Life Science Company News

Eton Pharmaceuticals Reports Record Revenue and Earnings

  • First quarter 2021 revenue of $11.9 million
  • First quarter 2021 operating earnings of $5.4 million; EPS of $0.19
  • Eton now has three commercial, revenue-generating products

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.

ALKINDI® SPRINKLE

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.

Pipeline Update

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 (PDUFA) dates:

  • May 27: Dehydrated Alcohol Injection
  • May 29: Zonisamide Oral Suspension
  • June 18: Ready-to-Use Ephedrine Injection
  • August 6: Topiramate Oral Solution

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
ProductStatus
ALKINDI® SPRINKLECommercial
Alaway® Preservative FreeCommercial
Biorphen®Commercial
Dehydrated Alcohol InjectionFiled
Zonisamide Oral SuspensionFiled
Topiramate Oral SolutionFiled
Lamotrigine for SuspensionFiled
RTU Ephedrine InjectionFiled
Cysteine InjectionFiled
ALKINDI® SPRINKLE - CanadaPre-Filing


Financial Results

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)
(Unaudited)
 
  For the three months ended
  March 31,  March 31,
  2021  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 amounts)
 
  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
(In thousands)
(Unaudited)
 
  Three months ended
March 31, 2021
 
 Three months ended
March 31, 2020
Cash flows from operating activities        
Net income (loss) $5,116  $(9,049)
         
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
Stock-based compensation  673   365 
Common stock issued for product candidate licensing rights     1,264 
Depreciation and amortization  155   162 
Debt discount amortization  36 
By: GlobenewsWire - 13 May 2021
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