Executive Summary

Reported total revenue of $12.3M, including $10.8M net COSELA revenue; Q3 vial volume grew 3% quarter-over-quarter despite a national platinum-based chemotherapy shortage .
Full-year 2023 COSELA net revenue guidance was lowered to $44–$47M due to the ongoing platinum-based chemotherapy shortage; prior guidance was $50–$60M (Q1/Q2) .
Net loss was $18.2M with basic/diluted EPS of $(0.35), reflecting lower license revenue year-over-year and higher cost of goods sold from a one-time inventory reserve .
Near-term stock reaction catalyst: interim OS analysis for the pivotal Phase 3 PRESERVE 2 (mTNBC) expected in Q1 2024; positive interim results could enable a prompt sNDA discussion with FDA .

What Went Well and What Went Wrong

What Went Well

Vial volume growth: “Vial volume grew 3% over the second quarter of 2023 despite the impact of an ongoing platinum-based chemotherapy shortage,” indicating continued commercial progress for COSELA in ES-SCLC .
External validation: ASCO’s updated SCLC guidelines recommend trilaciclib (COSELA) as a myeloid supportive agent; management highlighted this as indicative of the drug’s potential and a supportive tailwind for adoption .
Cash runway: Ended Q3 with $94.4M in cash, cash equivalents, and marketable securities; management now expects runway to fund operations and capex beyond Q3 2024 .

What Went Wrong

Guidance reduction: 2023 COSELA net revenue guidance lowered to $44–$47M, explicitly attributed to the platinum-based chemotherapy shortage—an external headwind affecting utilization .
Mix and one-time costs: Cost of goods sold rose to $3.1M, driven by increased sales volume and a one-time inventory reserve for potential product obsolescence, pressuring gross profitability .
Pipeline partner exit: EQRx terminated the lerociclib license (as part of its proposed acquisition), eliminating future milestones/royalties; GTHX received $1.6M to wind down study costs in Q3, but no further payments will be received from this program .

Financial Results

Income Statement (USD Millions unless noted)

Metric	Q1 2023	Q2 2023	Q3 2023
Total Revenues ($)	$12.946	$42.392	$12.300
Product Sales, net ($)	$10.492	$11.091	$10.839
License Revenue ($)	$2.454	$31.301	$1.461
Cost of Goods Sold ($)	$1.459	$1.404	$3.076
R&D Expense ($)	$15.480	$12.040	$8.811
SG&A Expense ($)	$21.753	$17.432	$16.781
Total OpEx ($)	$38.692	$30.876	$28.668
Net Income (Loss) ($)	$(27.595)	$8.710	$(18.204)
EPS (Basic/Diluted) ($)	$(0.53)	$0.17 / $0.14	$(0.35)

Notes: Q2 revenue includes a $31.3M license component primarily from Simcere relief of future royalties and reimbursements, driving Q2 profitability . Q3 COGS includes a one-time inventory reserve .

Balance Sheet (USD Millions)

Metric	Q1 2023 (Mar 31)	Q2 2023 (Jun 30)	Q3 2023 (Sep 30)
Cash & Marketable Securities	$116.317	$104.231	$94.352
Total Assets	$161.957	$147.891	$133.097
Total Stockholders’ Equity	$44.988	$57.548	$43.022

Segment/Revenue Mix

Revenue Component	Q1 2023	Q2 2023	Q3 2023
Net COSELA Product Revenue ($)	$10.492	$11.091	$10.839
License & Other Revenue ($)	$2.454	$31.301	$1.461

KPIs

KPI	Q1 2023	Q2 2023	Q3 2023
COSELA Vial Volume Growth QoQ	+21% vs Q4 2022	Not disclosed in Q2 release	+3% vs Q2 2023
Net COSELA Sales QoQ	+18% vs Q4 2022	+6% vs Q1 2023	Not disclosed in release; net sales were $10.8M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
COSELA Net Revenue ($)	FY 2023	$50–$60M (reiterated Q1, Q2)	$44–$47M	Lowered due to platinum-based chemotherapy shortage

No explicit guidance was provided for margins, OpEx, OI&E, tax rate, or dividends in Q3 materials .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
TNBC Phase 3 PRESERVE 2 Interim OS	Interim OS analysis timing updated to Q1 2024; primary endpoint OS; plan to meet FDA if positive	Interim OS still expected Q1 2024; if stopping criteria met, unblinding and top-line; potential sNDA as soon as possible in 2024	Consistent timing; increased emphasis on regulatory path
ADC Combination (SG + trilaciclib)	Phase 2 enrollment complete; preliminary data suggested reduced AEs; OS endpoints expected Q1 2024	Reiterated expectation of initial OS results in Q1 2024	Steady progress toward OS readout
Platinum-based chemo shortage	Commercial team driving adoption despite shortage	Explicit driver of guidance reduction; ongoing shortage cited	Headwind intensified impact on FY outlook
Real-world evidence & ASCO SCLC Guidelines	RWE and mechanism data presented at ASCO/ISPOR; mechanistic insights in TNBC	COSELA recommended in updated ASCO SCLC guidelines; multiple RWE posters presented	Strengthening external validation narrative
Capital & Debt Facility	Hercules facility amended; $50M outstanding; Simcere royalty relief proceeds	Cash $94.4M; runway beyond Q3 2024	Adequate liquidity, runway extended

Management Commentary

“Despite the impact of the ongoing platinum-based chemotherapy shortage, we continue to be encouraged by the mounting real-world evidence confirming the benefit of COSELA and the support of organizations like ASCO through their recent SCLC guideline update recommending its use; we believe these are indicative of the potential of COSELA.” — Jack Bailey, CEO .
“As we approach OS readouts from our ongoing trials, including most importantly the interim OS analysis of our pivotal Phase 3 TNBC trial, there is palpable excitement among clinicians regarding the potential for trilaciclib to improve survival.” — Jack Bailey, CEO .
ASCO guideline update confirming trilaciclib recommendation in ES-SCLC: company underscores “myeloid supportive agent” positioning and evidence-based endorsement .

Q&A Highlights

Timing and pathway for TNBC interim OS: Management reiterated Q1 2024 timing and noted that compelling data would prompt pursuit of regulatory avenues (e.g., sNDA discussion), pending interim results .
Clinical rationale emphasis: Discussion centered on survival endpoints in TNBC programs and potential additive benefit with checkpoint inhibitors from bladder trial maintenance phase observations .
Operating environment: The team acknowledged the platinum-based chemotherapy shortage as a current headwind to commercial momentum and the basis for guidance reduction .

Estimates Context

S&P Global consensus estimates for Q3 2023 (Revenue, EPS) were unavailable via our data connector due to a CIQ mapping gap for ticker GTHX; therefore, we cannot assess beat/miss versus S&P Global consensus for the quarter (Values retrieved from S&P Global)*.
In the absence of validated S&P Global consensus, we anchor comparisons to reported actuals only .

Key Takeaways for Investors

Commercial execution remains resilient: Q3 vial volume up 3% QoQ despite a chemotherapy supply headwind; continued ES-SCLC adoption supported by ASCO guideline inclusion .
FY guidance reduction is externally driven: Lowered COSELA net revenue guidance ($44–$47M) is explicitly tied to the platinum-based chemotherapy shortage; monitor supply normalization as a revenue reacceleration lever .
Upcoming binary clinical catalyst: Interim OS analysis for PRESERVE 2 (mTNBC) in Q1 2024 could enable accelerated regulatory dialogue if positive; this is the critical value inflection event .
Profitability sensitivity to mix/one-time items: Higher Q3 COGS (inventory reserve) and lower license revenue vs Q2 underscore earnings volatility tied to non-recurring items and revenue mix .
Liquidity adequate through clinical readouts: $94.4M in cash/marketable securities and runway beyond Q3 2024 support execution through key data milestones .
Pipeline partner risk realized: EQRx’s lerociclib termination removes future milestone/royalty optionality; focus shifts squarely to trilaciclib programs .
Near-term trading setup: Stock likely to be highly sensitive to any TNBC interim OS updates and evolving visibility on platinum supply; positioning should consider headline risk around Q1 2024 readout .

Appendix: Other Relevant Q3 2023 Press Releases

Upcoming ASCO Quality Care Symposium presentations (RWE on trilaciclib): company announced multiple posters; these bolster real-world support and healthcare utilization benefits narrative .
ASCO guideline update (October 2023): trilaciclib recommended as a myeloid supportive agent for ES-SCLC patients undergoing chemo or chemoimmunotherapy .

G1 Therapeutics, Inc. (GTHX)·Q3 2023 Earnings Summary