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G1 Therapeutics, Inc. (GTHX)·Q4 2023 Earnings Summary

Executive Summary

  • Q4 2023 revenue was $14.9M, up 45% year over year, with net COSELA product sales of $13.9M and license revenue of $1.0M; GAAP EPS was $(0.21) versus $(0.73) in Q4 2022 .
  • Results beat Street consensus: revenue $14.9M vs ~$13.07M, and EPS $(0.21) vs $(0.27) consensus; both represent positive surprises driven by strong vial volume growth despite platinum-based chemotherapy shortages .
  • 2024 guidance: COSELA net revenue $60–$70M; cash runway sufficient into 2025, suggesting adequate near-term liquidity to execute clinical and commercial plans .
  • Management highlighted continued vial volume momentum (+19% vs Q3) and confidence in the pivotal PRESERVE 2 mTNBC trial with final OS analysis expected in Q3 2024, a key stock catalyst for potential label expansion .

What Went Well and What Went Wrong

What Went Well

  • COSELA net revenue grew 29% sequentially to $13.9M; total revenue grew 45% year over year to $14.9M, signaling stronger U.S. commercial traction despite supply constraints .
  • Opex declined materially (Q4 operating expenses $23.8M vs $41.1M prior year), compressing quarterly net loss to $(10.9)M from $(33.6)M in Q4 2022, reflecting tighter cost discipline .
  • CEO tone confident on mTNBC: “The strong fourth quarter 2023 vial volume growth of COSELA… highlights… significant addressable market… Looking ahead, our primary clinical focus is on completing our ongoing trials… We remain confident… given the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis.” .

What Went Wrong

  • Platinum-based chemotherapy shortages continued to be a headwind, noted across Q3 and Q4 disclosures, potentially tempering near-term growth even as vial volumes improved .
  • License revenue reliance earlier in 2023 (e.g., Simcere) normalizes by Q4, keeping product execution paramount; cost of goods rose with higher sales volumes (COGS $1.3M vs $1.0M YoY) .
  • Past EQRx license termination removed potential future milestones/royalties; underscores limited external revenue tailwinds and increases execution risk on core COSELA growth and pipeline readouts .

Financial Results

MetricQ4 2022Q2 2023Q3 2023Q4 2023
Total Revenues ($USD Millions)$10.25 $42.39 $12.30 $14.87
Net Product Sales COSELA ($USD Millions)$8.87 $11.09 $10.84 $13.92
License Revenue ($USD Millions)$1.38 $31.30 $1.46 $0.95
Cost of Goods Sold ($USD Millions)$0.99 $1.40 $3.08 $1.26
R&D Expenses ($USD Millions)$16.59 $12.04 $8.81 $7.38
SG&A Expenses ($USD Millions)$23.56 $17.43 $16.78 $15.17
Loss from Operations ($USD Millions)$(30.89) $11.52 $(16.37) $(8.93)
Net Income (Loss) ($USD Millions)$(33.65) $8.71 $(18.20) $(10.88)
EPS (Basic/Diluted) ($USD)$(0.73)/$(0.73) $0.17/$0.14 $(0.35)/$(0.35) $(0.21)/$(0.21)

Estimate comparison (Q4 2023):

MetricConsensusActualSurprise
Revenue ($USD Millions)~$13.07 $14.87 +$1.80 (+13.8%)
EPS ($USD)$(0.27) $(0.21) +$0.06 (beat)

Revenue components:

ComponentQ2 2023Q3 2023Q4 2023
Net COSELA Sales ($USD Millions)$11.09 $10.84 $13.92
License Revenue ($USD Millions)$31.30 $1.46 $0.95

KPIs:

KPIQ3 2023Q4 2023
Vial Volume Growth vs Prior Quarter (%)+3% +19%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net COSELA RevenueFY 2023$50–$60M (reiterated Q2 2023) $44–$47M (lowered Q3 2023) Lowered
Net COSELA RevenueFY 2024N/A$60–$70M New
Cash RunwayCorporateN/ASufficient into 2025 New/Updated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2023)Trend
Commercial momentum & vial volumeQ3: +3% vial growth vs Q2 despite platinum shortage; total revenue $12.3M . Q2: Sequential net sales +6%; total revenue uplift from Simcere payment .Q4: Vial volume +19%; net sales $13.9M; total revenue $14.9M .Improving sequential volume; stronger product mix .
Platinum-based chemotherapy shortageQ2: Noted national shortage impacting uptake . Q3: Ongoing shortage cited .Still a headwind but volume grew meaningfully .Persistent but impact moderating via execution .
PRESERVE 2 (mTNBC) OS timing/confidenceQ2: Interim OS expected Q1 2024 . Q3: Interim OS expected Q1 2024; path to sNDA if positive .DMC recommended continuation to final analysis; final OS estimated Q3 2024; strong confidence in long-term survival benefit .Timing shifted to final; confidence reiterated .
ADC (SG combination) programQ2: >50% AEs reduction vs SG single-agent safety profile; OS endpoints expected Q1 2024 . Q3: Initial OS results expected Q1 2024 .Preliminary OS favorable: median OS 17.9m vs 12.1m historical; 12-month survival 59% (~+20% vs SG alone); update mid-2024 .Narrative strengthening on OS benefit .
Real-world/GuidelinesQ2: Real-world mechanism insights; ISPOR data on myelosuppression . Q3: ASCO SCLC guideline recommends COSELA; posters on reduced hospitalizations/cytopenias .Continued medical communications (SABCS analyses showing OS improvements with SACT after prior trilaciclib) .Reinforcing external validation .
Cost discipline & liquidityQ2: Debt amendment; cash $104.2M . Q3: Cash $94.4M; opex down .Cash $82.2M; runway into 2025; opex materially down YoY .Tightening costs; adequate runway .

Management Commentary

  • CEO perspective (prepared remarks): “The strong fourth quarter 2023 vial volume growth of COSELA… highlights… the significant addressable market… Looking ahead… completing our ongoing trials… We remain confident in the potential of trilaciclib… given the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis. If successful, we would… expeditiously file for label expansion…” .
  • Clinical execution update: DMC recommended PRESERVE 2 proceed to final analysis; Company remains blinded; final analysis on ITT population estimated Q3 2024 .
  • ADC program: Preliminary Phase 2 results suggest improved OS vs historical SG; median OS 17.9m vs 12.1m historical; 12-month survival 59% (~+20% improvement) .

Q&A Highlights

  • Street focused on the magnitude/sustainability of vial volume growth and commercialization trajectory; management reiterated continued momentum into early 2024 and operational discipline .
  • Clarifications on PRESERVE 2: timeline shifted to final OS analysis in Q3 2024 after DMC recommendation; management emphasized confidence tied to prior long-term survival observations .
  • Questions on ADC combination readouts: management noted preliminary OS benefit and mid-2024 update timing, indicating potential strategic optionality depending on results .

Estimates Context

  • S&P Global (Capital IQ) consensus estimates were unavailable via our SPGI tool for GTHX; we therefore reference third-party sources for consensus comparison.
  • External consensus indicated revenue ~$13.03–$13.07M and EPS $(0.26)–$(0.27); actual revenue $14.87M and EPS $(0.21), a clear beat on both metrics .
  • Implication: Near-term estimates may adjust upward for product revenue trajectory given sequential vial volume strength, while EPS trajectory benefits from opex reductions; however, chemotherapy supply dynamics remain a watch item .

Key Takeaways for Investors

  • Q4 2023 beat on revenue and EPS was driven by strong vial volume growth; sequential momentum suggests improving COSELA utilization despite macro supply constraints .
  • 2024 COSELA revenue guidance of $60–$70M implies continued acceleration; monitor early-quarter script/vial trends as a read-through to guidance achievability .
  • The Q3 2024 final OS analysis for PRESERVE 2 is the pivotal binary catalyst; positive OS could support a rapid sNDA and label expansion pathway, with significant value implications .
  • Preliminary ADC OS data are encouraging and could open additional combination opportunities; mid-2024 update is a secondary clinical catalyst .
  • Cost discipline has materially reduced quarterly losses; with cash runway into 2025, financing risk appears contained near term, contingent on commercial execution .
  • Near-term trading: potential for estimate revisions upward post-beat; volatility likely around chemotherapy supply headlines and as the PRESERVE 2 final analysis window approaches .
  • Medium-term thesis: Upside hinges on label expansion in mTNBC and sustaining COSELA growth; downside risks include trial outcomes, supply constraints, and limited external license revenue contributions post EQRx termination .