LianMedical

What they do

LianBio in-licenses product candidates from Western partners and develops and commercializes them in Greater China and other Asian markets, with operations in China, Asia Pacific, and the United States. The pipeline includes seven therapeutic candidates in oncology, ophthalmology, and inflammation, with three registrational studies ongoing as of the third quarter of 2023. The company generates no product revenue and is funding operations from capital raised in its November 2021 IPO and subsequent transactions.

Revenue drivers

• Mavacamten (BMS transaction) — No ongoing revenue. In October 2023, LianBio received a one-time $350 million payment from BMS for the exclusive rights to develop and commercialize mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and Thailand, and was released from $127.5 million in remaining milestone payments.
• TP-03 (Demodex blepharitis) — No revenue yet. LianBio plans to discuss Phase 3 LIBRA topline data with China's NMPA and expects to use the data to support a New Drug Application filing in China; TP-03 was approved in the U.S. for adults with Demodex blepharitis by partner Tarsus in July 2023.
• Infigratinib (gastric cancer) — No revenue yet. Phase 2a data in third-line or later gastric or gastroesophageal junction adenocarcinoma with FGFR2 amplification showed a confirmed objective response rate of 23.8% and median duration of response of 3.8 months.
• BBP-398 (SHP2 inhibitor) — No revenue yet. LianBio initiated a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations in August 2023, with osimertinib supplied under a clinical supply agreement with AstraZeneca in China.

Recent performance

LianBio reported cash, cash equivalents, and marketable securities of $252.2 million as of September 30, 2023, against total assets of $262.9 million and total liabilities of $26.8 million. The company had no product revenue and reported annual net losses of $139.6 million in 2020, $196.3 million in 2021, and $110.3 million in 2022. Operating cash flow was negative $98.1 million in 2020, negative $164.0 million in 2021, and negative $99.2 million in 2022. In October 2023, LianBio entered an agreement with Bristol Myers Squibb for mavacamten in its Asian territories, receiving a $350 million one-time payment and release from $127.5 million in remaining milestones.

Strategy

LianBio states it is conducting a comprehensive strategic review aimed at realizing the value of its platform and product candidates. The company in-licenses assets for development and commercialization in Greater China and other Asian markets, and has expanded its pipeline by anchoring therapeutic areas with core assets and building around them. With operations in China, Asia Pacific, and the United States, LianBio describes itself as a cross-border platform offering licensing partners regulatory, development, and commercial expertise. The company has stated it intends to continue evaluating complementary product candidates to deepen its pipeline.

Risks

• No product revenue — LianBio has no approved products in its licensed territories and depends on clinical and regulatory success of candidates such as TP-03, infigratinib, and BBP-398 for future revenue.
• Loss of mavacamten cash flow — The October 2023 BMS transaction transferred mavacamten rights and eliminated future milestone obligations, leaving the company with a narrower remaining pipeline.
• Cash burn — LianBio reported negative operating cash flow of $99.2 million in 2022 and cash, cash equivalents, and marketable securities of $252.2 million as of September 30, 2023, requiring continued funding for development.
• Clinical and regulatory risk — The TP-03 LIBRA trial's complete collarette cure endpoint showed a positive but not statistically significant trend (p 0.15), which may affect NMPA discussions and a potential New Drug Application filing in China.

Outlook

Management states that a comprehensive strategic review is ongoing, aimed at realizing the value of its platform and product candidates. The company plans to discuss TP-03 Phase 3 LIBRA data with China's NMPA and expects to use the data to support a New Drug Application filing in China. LianBio received a $350 million one-time payment from Bristol Myers Squibb for mavacamten rights in October 2023.