Executive Summary

Pre-revenue quarter with net loss narrowing year over year as R&D normalized vs 2022 milestone-heavy spend; Q2 GAAP EPS was $(0.20) vs $(0.39) in Q2 2022 and $(0.22) in Q1 2023 .
Regulatory execution strong: EXPLORER-CN met primary endpoint; NMPA accepted mavacamten NDA with priority review; approvals in Singapore and Macau; cash runway extended into H1 2025 .
Management guided for China mavacamten approval mid-2024 and commercial launch H2 2024; launches in Singapore/Macau expected in Q4 2023—key catalysts ahead .
S&P Global consensus estimates for LIAN were unavailable; no earnings call transcript was located for Q2 2023, limiting beat/miss commentary vs Street [GetEstimates error; S&P Global data unavailable] [ListDocuments showed 0 earnings-call-transcript].

What Went Well and What Went Wrong

What Went Well

EXPLORER-CN Phase 3 positive in Chinese oHCM: statistically significant and clinically meaningful improvement in Valsalva LVOT gradient; safety profile consistent with prior studies .
Regulatory momentum: NMPA priority review for mavacamten; approvals in Singapore and Macau; ESC late-breaking presentation acceptance—advances launch readiness .
Cash runway extended into H1 2025; management emphasized progressing toward first anticipated China approval and first launches in Asia over next 12 months .
- “We achieved multiple clinical development milestones and advanced our pipeline closer to patients… we are well positioned for LianBio’s first launches in our territories later this year” — CEO Yizhe Wang .

What Went Wrong

Still pre-revenue with continued operating losses; Q2 net loss $(21.6)M despite interest income and FX gains .
G&A increased YoY on headcount and share-based comp; Q2 G&A $15.6M vs $14.6M last year; ongoing public company and commercialization prep costs .
Heightened China data/cybersecurity regulatory risks may increase compliance costs and could affect clinical operations or data transfers; extensive new rules (PIPL, Data Security Law, HGR Implementing Rules) highlighted in risk factors .

Financial Results

Metric	Q4 2022	Q1 2023	Q2 2023
Research & Development Expense ($USD Millions)	$10.58	$10.83	$9.45
General & Administrative Expense ($USD Millions)	$18.67	$15.14	$15.59
Total Operating Expenses ($USD Millions)	$29.25	$25.97	$25.04
Interest Income ($USD Millions)	$2.08	$2.41	$2.75
Other Income, net ($USD Millions)	$8.54	$(0.04)	$0.87
Net Loss ($USD Millions)	$(18.28)	$(24.05)	$(21.62)
GAAP Diluted EPS ($USD)	$(0.17)	$(0.22)	$(0.20)
Weighted Avg Shares (Millions)	108.13	107.16	107.16
Cash, Cash Equivalents, Marketable Securities & Restricted Cash ($USD Millions, period-end)	$302.4	$286.6	$267.3

Segment R&D program spend (quarterly):

Program R&D ($USD Thousands)	Q2 2022	Q2 2023
Mavacamten	$6,520	$1,422
Infigratinib	$1,647	$668
BBP-398	$507	$508
NBTXR3	$988	$1,952
LYR-210	$105	$0
TP-03	$15,490	$1,499
Employee-related	$2,765	$2,876
Other costs	$569	$529
Total R&D	$28,591	$9,454

KPIs:

KPI	H1 2022	H1 2023
Operating Cash Flow ($USD Millions)	$(52.51)	$(36.95)

Notes:

Revenue not reported; LIAN remains pre-revenue in the periods presented .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company projection	Through end of 2024	Into H1 2025	Raised
Mavacamten China Approval	China	File NDA in 2023; pivotal data mid‑2023	Anticipates China NDA approval mid‑2024; China launch H2 2024	More specific; timeline set
Mavacamten APAC Launches	Singapore/Macau	NDAs under review (SG/HK); Macau approved	Approved in Singapore & Macau; launches expected Q4 2023	Advanced/accelerated
TP-03 LIBRA Data (China)	Q4 2023	Report topline Q4 2023	Report topline Q4 2023	Maintained
Infigratinib	H1 2024	Initiate pivotal Phase 2 in H1 2024	Initiate pivotal Phase 2 in H1 2024; NMPA Breakthrough Therapy Designation; Phase 2a ORR 25%	Strengthened with BTD/data

Earnings Call Themes & Trends

Note: No Q2 2023 earnings call transcript was available; themes below reflect press releases and 10‑Q MD&A.

Topic	Previous Mentions (Q4 2022)	Previous Mentions (Q1 2023)	Current Period (Q2 2023)	Trend
Regulatory/Launch Readiness (mavacamten)	EXPLORER‑CN visits complete; NDAs filed in HK/SG/Macau; build commercial team	NMPA priority review; EXPLORER‑CN topline positive; Macau approval; CCO appointed	Approvals in Singapore & Macau; ESC late‑breaking; NMPA priority review; China approval mid‑2024; APAC launches Q4 2023	Improving
R&D Execution (pipeline breadth)	TP‑03 Phase 3 LIBRA initiated; BBP‑398 Phase 1 initiated	TP‑03 LIBRA enrollment completed; US TP‑03 approval by partner	BBP‑398 + osimertinib Phase 1 initiated; AstraZeneca supply agreement; infigratinib Phase 2a positive; BTD granted	Accelerating
China Data/Cybersecurity Compliance	Noted general risks (prior filings)	—	Extensive risk factor updates on PIPL, Data Security Law, HGR Implementing Rules	Heightened regulatory scrutiny
Financial Discipline	R&D milestones drove 2022 spend	R&D down YoY; G&A lower vs Q1 2022	R&D down sharply YoY; G&A up YoY; runway extended H1 2025	Mixed (lower R&D, higher G&A)

Management Commentary

“During the first half of 2023, we achieved multiple clinical development milestones… we are looking forward to our first anticipated approval in China, building and developing our cardiovascular sales force… and initiating a pivotal trial of infigratinib in gastric cancer.” — CEO Yizhe Wang .
“We believe we are well positioned for LianBio’s first launches in our territories later this year when we begin to commercialize mavacamten in Singapore and Macau.” — CEO Yizhe Wang .

Q&A Highlights

No Q2 2023 earnings call transcript or Q&A session was available for LIAN in the document set, so we cannot provide Q&A detail for this quarter [ListDocuments showed 0 earnings-call-transcript].

Estimates Context

Wall Street consensus estimates via S&P Global for LIAN (EPS, revenue) were unavailable due to missing SPGI/Capital IQ mapping for the ticker at the time of analysis; therefore, we cannot provide beat/miss vs consensus for Q2 2023 [GetEstimates error: Missing CIQ mapping for 'LIAN'].
Given the pre-revenue profile and pipeline-stage operations, near-term Street models may focus on cash runway and milestone timing rather than P&L beats; we recommend monitoring future mapping availability to anchor estimate comparisons to S&P Global.

Key Takeaways for Investors

Execution milestones de-risk the near-term commercial path: EXPLORER‑CN success and priority review in China, with approvals in Singapore/Macau and planned launches in Q4 2023 .
China NDA approval for mavacamten mid‑2024 and China launch H2 2024 are the primary catalysts; progress at ESC 2023 increases visibility .
Operating profile improving YoY: EPS loss narrowed and R&D normalized as 2022 milestone payments rolled off; interest income helps offset burn .
Cash runway extended into H1 2025 provides funding clarity through key regulatory and launch milestones; monitor G&A growth tied to commercialization build .
Infigratinib’s positive Phase 2a (ORR 25%) and BTD in China expand optionality in oncology; pivotal Phase 2 planned H1 2024 .
Regulatory/data compliance in China is a non-trivial risk; ensure partners and CROs adhere to evolving PIPL/Data Security/HGR rules to avoid delays .
Near-term trading likely sensitive to regulatory updates (NMPA reviews), APAC launch execution, and any additional pipeline readouts; absence of Street estimates and call transcript reduces “beat/miss” headline risk but increases focus on milestone cadence .

LianBio (LIAN)·Q2 2023 Earnings Summary