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Eiger BioPharmaceuticals, Inc. (EIGR)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 revenue was $3.21M and GAAP EPS was −$0.41; net loss narrowed to $18.0M vs. −$27.1M YoY as OpEx fell materially, but U.S. sales declined and total revenue fell YoY .
  • The company discontinued the Phase 3 LIMT-2 study of peginterferon lambda in HDV due to safety findings, prioritizing resources toward avexitide in hyperinsulinemic hypoglycemia indications (PBH and HI) .
  • Cash, cash equivalents and short-term securities were $39.4M at quarter-end; workforce and HDV program spend reductions extended runway “into the third quarter of 2024,” down from “into the fourth quarter of 2024” previously .
  • Versus third‑party consensus, Q3 revenue missed ($3.209M vs. $4.911M) and EPS missed (−$0.41 vs. −$0.31); S&P Global consensus was unavailable via our mapping, so treat external estimates as directional only .
  • Corporate risk rose: Nasdaq sent deficiency notices on stockholders’ equity and minimum bid price; shares faced delisting risk absent remediation, a clear stock overhang in the near term .

What Went Well and What Went Wrong

What Went Well

  • Zokinvy drove $3.2M net revenue in Q3; France ATU sales helped offset weaker U.S. sales, and cost of sales fell YoY due to prior inventory write-off dynamics .
  • Operating discipline: R&D fell to $14.6M (from $22.2M YoY) and SG&A to $5.5M (from $7.0M YoY), reflecting lower headcount and outside services as the company reprioritized its pipeline .
  • Strategic clarity and FDA alignment on avexitide Phase 3 endpoints, sample size, and study design; CEO: “we continue to seek financial resources to advance avexitide in post‑bariatric hypoglycemia…[with] FDA alignment on Phase 3 endpoints, sample size, and study design” .

What Went Wrong

  • Top‑line pressure: total revenue declined YoY ($3.2M vs. $4.0M) on weaker U.S. sales; product momentum remains limited at current scale .
  • Pipeline setback: LIMT‑2 Phase 3 in HDV was discontinued due to safety, removing a potential near‑term HDV catalyst and elevating reliance on avexitide .
  • Listing risk and investor overhang: Nasdaq deficiency letters on both equity and bid price, with potential delisting path if compliance plans are not accepted or executed .

Financial Results

Income Statement and Key Metrics

MetricQ1 2023Q2 2023Q3 2023Q3 2022
Total Revenue ($USD Millions)$4.118 $4.643 $3.209 $4.024
Net Loss ($USD Millions)$(22.784) $(20.695) $(18.030) $(27.111)
GAAP Diluted EPS−$0.52 −$0.47 −$0.41 −$0.62
R&D Expense ($USD Millions)$16.748 $19.401 $14.568 $22.198
SG&A Expense ($USD Millions)$9.515 $5.533 $5.454 $6.964
Cost of Sales ($USD Millions)$0.118 $(0.310) $0.115 $1.231

Notes:

  • Q2 cost of sales reflects reversal of inventory accrual; Q3 YoY decline reflects prior write‑off in Q3 2022 .

Cash and Shares

MetricQ1 2023Q2 2023Q3 2023
Cash, Cash Equivalents & Short‑Term Securities ($USD Millions)$75.3 $53.6 $39.4
Common Shares Outstanding (Period End)44,296,417 44,296,417 44,384,684

Estimates vs. Actual (Third‑Party; S&P Global unavailable)

  • S&P Global consensus was unavailable via our mapping. External (third‑party) consensus indicates the following for Q3 2023; use directionally with caution .
MetricActualConsensusSurprise
Revenue ($USD Millions)$3.209 $4.911 −34.8%
GAAP Diluted EPS−$0.41 −$0.31 −32.3%
  • Bold misses: revenue and EPS both missed external consensus materially.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate“into the fourth quarter of 2024” (workforce and HDV program spend reductions) “into the third quarter of 2024” (43% workforce reduction and HDV spend cuts) Lowered (runway shortened)
HDV LIMT‑2 (Peginterferon Lambda)Program StatusPhase 3 ongoing (goal to complete randomization in 2023 per prior updates) Phase 3 discontinued due to safety findings Discontinued
Avexitide PBH (GLP‑1 antagonist)Phase 3 ReadinessFDA alignment on endpoints/sample size/design; prioritizing resources Continued prioritization; seeking financing; FDA alignment reiterated Maintained focus

No revenue, margin, or tax rate guidance was provided in Q3 materials .

Earnings Call Themes & Trends

Note: No Q3 earnings call transcript was available in our document set; themes below draw from company press releases and 8‑K filings.

TopicPrevious Mentions (Q1 & Q2 2023)Current Period (Q3 2023)Trend
Strategic Focus: Avexitide (PBH/HI)Phase 3 readiness; FDA alignment on endpoints; resource prioritization shift toward avexitide Continued prioritization; seeking financial resources; FDA alignment reiterated Stable focus, intensified resource shift
HDV Programs (Lonafarnib/Lambda)D‑LIVR positive; LIMT‑2 randomization to complete; pre‑NDA planned, NIH combo study LIMT‑2 discontinued due to safety Negative pivot (safety‑driven halt)
Operating DisciplineQ1 SG&A elevated on outside services; Q2 workforce reduction; OpEx control R&D and SG&A reduced sharply; 43% workforce reduction to date Strengthening cost control
Product Performance (Zokinvy)Q1: $4.1M; growth in Germany/France/U.S. Q3: $3.2M; France ATU helped offset weaker U.S. sales Mixed; geographic mix shift
Regulatory/Listing—Nasdaq deficiency notices (equity and bid price) Elevated listing risk

Management Commentary

  • “We continue to seek financial resources to advance avexitide in post‑bariatric hypoglycemia…where we see the highest revenue potential…[and] have FDA alignment on Phase 3 endpoints, sample size, and study design.” — CEO David Apelian, Q3 release .
  • “We are deploying our resources toward recognizing the compelling potential of avexitide in metabolic diseases…with FDA alignment on Phase 3 endpoints, sample size, and design.” — CEO David Apelian, Q2 release .
  • Corporate actions (workforce reduction and HDV program spend cuts) are expected to extend the company’s cash runway—now into Q3 2024 .

Q&A Highlights

  • No Q3 2023 earnings call transcript was found in our document set; Q&A highlights and clarifications were therefore not available [ListDocuments query returned none].

Estimates Context

  • S&P Global consensus estimates for Q3 2023 were unavailable via our mapping at this time.
  • External directional consensus shows misses on both revenue ($3.209M vs. $4.911M) and GAAP EPS (−$0.41 vs. −$0.31). Treat third‑party figures as directional until S&P Global data is accessible .

Key Takeaways for Investors

  • The pivot away from HDV (LIMT‑2 halted) increases dependence on avexitide execution; avexitide maintains FDA alignment and is prioritized for PBH/HI, but financing/partnering will be critical for Phase 3 advancement .
  • Cost controls are taking hold: R&D and SG&A reductions compressed net loss sequentially; sustained discipline is key to extending runway amid revenue volatility .
  • Near‑term listing risk is elevated due to Nasdaq deficiency notices (equity and bid price); management plans to submit a compliance plan and consider options to regain compliance .
  • Q3 revenue and EPS missed external consensus; with limited product revenue scale (Zokinvy $3.2M), estimate revisions may trend lower absent near‑term catalysts .
  • Geographic mix matters: France ATU supported Q3 revenue while U.S. sales declined; commercial strategy and access remain important levers for Zokinvy stabilization .
  • Cash runway shortened to Q3 2024 from Q4 2024; financing or partnering updates are likely stock catalysts over the next 1–2 quarters .
  • Headline risk persists: discontinuation news and listing compliance developments can drive trading volatility; position sizing should reflect binary pipeline and listing outcomes .

Additional Data and Notes

  • AP/Yahoo snapshot confirms Q3 net loss of $18.0M and revenue of $3.2M, consistent with company disclosures .
  • Some outlets reported material stock declines around discontinuation headlines; listing deficiency notices add to the negative sentiment and potential overhang .