I-Mab Q4 FY2021 earnings call

Key R&D Milestones and Pipeline Progress

• 2021 saw 20 key clinical milestones met, including successful completion of the registrational trial for felzartamab as a third-line therapy for multiple myeloma and positive data readouts for lemzoparlimab and uliledlimab.
• By the end of 2022, expected to advance the pipeline to include 3 of 4 registrational trials, 11 phase 2 clinical trials, and 3 phase 1 clinical trials.

Corporate and Partnership Developments

• In 2021, entered into partnership deals like a $350 million strategic commercial partnership with Jumpcan for eftansomatropin alfa and a partnership with Roche Diagnostics.
• Maintained a strong cash position with $671 million cash on hand, and expected milestone payments from existing out-licensing deals to sustain operations through 2025.

Capital Market and Commercialization Efforts

• Taking active measures to mitigate regulatory risks by switching to U.S.-based auditors recognized by U.S. PCAOB and pursuing a dual listing on the Hong Kong Stock Exchange.
• Pipeline approaching near-term commercialization, with expectations to file 4 BLAs and launch products between 2022 and 2025, focusing on hematologic oncology and solid tumors with products like felzartamab, lemzoparlimab, and eftansomatropin alfa.

In 2021, I-Mab Biopharma's net revenues were RMB88 million (US$13.8 million) compared to RMB1.543 billion in 2020. R&D expenses in 2021 were RMB1.213 billion (US$190 million) vs. RMB985 million in 2020, mainly due to the rapid advancement of the pipeline. Administrative expenses in 2021 were RMB899 million (US$141 million) vs. RMB402 million in 2020, primarily due to higher non-cash share-based compensation and payroll expenses. Non-GAAP adjusted net loss for the core business was RMB1.285 billion (US$202 million) in 2021. The actual operating cash burn in 2021 was about RMB1 billion (US$165 million). Cash and cash equivalents and short-term investments as of December 31, 2021, amounted to RMB4.3 billion (US$671 million) compared with RMB4.8 billion as of December 31, 2020.

Forward-Looking Statements

• 2022 aims to achieve 20 key clinical milestones, including initiating one or two registrational trials for lemzoparlimab.
• Expected to initiate 8 clinical trials and 5 IND submissions/approvals in 2022, with the pipeline advancing to include 3-4 registrational trials, 11 phase 2, and 3 phase 1 clinical trials by year-end.
• Revenue generation focus by combining existing milestone payments with near-term sales revenue to strengthen the financial position.

Regulatory Risks

• Facing risks related to U.S. HFCAA and ADR audit inspection requirements. However, taking proactive measures such as engaging PCAOB-inspectable accounting firms and pursuing a dual listing on the Hong Kong Stock Exchange, with positive signals from U.S. and Chinese regulators working towards a resolution.

Q: Kelly Shi at Jefferies asked about lemzoparlimab in combination with azacitidine data, safety differentiation, and timetables for key data readouts.

A: Andrew Zhu responded that the preliminary data with lemzoparlimab and AZA in MDS was comparable to magrolimab's data, had a better safety profile, and planned to initiate a Phase 3 registration trial in China this year, with data to be presented at various scientific congresses.

Q: Louise Chen at Cantor inquired about regulatory risks associated with HFCAA and dual listing progress.

A: Jingwu Zang mentioned proactive measures like switching auditors and pursuing a Hong Kong dual listing, with positive signals from regulators working towards a resolution.

Q: Joe Catanzaro with Piper asked about uliledlimab's 2nd phase data, tumor types, biomarker analysis, and global licensing collaboration expectations.

A: Andrew Zhu said the Phase 2 trial with uliledlimab in combination with toripalimab had safety and efficacy data, planned biomarker analysis, and ongoing efforts to secure a global business deal.

Q: Andres Maldonado at HCW asked about commercialization efforts and cash burn rate.

A: Jielun Zhu elaborated on commercialization plans for near-term products, and John Long stated the 2021 cash burn was $165 million, with expected burn between $180 million to $220 million in 2022-2023, and cash sufficient to support operations through 2025.

Q: Yingqi Peng at UBS inquired about TJ202's BLA submission in China, differences in declaring imported vs. domestic product, and expected BLA filing completion.

A: Jingwu Zang responded that there was a slight delay in submitting the BLA package due to communication with CDE on conditional approval policy and embedding localized manufacturing plan, with hopes to submit soon in 2022