Executive Summary

Q1 2025 results showed modest partner-related revenue and a larger, planned OpEx ramp ahead of potential taletrectinib launch; revenue was $3.08M and diluted EPS was $(0.16) . Versus S&P consensus, revenue materially beat while EPS was a slight miss (see Estimates Context). Values retrieved from S&P Global.*
Strategic and regulatory setup remained on track: FDA Priority Review for taletrectinib with a June 23, 2025 PDUFA, all inspections completed, and an EAP active in the U.S. .
Balance sheet strength: $461.7M in cash, cash equivalents, and marketable securities at quarter-end; plus up to $250M in non‑dilutive financing from Sagard (royalty + debt) contingent on approval, expected to fully fund U.S. launch and pipeline progress .
Management refrained from revenue guidance and emphasized that early launch KPI focus will be “patients on therapy,” implying Street models may need to shift from revenue to patient adoption proxies post-approval .
Near-term stock catalyst: PDUFA decision for taletrectinib on 6/23/25; call commentary stressed potential best-in-class profile (ORR 89%, median PFS 46 months, DOR 44 months in TKI‑naive) and commercial readiness (47 oncology account managers, access infrastructure) .

What Went Well and What Went Wrong

What Went Well

Regulatory momentum and publication record: Priority Review ongoing with inspections completed; pooled TRUST-I/II data published in JCO and presented at major meetings, reinforcing differentiated efficacy and CNS activity for taletrectinib .
Commercial readiness and access: Team in place with 47 oncology account managers; plans focused on rapid identification and initiation, patient support, and market education; NCCN guideline changes highlighted as a new tailwind .
Balance sheet and funding visibility: $461.7M quarter-end liquidity, with Sagard up to $250M non‑dilutive financing intended to fully fund U.S. launch and pipeline toward potential profitability without additional equity raises .

“Data recently published in the Journal of Clinical Oncology … further reinforce taletrectinib’s potential to deliver a differentiated profile with strong efficacy, high CNS activity, and favorable tolerability.” — David Hung, CEO

What Went Wrong

Operating expense step‑up ahead of launch: R&D rose to $24.6M (from $12.8M YoY); SG&A grew to $35.4M (from $7.4M YoY) on AnHeart integration and pre‑commercial build, contributing to a larger net loss of $(53.2)M .
Sequential revenue down: Q1 revenue of $3.08M declined from Q4’s $5.71M, reflecting variability in partner- and program-related activity QoQ .
No revenue guidance: Management is not providing revenue guidance and steered investors to non‑financial KPIs post-approval, which may complicate near-term modeling and consensus alignment .

Financial Results

P&L (Quarterly trend)

Metric	Q3 2024	Q4 2024	Q1 2025
Revenue ($)	$727,000	$5,711,000	$3,084,000
Cost of Revenue ($)	$1,515,000	$4,216,000	$2,094,000
Gross Profit ($)	$(788,000)	$1,495,000	$990,000
R&D Expense ($)	$27,731,000	$29,299,000	$24,601,000
SG&A Expense ($)	$19,582,000	$26,138,000	$35,393,000
Total Operating Expenses ($)	$47,313,000	$55,437,000	$59,994,000
Net Loss ($)	$(41,210,000)	$(49,445,000)	$(53,236,000)
Diluted EPS ($)	$(0.15)	$(0.15)	$(0.16)
Weighted Avg Shares (basic/diluted)	273,565,000	336,934,000	338,612,000

YoY snapshot (Q1 2025 vs Q1 2024)

Metric	Q1 2024	Q1 2025
Revenue ($)	$0 (–)	$3,084,000
R&D Expense ($)	$12,842,000	$24,601,000
SG&A Expense ($)	$7,357,000	$35,393,000
Net Loss ($)	$(14,792,000)	$(53,236,000)
Diluted EPS ($)	$(0.07)	$(0.16)

Balance Sheet/Liquidity

Cash, cash equivalents, and marketable securities: $461.7M as of 3/31/25 .
Sagard non‑dilutive financing: $150M royalty financing + up to $100M term loan upon approval/launch milestones; intended to fully fund U.S. launch and support pipeline .

Results vs S&P Global Consensus (Q1 2025)

Metric	Consensus*	Actual	Result
Revenue ($)	$357,140*	$3,084,000	Bold beat
Diluted EPS ($)	$(0.157)*	$(0.16)	Slight miss

Values retrieved from S&P Global.*

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY 2025	None	No formal revenue guidance; launch KPI = “patients on therapy”	Maintained: no guidance
Taletrectinib launch timing	2025	Priority Review in place	PDUFA 6/23/2025; inspections completed	Maintained timeline
Funding for launch/pipeline	2025–2026	Announced Sagard framework (Mar)	Up to $250M non‑dilutive financing upon approval/launch milestones	Reaffirmed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024 and Q4 2024)	Current Period (Q1 2025)	Trend
Taletrectinib efficacy/safety	ORR 89% and median DOR ≈ 44 months highlighted at ESMO; NDA submitted/accepted	Reinforced JCO publication; first‑line ORR 89%, median PFS 46 months, DOR 44 months; strong intracranial activity; low discontinuation	Strengthening data visibility/publication
Regulatory milestones	NDA accepted; Priority Review; PDUFA 6/23/25	Priority Review on track; all inspections completed; high FDA engagement	Progressing as planned
Commercial readiness	Building organization for mid‑2025 launch	47 oncology account managers; go‑to‑market plan, access programs, top prescriber focus	Execution readiness ramping
Market access/guidelines	—	2025 NCCN changes: stop IO chemo and start ROS1 TKI if ROS1+ identified; ROS1+ now a contraindication to IO; viewed as tailwind	Positive external tailwind emerges
Financing/runway	—	Up to $250M Sagard non‑dilutive (royalty + debt) contingent on approval; funds launch and pipeline	Improves funding flexibility
Pipeline beyond ROS1	Programs ongoing (safusidenib, NUV‑1511, NUV‑868)	Safusidenib pivotal design update 2H25; NUV‑1511 Phase 1/2 update 2H25	Additional catalysts later in 2025

Management Commentary

“We believe taletrectinib has the potential to become best in class … demonstrated consistent, durable responses, strong intracranial activity, and a favorable safety profile” .
“The review of our NDA is progressing on time, with all planned inspections now completed with favorable outcomes” .
“We’ve right-sized our commercial footprint with 47 oncology account managers … and a field access team already in place” .
“While we are not providing revenue guidance at this time … our primary KPI will be the number of patients on therapy” .

Q&A Highlights

Pricing and launch mechanics: Pricing not disclosed pre‑approval; EAP not expected to create a large initial bolus of patients at launch .
NCCN guideline changes: Management emphasized the 2025 update directing stops to IO chemo upon ROS1+ identification and initiation of a ROS1 TKI, seen as a demand tailwind .
Safusidenib path: Expect pivotal design update in 2H25; aim to share additional efficacy (ORR, first PFS look) later this year pending agreements with academic collaborator .
Share count clarification: Management referenced ~340M diluted shares during Q&A consistent with reported weighted average shares .

Estimates Context

Versus S&P Global consensus, NUVB’s Q1 revenue of $3.08M beat a $0.36M estimate materially, while diluted EPS $(0.16) modestly missed the $(0.157) estimate. Values retrieved from S&P Global.* Actuals are from company filings .
CFO indicated reported revenue includes product and R&D billings to partners (Nippon Kayaku, Innovent), helping reconcile Street under‑modeling of non‑commercial revenue lines pre‑launch .
With no revenue guidance and a patient‑centric KPI focus for early quarters post‑approval, Street models may pivot from near‑term net sales to patient starts and conversion metrics, then layer revenue as access and persistence data emerge .

Key Takeaways for Investors

PDUFA 6/23/25 is the primary near‑term catalyst; management tone confident with inspections completed and robust data package .
Q1 showed expected OpEx ramp into launch (SG&A build, commercial hires); cash runway plus Sagard financing should fund launch and pipeline without near‑term equity needs .
Consensus disconnect: large Q1 revenue beat vs S&P Global likely reflects under‑modeled partner-related revenue pre‑commercialization; EPS a slight miss amid planned OpEx growth. Values retrieved from S&P Global.*
Launch framework: team and distribution designed to prioritize rapid identification and initiation, access support, and persistence; primary KPI will be patients on therapy (early indicator of adoption) .
Market tailwind: 2025 NCCN updates favor earlier ROS1 TKI use and contraindicate IO in ROS1+—supportive for first‑line adoption if approved .
Differentiation narrative remains central: high ORR, prolonged PFS/DOR, CNS activity, and tolerability underpin best‑in‑class positioning claims vs first/second‑generation ROS1 TKIs .
Medium‑term: Additional 2H25 updates from safusidenib and NUV‑1511 offer pipeline catalysts beyond launch execution .

Appendix: Additional Relevant Press Releases (Q1/Q2 2025 window)

Expanded Access Program (U.S.) initiated Feb 2025 .
Sagard non‑dilutive financing up to $250M announced Mar 3, 2025 .
New nonclinical data at AACR (Apr 2025) and MAIC vs entrectinib (May 2025) .

Notes: Financial figures are from company filings/press releases as cited. Consensus figures marked with an asterisk are Values retrieved from S&P Global.*

Nuvation Bio Inc. (NUVB)·Q1 2025 Earnings Summary