Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
"In 2021, we plan to achieve important, value creating milestones in both of our HDV clinical programs," said
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 inJanuary 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 ofDecember 31, 2020 plus$47.4M from net PRV sale proceeds received inJanuary 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
The Company reported net losses of
Research and Development expenses were
General and Administrative expenses were
Total operating expenses include non-cash expenses of
As of
About
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approval. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). Outside the U.S.,
For additional information about
Note Regarding Forward-Looking Statements
This press release contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward-looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipating significant milestones in 2021, the timing of our ongoing and planned clinical development, including our ability to support the launch of a new product and ship to specialty pharmacies; the sufficiency of our cash, cash equivalents and investments to fund our operations through at least Q4 2023; our development programs for Zokinvy generally; and the potential approval of Zokinvy in jurisdictions outside of the
Investors and Media:
Email: [email protected]
Phone: 1-650-272-6138
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Condensed Consolidated Balance Sheets |
|||||||||
(in thousands) |
|||||||||
Year Ended |
Year Ended |
||||||||
|
|
||||||||
2020 |
2019(1) |
||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 28,864 |
$ 39,373 |
|||||||
Debt securities, available-for-sale |
99,976 |
55,621 |
|||||||
Prepaid expenses and other current assets |
8,966 |
5,390 |
|||||||
Total current assets |
137,806 |
100,384 |
|||||||
Property and equipment, net |
709 |
590 |
|||||||
Operating lease right-of-use assets |
1,176 |
1,654 |
|||||||
Other assets |
3,903 |
2,511 |
|||||||
Total assets |
$ 143,594 |
$ 105,139 |
|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 16,627 |
$ 16,949 |
|||||||
Other liabilities |
31,932 |
31,710 |
|||||||
Stockholders' equity |
95,035 |
56,480 |
|||||||
Total liabilities and stockholders' equity |
$ 143,594 |
$ 105,139 |
|||||||
(1) |
Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended |
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Condensed Consolidated Statements of Operations Financial Data |
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(in thousands, except per share and share amounts) |
||||||||||
Three Months Ended |
Year Ended |
|||||||||
|
|
|||||||||
(unaudited) |
||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||
Operating expenses: |
||||||||||
Research and development(1) |
$ 12,545 |
$ 11,928 |
$ 41,590 |
$ 51,791 |
||||||
General and administrative(1) |
5,418 |
4,584 |
20,559 |
17,113 |
||||||
Total operating expenses |
17,963 |
16,512 |
62,149 |
68,904 |
||||||
Loss from operations |
(17,963) |
(16,512) |
(62,149) |
(68,904) |
||||||
Interest expense |
(913) |
(888) |
(3,594) |
(3,406) |
||||||
Interest income |
75 |
475 |
704 |
2,073 |
||||||
Other income (expense), net |
(5) |
5 |
(12) |
(15) |
||||||
Net loss |
$ (18,806) |
$ (16,920) |
$ (65,051) |
$ (70,252) |
||||||
Net loss per common share: |
||||||||||
Basic and diluted |
$ (0.58) |
$ (0.69) |
$ (2.31) |
$ (3.08) |
||||||
Shares used to compute net loss per common share: |
||||||||||
Basic and diluted |
32,701,820 |
24,492,117 |
28,143,391 |
22,785,611 |
||||||
(1) |
Includes stock-based compensation expense of: |
|||||||||
Three Months Ended |
Year Ended |
|||||||||
|
|
|||||||||
2020 |
2019 |
2020 |
2019 |
|||||||
Research and development |
$ 340 |
$ 184 |
$ 1,494 |
$ 1,550 |
||||||
General and administrative |
1,097 |
1,164 |
4,479 |
4,129 |
||||||
Total stock-based compensation expense |
$ 1,437 |
$ 1,348 |
$ 5,973 |
$ 5,679 |
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