Eiger BioPharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update
"The recent completion of enrollment in our Phase 3 HDV D-LIVR study of Lonafarnib-based regimens sets up pivotal topline data by the end of 2022," said
Program Updates and Upcoming Milestones
HDV Platform
Lonafarnib for HDV
- First-in-class prenylation inhibitor and only oral agent in development
- D-LIVR, largest Phase 3 global study conducted in HDV
- Fully enrolled with over 400 patients
- Opportunity for approval of two Lonafarnib-based regimens:
- All-oral and combination with peginterferon alfa
- Pivotal topline data planned by end of 2022
Peginterferon Lambda for HDV
- Well-tolerated interferon administered as a weekly subcutaneous injection
- LIMT-2 (N=150), pivotal study of Peginterferon Lambda monotherapy
- Now activating sites and screening patients
Avexitide for Rare Metabolic Disorders
- Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022
Zokinvy® for Progeria and Processing-Deficient Progeroid Laminopathies
- MAA is under EMA review, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected around end of 2021
- Cohort ATU program (Temporary Use Authorization) approved in
France - First ATU shipment completed
Peginterferon Lambda for COVID-19
- Phase 3 TOGETHER study enrolling patients across clinical sites in
Brazil - DSMB interim futility analysis (n=453) recommended study continuation
- Next interim futility data analysis by end of 2021
- Positive data could support emergency use authorization package
Corporate
- Appointed
Erik Atkisson General Counsel and Chief Compliance Officer - Cash and investments of
$120.4 million at the end of third quarter 2021 expected to fund planned operations into fourth quarter 2023
Third Quarter Financial Results
Net revenues from Zokinvy product sales were
Cost of Sales were
Research and Development expenses were
Selling, General and Administrative expenses were
Total operating expenses include non-cash expenses of
Cash, cash equivalents, and investments as 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 2021 and 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 activate sites and fully enroll the Phase 3 LIMT-2 study; initiating a Phase 3 study for avexitide in post-bariatric hypoglycemia and congenital hyperinsulinism; the potential approval of Zokinvy in jurisdictions outside of the
Investors and Media:
CFO
Email: [email protected]
Phone: 1-650-272-6138
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Condensed Consolidated Balance Sheets |
|||||||||
(in thousands) |
|||||||||
|
|
||||||||
2021 |
2020(1) |
||||||||
(unaudited) |
|||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 49,255 |
$ 28,864 |
|||||||
Short-term debt securities |
36,051 |
99,976 |
|||||||
Accounts receivable |
2,762 |
- |
|||||||
Inventories |
2,621 |
93 |
|||||||
Prepaid expenses and other current assets |
8,397 |
8,873 |
|||||||
Total current assets |
99,086 |
137,806 |
|||||||
Long-term debt securities |
35,093 |
- |
|||||||
Property and equipment, net |
581 |
709 |
|||||||
Operating lease right-of-use assets |
777 |
1,176 |
|||||||
Other assets |
4,740 |
3,903 |
|||||||
Total assets |
$ 140,277 |
$ 143,594 |
|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 22,012 |
$ 16,627 |
|||||||
Other liabilities |
28,800 |
31,932 |
|||||||
Stockholders' equity |
89,465 |
95,035 |
|||||||
Total liabilities and stockholders' equity |
$ 140,277 |
$ 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 |
Nine Months Ended |
|||||||||
|
|
|||||||||
(unaudited) |
(unaudited) |
|||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Product revenue, net |
$ 3,039 |
$ — |
$ 8,782 |
$ — |
||||||
Costs and operating expenses: |
||||||||||
Cost of sales |
318 |
— |
641 |
— |
||||||
Research and development(1) |
18,106 |
9,810 |
46,250 |
29,045 |
||||||
Selling, general and administrative(1) |
6,466 |
5,027 |
17,916 |
15,141 |
||||||
Total operating expenses |
24,890 |
14,837 |
64,807 |
44,186 |
||||||
Loss from operations |
(21,851) |
(14,837) |
(56,025) |
(44,186) |
||||||
Interest expense |
(894) |
(906) |
(2,659) |
(2,681) |
||||||
Interest income |
35 |
76 |
119 |
629 |
||||||
Other income (expense), net |
503 |
(13) |
46,462 |
(7) |
||||||
Income (loss) before provision for taxes |
(22,207) |
(15,680) |
(12,103) |
(46,245) |
||||||
Provision for income taxes |
16 |
— |
46 |
— |
||||||
Net loss |
$ (22,223) |
$ (15,680) |
$ (12,149) |
$ (46,245) |
||||||
Net income (loss) per common share: |
||||||||||
Basic and diluted |
$ (0.65) |
$ (0.52) |
$ (0.36) |
$ (1.74) |
||||||
Weighted-average common shares outstanding: |
||||||||||
Basic and diluted |
33,946,559 |
29,879,135 |
33,922,080 |
26,639,201 |
||||||
(1) |
Includes stock-based compensation expense of: |
|||||||||
Three Months Ended |
Nine Months Ended |
|||||||||
|
|
|||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Research and development |
$ 686 |
$ 367 |
$ 1,627 |
$ 1,154 |
||||||
General and administrative |
1,644 |
1,078 |
4,310 |
3,382 |
||||||
Total stock-based compensation expense |
$ 2,330 |
$ 1,445 |
$ 5,937 |
$ 4,536 |
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