Eiger BioPharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update
"The Phase 3 D-LIVR study is now 75% enrolled, and by year-end we expect to complete enrollment of this landmark global study advancing Lonafarnib, the only oral agent in development for HDV, setting the stage for Week 48 end of treatment data in 2022," said
Program Updates and Upcoming Milestones
Lonafarnib for HDV
- First and only oral therapy in clinical development for HDV
- Phase 3 D-LIVR study is the largest and only global HDV study
- Study is 75% enrolled, including patients randomized to date and patients in screening that are expected to be randomized
- Full enrollment of 400 patients expected by end of 2021
Peginterferon Lambda (Lambda) for HDV
- Well-tolerated interferon for convenient once weekly subcutaneous injection
- Phase 3 LIMT-2 study (N=150) expected to initiate in the second half of 2021
Zokinvy® (lonafarnib) for Progeria
U.S. commercial launch inJanuary 2021 - EMA approval expected by end of 2021
Lambda for COVID-19
U.S. IND now open and includes Phase 2/3 study protocol- Lambda to be included in ongoing Phase 3 TOGETHER platform study
- Recruiting at 11 sites in
Brazil with plans to add a site inToronto, Canada - Lambda arm will include up to 800 high-risk, non-hospitalized patients
- Endpoints align with FDA Guidance for COVID-19 therapeutics
- Recruiting at 11 sites in
Avexitide for Post-Bariatric Hypoglycemia (PBH) and Congenital Hyperinsulinism (CHI)
- Advancing manufacturing, device, clinical and regulatory activities in 2021
- Registration-enabling studies for PBH and CHI could begin in 2022
Corporate
- Appointed
Kim Sablich , Industry Veteran, to Board of Directors inApril 2021 - Cash, cash equivalents and investments of
$160.5 million at the end of first quarter 2021 expected to fund planned operations into fourth quarter 2023
First Quarter 2021 Financial Results
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
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; 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:
Email: [email protected]
Phone: 1-650-272-6138
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Condensed Consolidated Balance Sheets |
|||||||||
(in thousands) |
|||||||||
Three Months Ended |
Year Ended |
||||||||
|
|
||||||||
2021 |
2020(1) |
||||||||
(unaudited) |
|||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 108,410 |
$ 28,864 |
|||||||
Debt securities, available-for-sale |
52,082 |
99,976 |
|||||||
Accounts receivable |
639 |
- |
|||||||
Inventories |
1,397 |
93 |
|||||||
Prepaid expenses and other current assets |
7,358 |
8,873 |
|||||||
Total current assets |
169,886 |
137,806 |
|||||||
Property and equipment, net |
659 |
709 |
|||||||
Operating lease right-of-use assets |
1,049 |
1,176 |
|||||||
Other assets |
3,921 |
3,903 |
|||||||
Total assets |
$ 175,515 |
$ 143,594 |
|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 17,517 |
$ 16,627 |
|||||||
Other liabilities |
31,808 |
31,932 |
|||||||
Stockholders' equity |
126,190 |
95,035 |
|||||||
Total liabilities and stockholders' equity |
$ 175,515 |
$ 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 |
||||||
March 31 |
||||||
(unaudited) |
||||||
2021 |
2020 |
|||||
Product revenue, net |
$ 3,646 |
$ - |
||||
Costs and operating expenses: |
||||||
Costs of sales |
53 |
- |
||||
Research and development(1) |
13,842 |
9,481 |
||||
Selling, general and administrative(1) |
5,564 |
5,241 |
||||
Total costs and operating expenses |
19,459 |
14,722 |
||||
Loss from operations |
(15,813) |
(14,722) |
||||
Interest expense |
(885) |
(884) |
||||
Interest income |
51 |
367 |
||||
Other income, net |
45,914 |
- |
||||
Income before provision for income taxes |
29,267 |
(15,239) |
||||
Provision for income taxes |
19 |
— |
||||
Net income (loss) |
$ 29,248 |
$ (15,239) |
||||
Net income (loss) per common share: |
||||||
Basic |
$ 0.86 |
$ (0.62) |
||||
Diluted |
$ 0.85 |
$ (0.62) |
||||
Weighted-average common shares outstanding: |
||||||
Basic |
33,886,896 |
24,501,350 |
||||
Diluted |
34,220,895 |
24,501,350 |
||||
(1) |
Includes stock-based compensation expense of: |
|||||
Three Months Ended |
||||||
March 31 |
||||||
2021 |
2020 |
|||||
Research and development |
$ 391 |
$ 389 |
||||
Selling, general and administrative |
1,158 |
1,240 |
||||
Total stock-based compensation expense |
$ 1,549 |
$ 1,629 |
||||
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