On March 9, 2021 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical stage company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, reported financial results for fourth quarter and full year 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 9, 2021, View Source [SID1234576353]).
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"In 2021, we plan to achieve important, value creating milestones in both of our HDV clinical programs," said David Cory, President and CEO of Eiger. "We will complete enrollment of the Phase 3 D-LIVR study of Lonafarnib, the first and only oral agent in development for HDV, and we will initiate the Phase 3 LIMT-2 study of Lambda, a well-tolerated interferon. Lonafarnib and Lambda are potential foundational treatments for HDV that will offer convenience and optionality for patients affected by this serious disease."
Program & Product Updates
Lonafarnib for HDV
First and only oral therapy in development for HDV
Global Phase 3 D-LIVR study enrollment completion planned in 2021
Peginterferon Lambda for HDV
Well-tolerated interferon with weekly subcutaneous injection
Global Phase 3 LIMT-2 study initiation planned in 2021
Zokinvy (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies
U.S. commercial launch in January 2021
EMA decision expected in 2H21
Lambda for COVID-19
Positive Phase 2 ILIAD study in Lancet Respiratory Medicine (Feld et al, 2021)
Considering strategic options to advance program
Avexitide for Post-Bariatric Hypoglycemia (PBH)
Positive Phase 2 PREVENT study published in JCEM (Craig et al, 2021)
Corporate
Pro-forma cash, cash equivalents and investments of $176.2M, including $128.8M as of December 31, 2020 plus $47.4M from net PRV sale proceeds received in January 2021, expected to fund planned operations through Q4 2023
Fourth Quarter and Full Year 2020 Financial Results
Cash, cash equivalents, and short-term investments as of December 31, 2020 totaled $128.8 million compared to $95.0 million on December 31, 2019. In addition, the Company received net proceeds of $47.4 million in January 2021 for sale of a Priority Review Voucher (PRV) issued in conjunction with FDA approval of Zokinvy.
The Company reported net losses of $18.8 million, or $0.58 per share, and $65.1 million, or $2.31 per share, for fourth quarter and full year 2020, respectively, as compared to $16.9 million, or $0.69 per share, and $70.3 million, or $3.08 per share, for the same periods in 2019.
Research and Development expenses were $12.5 million and $41.6 million for fourth quarter and full year 2020, respectively, as compared to $11.9 million and $51.8 million for the same periods in 2019. The increase in fourth quarter 2020 was primarily due to an increase in regulatory expenses. The decrease in full year 2020 expenses was primarily due to a decrease in contract manufacturing and clinical expenditures, partially offset by an increase in regulatory, headcount related, and other operating expenses.
General and Administrative expenses were $5.4 million and $20.6 million for fourth quarter and full year 2020, respectively, as compared to $4.6 million and $17.1 million for the same periods in 2019. The increases in fourth quarter 2020 and full year 2020 were primarily due to an increase in personnel related expenses attributed to an increase in headcount and an increase in outside services, including consulting and advisory services.
Total operating expenses include non-cash expenses of $2.1 million and $7.8 million for fourth quarter and full year 2020, respectively, as compared to $1.6 million and $6.6 million for the same periods in 2019.
As of December 31, 2020, the company had 33.9 million of common shares outstanding.