EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-03-31
Management highlights
- Faced challenges like geopolitical issues, ADR delisting risks, macroeconomic factors, and COVID-19. Strategic efforts included repositioning business, prioritizing pipeline, streamlining structure and workforce. - PCAOB vacated previous determination removing delisting risk. - Achieved 13 key clinical milestones in 2022 for five key assets: eftansomatropin alfa (Phase 3 trial enrollment completed, data readout expected in 2023), felzartamab (Phase 3 study on track), lemzoparlimab (Phase 3 stage, favorable safety and efficacy), uliledlimab (Phase 2 trial in NSCLC, efficacy correlated with CD73 expression), givastomig (Claudin18.2 4-1BB bispecific antibody with clinical progress). - AbbVie and I-Mab amended collaboration on lemzoparlimab. - Streamlined corporate structure and reduced cash burn rate.
Segment performance
Total revenue for the full year of 2022 was RMB-221.6 million (US$32.1 million) compared to RMB88 million in 2021. The decrease in revenue was due to a one-off accounting treatment. R&D expenses in 2022 were RMB904.9 million (US$131 million) vs RMB1.2 billion in 2021, primarily due to reduced demand for pipeline products and lower share-based compensation. Administrative expenses in 2022 were RMB720 million (US$104.4 million) vs RMB899 million in 2021, mainly due to lower share-based compensation and optimized expenses. Net other expenses in 2022 were RMB126.6 million (US$18.4 million) vs net other income of RMB83.2 million in 2021, mainly due to unrealized exchange losses.
Guidance
- Expected Phase 3 data readout on eftansomatropin in second half of 2023 followed by BLA submission. - Initiate Phase 3 clinical trial for lemzoparlimab as first line MDS treatment. - Expect data readout for uliledlimab Phase 2 NSCLC trial in 2023, plan biomarker-guided pivotal trial and global study. - Continue with givastomig Phase 1 trial and engage in partnership discussions. - Expected to further reduce costs in 2023 with a net burn rate range of US$130 million to US$140 million.
Risks
- Geopolitical issues and ADR delisting risks were past challenges. - Competitive landscape in biopharma pipeline development. - Uncertainties in clinical trial outcomes and commercialization of assets.
Q&A highlights
Q: Has I-Mab been able to resolve its delisting risks fully?
A: Most delisting risk has been mitigated by working with auditor through PCAOB new rules.
Q: Regarding Phase 2 trial of CD73 antibody in Stage 4 NSCLC, details on patient baseline characteristics?
A: The trial targets treatment naive Stage 4 NSCLC patients, naive to all treatments including PD-1.
Q: Thoughts on Claudin18.2 space competitiveness and givastomig's position?
A: Zolbetuximab validates Claudin18.2 as target. Givastomig targets wider Claudin18.2 expression, local activation of 4-1BB avoids systemic toxicity, has milder GI toxicity.
Q: Concerns regarding toxicity of 4-1BB agonists?
A: Givastomig's design induces 4-1BB activation only at tumor site, sparing systemic toxicity like hepatic toxicity and cytokine release syndrome.
Q: Expected cash burn rate in 2023 and pipeline plans?
A: Expected net burn rate in 2023 is US$130 million to US$140 million. Focus on key assets, have innovative discovery engine, reassess licensing efforts for external assets but focus on internal key assets.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | — | — | — | — |
| Revenue | — | — | — | — |
Transcript
March 31, 2023Full transcript unavailable for redistribution
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