2019-03-07 17:18Financial Data and Key Metrics Changes - As of December 31, 2018, cash and cash equivalents and short-term investments totaled $263.3 million, including net proceeds from a follow-on offering in September 2018 [26] - R&D expenses increased to $120.3 million for the year ended December 31, 2018, compared to $39.3 million for the same period in 2017, primarily due to increased upfront licensing fees and ongoing clinical trials [26] - SG&A expenses rose to $21.6 million for the year ended December 31, 2018, up from $12.0 million in 2017, driven by increased payroll and headcount [26] - The net loss for the year was $139.1 million, or $2.64 per share, compared to a net loss of $50.4 million, or $2.32 per share for the previous year [26] Business Line Data and Key Metrics Changes - The company has seven late-stage programs, three of which are U.S. FDA approved: Niraparib, Optune, and Omadacycline [9] - Niraparib, branded as Zejula, is positioned as a best-in-class PARP inhibitor for ovarian cancer and other solid tumors, with an NDA submitted for priority review in China [16][17] - Optune is marketed in the U.S., EU, and Japan for glioblastoma and has shown clinical proof of concept in multiple tumor types [20] Market Data and Key Metrics Changes - The company anticipates launching Niraparib in China in the second half of 2019, which is over a year ahead of initial expectations [17] - The company has built a commercial infrastructure in Mainland China, with over 180 employees dedicated to R&D and commercial operations [10][25] Company Strategy and Development Direction - Zai Lab aims to address significant unmet medical needs with a pipeline focused on first-in-class or best-in-class products [9] - The company plans to continue expanding its oncology portfolio and has established a U.S. headquarters to enhance its discovery and business development capabilities [11] - The strategic theme includes building strongholds in women's cancer, GI cancers, and glioma, with multiple synergistic assets in each area [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Niraparib and Optune to gain reimbursement in China, highlighting the importance of being included in the national reimbursement list [73][74] - The company is confident in its ability to manage commercial operations regardless of reimbursement outcomes, leveraging experience in provincial reimbursement processes [74] - Management noted that innovative oncology drugs have been performing well in China, which bodes well for upcoming product launches [35] Other Important Information - The company has strengthened its executive team, including the appointment of Tao Fu as President and COO, and Dr. Yong-Jiang Hei as Chief Medical Officer for Oncology [12][13] - Zai Lab has established partnerships with several companies, adding six assets through four major strategic partnerships in 2018 [11] Q&A Session Summary Question: Metrics for tracking Zejula and Optune launches in China - Management indicated they will track non-revenue KPIs such as reach to targeted physicians and listing status [31] Question: Recent oncology launches in China - Management referenced the successful launch of Tagrisso, which achieved nearly $150 million in its first year [34] Question: Approval status for Niraparib - Management confirmed that the priority review for Niraparib is a full approval, and they expect to launch in the second half of 2019 [36][38] Question: Pricing strategy for Optune and Niraparib - Management is still formulating pricing strategies but indicated a potential 30% discount to U.S. prices for Niraparib [77] Question: Timeline for first-line ovarian cancer approval - Management expects to leverage data from the PRIMA study for NDA submission in China, with readouts anticipated in the second half of 2019 [78]