeds from employee stock option exercises     103 
Net cash (used in) provided by financing activities  (385)  103 
        
Change in cash and cash equivalents  823   3,818 
Cash and cash equivalents at beginning of period  14,406   21,295 
Cash and cash equivalents at end of period $15,229  $25,113 
        
Supplemental disclosures of cash flow information       
Cash paid for interest $215  $214 
Cash paid for income taxes $  $ 
        
Supplemental disclosures of non-cash investing activities:       
Payable for product license fee $750  $ 
         

Investor Contact:

David Krempa
dkrempa@etonpharma.com 
612-387-3740


Eton Pharmaceuticals Inc

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About ETON

eton pharmaceuticals, inc. is a deer park, illinois-based pharmaceutical company focused on developing and commercializing innovative pharmaceutical products utilizing the u.s. food and drug administration’s 505(b)(2) regulatory pathway. our mission is to advance healthcare through the introduction of innovative medicines that are affordable and available to all patients.