Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
- Phase 3 COVID-19 TOGETHER (Lambda) Study Data in
March 2022 - Phase 3 HDV D-LIVR (Lonafarnib) Study Topline Data Planned by End of 2022
- Phase 3 HDV LIMT-2 (Lambda) Study Enrolling
- Strong Cash Position of Approximately
$106 Million as of12/31/21 - Company to Host Conference Call Today at
4:30 PM ET
"We expect 2022 to be a transformational year for
Program Highlights
Lonafarnib: Oral Prenylation Inhibitor for HDV
- D-LIVR Phase 3 multi-center, global study
- Two Lonafarnib-based regimens, both with potential for registration
- Lonafarnib oral and Lonafarnib / peginterferon alfa combination
- Fully enrolled N=407, with topline data planned by end of 2022
- D-LIVR study design includes conservative powering assumptions, modeling response rates well below what was demonstrated in Phase 2
Ukraine and Russia UpdateUkraine :Eiger continues to closely assess this evolving situation, prioritizing patient care and patient monitoring to ensure continuity in the studyEiger believes the study remains more than adequately powered to demonstrate statistical significance over placebo even if these patients discontinue from studyRussia :- To date, no interruption to patient visits, safety monitoring, or drug supply; contingency plans in place to ensure continuity of drug supply, sample storage and analysis to preserve integrity of results
Peginterferon Lambda: Well-tolerated Interferon for HDV
- LIMT-2 Phase 3 multi-center, global study
- Peginterferon Lambda monotherapy for registration
- Enrolling patients, targeting N=150
Peginterferon Lambda and Lonafarnib Combination for HDV
- LIFT-2 Phase 2 study at
National Institutes of Health - Initiating 1H22, targeting N=30
- Potential to be interferon of choice in HDV combination therapies
Peginterferon Lambda for Non-hospitalized COVID-19 Infection
- Novel mechanism of action, agnostic to variants and mutations
- TOGETHER Phase 3 study fully enrolled, N>1,800
- Includes unvaccinated and vaccinated patients across multiple variants
- Topline data planned in
March 2022
Avexitide for Rare Metabolic Disorders
- Granted Breakthrough Therapy Designation for Congenital Hyperinsulinism (HI)
- Granted Rare Pediatric Disease Designation for HI; PRV eligible
- Phase 3 ready in 2022
Zokinvy® for Progeria and Processing-Deficient Progeroid Laminopathies
- Successful
U.S. commercial launch - Approximately 80% of identified
U.S. patients converted to commercial supply - EMA review of MAA
- CHMP opinion expected in first half of 2022
Corporate
- Cash, cash equivalents and investments of
$106.1 million to begin 2022 expected to fund planned operations through Q3 2023
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents, and total investments as of
Net product sales of Zokinvy were
Cost of Sales was
Research and Development expenses were
Selling, General and Administrative expenses were
Total operating expenses include non-cash expenses of
The Company reported net losses of
As of
CONFERENCE CALL
At
About
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipated significant milestones in 2022; the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; expectations regarding the timing and availability of topline data from our Phase 3 D-LIVR study in HDV; the ability to fully enroll the Phase 3 LIMT-2 study; initiating a Phase 3 study for avexitide in congenital hyperinsulinism; the approval of Zokinvy in jurisdictions outside of the
Investors:
Sri Ryali – CFO
[email protected]
[email protected]
Media:
Aljanae Reynolds –
[email protected]
|
|||||
Condensed Consolidated Balance Sheets |
|||||
(in thousands) |
|||||
Year Ended |
Year Ended |
||||
|
|
||||
2021 |
2020(1) |
||||
ASSETS |
|||||
Cash and cash equivalents |
$ 22,221 |
$ 28,864 |
|||
Short-term debt securities |
66,594 |
99,976 |
|||
Accounts receivable |
2,576 |
- |
|||
Inventories |
2,612 |
93 |
|||
Prepaid expenses and other current assets |
9,361 |
8,873 |
|||
Total current assets |
103,364 |
137,806 |
|||
Long-term debt securities |
17,262 |
- |
|||
Property and equipment, net |
613 |
709 |
|||
Operating lease right-of-use assets |
653 |
1,176 |
|||
Other assets |
4,510 |
3,903 |
|||
Total assets |
$ 126,402 |
$ 143,594 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 29,901 |
$ 16,627 |
|||
Other liabilities |
24,102 |
31,932 |
|||
Stockholders' equity |
72,399 |
95,035 |
|||
Total liabilities and stockholders' equity |
$ 126,402 |
$ 143,594 |
(1) |
Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended |
|
||||||||||
Condensed Consolidated Statements of Operations Financial Data |
||||||||||
(in thousands, except per share and share amounts) |
||||||||||
Three Months Ended |
Year Ended |
|||||||||
|
|
|||||||||
(unaudited) |
||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Product revenue, net |
$ 3,360 |
$ — |
$ 12,142 |
$ — |
||||||
Costs and operating expenses: |
||||||||||
Cost of sales |
104 |
— |
745 |
— |
||||||
Research and development(1) |
18,186 |
12,545 |
64,436 |
41,590 |
||||||
Selling, general and administrative(1) |
5,984 |
5,418 |
23,900 |
20,559 |
||||||
Total operating expenses |
24,274 |
17,963 |
89,081 |
62,149 |
||||||
Loss from operations |
(20,914) |
(17,963) |
(76,939) |
(62,149) |
||||||
Interest expense |
(900) |
(913) |
(3,559) |
(3,594) |
||||||
Interest income |
39 |
75 |
158 |
704 |
||||||
Other income (expense), net |
25 |
(5) |
46,487 |
(12) |
||||||
Income(loss) before provision for taxes |
(21,750) |
(18,806) |
(33,853) |
(65,051) |
||||||
Provision for income taxes |
18 |
— |
64 |
— |
||||||
Net loss |
$ (21,768) |
$ (18,806) |
$ (33,917) |
$ (65,051) |
||||||
Net income (loss) per common share: |
||||||||||
Basic and diluted |
$ (0.64) |
$ (0.58) |
$ (1.00) |
$ (2.31) |
||||||
Weighted-average common shares outstanding: |
||||||||||
Basic and diluted |
34,010,405 |
32,701,820 |
33,944,342 |
28,143,391 |
||||||
(1) |
Includes stock-based compensation expense of: |
|||||||||
Three Months Ended |
Year Ended |
|||||||||
|
|
|||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Research and development |
$ 625 |
$ 340 |
$ 2,252 |
$ 1,494 |
||||||
General and administrative |
1,339 |
1,097 |
5,649 |
4,479 |
||||||
Total stock-based compensation expense |
$ 1,964 |
$ 1,437 |
$ 7,901 |
$ 5,973 |
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