Executive Summary

Q1 2023 reflected continued pre-commercial investment: R&D $10.831M, G&A $15.138M, net loss $(24.045)M or $(0.22) per share; liquidity of $286.6M in cash, equivalents, marketable securities and restricted cash supports runway through end-2024 .
Clinical/regulatory catalysts advanced: EXPLORER-CN Phase 3 in oHCM met its primary endpoint; China NMPA accepted the mavacamten NDA with priority review; mavacamten approved in Macau; NDAs under review in Singapore/Hong Kong—setting up a potential first commercial launch in 2024 .
Operating cadence stable: OpEx moderated YoY (driven by lower milestone payments vs 2022), while interest income rose with higher rates, partially offsetting OpEx; sequential net loss widened vs Q4 2022 given seasonally higher OpEx and lower other income .
Program timing shift: BBP-398 EGFR-inhibitor combo trial initiation moved from 1H23 (prior update) to 2H23, modestly pushing that oncology catalyst to the right .
Consensus context: The company did not provide guidance ranges; S&P Global Wall Street consensus for Q1 2023 EPS/revenue was not available in our connector for LIAN at the time of analysis; therefore, estimate comparisons are not presented .

What Went Well and What Went Wrong

What Went Well

EXPLORER-CN success and regulatory momentum: “EXPLORER-CN met the primary endpoint… and [NMPA] accepted with priority review the NDA” for mavacamten, materially de-risking the China approval pathway and supporting 2024 launch preparations .
Regional approvals/filings: Mavacamten was approved in Macau; NDAs are under review in Singapore and Hong Kong, extending potential early market access across Greater China/APAC ahead of mainland China approval .
Commercial readiness: Promotion of Pascal Qian to Chief Commercial Officer and continued build-out of China commercial infrastructure signal preparedness for an anticipated 2024 launch .

Quote (CEO): “We continue to achieve multiple significant milestones, propelling the company towards the anticipated commercial launch of mavacamten in China… we believe we are on track to bring our first drug to market in China next year” .

What Went Wrong

Oncology timing push: BBP-398 NSCLC combo trial start moved to 2H23 from prior guidance of 1H23, delaying that readout path by at least one half-year .
Sequential P&L pressure: Net loss widened to $(24.045)M from Q4’s $(18.276)M as operating expenses rose sequentially and other income normalized vs Q4’s elevated level .
Working capital shift: Accounts payable increased to $5.431M from $1.453M at year-end 2022, reflecting timing of payments as programs advance (not atypical but worth monitoring) .

Financial Results

P&L and Liquidity (oldest → newest)

Metric	Q3 2022	Q4 2022	Q1 2023
Research & Development Expense ($USD Millions)	$8.258	$10.577	$10.831
General & Administrative Expense ($USD Millions)	$16.291	$18.668	$15.138
Total Operating Expenses ($USD Millions)	$24.549	$29.245	$25.969
Interest Income, net ($USD Millions)	$1.405	$2.083	$2.406
Net Loss ($USD Millions)	$(21.897)	$(18.276)	$(24.045)
Net Loss per Share (Basic & Diluted) ($)	$(0.20)	$(0.17)	$(0.22)
Liquidity: Cash, Equivalents, Mkt. Sec., Restricted ($USD Millions)	$331.8	$302.4	$286.6

Notes:

Pre-revenue biotech; gross margin/operating margin not applicable; company reports no product revenue in these periods .

Estimates vs. Actuals (Q1 2023)

Metric	Consensus	Actual	Beat/Miss
Revenue	N/A (S&P Global data unavailable)	N/A (pre-revenue)	N/A
EPS (Basic & Diluted)	N/A (S&P Global data unavailable)	$(0.22)	N/A

Guidance Changes

Metric	Period	Previous Guidance/Status	Current Guidance/Status	Change
Cash Runway	Through end-2024	“Sufficient to fund current operations through the end of 2024” (as of FY22)	“Projected to extend through the end of 2024”	Maintained
Mavacamten China NDA	2023	“Expect to file NDA in 2023”	NDA accepted with priority review (Apr 2023)	Upgraded (milestone achieved)
Mavacamten Launch Timing (China)	2024	“Anticipated commercial launch in 2024” (implied)	Launch preparations continue for anticipated 2024	Maintained
TP-03 (LIBRA) China Topline	Q4 2023	Topline expected Q4 2023	Topline expected Q4 2023	Maintained
Infigratinib (FGFR2 amp GC)	2H 2023 topline; 1H 2024 pivotal start	2H23 topline; initiate pivotal P2 in 1H24	2H23 topline; initiate pivotal P2 in 1H24	Maintained
BBP-398 + EGFR inhibitor (NSCLC)	Trial initiation	Initiate in 1H 2023	Initiate in 2H 2023	Pushed back

Earnings Call Themes & Trends

Note: No Q1 2023 earnings call transcript was available in our document set; themes reflect company disclosures in press releases across periods.

Topic	Q3 2022 (Prior-2)	Q4 2022 (Prior-1)	Q1 2023 (Current)	Trend
Mavacamten China (oHCM)	Enrollment complete; market-building underway	EXPLORER-CN patient visits completed; NDA filings in HK/SG/Macau	EXPLORER-CN met primary endpoint; China NDA accepted priority review; Macau approval	Accelerating toward approval/launch
Commercial Readiness (China)	Hiring medical affairs, MSLs, BU leaders	Continued build-out for expected launch	CCO promoted; launch prep continues	Strengthening infrastructure
Ophthalmology (TP-03)	LIBRA P3 initiated; China registration path	LIBRA ongoing; U.S. NDA accepted by FDA (partner)	LIBRA topline expected Q4 2023	On plan
Oncology (Infigratinib)	China P2a ongoing	Topline expected 2H23; pivotal start 1H24	Topline expected 2H23; pivotal start 1H24	On plan
Oncology (BBP-398)	China P1 mono initiated	Combo NSCLC trial planned 1H23	Combo NSCLC trial moved to 2H23	Slight delay
Liquidity/Runway	Into 2H24	Through end-2024	Through end-2024	Stable

Management Commentary

“We continue to achieve multiple significant milestones, propelling the company towards the anticipated commercial launch of mavacamten in China… we believe we are on track to bring our first drug to market in China next year” — Yizhe Wang, Ph.D., CEO .
“Cash, cash equivalents, marketable securities and restricted cash… totaled $286.6 million… projected to extend through the end of 2024” (emphasis on runway and operational discipline) .

Q&A Highlights

No Q1 2023 earnings call transcript was available in our document set; the company furnished a press release (8-K 2.02) with detailed financials and corporate updates but no transcripted Q&A .

Estimates Context

The company did not provide numerical guidance for revenue or EPS; it reiterated cash runway through end-2024 .
S&P Global Wall Street consensus for Q1 2023 EPS/revenue was not available in our connector for LIAN at the time of analysis; as such, we cannot present beat/miss vs consensus for the period .

Key Takeaways for Investors

Mavacamten’s China path de-risked: EXPLORER-CN success and NMPA priority review materially increase probability/timing of approval; Macau approval and regional NDAs create optional earlier access points .
Commercial readiness advancing: Leadership and infrastructure build-outs support a potential 2024 launch, offering a clear route to first revenue upon approval .
Oncology cadence: Infigratinib timelines unchanged; BBP-398 combo start moved to 2H23—monitor for initiation and early safety/PK signals in combo .
Cash runway intact: $286.6M liquidity funds operations through end-2024, bridging to key catalysts (mavacamten approval/launch, TP-03 LIBRA topline, infigratinib data) .
Near-term catalysts: Presentation of detailed EXPLORER-CN results; regulatory progression in China; TP-03 China Phase 3 topline in Q4 2023; infigratinib P2a topline in 2H23 .
P&L watch items: Sequential OpEx and net loss volatility typical of pipeline-heavy biotechs; rising interest income provides a modest offset; monitor working-capital timing as programs ramp .
Trading setup: Regulatory headlines (priority review milestones/approvals) are likely stock movers; absence of consensus estimates reduces earnings-day volatility, focusing investor attention on catalysts and cash runway .

LianBio (LIAN)·Q1 2023 Earnings Summary