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LianBio (LIAN)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 results reflected continued operating discipline but no product revenue; net loss was $24.0M ($0.22 per ADS) with modest YoY increases in R&D and G&A driven by 2022 milestone comps and higher headcount costs .
  • Strategically, LianBio transferred Asia rights for mavacamten to BMS for $350M total consideration, and initiated a comprehensive strategic review with an update expected in 1H24—key potential stock catalysts alongside portfolio readouts .
  • Pipeline execution was active: EXPLORER-CN Phase 3 data for mavacamten were presented at ESC and published in JAMA Cardiology; LIBRA Phase 3 topline for TP‑03 met mite eradication but not collarette cure statistical significance (p=0.15); infigratinib Phase 2a in FGFR2‑amplified gastric cancer showed cORR 23.8% and DCR 76.2% .
  • Liquidity remains solid with $252.2M in cash, equivalents, marketable securities and restricted cash at 9/30/23; the company did not restate runway in Q3 (prior quarter guided into 1H25) .

What Went Well and What Went Wrong

  • What Went Well

    • Mavacamten strategic transaction: BMS obtained exclusive rights across key Asian territories; LianBio to receive $350M total consideration—validating asset value and simplifying focus .
    • Clinical validation and visibility: EXPLORER‑CN Phase 3 data presented at ESC 2023 and published in JAMA Cardiology, enhancing scientific credibility for mavacamten in China .
    • Portfolio progress: Infigratinib Phase 2a in FGFR2‑amplified gastric cancer reported cORR 23.8% (95% CI 8.2–47.2), DCR 76.2% (95% CI 52.8–91.8); TP‑03 LIBRA achieved significant mite eradication, supporting planned China NDA .
    • Management tone: “We continue to make significant progress bringing innovative medicines to patients… Following our recent transaction granting development and commercial rights to BMS… we look forward to conducting a comprehensive strategic review aimed at realizing the value of our platform and product candidates.” — CEO Yizhe Wang .
  • What Went Wrong

    • TP‑03 LIBRA co‑primary: Complete collarette cure showed a positive trend but did not reach statistical significance (p=0.15), introducing some regulatory/commercial uncertainty near‑term .
    • Operating expense uptick YoY: Q3 R&D rose to $9.0M (vs $8.3M), G&A to $17.3M (vs $16.3M), reflecting headcount‑driven payroll and personnel expense increases as disclosed .
    • Loss widened slightly YoY: Net loss was $24.0M vs $21.9M a year ago; EPS was $(0.22) vs $(0.20), with no offsetting revenue contribution .

Financial Results

Quarterly P&L (oldest → newest)

Metric ($USD Millions, except per ADS)Q1 2023Q2 2023Q3 2023
Research & Development$10.8 $9.5 $9.0
General & Administrative$15.1 $15.6 $17.3
Total Operating Expenses$26.0 $25.0 $26.3
Interest Income, net$2.4 $2.8 $2.7
Net Loss$(24.0) $(21.6) $(24.0)
Net Loss per ADS (basic/diluted)$(0.22) $(0.20) $(0.22)

Year-over-Year (Q3 2023 vs Q3 2022)

Metric ($USD Millions, except per ADS)Q3 2022Q3 2023
Research & Development$8.3 $9.0
General & Administrative$16.3 $17.3
Total Operating Expenses$24.5 $26.3
Net Loss$(21.9) $(24.0)
Net Loss per ADS (basic/diluted)$(0.20) $(0.22)

Management drivers: R&D YoY decrease for YTD driven by higher 2022 milestone payments; G&A increase driven by payroll/personnel and share‑based comp; Q3 specific commentary aligns with these drivers .

Liquidity

| Metric | Q1 2023 | Q2 2023 | Q3 2023 | |---|---:|---:| | Cash, cash equivalents, marketable securities & restricted cash | $286.6M | $267.3M | $252.2M |

Revenue and Margins vs Estimates

MetricEstimate (Wall St.)ActualVariance
RevenueNA (S&P Global consensus unavailable)Not reported; income statement presented only operating expenses NA
EPS (basic/diluted)NA (S&P Global consensus unavailable)$(0.22) NA
Gross MarginNANA (no product revenue) NA
EBITDA MarginNANA (no product revenue) NA

Note: S&P Global consensus estimates were unavailable for LIAN in our data pull this quarter; therefore, estimate comparisons are not provided.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance (Q3)Change
Mavacamten China commercialization2024Anticipated China NDA approval mid‑2024; launch in 2H24 (LianBio commercialization) Rights transferred to BMS in Oct‑2023; LianBio to receive $350M consideration Superseded/terminated prior commercialization plan
TP‑03 LIBRA topline4Q23Topline data expected in 4Q23 Topline announced Oct‑2023; mite eradication met; collarette cure trend (p=0.15) Delivered
Infigratinib pivotal Phase 2 start (FGFR2 amp GC)1H24Plan to initiate pivotal Phase 2 in 1H24 Not updated in Q3 press release (data presented at ESMO) Maintained (not reiterated)
Cash runwayN/AInto 1H25 (as of Q2) Not restated in Q3; cash at 9/30/23: $252.2M Not updated
Strategic review1H24N/AComprehensive review underway; update anticipated in 1H24 New

Earnings Call Themes & Trends

Note: We did not locate a Q3’23 earnings call transcript in the company document set; themes below reflect disclosures from Q1/Q2/Q3 earnings press releases.

TopicPrevious Mentions (Q‑2 and Q‑1)Current Period (Q3 2023)Trend
Mavacamten regulatory/commercialQ1: China NDA accepted with priority review; Macau approval; commercialization build underway . Q2: Singapore and Macau approvals; China NDA under review .EXPLORER‑CN data presented at ESC and in JAMA; October transaction transferring Asia rights to BMS .Shift from in‑house commercialization to partner‑led execution (BMS).
Commercial readinessQ1: CCO appointment to build China capabilities . Q2: 17 key hospitals in HCM COE pilot with CCA .Strategic review initiated, potentially re‑shaping commercial build .Pivoting strategy via asset monetization/portfolio review.
TP‑03 (Demodex blepharitis)Q1: LIBRA topline planned 4Q23 . Q2: Completed enrollment; US approval by partner noted .LIBRA topline: significant mite eradication; collarette cure trend (p=0.15); plan to discuss with NMPA for NDA .Progressing toward China NDA with mixed co‑primary outcomes.
Infigratinib (FGFR2 amp GC)Q1: Topline 2H23 expected . Q2: Topline accepted for ESMO; BTD granted in China .Phase 2a data at ESMO: cORR 23.8%, DCR 76.2% .Strengthening clinical rationale; potential pivotal start 1H24 (not updated in Q3).
BBP‑398 (SHP2 inhibitor)Q1: Phase 1 combo initiation planned 2H23 . Q2: AZ supply agreement; Phase 1 with osimertinib slated .Phase 1 initiation in China with osimertinib announced .Initiated as planned.
Corporate/StrategicComprehensive strategic review; update 1H24 .New strategic pathway.

Management Commentary

  • “We continue to make significant progress bringing innovative medicines to patients in our region, including the achievement of critical clinical development and market building milestones.” — Yizhe Wang, Ph.D., CEO .
  • “Following our recent transaction granting development and commercial rights to BMS for mavacamten in our territories, we look forward to conducting a comprehensive strategic review aimed at realizing the value of our platform and product candidates.” — Yizhe Wang, Ph.D., CEO .

Q&A Highlights

  • No earnings call transcript for Q3 2023 was found in the company document set; no Q&A highlights are available.

Estimates Context

  • Wall Street consensus estimates via S&P Global were unavailable for LIAN this quarter in our system; therefore, we cannot provide vs‑consensus comparisons for revenue or EPS.
  • All actuals presented above are sourced from company filings/press releases.

Key Takeaways for Investors

  • The BMS transaction for mavacamten ($350M consideration) repositions LIAN toward a cash‑rich, option‑value portfolio while removing commercialization spend/risk for that asset—near‑term strategic review update in 1H24 is a key potential catalyst .
  • TP‑03 LIBRA achieved significant mite eradication but missed statistical significance on collarette cure, implying a nuanced regulatory path; LIAN plans to discuss with NMPA and still intends to file an NDA .
  • Infigratinib Phase 2a data (cORR 23.8%, DCR 76.2%) in FGFR2‑amplified gastric cancer support progression toward a pivotal program (previously guided for 1H24) .
  • Operating cadence is stable: Q3 opex of $26.3M with EPS $(0.22) is broadly consistent with recent quarters; YoY increases reflect 2022 milestone comps and higher headcount costs .
  • Liquidity of $252.2M provides multi‑quarter runway even before BMS consideration, though Q3 did not reiterate the prior runway guide; cash discipline remains central amid the strategic review .
  • Without consensus estimates, the stock narrative hinges more on strategic outcomes (review, potential portfolio actions) and regulatory/clinical milestones than on near‑term “beat/miss” dynamics .

Sources: Q3 2023 8‑K/press release and financial statements ; Q2 2023 8‑K/press release and financial statements ; Q1 2023 8‑K/press release and financial statements .