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FIBROGEN INC (FGEN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 continuing operations revenue was $3.1M (vs $3.6M YoY) and net loss from continuing operations was $8.7M (or $0.08/share); GAAP EPS was $0.18 due to income from discontinued operations tied to China, masking a loss in continuing ops .
  • Announced sale of FibroGen China to AstraZeneca for ~$160M (EV $85M + ${75}M net cash), expected to close by mid-2025; upon close, company plans to repay its MSTV term loan ($80M) and extend cash runway into 2027 .
  • 2025 outlook: total revenue $4–$8M and total operating costs/expenses $70–$80M, reflecting a leaner model focused on FG-3246 (CD46 ADC) and FG-3180; company expects to be consolidated cash-flow positive in Q1 2025 prior to China close due to continued accrual from China operations pre-closing .
  • Listing risk remains a watch item: Nasdaq minimum bid deficiency triggered delisting proceedings; appeal is pending, and a reverse split is contemplated if necessary to regain compliance, which could be a stock reaction catalyst alongside China-close milestones and Phase 2 initiations/results .

What Went Well and What Went Wrong

What Went Well

  • Cost reset is taking hold: Q4 total operating costs/expenses fell to $10.3M from $66.3M YoY (–84%); R&D and SG&A down 86% and 49% YoY, respectively, materially improving cash burn trajectory .
  • Balance sheet strategy: Sale of China to AstraZeneca is “truly transformative,” expected to fund term-loan payoff (~$80M) and extend runway into 2027 post-close, simplifying the capital structure .
  • Pipeline clarity and near-term catalysts: Initiation of Phase 2 monotherapy dose optimization for FG-3246 by mid-2025; Phase 2 combination topline (FG-3246 + enzalutamide) expected 2H’25; FDA meeting for roxadustat in LR-MDS planned in Q2’25. “We entered 2025 optimistic,” with a “laser focus” on FG-3246/FG-3180 and LR‑MDS for roxadustat .

What Went Wrong

  • Topline remains small in continuing ops: Q4 continuing operations revenue declined to $3.1M vs $3.6M YoY; 2025 revenue guidance of just $4–$8M underscores limited near-term commercial contribution from continuing ops while pipeline advances .
  • Ongoing losses in continuing ops (despite cost reductions): Q4 loss from continuing ops was $8.7M, though improved YoY from $62.5M; GAAP EPS positive only due to discontinued ops income .
  • Listing overhang: Nasdaq minimum bid deficiency and pending hearing create technical risk; management indicated a reverse split may be used if needed to regain compliance .

Financial Results

Note: Comparability is affected by reclassification of China as discontinued operations in Q4 2024. Q2 and Q3 2024 totals include China; Q4 2024 “continuing operations” excludes China.

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Total Revenue ($M)$3.627 $50.641 $46.333 $3.136
GAAP EPS (Basic & Diluted)$(0.57) $(0.16) $(0.17) $0.18
EPS – Continuing Ops (Basic & Diluted)$(0.63) N/AN/A$(0.08)
Loss from Operations ($M)$(62.662) $(10.919) $(16.778) $(7.134)
Operating Margin %(1728.4%) (calc from )(21.6%) (calc from )(36.2%) (calc from )(227.5%) (calc from )

Revenue mix (note classification change in Q4):

Revenue Component ($M)Q4 2023Q2 2024Q3 2024Q4 2024
License Revenue$0.000 $0.000 $0.000 $0.000
Development & Other$2.575 $0.269 $0.385 $0.416
Product Revenue, netN/A$49.643 $46.210 N/A
Drug Product Revenue, net$1.052 $0.729 $(0.262) $2.720

Operating expense KPIs and liquidity:

KPI ($M)Q4 2023Q2 2024Q3 2024Q4 2024
R&D Expense$48.710 $34.106 $21.708 $6.870
SG&A Expense$16.378 $22.276 $17.554 $8.345
Total Operating Costs & Expenses$66.289 $61.560 $63.111 $10.270
Cash, Cash Equivalents & A/R (Consolidated)N/A$147.1 $160.0 $121.1
Cash, Cash Equivalents & A/R (U.S.)N/AN/AN/A$51.0

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025N/A$4–$8M New
Total Operating Costs & Expenses (incl. SBC)FY 2025N/A$70–$80M New
Cash RunwayMulti‑yearInto 2026 (pre‑deal, Q3’24) Into 2027 (post China close) Raised
Consolidated Cash FlowQ1 2025N/AExpected positive New
Capital StructureAt China closeN/ARepay MSTV term loan (~$80M) De‑lever plan

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024)Trend
Portfolio focus & cost reductionsMajor U.S. cost cuts and ~75% workforce reduction; shift to FG‑3246/FG‑3180; cost plan substantial by YE’24 .Opex down 84% YoY in Q4; restructuring complete; 2025 opex guided $70–$80M .Improving cost discipline
China business/transactionStrong China roxadustat sales; 2024 net product revenue guidance $135–$150M; runway into 2026 with repatriation .Sale of China to AstraZeneca for ~$160M; runway into 2027; continue accruing China cash until close .De‑risk balance sheet; simplify ops
FG‑3246/FG‑3180 programPositive Phase 1 data; Phase 2 combo topline 1H’25; Phase 2 mono start 1Q’25 anticipated .Phase 2 mono start by mid‑2025; combo topline 2H’25; biomarker (FG‑3180) integration emphasized .On track; biomarker strategy
Roxadustat (LR‑MDS in U.S.)Noted opportunity; China CIA sNDA pending .FDA meeting planned Q2’25; exploring 2nd/3rd‑line LR‑MDS, placebo‑controlled trial; ~200 pts envisaged .Pathfinding with FDA
Capital structure/liquidityCash/A/R $147.1M (Q2) and $160.0M (Q3) .Pay down MSTV (~$80M) at China close; positive consolidated cash flow expected in Q1’25 .Strengthening
Listing status—Nasdaq minimum bid deficiency; appeal pending; reverse split if needed .Technical overhang

Management Commentary

  • “This is a truly transformative transaction for our company… allows the payoff of our term loan… and provides the most efficient pathway to access the company's net cash held in China, extending the company's cash runway into 2027.”
  • “We are confident that the shift to a lean U.S. organization focused on high value indications… has the potential to create tremendous value… with an extended cash runway into 2027.”
  • On FG‑3246: “We believe that having a patient selection biomarker [FG‑3180] would… allow us to better enrich the patient population… and enable differentiation… in the prostate cancer treatment paradigm.”
  • On LR‑MDS: “We plan to meet with the FDA in the second quarter of 2025… which could pave the way for developing roxadustat… either on our own or through a partnership.”

Q&A Highlights

  • Phase 2 monotherapy futility analysis (mid‑2026) will check safety/tolerability and efficacy across dose cohorts; details on stringency not disclosed; prior Pluvicto use is allowed (not within prior 28 days) in the post‑ARSI, pre‑chemo setting .
  • LR‑MDS trial sizing: company anticipates ~200 patients; prior CKD safety database is informative but not instructive; pursuing placebo‑controlled design in ESA‑refractory pts post another therapy (e.g., luspatercept) as a second/third‑line approach (pending FDA feedback) .
  • Business development posture: no new assets contemplated near‑term; “laser‑focused” on advancing FG‑3246/FG‑3180 and securing LR‑MDS clarity for roxadustat .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 and next quarter could not be retrieved at this time due to data access limits; therefore, beat/miss vs consensus is not included. We attempted to pull “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for Q4 2024 and Q1 2025 but the request was blocked by an S&P Global daily limit. As a result, estimate comparisons are unavailable for this recap at this time.

Key Takeaways for Investors

  • Balance sheet inflection pending: China sale closing and MSTV payoff are pivotal de‑risking events that extend runway into 2027 and concentrate resources on oncology value drivers .
  • 2025 P&L reset: revenue guide of $4–$8M and opex of $70–$80M reflect limited near‑term revenue while pipeline advances; burn should be meaningfully lower post‑restructuring .
  • Pipeline catalysts: FG‑3246 Phase 2 monotherapy initiation by mid‑2025 and combo topline in 2H’25 offer multiple data catalysts; biomarker strategy (FG‑3180) may enhance differentiation and trial efficiency .
  • Regulatory pathfinding: Q2’25 FDA meeting for roxadustat in LR‑MDS could unlock a Phase 3‑ready opportunity in a differentiated oral therapy niche; watch for study design feedback (control, line of therapy, size) .
  • Technical overhang: Nasdaq bid deficiency and potential reverse split keep trading technicals in focus until compliance is achieved; panel outcome and any corporate actions may drive volatility .
  • Print dynamics: GAAP EPS was positive in Q4 due to discontinued ops; focus on continuing ops loss and cash guidance to understand core trajectory .

Additional References

  • Full Q4 2024 8‑K Earnings Release, including financial statements .
  • Q4 2024 Earnings Call Transcript for detailed strategy and guidance commentary .
  • Press Release: Sale of FibroGen China to AstraZeneca (~$160M), expected mid‑2025 close .
  • Prior quarters for trend: Q3 2024 8‑K (revenue $46.3M; cash/A&R $160.0M) and Q2 2024 8‑K (revenue $50.6M; cash/A&R $147.1M) .