Eiger BioPharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
"Our rapidly advancing HDV platform strategy, which includes Lonafarnib and Peginterferon Lambda, provides multiple opportunities to deliver a win for HDV patients and positions us to be a leader in this space," said
Program Updates and Upcoming Milestones
HDV Platform Strategy
Lonafarnib for HDV
- Only oral therapy in development for HDV
- Phase 3 D-LIVR (N=400) is the largest global study in HDV
- Provides multiple opportunities for approval of Lonafarnib-based regimens: an all-oral and a combination with peginterferon alfa
- > 90% enrolled, including patients randomized to date and patients in screening that are expected to be randomized
- Full enrollment expected before end of 2021
- Pivotal topline data release expected in late-2022
Peginterferon Lambda for HDV
- Well-tolerated interferon administered as a weekly subcutaneous injection
- Phase 3 LIMT-2 (N=150) is a pivotal study of Peginterferon Lambda as a single agent for HDV
- First patient enrolled expected by end of 2021
Avexitide for Rare Metabolic Disorders
- FDA Breakthrough Therapy Designation granted for congenital hyperinsulinism
- Phase 3-enabling manufacturing, device development, and regulatory activities are ongoing in 2021
- Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022
Zokinvy® for Progeria and Processing-Deficient Progeroid Laminopathies
- EMA approval expected by end of 2021
- Recipient of 2021 NORD Industry Innovation Award
- Nominee for 2021 Prix Galien
USA Best Pharmaceutical Product Award
Peginterferon Lambda for COVID-19
- Phase 3 TOGETHER study enrolling patients across clinical sites in
Brazil - Interim futility data analysis potentially by end of 2021
- Positive data could support submission for emergency use authorization
Corporate
- Cash and investments of
$139.8 million at the end of second quarter 2021 is expected to fund planned operations into fourth quarter 2023
Second Quarter Financial Results
Net revenues from Zokinvy product sales were
Research and Development expenses were
Cost of Sales 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
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient progeroid laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the
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 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 into the fourth quarter of 2023; our development programs for Zokinvy generally; , and the potential approval of Zokinvy in jurisdictions outside of the
Investors and Media:
VP, Investor Relations and Corporate Communications
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 |
$ 65,056 |
$ 28,864 |
|||
Short-term debt securities |
42,311 |
99,976 |
|||
Accounts receivable |
1,438 |
- |
|||
Inventories |
2,065 |
93 |
|||
Prepaid expenses and other current assets |
7,933 |
8,873 |
|||
Total current assets |
118,803 |
137,806 |
|||
Long-term debt securities |
32,426 |
- |
|||
Property and equipment, net |
621 |
709 |
|||
Operating lease right-of-use assets |
903 |
1,176 |
|||
Other assets |
4,085 |
3,903 |
|||
Total assets |
$ 156,838 |
$ 143,594 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 15,875 |
$ 16,627 |
|||
Other liabilities |
31,838 |
31,932 |
|||
Stockholders' equity |
109,125 |
95,035 |
|||
Total liabilities and stockholders' equity |
$ 156,838 |
$ 143,594 |
|||
(1) Derived from the audited financial statements, included in the Company's Annual Report on |
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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 |
Six Months Ended |
|||||||||
|
|
|||||||||
(unaudited) |
(unaudited) |
|||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Product revenue, net |
$ 2,097 |
$ - |
$ 5,743 |
$ - |
||||||
Costs and operating expenses: |
||||||||||
Cost of sales |
270 |
— |
323 |
— |
||||||
Research and development(1) |
14,302 |
9,754 |
28,144 |
19,235 |
||||||
Selling, general and administrative(1) |
5,886 |
4,873 |
11,450 |
10,114 |
||||||
Total operating expenses |
20,458 |
14,627 |
39,917 |
29,349 |
||||||
Loss from operations |
(18,361) |
(14,627) |
(34,174) |
(29,349) |
||||||
Interest expense |
(880) |
(891) |
(1,765) |
(1,775) |
||||||
Interest income |
33 |
186 |
84 |
553 |
||||||
Other income (expense), net |
45 |
6 |
45,959 |
6 |
||||||
Income(loss) before provision for taxes |
(19,163) |
(15,326) |
10,104 |
(30,565) |
||||||
Provision for income taxes |
11 |
— |
30 |
— |
||||||
Net loss |
$ (19,174) |
$ (15,326) |
$ 10,074 |
$ (30,565) |
||||||
Net income (loss) per common share: |
||||||||||
Basic |
$ (0.57) |
$ (0.60) |
$ 0.30 |
$ (1.22) |
||||||
Diluted |
$ (0.57) |
$ (0.60) |
$ 0.29 |
$ (1.22) |
||||||
Weighted-average common shares outstanding: |
||||||||||
Basic |
33,932,127 |
25,501,514 |
33,909,637 |
25,001,432 |
||||||
Diluted |
33,932,127 |
25,501,514 |
34,156,877 |
25,001,432 |
||||||
(1) |
Includes stock-based compensation expense of: |
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Three Months Ended |
Six Months Ended |
|||||||||
|
|
|||||||||
2021 |
2020 |
2021 |
2020 |
|||||||
Research and development |
$ 551 |
$ 398 |
$ 942 |
$ 787 |
||||||
General and administrative |
1,507 |
1,064 |
2,665 |
2,304 |
||||||
Total stock-based compensation expense |
$ 2,058 |
$ 1,462 |
$ 3,607 |
$ 3,091 |
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