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G1 Therapeutics, Inc. (GTHX)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 total revenue was $14.476M, with COSELA net product sales of $14.079M and license revenue of $0.397M; diluted EPS was $-0.20. Management reaffirmed FY 2024 COSELA net revenue guidance of $60–$70M and projected cash runway into Q3 2025 .
  • Versus consensus, revenue missed by ~$0.6M and EPS missed by $0.01 (consensus: revenue $15.07M, EPS $-0.19). Bold miss: revenue and EPS were modestly below Street expectations .
  • Operationally, vial volume grew 4% sequentially; upcoming catalysts include mature Phase 2 TROP2 ADC combo data at ASCO (early June) and final PRESERVE 2 OS analysis in 1L mTNBC expected late Q2 2024, potentially enabling an sNDA if positive .
  • CEO emphasized focus on building category leadership in TNBC and maximizing COSELA uptake in ES-SCLC; CFO detailed lower OpEx and reiterated cash runway into Q3 2025 as a support for execution ahead of clinical readouts .

What Went Well and What Went Wrong

What Went Well

  • COSELA net product revenue rose to $14.079M, up ~34% YoY versus Q1 2023; vial volume grew 4% QoQ, supporting revenue trajectory and guidance reaffirmation .
  • Operating discipline: total operating expenses fell to $23.524M (vs. $38.692M in Q1 2023) with R&D at $7.318M and SG&A at $15.127M, driving a markedly smaller net loss of $10.219M YoY .
  • Strategic pipeline/events: mature ADC combo (trilaciclib + sacituzumab govitecan) efficacy update slated for ASCO; final PRESERVE 2 OS analysis timing advanced to late Q2 2024 after FDA methodology alignment, with sNDA intent if positive .
    • “We have two important readouts later this year…ASCO poster…followed by the readout of our Phase 3 PRESERVE 2 1L mTNBC trial late in the second quarter of this year” — CEO Jack Bailey .

What Went Wrong

  • Missed consensus: revenue $14.476M vs. $15.07M consensus; EPS $-0.20 vs. $-0.19 consensus. Bold miss: both revenue and EPS slightly below Street .
  • Cash declined to $65.186M from $82.156M at year-end; although CFO flagged an $8.7M debt paydown tied to borrowing base limits, it still represents higher cash usage, with operational cash burn of ~$8M for the quarter discussed on the call .
  • Executional headwinds and regional variances cited by Commercial leadership impacting growth consistency despite overall progress; management noted actions taken to address these within the quarter .

Financial Results

Income Statement Summary (USD)

MetricQ1 2023Q4 2023Q1 2024
Total Revenues ($M)$12.946 $14.873 $14.476
Net Income (Loss) ($M)$(27.595) $(10.878) $(10.219)
Diluted EPS ($)$(0.53) $(0.21) $(0.20)
Total Operating Expenses ($M)$38.692 $23.802 $23.524
Net Income Margin (%)-213.1% (calc. from )-73.1% (calc. from )-70.6% (calc. from )

Revenue Breakdown (USD)

MetricQ1 2023Q4 2023Q1 2024
COSELA Net Product Sales ($M)$10.492 $13.922 $14.079
License Revenue ($M)$2.454 $0.951 $0.397

Key KPIs and Operating Metrics

KPIQ1 2023Q4 2023Q1 2024
COSELA Vial Volume Growth QoQ (%)—+19% +4%
Cash, Cash Equivalents & Marketable Securities ($M)—$82.156 $65.186
Working Capital ($M)—$85.232 $63.236
Weighted Avg. Shares (Basic/Diluted)51,647,934 51,838,834 52,171,684

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
COSELA Net RevenueFY 2024$60–$70M (issued 2/28/24) $60–$70M (reaffirmed 5/1/24) Maintained
Cash RunwayCorporateInto 2025 (2/28/24) Into Q3 2025 (5/1/24) Updated (more specific)
PRESERVE 2 Final OS Analysis Timing1L mTNBCQ3 2024 expected (2/28/24) Late Q2 2024 expected (5/1/24) Pulled forward
ADC Combo (Trila + SG) DataEventInitial OS mid-2024 (2/28/24) Mature efficacy at ASCO (May 31–Jun 4, 2024) Scheduled disclosure

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023 and Q4 2023)Current Period (Q1 2024)Trend
Product performance (COSELA)Q3: Net COSELA revenue $10.8M; Q3 vial +3% QoQ despite platinum shortage; Q4: Net COSELA revenue $13.9M with vial +19% QoQ Net COSELA revenue $14.079M; vial volume +4% QoQ Continued growth; moderation QoQ post shortage easing
Supply chain (platinum-based chemo)Q3: Ongoing shortage dampened growth; Q4: impact began to abate No new constraints cited; focus on execution and regional variances Improving backdrop; execution focus
Regulatory/clinical timingQ3: Interim OS in Q1 2024; final in 2024 Final OS late Q2 2024 after FDA methodology alignment; sNDA plan if positive Clearer, nearer catalyst
ADC combinations (Trila + SG)Q4: Preliminary data suggest improved OS; updated OS expected mid-2024 Mature efficacy update at ASCO; 12‑month survival estimate 59% (prior cut) Advancing external validation
Commercial executionQ4: Momentum regained in Q4; strong vial growth Mgmt flagged executional headwinds in some regions; actions taken Mixed; corrective actions underway
Cash/OpEx disciplineQ4: OpEx down YoY; cash $82.2M; runway into 2025 OpEx $23.5M; cash $65.2M; runway into Q3 2025; debt paydown reduces interest Tightening cost controls; more precise runway

Management Commentary

  • CEO Jack Bailey: “Our focus for 2024 is on developing trilaciclib toward potential category leadership in triple negative breast cancer and maximizing the uptake of COSELA in its first indication in extensive stage small cell lung cancer; we've made progress on both in the first four months of the year” .
  • CFO commentary (call): “Net sales of COSELA were $14,100,000… total revenue $14,500,000… total operating expenses were $23,500,000… cash, cash equivalents and marketable securities of $65,200,000” .
  • Commercial update (call): Q1 aimed to build on Q4 vial growth; regional variances and short-term execution headwinds addressed during the quarter .
  • Pipeline timing: “Final overall survival analysis will be conducted at the end of the second quarter of 2024… If positive, we will meet with the FDA to discuss… sNDA filing” .

Q&A Highlights

  • Market penetration: “About 90% of our use today is in the first‑line setting… our first‑line market share is around 13%… our overall market share is not too different from that… in the second‑line setting” — Jack Bailey .
  • Label expansion strategy: CMO indicated approach to pursue as broad an approval as possible for gemcitabine‑carboplatin combinations, spanning first line and beyond, subject to data and FDA discussion .
  • Executional headwinds: Management acknowledged regional/segment variances and took actions intra‑quarter to address them .
  • Debt/cash: CFO discussed an $8.7M principal paydown tied to borrowing base limits and expected ~$1M annual interest savings; no further paydowns anticipated until scheduled principal begins in December .

Estimates Context

  • S&P Global consensus was unavailable via our tool for GTHX; we use public sources. Q1 2024 consensus: revenue $15.07M; EPS $-0.19. Actuals: revenue $14.476M; EPS $-0.20. Bold miss: revenue missed by ~$0.6M; EPS missed by $0.01 .
  • Alternative sources corroborate miss: Zacks reported revenue $14.48M vs. consensus; EPS $-0.20 vs. $-0.19 .

Actuals vs. Consensus (Q1 2024)

MetricActualConsensusVariance
Revenue ($M)$14.476 $15.07 $(0.59)
Diluted EPS ($)$(0.20) $(0.19) $(0.01)

Key Takeaways for Investors

  • Q1 fundamentals show disciplined OpEx and YoY revenue growth; however, modest misses vs. consensus and lower cash highlight the importance of near‑term clinical catalysts to support the equity narrative .
  • Bold catalyst path: ASCO ADC combo update in early June and final PRESERVE 2 OS in late Q2 could be stock‑moving events; positive OS readouts may enable sNDA and broaden label, which is central to the medium‑term thesis .
  • Commercial trajectory remains constructive with sequential vial growth; continuing execution improvements in identified regions should support FY guidance maintenance ($60–$70M) .
  • Risk management: watch borrowing base dynamics and cash burn; CFO’s noted interest savings and no further near‑term paydowns reduce financing pressure, but execution and clinical outcomes are key .
  • If PRESERVE 2 OS meets endpoint, expect label expansion strategy and potential for broader reimbursement markets; failure would likely pressure valuation and require recalibration toward ES‑SCLC and ADC combos .
  • Street models likely need minor downward Q1 adjustments given the miss, but FY guidance reaffirmation suggests limited changes unless clinical timelines shift materially .
  • Trading implication: Near‑term setup is binary around late‑Q2 OS; positioning should reflect catalyst risk/reward, with ASCO visibility potentially shaping expectations ahead of mTNBC readout .

Additional Source References and Prior-Quarter Context

  • Q4 2023 press release (financials, guidance): total revenue $14.873M; COSELA net $13.922M; guidance for 2024 $60–$70M; runway into 2025 .
  • Q3 2023 press release: total revenue $12.300M; COSELA net $10.839M; lowered FY 2023 COSELA net revenue guidance to $44–$47M due to platinum shortage .
  • January 8, 2024 8‑K/JPM presentation: commercial momentum, ES‑SCLC market dynamics, vial growth reacceleration in Q4, and ADC/TNBC development rationale .