Eiger BioPharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update
- Phase 3 HDV D-LIVR (lonafarnib-based regimens) Study Topline Data in December
- Phase 3 HDV LIMT-2 (peginterferon lambda) Study Activating Sites and Enrolling Patients
- Phase 3 Congenital Hyperinsulinism Avant (avexitide) Program Initiated
- Strong Cash Position:
$121.0 Million in Cash, Cash Equivalents, and Total Investments
"We look forward to reporting topline data next month from our landmark Phase 3 D-LIVR study of lonafarnib-based regimens for the treatment of hepatitis delta virus, an important milestone for
Business Highlights
Hepatitis Delta Virus Platform
Lonafarnib-Based Regimens for HDV
- First-in-class, oral prenylation inhibitor
- D-LIVR Phase 3 study to support registration of two lonafarnib-based regimens
- Oral lonafarnib/ritonavir and combination with peginterferon alfa
- Topline Week 48 data expected in December
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/Ritonavir 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
- Granted marketing authorization in EU and
U.K. - Reimbursement agreed in
Germany
Avexitide for Rare Metabolic Disorders
- Phase 3 Avant congenital hyperinsulinism (HI) program initiated
- Breakthrough Therapy designation for HI
- Rare Pediatric Disease designation for HI – Priority Review Voucher eligible
Financial Guidance
$121.0 million in cash, cash equivalents, and total investments as ofSeptember 30, 2022 expected to fund planned operations through 2024- Ability to access up to an additional
$35.0 million over two tranches under existing debt facility, with the availability of both tranches being based on predetermined regulatory and clinical milestones, to support funding of potential HDV commercial launch
Third Quarter 2022 Financial Results
Total revenue was
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 a net loss of
Cash, cash equivalents, and total investments as of
As of
At
For additional information about
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, prospective products, preclinical and clinical pipelines, 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, 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 identifying registration pathways 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 and Phase 3 Avant study; our capability to provide sufficient quantities of any of our product candidates, including peginterferon lambda, to meet anticipated full-scale commercial demands; our ability to finance, independently or through collaborations, the continued advancement of our development pipeline; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that
Investors:
[email protected]
Media:
SVP, Corporate Affairs
[email protected]
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Condensed Consolidated Balance Sheets |
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(in thousands) |
|||||
|
|
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(Unaudited) |
|||||
Assets |
|||||
Current assets: |
|||||
Cash and cash equivalents |
$ 26,308 |
$ 22,221 |
|||
Short-term debt securities |
94,736 |
66,594 |
|||
Accounts receivable, net |
2,458 |
2,576 |
|||
Inventories |
2,817 |
2,612 |
|||
Prepaid expenses and other current assets |
15,970 |
9,361 |
|||
Total current assets |
142,289 |
103,364 |
|||
Long-term debt securities |
— |
17,262 |
|||
Property and equipment, net |
511 |
613 |
|||
Operating lease right-of-use assets |
246 |
653 |
|||
Other assets |
698 |
4,510 |
|||
Total assets |
$ 143,744 |
$ 126,402 |
|||
Liabilities and Stockholders' Equity |
|||||
Current liabilities |
26,119 |
29,901 |
|||
Other liabilities |
39,317 |
24,102 |
|||
Stockholders' equity |
78,308 |
72,399 |
|||
Total liabilities and stockholders' equity |
$ 143,744 |
$ 126,402 |
|||
(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended |
|
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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 |
Nine Months Ended |
|||
(Unaudited) |
(Unaudited) |
|||
2022 |
2021 |
2022 |
2021 |
|
Product revenue, net |
$ 4,024 |
$ 3,039 |
$ 10,038 |
$ 8,782 |
Other revenue |
— |
— |
750 |
— |
Total revenue |
4,024 |
3,039 |
10,788 |
8,782 |
Costs and operating expenses: |
||||
Cost of sales |
1,231 |
318 |
1,492 |
641 |
Research and development |
22,198 |
18,106 |
56,761 |
46,250 |
Selling, general and administrative |
6,964 |
6,466 |
20,804 |
17,916 |
Total costs and operating expenses |
30,393 |
24,890 |
79,057 |
64,807 |
Loss from operations |
(26,369) |
(21,851) |
(68,269) |
(56,025) |
Interest expense |
(1,092) |
(894) |
(2,912) |
(2,659) |
Interest income |
347 |
35 |
613 |
119 |
Other (expense) income, net |
3 |
503 |
(1,044) |
46,462 |
Loss before provision for income taxes |
(27,111) |
(22,207) |
(71,612) |
(12,103) |
Provision for income taxes |
— |
16 |
26 |
46 |
Net loss |
$ (27,111) |
$ (22,223) |
$ (71,638) |
$ (12,149) |
Net loss per common share: |
||||
Basic |
$ (0.62) |
$ (0.65) |
$ (1.76) |
$ (0.36) |
Diluted |
||||
Weighted-average common shares outstanding: |
||||
Basic |
44,010,553 |
33,946,559 |
40,806,581 |
33,922,080 |
Diluted |
||||
(1) Includes stock-based compensation expense of: |
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Three Months Ended |
Nine Months Ended |
|||
2022 |
2021 |
2022 |
2021 |
|
Research and development |
$ 856 |
$ 686 |
$ 2,301 |
$ 1,627 |
General and administrative |
1,366 |
1,644 |
4,176 |
4,310 |
Total stock-based compensation expense |
$ 2,222 |
$ 2,330 |
$ 6,477 |
$ 5,937 |
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