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Eiger BioPharmaceuticals, Inc. (EIGR)·Q1 2023 Earnings Summary

Executive Summary

  • Product revenue grew 54% year over year to $4.12M on higher Zokinvy sales in Germany, France ATU, and the U.S; net loss was $22.8M with diluted EPS of $(0.52) .
  • Cash, cash equivalents, and short-term debt securities declined to $75.3M as of March 31, 2023, down from $98.9M at year-end, reflecting operating cash usage and securities maturities/reinvestment .
  • HDV pipeline milestones: Pre-NDA meeting for lonafarnib/ritonavir in Q2; LIMT-2 peginterferon lambda Phase 3 randomization on track to complete by end of Q2; D-LIVR Week 72 data targeted for EASL in June—key near-term regulatory catalysts .
  • Corporate strengthening: Appointment of CFO William G. Kachioff and General Counsel/CCO James A. Vollins in April; management reiterated program prioritization to focus on shareholder value .
  • Wall Street consensus (S&P Global) for Q1 2023 EPS and revenue was unavailable; estimate comparisons are therefore not included (values retrieved from S&P Global were unavailable).

What Went Well and What Went Wrong

What Went Well

  • Revenue inflection: Net product revenue rose to $4.118M vs $2.673M a year ago, driven by Germany, France ATU, and U.S. demand; cost of sales was essentially flat year over year .
  • HDV clinical progress: “We look forward to our pre-NDA meeting with the FDA in the second quarter, which will inform our strategy for the lonafarnib HDV program,” said Interim CEO David Apelian; LIMT-2 randomization completion by end of Q2; Week 72 D-LIVR data to be presented at EASL in June .
  • EU/UK regulatory footprint and execution: Zokinvy achieved EU and U.K. approvals; first European sales recognized in Q4 2022; Q1 revenue benefited from France ATU contributions ($0.5M) .

What Went Wrong

  • Continued operating losses: Net loss was $22.8M with $(0.52) diluted EPS; interest expense increased due to Innovatus term loan balance .
  • SG&A stepped up 40% YoY to $9.5M, reflecting higher outside services and personnel costs amid corporate transitions and program readiness activities .
  • Cash drawdown: Cash and short-term debt securities fell to $75.3M from $98.9M at year-end, implying a tighter liquidity runway without incremental financings or tranche draws .

Financial Results

Quarterly P&L and Balance Highlights (oldest → newest)

MetricQ3 2022Q4 2022Q1 2023
Product revenue, net ($USD Millions)$4.024 $2.696 $4.118
Cost of sales ($USD Millions)$1.231 $0.345 $0.118
Research & Development ($USD Millions)$22.198 $18.521 $16.748
SG&A ($USD Millions)$6.964 $8.301 $9.515
Total operating expenses ($USD Millions)$30.393 $27.167 $26.381
Net loss ($USD Millions)$(27.111) $(25.138) $(22.784)
Diluted EPS ($USD)$(0.62) $(0.57) $(0.52)
Cash, cash equivalents & short-term debt securities ($USD Millions)$121.0 (includes total investments) $98.9 $75.3
Common shares outstanding (Millions)44.0 44.07 44.30

Year-over-Year (Q1 2023 vs Q1 2022)

MetricQ1 2022Q1 2023
Product revenue, net ($USD Millions)$2.673 $4.118
Net loss ($USD Millions)$(22.643) $(22.784)
Diluted EPS ($USD)$(0.64) $(0.52)
R&D ($USD Millions)$17.570 $16.748
SG&A ($USD Millions)$6.813 $9.515

KPIs

KPIQ3 2022Q4 2022Q1 2023
Accounts receivable ($USD Millions)$2.458 $1.749 $3.891
Inventories ($USD Millions)$2.817 $2.853 $5.338
France ATU revenue ($USD Millions)——$0.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue, margins, OpEx, OI&E, tax rateQ1 2023Not providedNot providedMaintained (no financial guidance issued)
Liquidity disclosureAs of Q1 2023$98.9M cash/short-term debt securities (12/31/22) $75.3M cash/short-term debt securities (3/31/23) N/A (disclosure, not formal guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2022)Previous Mentions (Q4 2022)Current Period (Q1 2023)Trend
HDV D-LIVR (lonafarnib/ritonavir)Topline Week 48 data expected Dec; registration aim for two regimens Week 48 data met primary endpoints; pre-NDA by end of Q2 Pre-NDA meeting in Q2; Week 72 data at EASL in June Advancing toward regulatory interactions
HDV LIMT-2 (peginterferon lambda)Enrolling; target N=150 Screening completed; randomization by end of Q2 Randomization completion by end of Q2 Execution progressing
Avexitide (HI program)Phase 3 program initiated Phase 3 startup; optimizing product-related impurities Phase 3 readiness activities continue; supply/shelf-life gating dosing start Manufacturing readiness gating timeline
Zokinvy commercial footprintEU/UK approvals; Germany reimbursement First EU sales recognized Q1 net revenue $4.1M; ATU France revenue noted International uptake contributing
Corporate/ManagementCash runway expectation through 2024; debt facility availability Program prioritization update anticipated Q2 CFO and GC/CCO appointed; formal prioritization ongoing Leadership changes; focus on value drivers
Liquidity/Debt$121.0M cash/equivalents/investments $98.9M cash/short-term debt securities $75.3M cash/short-term debt securities Lower balance; continued cash burn

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 our pre-NDA meeting with the FDA in the second quarter, which will inform our strategy for the lonafarnib HDV program.” — David Apelian, MD, PhD, Interim CEO .
  • “We strengthened our management team with the appointments of our new Chief Financial Officer and our new General Counsel, Chief Compliance Officer and Corporate Secretary, both of which come during a pivotal time as we complete our program prioritization analyses this quarter to determine the most promising drivers for shareholder value.” — David Apelian .
  • Prior quarter context: “We look forward to the pre-NDA meeting with the FDA, which we expect by end of Q2… we remain focused on preparing for a planned pre-NDA meeting and guidance from FDA on the D-LIVR program in mid-2023.” — David Apelian .

Q&A Highlights

  • A Q1 2023 earnings call transcript was not available in the document set; the company’s press release furnished an operational and financial update but no accessible transcript was retrieved for Q&A analysis .

Estimates Context

  • S&P Global/Capital IQ consensus EPS and revenue estimates for Q1 2023 were unavailable; as a result, beat/miss analysis vs Wall Street consensus cannot be provided (values retrieved from S&P Global were unavailable).

Key Takeaways for Investors

  • Revenue momentum from Zokinvy and international channels drove a 54% YoY increase; monitor sustainability as ATU France transitions to commercial reimbursement and EU uptake normalizes .
  • Operating discipline improved sequentially (lower R&D), but SG&A growth highlights cost intensity of regulatory and program readiness; watch for normalization as prioritization completes .
  • Liquidity fell to $75.3M; with cash burn evident, financing optionality (ATM capacity, Innovatus tranches) and regulatory catalysts are critical to sentiment and runway .
  • Near-term catalysts: Pre-NDA meeting outcomes and Week 72 D-LIVR data at EASL could reset expectations on HDV path to approval; investor focus on FDA feedback timing and scope .
  • Avexitide Phase 3 dosing start hinges on manufacturing/material readiness; clarity on timeline could support medium-term optionality beyond HDV .
  • Corporate appointments and prioritization may streamline focus and spending; look for updates on portfolio emphasis and cost structure trajectory .
  • Absent consensus estimates, trading will likely anchor to pipeline/regulatory milestones and cash runway disclosures rather than near-term P&L beats/misses (S&P Global consensus unavailable).