Eton Pharmaceuticals Announces Fourth Quarter and Full Year 2020 Financial Results

Pharmaceuticals Announces Fourth Quarter and Full Year 2020 Financial Results

PARK, Ill., March 16, 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 fourth quarter

and full year ended December 31, 2020 and provided an update on business progress.

was a transformational year for Eton and the momentum has continued through the start of 2021. In recent months, we have seen

two of our products commercially launched, completed an important value-creating transaction with our neurology portfolio, and

expanded our ALKINDI SPRINKLE franchise to include Canada," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "With

these recent events, we believe we have a clear pathway to achieve of our goal of profitability by the end of 2021 and we expect

to report more than $25 million of revenue in 2021."

Quarter and Recent Business Milestones

launched ALKINDI SPRINKLE in late 2020 and promotional activities have accelerated in 2021. The company's pediatric endocrinology

focused sales force has now reached a large number of the company's initial targets. In addition to virtual meetings, sales

reps are beginning to hold in-person meetings with prescribers as COVID restrictions have started to ease. The company expects

the rate of in-person meetings to increase in the coming months, which is expected to drive even greater adoption of ALKINDI SPRINKLE.

New patient starts have grown every month since launch, and the company expects the growth to continue.

to the strong initial reception to ALKINDI SPRINKLE in the United States and inbound interest from Canadian patients and physicians,

Eton acquired the Canadian rights to ALKINDI SPRINKLE in January 2021. Eton is exploring the possibility of immediately supplying

the product to patients through Canada's Special Access Program while it works on compiling the product's regulatory

application to seek formal approval from Health Canada.

Oral Liquids Transaction

February 2021, Eton announced the sale of its neurology oral liquid products to Azurity Pharmaceuticals for payments of up to

$45 million and royalties on future sales of the products. The transaction allows Eton to realize an attractive return on its

investment and still maintain an economic interest in the products' sales. In addition, Eton will no longer need to invest

in a neurology sales force in 2021, which will significantly increase near-term profitability and allow Eton's commercial

team to focus on the high-value ALKINDI SPRINKLE opportunity. The transaction is expected to result in significant cash flow in

2021, which should provide Eton with capital to continue growing its orphan drug portfolio through the acquisition of additional

has experienced steady volume growth as more hospitals have adopted the product, however, the company still expects that overall

adoption will be limited until the product is converted from an ampule to a vial container. Eton expects to submit the Prior Approval

Supplement needed to enact this container change later this year.

Alcohol Injection. The product is under review with the FDA, and Eton believes the application remains on track to be approved

by its Prescription Drug User Fee Act ("PDUFA") date of May 27, 2021.

Oral Suspension. The product is under review with the FDA and has been assigned a PDUFA date of May 29, 2021.

Oral Solution. The product is under review with the FDA and has been assigned a PDUFA date of August 6, 2021.

for Oral Suspension. The product's human factor study is ongoing and expected to be completed shortly. The company expects

the results to resubmitted to the FDA shortly, which would allow for an approval in 2021.

Injection. The product is under review with the FDA and the company expects to receive tentative approval in 2021. The company's

Paragraph IV litigation against the innovator product, Elcys, is ongoing. The application's 30-month stay expires in August

2022, which may allow the company to launch the product at-risk prior to the conclusion of litigation.

RTU Injection. The product's NDA was submitted by Eton's partner and the review is ongoing with a PDUFA date of

Eton reported revenue of $0.1 million for the fourth quarter of 2020. ALKINDI SPRINKLE revenue benefit was minimal in the

period due to the product's commercial launch occurring late in the quarter. Eton reported $0.5 million of revenue in the

fourth quarter of 2019, which was composed of initial stocking orders related to the Biorphen product launch. Full year 2020 revenue

was negatively impacted by a $0.2 million reduction due a Biorphen price change that resulted in a shelf stock adjustment for

inventory on hand with wholesale customers.

and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2020 were $3.4 million, compared to $0.2 million

in the prior year period. The fourth quarter 2020 period included a $1.4 million FDA filing fee related to the topiramate product

candidate's New Drug Application submission, expenses associated converting Biorphen into a vial, and general product development

related spending. For the full year 2020, R&D expenses were $14.1 million versus $11.6 million. The full year 2020 expense

include approximately $4.8 million related to the acquisition of rights to ALKINDI SPRINKLE and $2.9 million worth of FDA filing

General, and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2020 were $3.8 million compared

with $2.4 million in the prior year period. The increase was largely due to increased sales and marketing costs associated with

the commercialization of ALKINDI SPRINKLE and costs related to the cysteine product candidate's Paragraph IV litigation.

For the full year 2020, SG&A expenses increased to $12.8 million compared with $7.6 million in the prior year period, primarily

due to increased sales and marketing costs associated with the commercialization ALKINDI SPRINKLE and legal costs related to the

cysteine product candidate's Paragraph IV litigation.

Loss: Net loss for the fourth quarter of 2020 was $7.7 million compared with $2.7 million in the prior year period. The increase

in the net loss was largely due to increased expenses in the 2020 period. For the full year 2020, net loss was $28.0 million compared

with $18.3 million in 2019. The increase in net loss was largely due to increased expenses and lower revenue due to a one-time

licensing payment received in 2019.

Position: Eton reported cash and cash equivalents of $21.3 million as of December 31, 2020. After the end of the quarter,

Eton received $9.5 million of proceeds from its transaction with Azurity Pharmaceuticals.

Call and Webcast Information:

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 1891934. 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.

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 three FDA-approved products, including ALKINDI SPRINKLE,

Biorphen , and Alaway Preservative Free, and has six additional products that have been submitted

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.

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