Eiger BioPharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
08/05/2021 - 04:01 PM
PALO ALTO, Calif. , Aug. 5, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported its second quarter 2021 financial results and provided a business update.
"Our rapidly advancing HDV platform strategy, which includes Lonafarnib and Peginterferon Lambda, provides multiple opportunities to deliver a win for HDV patients and positions us to be a leader in this space," said David Cory , President and CEO of Eiger. "We are on track to complete enrollment in our Phase 3 HDV D-LIVR study this year, setting up pivotal topline data release in late-2022. Additionally, LIMT-2 , our Phase 3 study of Peginterferon Lambda for HDV, is on track to enroll its first patient by end of 2021."
Program Updates and Upcoming Milestones
HDV Platform Strategy
Lonafarnib for HDV
Only oral therapy in development for HDV Phase 3 D-LIVR (N=400) is the largest global study in HDV Provides multiple opportunities for approval of Lonafarnib-based regimens: an all-oral and a combination with peginterferon alfa > 90% enrolled, including patients randomized to date and patients in screening that are expected to be randomized Full enrollment expected before end of 2021 Pivotal topline data release expected in late-2022 Peginterferon Lambda for HDV
Well-tolerated interferon administered as a weekly subcutaneous injection Phase 3 LIMT-2 (N=150) is a pivotal study of Peginterferon Lambda as a single agent for HDV First patient enrolled expected by end of 2021 Avexitide for Rare Metabolic Disorders
FDA Breakthrough Therapy Designation granted for congenital hyperinsulinism Phase 3-enabling manufacturing, device development, and regulatory activities are ongoing in 2021 Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022 Zokinvy ® for Progeria and Processing-Deficient Progeroid Laminopathies
EMA approval expected by end of 2021 Recipient of 2021 NORD Industry Innovation Award Nominee for 2021 Prix Galien USA Best Pharmaceutical Product Award Peginterferon Lambda for COVID-19
Phase 3 TOGETHER study enrolling patients across clinical sites in Brazil Interim futility data analysis potentially by end of 2021 Positive data could support submission for emergency use authorization Corporate
Cash and investments of $139.8 million Second Quarter Financial Results
Net revenues from Zokinvy product sales were $2.1 million January 2021 and reported $3.6 million
Research and Development expenses were $14.3 million $9.8 million
Cost of Sales were $0.3 million
Selling, General and Administrative expenses were $5.9 million $4.9 million
Total operating expenses include non-cash expenses of $2.7 million $1.8 million
Eiger reported a second quarter 2021 net loss of $19.2 million $0.57 $15.3 million $0.60
Cash, cash equivalents, and investments as of June 30, 2021 , totaled $139.8 million $160.5 million March 31, 2021 .
As of June 30, 2021 , the company had 33,951,314 common shares outstanding.
Conference Call
At 4:30 PM Eastern Time today, August 5, 2021 , 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, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 9482721. 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 and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger's lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis. Eiger's HDV platform strategy includes two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy®
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 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 and 2022; 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 U.S., including the EU; our progression and continued enrollment of our Phase 3 D-LIVR study in HDV and expectations regarding the timing and availability of topline data; our ability to maintain supply of our commercial and clinical trial materials; our plans to advance Lambda in HDV in the U.S. and EU; our progression of Lambda for COVID-19 and Avexitide for post-bariatric hypoglycemia and congenital hyperinsulinism; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates. These statements concern product candidates that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). No representation is made as to their safety or effectiveness for the purposes for which they are being investigated. 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 March 31, 2021 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 and Media: Charles Butler cbutler@eigerbio.com Phone: 1-650-272-6138
Eiger BioPharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands)
June 30,
December 31,
2021
2020(1)
(unaudited)
ASSETS
Cash and cash equivalents
$ 65,056
$ 28,864
Short-term debt securities
42,311
99,976
Accounts receivable
1,438
-
Inventories
2,065
93
Prepaid expenses and other current assets
7,933
8,873
Total current assets
118,803
137,806
Long-term debt securities
32,426
-
Property and equipment, net
621
709
Operating lease right-of-use assets
903
1,176
Other assets
4,085
3,903
Total assets
$ 156,838
$ 143,594
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
$ 15,875
$ 16,627
Other liabilities
31,838
31,932
Stockholders' equity
109,125
95,035
Total liabilities and stockholders' equity
$ 156,838
$ 143,594
(1) Derived from the audited financial statements, included in the Company's Annual Report on
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)
2021
2020
2021
2020
Product revenue, net
$ 2,097
$ -
$ 5,743
$ -
Costs and operating expenses:
Cost of sales
270
—
323
—
Research and development(1)
14,302
9,754
28,144
19,235
Selling, general and administrative(1)
5,886
4,873
11,450
10,114
Total operating expenses
20,458
14,627
39,917
29,349
Loss from operations
(18,361)
(14,627)
(34,174)
(29,349)
Interest expense
(880)
(891)
(1,765)
(1,775)
Interest income
33
186
84
553
Other income (expense), net
45
6
45,959
6
Income(loss) before provision for taxes
(19,163)
(15,326)
10,104
(30,565)
Provision for income taxes
11
—
30
—
Net loss
$ (19,174)
$ (15,326)
$ 10,074
$ (30,565)
Net income (loss) per common share:
Basic
$ (0.57)
$ (0.60)
$ 0.30
$ (1.22)
Diluted
$ (0.57)
$ (0.60)
$ 0.29
$ (1.22)
Weighted-average common shares outstanding:
Basic
33,932,127
25,501,514
33,909,637
25,001,432
Diluted
33,932,127
25,501,514
34,156,877
25,001,432
(1)
Includes stock-based compensation expense of:
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Research and development
$ 551
$ 398
$ 942
$ 787
General and administrative
1,507
1,064
2,665
2,304
Total stock-based compensation expense
$ 2,058
$ 1,462
$ 3,607
$ 3,091
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SOURCE Eiger BioPharmaceuticals, Inc.
