Palo Alto, Calif. — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, reported financial results for fourth quarter and full year 2022 and provided a business update.
“In December, we announced that both our lonafarnib-based treatments met the primary endpoint in our pivotal Phase 3 D-LIVR trial in hepatitis delta virus (HDV), and we look forward to the pre-NDA meeting with the FDA, which we expect by end of Q2,” said David Apelian, MD, PhD, Interim CEO, Eiger. “In addition, we have completed screening in our Phase 3 LIMT-2 study and expect to complete enrollment by the end of Q2. We continue to execute on our unwavering mission to develop innovative therapies for patients with rare diseases, with a focus on maintaining a position of readiness and being thoughtful about how best to employ our resources.”
Dr. Apelian continued, “On the corporate front, using both internal and external advisors, we continue our program prioritization analyses to assess the most promising drivers for shareholder value. Given the robust nature of this process, we anticipate providing an update in Q2. In addition, we remain focused on preparing for a planned pre-NDA meeting and guidance from FDA on the D-LIVR program in mid-2023.”
Hepatitis Delta Virus Platform
Lonafarnib-Based Regimens for HDV
- First-in-class, oral prenylation inhibitor
- In December, announced Phase 3 D-LIVR study topline Week 48 data met the primary endpoint
- Lonafarnib/ritonavir response rate of 10.1% (p=0.0044)
- Lonafarnib/ritonavir in combination with peginterferon alfa response rate of 19.2% (p<0.0001)
- Key secondary endpoint of proportion of patients with improvement in histological response rate demonstrated with statistical significance in combination arm vs placebo
- Pre-NDA meeting planned by end of Q2
- D-LIVR Week 72 data expected to be presented in mid-2023
Peginterferon Lambda for HDV
- Potential first-in-class, well-tolerated interferon
- Potential to be interferon of choice in HDV combination therapies
- Phase 3 LIMT-2 study of peginterferon lambda monotherapy
- Anticipate complete randomization by end of Q2 (N=150)
Combination of Peginterferon Lambda and Lonafarnib/Ritonavir for HDV
- Combination of Eiger’s two proprietary HDV therapies in development
- Phase 2 LIFT-2 study in collaboration with National Institutes of Health initiating in 2023
- 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 approval in EU and U.K.
Avexitide for Rare Metabolic Disorders
- Phase 3 startup activities initiated in AVANT congenital hyperinsulinism (HI) program
- Optimizing product-related impurities in the finished drug product to support Phase 3 dosing
- Rare Pediatric Disease designation for HI – Priority Review Voucher eligible
- $98.9 million in cash, cash equivalents, and short-term debt securities as of December 31, 2022
Fourth Quarter and Full Year 2022 Financial Results
Net revenue was $2.7 million and $13.5 million in fourth quarter and full year 2022, respectively, as compared to $3.4 million and $12.1 million for the same periods in 2021. The decrease in fourth quarter was primarily driven by a decrease in units shipped during the quarter and the increase in full year 2022 was primarily driven by the upfront payment received from AnGes, Inc. pursuant to the Marketing and Distribution Agreement, which was executed in May 2022.
Cost of sales was $0.3 million and $1.8 million for fourth quarter and full year 2022, respectively, as compared to $0.1 million and $0.7 million for the same periods in 2021. The increase in fourth quarter was primarily driven by a minimum purchase commitment by our contract manufacturer. The increase in full year was primarily driven by a one-time write-off of a non-conforming batch of inventory.
Research and Development expenses were $18.5 million and $75.3 million for fourth quarter and full year 2022, respectively, as compared to $18.2 million and $64.4 million for the same periods in 2021. Net change in the fourth quarter was relatively flat. The increase in full year was primarily driven by an increase in headcount related expenses, including stock-based compensation expense and travel expenses related to participation in scientific conferences, an increase in clinical and manufacturing expenditures related to avexitide Phase 3 readiness, and a milestone related to the Phase 3 LIMT-2 study of peginterferon lambda. This increase was primarily offset by a decrease in contract manufacturing expenditures on lonafarnib.
Selling, General and Administrative expenses were $8.3 million and $29.1 million for fourth quarter and full year 2022, respectively, as compared to $6.0 million and $23.9 million for the same periods in 2021. The increase in fourth quarter and full year primarily relate to outside services, including consulting and advisory services to support the Company’s growth.
Total operating expenses include non-cash expenses of $2.4 million and $13.3 million for fourth quarter and full year 2022, respectively, as compared to $2.8 million and $10.7 million for the same periods in 2021.
The Company reported a net loss of $25.1 million, or $0.57 per share basis and $96.8 million, or $2.32 per share basis for fourth quarter and full year 2022, respectively. This compares to a net loss of $21.8 million, or $0.64 per share basis and $33.9 million, or $1.00 per share basis for the same periods in 2021.
Cash, cash equivalents, and short-term debt securities as of December 31, 2022 totaled $98.9 million compared to $106.1 million as of December 31, 2021.
As of December 31, 2022, the Company had 44,074,284 common shares outstanding.
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. All five Eiger rare disease programs have been granted FDA breakthrough therapy designation.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.