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LianBio (LIAN)·Q4 2022 Earnings Summary

Executive Summary

  • Q4 2022 net loss improved year over year to $18.3M vs. $21.2M in Q4 2021; EPS was $(0.17) vs. $(0.28) YoY, driven by lower milestone and upfront licensing payments and higher other income .
  • Entered a commercial agreement with Pfizer for RSV candidate sisunatovir, receiving $20.0M (release of previously restricted cash) and setting up to $135.0M in potential milestones plus low single-digit tiered net sales payments; Pfizer assumes all regional costs and releases LIAN from royalty/milestone obligations for sisunatovir .
  • Cash, cash equivalents and marketable securities were $302.4M at year-end, with runway projected through the end of 2024, modestly extending from “into the second half of 2024” communicated in Q3 2022 .
  • 2023 catalysts include mid-year Phase 3 EXPLORER-CN topline for mavacamten and Q4 LIBRA topline for TP-03, with plans to file the mavacamten NDA in China in 2023—key potential stock catalysts around data and regulatory events .

What Went Well and What Went Wrong

What Went Well

  • Strategic agreement with Pfizer on sisunatovir: $20.0M cash released, up to $135.0M milestones, and low single-digit sales-based payments, with Pfizer assuming development/commercial costs regionally—de-risking capital needs in RSV .
  • Pipeline execution: Phase 3 EXPLORER-CN patient visits completed (oHCM), TP-03 Phase 3 ongoing in China, BBP-398 Phase 1 initiated, and NDAs filed for mavacamten in Singapore, Hong Kong, Macau; management aims to become commercial-stage with mavacamten .
  • Management tone: “2022 marked a pivotal year… With a cash runway through the end of 2024, we believe LianBio is well positioned to become a commercial-stage company” — CEO Yizhe Wang .

What Went Wrong

  • Operating expenses increased: G&A rose to $18.7M in Q4 2022 (vs. $14.4M in Q4 2021) on payroll, legal, consulting, and accounting costs; R&D rose to $10.6M (vs. $7.7M) reflecting higher development activities and personnel expenses .
  • Continued operating losses: Q4 net loss of $18.3M and FY 2022 net loss of $110.3M underscore pre-commercial burn profile despite cost optimizations YoY .
  • No numerical revenue/margin guidance or product revenues; the company remains pre-revenue as it advances registrational programs and commercial readiness in China .

Financial Results

P&L and EPS – sequential trend

MetricQ2 2022Q3 2022Q4 2022
Research & Development ($USD Millions)$28.6 $8.3 $10.6
General & Administrative ($USD Millions)$14.6 $16.3 $18.7
Total Operating Expenses ($USD Millions)$43.1 $24.5 $29.2
Interest Income, net ($USD Millions)$0.6 $1.4 $2.1
Other Income (Expense), net ($USD Millions)$0.2 $1.3 $8.5
Net Loss ($USD Millions)$(42.4) $(21.9) $(18.3)
Net Loss per Share (Basic & Diluted) ($USD)$(0.39) $(0.20) $(0.17)

Q4 year-over-year comparison

MetricQ4 2021Q4 2022
Research & Development ($USD Millions)$7.7 $10.6
General & Administrative ($USD Millions)$14.4 $18.7
Other Income (Expense), net ($USD Millions)$(0.3) $8.5
Net Loss ($USD Millions)$(21.2) $(18.3)
Net Loss per Share (Basic & Diluted) ($USD)$(0.28) $(0.17)

Liquidity

MetricQ2 2022Q3 2022Q4 2022
Cash & Cash Equivalents ($USD Millions)$134.3 $78.9 $79.2
Marketable Securities ($USD Millions)$195.0 $232.9 $223.1
Restricted Cash, Non-current ($USD Millions)$20.1 $20.1 $0.073
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$329.3 $311.7 $302.4

Notes:

  • LIAN did not disclose product revenue; statements of operations present only operating expenses and other income components, consistent with pre-commercial operations .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperating plan“Into the second half of 2024” (Q3 2022) “Through the end of 2024” (Q4 2022) Raised (extended)
Mavacamten EXPLORER-CN topline2023Mid-2023 (Q3 2022) Mid-2023 (Q4 2022) Maintained
Mavacamten NDA (China)2023Anticipated filing (Q3 2022 narrative implied via launch prep) File NDA in 2023 (explicit) Clarified (timing confirmed)
TP-03 LIBRA topline2023Q4 2023 (Q3 2022) Q4 2023 (Q4 2022) Maintained
Infigratinib P2a topline20232H 2023 (Q3 2022) 2H 2023 (Q4 2022) Maintained

No numerical guidance provided for revenue, margins, OpEx, OI&E or tax rate .

Earnings Call Themes & Trends

Note: We did not locate a Q4 2022 earnings call transcript in our document catalog; themes below reflect company press releases across quarters .

TopicPrevious Mentions (Q2 & Q3 2022)Current Period (Q4 2022)Trend
Mavacamten (oHCM) China development & launch prepEnrollment completed; NDA filed in Singapore; HCM awareness campaign launched; added to Chinese guidelines EXPLORER-CN visits completed; NDAs filed in Hong Kong/Macau; plan to file China NDA in 2023 Advancing toward registration and launch readiness
TP-03 (Demodex blepharitis)Plan to initiate Phase 3 in China (H2 2022) Phase 3 LIBRA trial ongoing; topline in Q4 2023 Execution on registrational trial timeline
Infigratinib (FGFR2)HK NDA submitted; ongoing China P2a; plan to join global Phase 3 PROOF-301 P2a topline expected 2H 2023; plan for pivotal Phase 2 in 1H 2024 Pipeline maturation; clearer China registration path
BBP-398 (SHP2)Plan to initiate Phase 1 and combo trials Phase 1 monotherapy initiated; combo trial planned 2H 2023 Clinical execution on early-stage asset
Supply chain/COVID impactsQ2 noted lockdown-related disruptions but continued execution Not emphasized in Q4 Easing operational headwinds
Commercial buildHiring medical affairs/MSLs/business leaders for launch Expanded hiring; launch readiness ongoing for mavacamten Scaling commercial infrastructure

Management Commentary

  • “2022 marked a pivotal year for LianBio, with sustained progress across our pipeline and building of our commercial infrastructure in anticipation of registration of mavacamten in China… With a cash runway through the end of 2024, we believe LianBio is well positioned to become a commercial-stage company” — Yizhe Wang, Ph.D., CEO (Q4 press release) .
  • “We believe the progress we are making across our pipeline ensures we are well-positioned to bring innovative medicines to patients in China, with our first launch anticipated in 2024” — Yizhe Wang, Ph.D. (Q3 press release) .
  • “Despite clinical site and agency disruptions due to COVID-19 lockdowns… LianBio continued to execute our key clinical development and regulatory priorities” (Q2 press release) .

Q&A Highlights

We did not find a Q4 2022 earnings call transcript in our sources; therefore, Q&A highlights and any call-only guidance clarifications are unavailable from primary transcripts .

Estimates Context

  • Wall Street consensus (S&P Global) EPS and revenue estimates for Q4 2022 were unavailable in our system for LIAN; comparison to consensus cannot be provided.
  • As a result, there are no estimate beat/miss determinations included for Q4 2022.

Key Takeaways for Investors

  • Operating losses narrowed YoY in Q4 2022 (net loss $(18.3)M vs. $(21.2)M) with EPS improvement to $(0.17); other income contributed to the YoY improvement .
  • The Pfizer sisunatovir transaction adds non-dilutive capital ($20.0M released) and future milestone/sales-based economics while offloading development/commercial costs, improving capital efficiency in respiratory .
  • Liquidity remains solid ($302.4M cash, equivalents, and marketable securities at year-end) with runway through end of 2024, supporting execution on near-term registrational readouts and China NDA filing for mavacamten .
  • 2023 is data-rich: mid-year EXPLORER-CN topline and Q4 TP-03 LIBRA topline; positive outcomes would be significant catalysts for regulatory progression and potential 2024 launch setup .
  • Near-term trading implications: watch for mavacamten EXPLORER-CN data timing and China NDA submission; any clarity on commercialization timelines/NRDL inclusion could re-rate China launch expectations .
  • Medium-term thesis: pipeline breadth (cardiovascular, ophthalmology, oncology) and China-focused registrations position LIAN to transition to commercial-stage; execution on launch readiness and regulatory milestones is key to de-risking the story .
  • Risk factors: ongoing G&A and R&D spend ahead of commercialization, regulatory timing uncertainty, and absence of product revenues until approvals/launches .