Eiger BioPharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update
- Active Dialogue with FDA on Potential Peginterferon Lambda COVID-19 EUA Application
- Phase 3 HDV D-LIVR (lonafarnib) Study Topline Data Planned by Year End
- Phase 3 Congenital Hyperinsulinism AVANT (avexitide) Program Initiated
- Approval of Zokinvy in
Europe ; Partnership with AnGes inJapan - Strong Cash Position:
$141.8M Cash, Cash Equivalents, and Total Investments
"We delivered a quarter of continued execution in which we strengthened and expanded our business through achievements including the approval of Zokinvy in
Business Highlights
Peginterferon Lambda for Newly Diagnosed Outpatient COVID-19 Infection
- Single sub-cutaneous injection
- Stimulates immune responses critical for host protection during viral infections
- Actively engaged with
U.S. Food and Drug Administration (FDA) on potential Emergency Use Authorization (EUA) application since announcement of topline data inMarch 2022 and have provided responses to all ofFDA's information requests during this time
Hepatitis Delta Virus (HDV) 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 expected 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 (Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies)
- EU marketing authorization granted by the
European Commission - Entered into exclusive partnership with AnGes, Inc. to seek regulatory approval and commercialization of Zokinvy in
Japan
Avexitide for Rare Metabolic Disorders
- Initiated Phase 3 AVANT congenital hyperinsulinism (HI) program
- Breakthrough Therapy designation for HI
- Rare Pediatric Disease designation for HI – Priority Review Voucher eligible
Corporate
- Appointed
Lisa Kelly-Croswell , senior human resources executive, to board of directors - Entered into term loan agreement with
Innovatus Capital Partners to refinance previous debt facility, extend interest-only period by 5 years, and further strengthen cash position ahead of key milestones
Financial Guidance
$141.8 million in cash, cash equivalents, and total investments as ofJune 30, 2022 expected to fund planned operations through 2024
Second 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
Conference Call
At
The live and replayed webcast of the call will be available through the company's website at www.eigerbio.com. To participate in the live call by phone, please register in advance at https://register.vevent.com/register/BIfd526d893fcb47fc96359096e28232bb to receive the dial-in number and unique passcode to access the call. The webcast will be archived and available for replay for at least 90 days after the event.
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, 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 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 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 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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2022 |
2021(1) |
||||
(unaudited) |
|||||
ASSETS |
|||||
Cash and cash equivalents |
$ 36,572 |
$ 22,221 |
|||
Short-term debt securities |
105,220 |
66,594 |
|||
Accounts receivable |
1,038 |
2,576 |
|||
Inventories |
2,876 |
2,612 |
|||
Prepaid expenses and other current assets |
11,997 |
9,361 |
|||
Total current assets |
157,703 |
103,364 |
|||
Long-term debt securities |
- |
17,262 |
|||
Property and equipment, net |
525 |
613 |
|||
Operating lease right-of-use assets |
385 |
653 |
|||
Other assets |
5,078 |
4,510 |
|||
Total assets |
$ 163,691 |
$ 126,402 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 21,847 |
$ 29,901 |
|||
Other liabilities |
38,919 |
24,102 |
|||
Stockholders' equity |
102,925 |
72,399 |
|||
Total liabilities and stockholders' equity |
$ 163,691 |
$ 126,402 |
|||
(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) |
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Three Months Ended |
Six Months Ended |
|||||||||
|
|
|||||||||
(unaudited) |
(unaudited) |
|||||||||
2022 |
2021 |
2022 |
2021 |
|||||||
Product revenue, net |
$ 3,341 |
$ 2,097 |
$ 6,014 |
$ 5,743 |
||||||
Other revenue |
750 |
- |
750 |
- |
||||||
Total revenue |
$ 4,091 |
$ 2,097 |
$ 6,764 |
$ 5,743 |
||||||
Costs and operating expenses: |
||||||||||
Cost of sales |
151 |
270 |
261 |
323 |
||||||
Research and development(1) |
16,993 |
14,302 |
34,563 |
28,144 |
||||||
Selling, general and administrative(1) |
7,027 |
5,886 |
13,840 |
11,450 |
||||||
Total costs and operating expenses |
24,171 |
20,458 |
48,664 |
39,917 |
||||||
Loss from operations |
(20,080) |
(18,361) |
(41,900) |
(34,174) |
||||||
Interest expense |
(934) |
(880) |
(1,820) |
(1,765) |
||||||
Interest income |
221 |
33 |
266 |
84 |
||||||
Other income (expense), net |
(1,074) |
45 |
(1,047) |
45,959 |
||||||
Income(loss) before provision for taxes |
(21,867) |
(19,163) |
(44,501) |
10,104 |
||||||
Provision for income taxes |
17 |
11 |
26 |
30 |
||||||
Net loss |
$ (21,884) |
$ (19,174) |
$ (44,527) |
$ 10,074 |
||||||
Net income (loss) per common share: |
||||||||||
Basic |
$ (0.51) |
$ (0.57) |
$ (1.14) |
$ 0.30 |
||||||
Diluted |
$ (0.51) |
$ (0.57) |
$ (1.14) |
$ 0.29 |
||||||
Weighted-average common shares outstanding: |
||||||||||
Basic |
43,059,809 |
33,932,127 |
39,178,043 |
33,909,637 |
||||||
Diluted |
43,059,809 |
33,932,127 |
39,178,043 |
34,156,877 |
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(1) |
Includes stock-based compensation expense of: |
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Three Months Ended |
Six Months Ended |
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|
|
|||||||||
2022 |
2021 |
2022 |
2021 |
|||||||
Research and development |
$ 820 |
$ 551 |
$ 1,445 |
$ 942 |
||||||
General and administrative |
1,388 |
1,507 |
2,810 |
2,665 |
||||||
Total stock-based compensation expense |
$ 2,208 |
$ 2,058 |
$ 4,255 |
$ 3,607 |
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