Eiger BioPharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update
- Peginterferon lambda COVID-19 EUA Application to be Submitted in Q2 2022
- Phase 3 HDV D-LIVR (lonafarnib) Study Topline Data Anticipated by Year End
- Zokinvy® (lonafarnib) CHMP Opinion Expected in Q2 2022
- Phase 3 Avexitide Congenital Hyperinsulinism Program Initiation Planned by Year End
- Strong Cash Position:
$153.5M ProForma Cash
"We are laser focused on executing our development and commercialization strategies and anticipate significant value-creating milestones this quarter, including the submission of an Emergency Use Authorization application for lambda to treat COVID-19 as well a CHMP opinion on our Zokinvy MAA for progeria," said
Business Highlights
Peginterferon Lambda for COVID-19 Infection
- Actively engaging with FDA on Emergency Use Authorization (EUA) application
- Preparing to submit EUA application and publish full dataset
- Gating component for EUA application is full data analyses from TOGETHER team which is in process and nearing completion
- Announced Phase 3 TOGETHER study topline data in mid-March
- Novel mechanism of action, likely agnostic to variants
- Second largest outpatient study to date in COVID-19 (N>1,900)
- Single-dose peginterferon lambda for COVID-19 reduced risk of hospitalization or ER visits greater than six hours by 50% in a predominantly vaccinated population
- Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint
- Primary endpoint of reduced risk of hospitalization or ER visits achieved across multiple SARS-CoV-2 variants
Hepatitis Delta Virus Platform
Lonafarnib for HDV
- First-in-class, oral prenylation inhibitor
- D-LIVR Phase 3 study with potential approval of two lonafarnib-based regimens
- Oral lonafarnib/ritonavir and in combination with peginterferon alfa
- Topline data planned by end of 2022
Peginterferon Lambda for HDV
- First-in-class well-tolerated interferon
- Potential to be interferon of choice in HDV combination therapies
- LIMT-2 Phase 3 study of peginterferon lambda monotherapy
- Enrolling patients, targeting N=150
Combination of Peginterferon Lambda and Lonafarnib for HDV
- Combination of
Eiger's two proprietary HDV therapies in development - LIFT-2 Phase 2 study in collaboration with
National Institutes of Health initiating in 2022 - Single arm study (N=30), 48 weeks of treatment with 24 weeks of follow-up
Zokinvy® (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies
- CHMP opinion expected in Q2 2022
Avexitide for Rare Metabolic Disorders
- Planned Phase 3 congenital hyperinsulinism (HI) program to be initiated by end of 2022
- Granted Breakthrough Therapy designation for HI
- Granted Rare Pediatric Disease designation for HI – Priority Review Voucher eligible
- Reported positive Phase 2 data from
Children's Hospital of Philadelphia (CHOP) published in Diabetes Care
Corporate
- Strengthened leadership team with new biopharma executive hires
Chris Kurtz hired as Chief Technical OfficerSarah Mathieson hired as Senior Vice President, Corporate Affairs
First Quarter 2022 Financial Results
Cash, cash equivalents, and total investments as of
Net product sales of Zokinvy were
Cost of sales was approximately
Research and Development expenses were
Selling, General and Administrative expenses were
Total operating expenses include non-cash expenses of
The Company reported a net loss 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, regulatory objectives, 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; the likelihood of timely submitting and obtaining an Emergency Use Authorization from the FDA for peginterferon lambda for COVID-19; 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; commencing a Phase 3 study of avexitide in congenital hyperinsulinism; the approval of Zokinvy in jurisdictions outside of the
Investors:
[email protected]
Media:
SVP, Corporate Affairs
[email protected]
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Quarter Ended |
Year Ended |
||||
|
|
||||
2022 |
2021(1) |
||||
ASSETS |
|||||
Cash and cash equivalents |
$ 46,562 |
$ 22,221 |
|||
Short-term debt securities |
86,155 |
66,594 |
|||
Accounts receivable |
2,287 |
2,576 |
|||
Inventories |
1,910 |
2,612 |
|||
Prepaid expenses and other current assets |
10,442 |
9,361 |
|||
Total current assets |
147,356 |
103,364 |
|||
Long-term debt securities |
- |
17,262 |
|||
Property and equipment, net |
545 |
613 |
|||
Operating lease right-of-use assets |
521 |
653 |
|||
Other assets |
4,907 |
4,510 |
|||
Total assets |
$ 153,329 |
$ 126,402 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 36,612 |
$ 29,901 |
|||
Other liabilities |
19,450 |
24,102 |
|||
Stockholders' equity |
97,267 |
72,399 |
|||
Total liabilities and stockholders' equity |
$ 153,329 |
$ 126,402 |
|||
- |
- |
(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 |
||||||
|
||||||
(unaudited) |
||||||
2022 |
2021 |
|||||
Product revenue, net |
$ 2,673 |
$ 3,646 |
||||
Costs and operating expenses: |
||||||
Cost of sales |
110 |
53 |
||||
Research and development(1) |
17,570 |
13,842 |
||||
Selling, general and administrative(1) |
6,813 |
5,564 |
||||
Total operating expenses |
24,493 |
19,459 |
||||
Loss from operations |
(21,820) |
(15,813) |
||||
Interest expense |
(886) |
(885) |
||||
Interest income |
45 |
51 |
||||
Other income (expense), net |
27 |
45,914 |
||||
Income (loss) before provision for taxes |
(22,634) |
29,267 |
||||
Provision for income taxes |
9 |
19 |
||||
Net loss |
$ (22,643) |
$ 29,248 |
||||
Net income (loss) per common share: |
||||||
Basic |
$ (0.64) |
$ 0.86 |
||||
Diluted |
$ (0.64) |
$ 0.85 |
||||
Weighted-average common shares outstanding: |
||||||
Basic |
35,253,147 |
33,886,896 |
||||
Diluted |
35,253,147 |
34,220,895 |
||||
(1) |
Includes stock-based compensation expense of: |
|||||
Three Months Ended |
||||||
|
||||||
2022 |
2021 |
|||||
Research and development |
$ 625 |
$ 391 |
||||
General and administrative |
1,422 |
1,158 |
||||
Total stock-based compensation expense |
$ 2,047 |
$ 1,549 |
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