On March 10, 2022 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious diseases, reported financial results for fourth quarter and full year 2021 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 10, 2022, View Source [SID1234609938]).

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"We expect 2022 to be a transformational year for Eiger with topline data planned from two Phase 3 studies," said David Cory, President and CEO of Eiger. "The Phase 3 TOGETHER study of Peginterferon Lambda for COVID-19 is expected to readout later this month and the Phase 3 D-LIVR study of Lonafarnib for HDV is planned to readout by end of year. We look forward to reporting results from these potentially registration enabling studies as well as progress across our other late-stage pipeline programs with multiple catalysts this year."

Program Highlights

Lonafarnib: Oral Prenylation Inhibitor for HDV

D-LIVR Phase 3 multi-center, global study
Two Lonafarnib-based regimens, both with potential for registration
Lonafarnib oral and Lonafarnib / peginterferon alfa combination
Fully enrolled N=407, with topline data planned by end of 2022
D-LIVR study design includes conservative powering assumptions, modeling response rates well below what was demonstrated in Phase 2
Ukraine and Russia Update
Ukraine:
Eiger continues to closely assess this evolving situation, prioritizing patient care and patient monitoring to ensure continuity in the study
Eiger believes the study remains more than adequately powered to demonstrate statistical significance over placebo even if these patients discontinue from study
Russia:
To date, no interruption to patient visits, safety monitoring, or drug supply; contingency plans in place to ensure continuity of drug supply, sample storage and analysis to preserve integrity of results
Peginterferon Lambda: Well-tolerated Interferon for HDV

LIMT-2 Phase 3 multi-center, global study
Peginterferon Lambda monotherapy for registration
Enrolling patients, targeting N=150
Peginterferon Lambda and Lonafarnib Combination for HDV

LIFT-2 Phase 2 study at National Institutes of Health
Initiating 1H22, targeting N=30
Potential to be interferon of choice in HDV combination therapies
Peginterferon Lambda for Non-hospitalized COVID-19 Infection

Novel mechanism of action, agnostic to variants and mutations
TOGETHER Phase 3 study fully enrolled, N>1,800
Includes unvaccinated and vaccinated patients across multiple variants
Topline data planned in March 2022
Avexitide for Rare Metabolic Disorders

Granted Breakthrough Therapy Designation for Congenital Hyperinsulinism (HI)
Granted Rare Pediatric Disease Designation for HI; PRV eligible
Phase 3 ready in 2022
Zokinvy for Progeria and Processing-Deficient Progeroid Laminopathies

Successful U.S. commercial launch
Approximately 80% of identified U.S. patients converted to commercial supply
EMA review of MAA
CHMP opinion expected in first half of 2022
Corporate

Cash, cash equivalents and investments of $106.1 million to begin 2022 expected to fund planned operations through Q3 2023
Fourth Quarter and Full Year 2021 Financial Results

Cash, cash equivalents, and total investments as of December 31, 2021 totaled $106.1 million compared to $128.8 million on December 31, 2020.

Net product sales of Zokinvy were $3.4 million for fourth quarter 2021, as compared to $3.0 million for third quarter 2021. The increase reflects shipment of product under a reimbursed early access program approved in France, partially offset by fewer shipments to the U.S. specialty pharmacy due to timing of patient refills. The Company commercially launched Zokinvy in the U.S. in January 2021 and reported full year 2021 net sales of $12.1 million.

Cost of Sales was $0.1 million and $0.7 million for fourth quarter and full year 2021, respectively, and related to certain manufacturing, shipping, and distribution costs associated with Zokinvy that were incurred after FDA approval.

Research and Development expenses were $18.2 million and $64.4 million for fourth quarter and full year 2021, respectively, as compared to $12.5 million and $41.6 million for the same periods in 2020. The increases in fourth quarter and full year 2021 expenses were primarily due to contract manufacturing and clinical trial related expenses for increased clinical development activities and personnel related expenses, including stock-based compensation, due to an increase in headcount.

Selling, General and Administrative expenses were $6.0 million and $23.9 million for fourth quarter and full year 2021, respectively, as compared to $5.4 million and $20.6 million for the same periods in 2020. The increases in fourth quarter and full year 2021 were primarily due to an increase in personnel related expenses attributed to an increase in headcount and an increase in outside services, including consulting and advisory services to support the growth of the Company.

Total operating expenses include non-cash expenses of $2.8 million and $10.7 million for fourth quarter and full year 2021, respectively, as compared to $2.1 million and $7.8 million for the same periods in 2020.

The Company reported net losses of $21.8 million, or $0.64 per share, and $33.9 million, or $1.00 per share, for fourth quarter and full year 2021, respectively, as compared to $18.8 million, or $0.58 per share, and $65.1 million, or $2.31 per share, for the same periods in 2020.

As of December 31, 2021, the company had 34.6 million of common shares outstanding.

CONFERENCE CALL
At 4:30 PM Eastern Time today, March 10, 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, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 4338659. The webcast will be archived and available for replay for at least 90 days after the event.