Executive Summary

Q4 2022 in line with Eiger’s transition toward HDV regulatory milestones: net revenue $2.7M (down vs $3.4M YoY) and basic/diluted EPS of -$0.57; cash and investments ended the quarter at $98.9M as the company prioritized HDV programs and Phase 3 readiness activities .
Clinical catalyst: Phase 3 D-LIVR topline Week 48 data achieved statistical significance on the composite primary endpoint in both lonafarnib/ritonavir arms (10.1% all-oral; 19.2% in combination with peginterferon alfa), positioning the program for a pre-NDA meeting now planned by end of Q2 2023 (pushed from prior Q1 expectation) .
Operating spend remained elevated on R&D and SG&A to support Phase 3 activity and corporate growth initiatives; Q4 R&D was $18.5M and SG&A $8.3M; full-year R&D $75.3M and SG&A $29.1M .
Consensus data from S&P Global was unavailable via our tool for Q4 2022; third-party aggregates indicate an EPS miss (actual -$17.10 vs est. -$16.20) and do not provide a clear revenue consensus, limiting beat/miss precision; we anchor analysis to company-reported actuals and clearly note the estimates constraint .

What Went Well and What Went Wrong

What Went Well
- D-LIVR met its composite primary endpoint in both treatment arms (10.1% all-oral, p=0.0044; 19.2% combo with peginterferon alfa, p<0.0001), with the combo arm also showing significant histologic improvement (53% vs 27% placebo, p=0.0139), validating the HDV mechanism and supporting regulatory engagement .
- Management advanced key timelines: pre-NDA meeting for lonafarnib/ritonavir targeted by end of Q2 2023; LIMT-2 Phase 3 randomization targeted to complete by end of Q2; Phase 2 LIFT-2 combo study initiating in 2023 .
- Zokinvy gained EU and U.K. approvals, expanding the ex-U.S. commercial footprint and providing optionality for future revenue contributions .
What Went Wrong
- Revenue softness in Q4 ($2.7M) driven by lower units shipped versus prior-year Q4 ($3.4M), highlighting variability at current scale of commercial operations .
- Operating losses widened YoY with Q4 net loss of $25.1M (vs $21.8M in Q4 2021) as Phase 3 readiness and corporate growth spending lifted R&D and SG&A .
- Timing: guidance on pre-NDA meeting shifted from “anticipated in Q1 2023” (Dec 8 topline release) to “planned by end of Q2 2023,” modestly pushing regulatory interaction and creating a near-term timing overhang for investors .

Financial Results

Quarterly trend – actuals

Metric	Q2 2022	Q3 2022	Q4 2022
Total Revenue ($M)	$4.091	$4.024	$2.696
Product Revenue, net ($M)	$3.341	$4.024	$2.696
Other Revenue ($M)	$0.750	$0.000	$0.000
Cost of Sales ($M)	$0.151	$1.231	$0.345
R&D Expense ($M)	$16.993	$22.198	$18.521
SG&A Expense ($M)	$7.027	$6.964	$8.301
Net Loss ($M)	$(21.884)	$(27.111)	$(25.138)
EPS (basic & diluted)	$(0.51)	$(0.62)	$(0.57)
Weighted Avg. Shares (M)	43.060	44.011	44.066
Cash, Equivalents & Investments ($M, period-end)	$141.8	$121.0	$98.9

YoY comparison – Q4

Metric	Q4 2021	Q4 2022
Total/Net Revenue ($M)	$3.360	$2.696
Cost of Sales ($M)	$0.104	$0.345
R&D Expense ($M)	$18.186	$18.521
SG&A Expense ($M)	$5.984	$8.301
Net Loss ($M)	$(21.768)	$(25.138)
EPS (basic & diluted)	$(0.64)	$(0.57)

Estimates vs. Actual (Q4 2022)

Metric	Consensus	Actual	Beat/Miss
EPS (basic & diluted)	-$16.20 (3rd-party)	-$17.10 (3rd-party)	Miss (by $0.90)
Revenue ($M)	Not available from S&P Global via our tool	$2.696	N/A

Notes: S&P Global consensus was unavailable for EIGR via our estimates tool for Q4 2022; we therefore cite a third-party aggregate for directional EPS context and anchor all comparisons to company-reported actuals .

Segment breakdown: Eiger reports consolidated results; revenues primarily reflect Zokinvy net product sales and occasional collaboration/other revenue (e.g., AnGes upfront in 2022) .

KPIs (operational spend and scale)

KPI	Q2 2022	Q3 2022	Q4 2022
Product Revenue, net ($M)	$3.341	$4.024	$2.696
Cost of Sales ($M)	$0.151	$1.231	$0.345
R&D ($M)	$16.993	$22.198	$18.521
SG&A ($M)	$7.027	$6.964	$8.301

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
D-LIVR (lonafarnib/ritonavir) pre-NDA meeting timing	2023	Anticipated in Q1 2023	Planned by end of Q2 2023	Timing pushed out
LIMT-2 (peginterferon lambda) enrollment	H1 2023	Enrolling; target N=150	Complete randomization by end of Q2 (N=150)	Timeline specified/maintained
LIFT-2 (lambda + lonafarnib/ritonavir)	2023	Initiating in 2022	Initiating in 2023	Timing updated
Avexitide AVANT (HI)	Ongoing	Phase 3 program initiated	Phase 3 startup activities initiated; optimizing impurities for Phase 3 dosing	Maintained with manufacturing readiness detail
Cash runway	Through 2024	“Expected to fund planned operations through 2024” (as of Q2/Q3)	Not reiterated; YE22 cash/investments $98.9M	Runway not restated

Earnings Call Themes & Trends

Note: We were unable to locate a Q4 2022 earnings call transcript via our document tools; themes below reflect disclosures from Q2/Q3/Q4 press releases.

Topic	Previous Mentions (Q2 2022, Q3 2022)	Current Period (Q4 2022)	Trend
HDV – D-LIVR efficacy/regulatory	Topline data expected YE22; registration-intent for two lonafarnib regimens	Topline met primary endpoint; pre-NDA planned by end of Q2	Positive clinical validation; regulatory timing pushed slightly
HDV – LIMT-2 (lambda)	Enrolling; target N=150	Complete randomization by end of Q2	Execution progressing
HDV – LIFT-2 combo	Initiating in 2022	Initiating in 2023	Minor timing shift
Zokinvy commercialization	EU approval; Japan partnership with AnGes	EU and U.K. approvals highlighted	Geographic expansion maintained
Cash/runway	$141.8M (Q2) and $121.0M (Q3); runway “through 2024”	$98.9M at YE22; runway not reiterated	Liquidity lower; disclosure tightened

Management Commentary

“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.” — David Apelian, Interim CEO .
“We continue our program prioritization analyses to assess the most promising drivers for shareholder value... we anticipate providing an update in Q2.” — David Apelian .
“Topline Week 48 results showed that both treatment arms achieved statistical significance over placebo in the composite primary endpoint… The composite response rate in the combination arm was twice that of the peginterferon alfa arm (19.2% vs 9.6%).” — Company topline summary .
“Combining lonafarnib and ritonavir with peginterferon alfa demonstrated the potential to nearly double the response rate… combination treatment may lead to significant histologic improvement.” — D-LIVR co-lead investigator, Dr. Ohad Etzion .

Q&A Highlights

We could not locate a Q4 2022 earnings call transcript via our document tools; no Q&A or clarifications were available to cite. Analysis relies on the 8‑K Item 2.02 press release and the Dec 8, 2022 D‑LIVR topline 8‑K .

Estimates Context

S&P Global consensus (via our tool) was unavailable for EIGR in Q4 2022; we searched for EPS and revenue estimates but no SPGI mapping exists in our system.
Third-party aggregate indicates Q4 2022 EPS of -$17.10 vs an estimate of -$16.20 (miss by $0.90); revenue consensus not available; actual revenue reported at $2.696M .
Implications: Absent reliable Street revenue consensus, estimate revisions are likely to hinge on regulatory milestones and clinical de-risking rather than near-term commercial scale.

Key Takeaways for Investors

D-LIVR’s statistically significant topline and planned pre‑NDA meeting by end of Q2 2023 underpin the HDV thesis; combo regimen strength (including histology) supports potential clinical differentiation .
Regulatory timing shifted modestly (pre‑NDA Q1 → end‑Q2), extending the catalyst window; watch for Week 72 data mid‑2023 and FDA feedback as near‑term stock drivers .
Operating losses remain elevated given Phase 3 activity and corporate support; cash declined to $98.9M at YE22 (from $121.0M at Q3 and $141.8M at Q2). Liquidity management and potential partnering will be focal points if timelines extend .
Zokinvy ex‑U.S. approvals expand the durable base but current revenue scale is small and variable; near-term financials are still driven by R&D cadence rather than product margin .
Without robust consensus visibility, trading may skew to binary/regulatory headlines; de‑risking in LIMT‑2 and clarity on LIFT‑2 could re‑rate probability of success across the HDV platform .
Monitor any update from ongoing program prioritization analyses for potential pipeline focus changes or capital allocation signals in Q2 .

Supporting citations:

Q4 2022 8‑K Item 2.02 press release and financials .
D‑LIVR topline 8‑K and Exhibit 99.1 (Dec 8, 2022) .
Prior quarters’ 8‑K Item 2.02 press releases for trends (Q2 2022, Q3 2022) .
Third-party EPS estimate context (Q4 2022) .

Eiger BioPharmaceuticals, Inc. (EIGR)·Q4 2022 Earnings Summary