SKB264 has submitted a domestic listing application. Colombotai's core product TROP2 ADC (SKB264/MK-2870) focuses on breast cancer and lung cancer indications: the marketing application for the treatment of 3L TNBC indications was accepted by the FDA in December '23 and is expected to be approved for marketing in 2024; phase 3 clinical trials for 1L TNBC indications and 2L+ HR+/HER2- MBC indications have also begun. In the field of lung cancer, SKB264 has also initiated phase 3 clinical trials of 2/3L eGFRM NSCLC indications in China. SKB264 revealed phase 1/2 clinical data for lung cancer, TNBC, and HR+/HER2-MBc in 2023, showing good efficacy and safety; SKB264 is expected to open phase 3 clinical trials with more combination treatments this year.
SKB264 overseas clinical trials are progressing at an accelerated pace. In 2023, MSD launched three global phase 3 clinical trials of SKB264, namely single-agent treatment of 3L EGFRM NSCLC, single-agent treatment of 3L endometrial cancer, and combined K-drug treatment of 1L PD-L1 > 50% NSCLC. Since 24 years, SKB264 has added three new global phase 3 clinical trials: 2L HR+/hER2-MBC, 2L eGFRM NSCLC, and adjuvant treatment of NSCLC. As one of MSD's important assets in the field of oncology ADC, SKB264 has quickly launched a number of global multi-center phase 3 clinical trials, and is expected to become the core product of the next generation of IO+ADC therapies in the case of single drugs or combination K drugs.
Authorization revenue has increased dramatically, and R&D investment continues to increase. Collumbotai's revenue in 2023 was 1,540 million yuan (+92%), mainly from funds authorized by external authorities; gross profit of 759 million yuan (+44%), and annual loss of 574 million yuan (loss of 616 million yuan in the same period last year). The company spent 1,031 million yuan (+22%) on R&D throughout the year, and the increase was mainly due to continuous clinical progress; administrative expenses were 182 million yuan (+91%).
Risk warning: Innovative drug development has failed or is progressing less than expected; commercialization falls short of expectations Investment suggestions: Maintaining a “buy” rating
The company currently has no commercially listed products, and its revenue mainly comes from externally authorized down payments and potential milestone payments. We expect the company's products to be approved one after another starting in 2024 and contributing significant sales revenue from 2025-26. We maintain the company's revenue forecast. We expect 24-26 revenue to be 860/984/1,930 million yuan, respectively, up -44%/14%/96% year over year. Due to the company's R&D expenses slightly higher than expected, we slightly lowered our net profit forecast for 2024-25. We expect net profit to be -6.82/-7.00/ -461 million yuan for 24-26, respectively (-5.38/- 627 million yuan in 24-25 years ago).
We are optimistic that the company's core product SKB264 will achieve commercial value on a global scale and maintain a “buy” rating.