ZAI LAB(ZLAB) - 2023 Q4 - Annual Results

Revenue Growth and Performance - Total product revenue for 2023 was $266.7 million, representing 25% year-over-year growth (31% at constant exchange rate)[1] - Zai Lab's product revenue increased by 25% YoY to $266.719 million in 2023[39] - VYVGART generated $10.0 million in revenue in 2023, with nearly 1,000 patients treated in Q4 2023 and an additional 1,000 patients treated in January 2024 alone[5] - ZEJULA revenue increased 16% year-over-year to $168.8 million in 2023, maintaining its position as the leading PARP inhibitor in China[4] - NUZYRA revenue surged 316% year-over-year to $21.7 million in 2023, driven by its inclusion in the NRDL[8] - VYVGART sales are expected to exceed $70.0 million in 2024[5] Financial Position and Expenses - Cash position decreased to $807.6 million as of December 31, 2023, compared to $1.0 billion in 2022[9] - Zai Lab's cash and cash equivalents decreased to $790.151 million in December 2023 from $1,008.470 million in December 2022[36] - Zai Lab's total assets decreased to $1,036.295 million in 2023 from $1,220.140 million in 2022[36] - R&D expenses decreased to $265.9 million in 2023 from $286.4 million in 2022, primarily due to reduced upfront and milestone payments[8] - Zai Lab's R&D expenses decreased to $265.868 million in 2023 from $286.408 million in 2022[39] Net Loss and Operational Improvement - Net loss improved to $334.6 million in 2023 from $443.3 million in 2022, driven by faster revenue growth and increased interest income[9] - Zai Lab's net loss decreased to $334.620 million in 2023 from $443.286 million in 2022[39] - Zai Lab's loss from operations improved to $366.573 million in 2023 from $404.357 million in 2022[44] Regulatory Submissions and Approvals - Up to four new regulatory submissions are expected in 2024, including sulbactam-durlobactam, efgartigimod SC, and repotrectinib[1] - Zai Lab plans to submit a Marketing Authorization Application (MAA) for Tumor Treating Fields in second-line+ NSCLC in 2024[15] - Zai Lab plans to submit an NDA for Tisotumab Vedotin in second-line+ cervical cancer to the NMPA[25] - Potential NMPA approval of efgartigimod SC for gMG and submission of sBLA for CIDP in H1 2024[25] Clinical Trials and Studies - Zai Lab to complete patient enrollment in the China bridging study for Xanomeline-Trospium in schizophrenia by Q4 2024[27] - Zai Lab to initiate a global Phase 2 study for ZL-1102 in mild-to-moderate chronic plaque psoriasis in mid-2024[28]