DEER PARK, Ill., March 05, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today reported financial results for the fourth quarter ended December 31, 2019 and provided an update on business progress.
“2019 was an important year for Eton. Our team achieved a number of major milestones in the advancement of our pipeline, the most significant of which was the approval and launch of Biorphen, our first commercial product,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We are excited to transition to a commercial revenue company and we look forward to earning additional product approvals in 2020.”FDA approval and commercial Launch of Biorphen. Biorphen, Eton’s first commercial product, was launched in December. More than 100 different institutions have already placed orders for Biorphen.DS-300 ANDA filing. In December, Eton submitted an ANDA for DS-300. The application was accepted for review and was confirmed to be the first-to-file ANDA against the innovator product. The innovator product represents an estimated market size of more than $60 million.EM-100 amendment submitted. In December, Eton’s licensing partner submitted an amendment to the EM-100 application in response to the Complete Response Letter received in July 2019. Eton believes the amendment fully addressed all issues raised by the FDA and expects EM-100 to be approved in 2020.
Biorphen Commercial Launch UpdateEM-100. In December, the company’s licensing partner, Bausch Health, submitted an amendment to the EM-100 product application, and Eton believes the amendment fully addresses all issues raised by the FDA in the July 2019 Complete Response Letter (CRL). The amendment was classified as a major amendment and was assigned a Generic Drug User Fee Act(GDUFA) target action date in August 2020.Cost of Product Sales: Cost of product sales for the fourth quarter of 2019 was $0.5 million. The expense consisted primarily of profit share payments made to Eton’s licensing partner on Biorphen. Under terms of the licensing agreement, Eton’s partner was entitled to receive the first $0.5 million of profit from commercialization of the product. Cost of product sales for the full year 2019 was $0.5 million. There was no cost of product sales associated with the $0.5 million milestone payment received from Bausch Health.Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2019 totaled $0.2 million compared with $1.1 million in the fourth quarter of 2018. R&D expenses in the fourth quarter of 2019 were reduced by $1.0 million due to Eton receiving a refund of its original licensing payment for ET-203. The $1.0 million licensing payment had originally been expensed in the first quarter of 2019.For the full year 2019, R&D expenses were $11.6 million compared to $5.6 million for the full year 2018. The increase was primarily driven by $4.0 million of total expenses for the initial licensing payments for Biorphen (ET-202) and ET-105, as well as increased headcount and operation costs associated with the company’s research and development lab that was opened in late-2018.Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2019 were $2.4 million compared with $1.2 million in the fourth quarter of 2018. The increase was primarily due to increased sales, marketing and distribution costs associated with the commercialization of Biorphen, higher employee-related costs from increased headcount, and higher expenses associated with being a public company.For the full year 2019, SG&A expenses were $7.6 million compared to $4.7 million for the full year 2018. The increase was primarily due to higher employee-related costs from increased headcount, increased expenses associated with being a public company, and costs associated with the commercialization of Biorphen.Net Loss: Net loss for the fourth quarter of 2019 was $2.7 million compared with $2.3 million in the fourth quarter of 2018. The increase was driven by higher SG&A expenses, partially offset by reduced R&D expenses.For the full year 2019, net loss was $18.3 million compared with $12.7 million for the full year 2018. The increased loss was driven by increased SG&A and R&D expenses in 2019.Cash Position: As of December 31, 2019, Eton reported cash and cash equivalents of $12.1 million.
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 5119269. 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, Inc.
Statements of Operations
(In thousands, except per share amounts)
Eton Pharmaceuticals, Inc.
BALANCE SHEETS
(in thousands, except share and per share amounts)Eton Pharmaceuticals, Inc.
STATEMENTS OF CASH FLOWS
(In thousands)Investor Contact:
David Krempa
[email protected]
847-805-1077
Bay Street News