- 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 in Japan
- Strong Cash Position: $141.8M Cash, Cash Equivalents, and Total Investments
PALO ALTO, Calif., Aug. 4, 2022 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) infection and other serious diseases, today reported financial results for second quarter 2022 and provided a business update.
"We delivered a quarter of continued execution in which we strengthened and expanded our business through achievements including the approval of Zokinvy in Europe," said David Cory, President and CEO Eiger. "Looking ahead, we are excited about the major upcoming catalysts across our development programs which, alongside our strong cash position, give us confidence in our ability to deliver long-term shareholder value."
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 in March 2022 and have provided responses to all of FDA'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 of June 30, 2022 expected to fund planned operations through 2024
Second Quarter 2022 Financial Results
Total revenue was $4.1 million in second quarter 2022 compared to $2.1 million for the same period in 2021. The increase was primarily driven by $1.2 million in higher Zokinvy net product sales and $0.8 million from an upfront payment the Company received related to its exclusive partnership with AnGes, Inc. to seek regulatory approval and commercialization of Zokinvy in Japan.
Cost of sales was $0.2 million for second quarter 2022 as compared to $0.3 million for the same period in 2021. The decrease was primarily driven by product manufacturing related costs, including product testing.
Research and Development expenses were $17.0 million for second quarter 2022, as compared to $14.3 million for the same period in 2021. The increase is primarily driven by personnel related costs, including stock-based compensation, from additional headcount, and outside services, including consulting and advisory services.
Selling, General and Administrative expenses were $7.0 million for second quarter 2022, as compared to $5.9 million for the same period in 2021. The increase was primarily due to outside services, including consulting and advisory services, and an increase in headcount related expenses and other operating related expenses.
Total operating expenses include non-cash expenses of $4.1 million for second quarter 2022, as compared to $2.7 million for the same period in 2021.
The Company reported a net loss of $21.9 million, or $0.51 on a per share basis, for second quarter 2022. This compares to a net loss of $19.2 million, or $0.57 on a per share basis, for the same period in 2021.
Cash, cash equivalents, and total investments as of June 30, 2022 totaled $141.8 million compared to $106.1 million as of December 31, 2021.
As of June 30, 2022, the company had 44.0 million of common shares outstanding.
Conference Call
At 4:30 PM Eastern Time today, August 4, 2022, Eiger will host a conference call to discuss its financial results and provide a business update.
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 Eiger
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious rare diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Eiger is also developing peginterferon lambda as a therapeutic for COVID-19. All five Eiger rare disease programs have been granted FDA breakthrough therapy designation. Eiger is also developing peginterferon lambda as a therapeutic for COVID-19.
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 Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Media:
Sarah Mathieson
SVP, Corporate Affairs
smathieson@eigerbio.com
Eiger BioPharmaceuticals Inc.
| Condensed Consolidated Balance Sheets
| (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30,
|
| December 31,
|
|
|
| 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
Form 10-K for the year ended December 31, 2021.
|
Eiger BioPharmaceuticals Inc.
| Condensed Consolidated Statements of Operations Financial Data
| (in thousands, except per share and share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended
|
|
| Six Months Ended
|
|
|
| June 30,
|
|
| June 30,
|
|
|
| (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
|
|
|
|
|
|
|
|
|
|
|
| (1)
| Includes stock-based compensation expense of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended
|
|
| Six Months Ended
|
|
|
| June 30,
|
|
| June 30,
|
|
|
| 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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SOURCE Eiger BioPharmaceuticals, Inc.
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