Key points of investment
Tripley has made a breakthrough in internationalization, sales continue to grow rapidly, and it is optimistic that major indications will continue to drive rapid performance growth.
Performance: Trepley continues to grow rapidly
In 2023, the company achieved operating revenue of 1,503 million yuan (YOY 3.38%), of which treprilizumab achieved sales revenue of about 919 million yuan (YOY 25%). 2024Q1 achieved revenue of 381 million yuan (YOY 49.24%), of which the core product treprilizumab achieved sales revenue of about 307 million yuan (YOY 56.82%) in the domestic market. The company continues to strengthen cost control, focus on more promising R&D pipelines, and reduce losses compared to the same period last year.
Research and development progress: Three new indications of treprapril were added to medical insurance, and the FDA approved the marketing of Trepri in 2023: the marketing application for new indications for perioperative treatment of patients with non-small cell lung cancer was approved by the State Drug Administration, and the new application for new indications for advanced triple-negative breast cancer, first-line treatment of advanced renal cell cancer (approved domestically in April 2024), and first-line treatment of extensive small cell lung cancer was accepted by the State Drug Administration, and phase III clinical research on first-line treatment of melanoma reached the main research end point; 2023/10 In January, treprilizumab was approved by the FDA as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal cancer, and as a monotherapy for adult patients with recurrent, unresectable, or metastatic nasopharyngeal cancer whose disease progresses during or after previous platinum-containing treatment. Health insurance negotiations have also made positive progress. In 2024, 3 new indications were added to health insurance. Currently, all 6 indications approved for marketing in China are included in the national health insurance catalogue. It is the only anti-PD-1 monoclonal antibody drug used to treat melanoma in the national health insurance catalogue. We are optimistic that the new indications of Trepri will drive revenue in 2024-2026, while we are optimistic about continued breakthroughs in internationalization and the revenue and profit elasticity that overseas markets will bring to Trepri.
The world's first anti-tumor anti-BTLA monoclonal antibody tifcemalimab combined with treprilimab to enter clinical development as a randomized, double-blind, placebo-controlled, international multi-center phase III clinical study for patients with limited stage small cell lung cancer that has not progressed after radiotherapy has completed the world's first patient enrollment and first administration. tifcemalimab for the treatment of CHL has officially started; the recombinant humanized anti-PCSK9 monoclonal antibody has officially started; injections The marketing application for angerizimab as a new drug has been accepted by the State Drug Administration; the recombinant humanized anti-IL-17A monoclonal antibody has entered phase III registered clinical research.
Profit forecasting and valuation
Considering that the company's R&D investment in 2023 remains high in absolute value, we raised our R&D investment in 2024-2025, which in turn led to a decrease in net profit to mother in 2024-2025. We are optimistic about major indication-driven inflection points such as the perioperative period of treprilizumab, revenue elasticity under commercialization of multiple product portfolios such as PCSK9 and IL-17 inhibitors, and inflection points in performance growth brought about by international breakthroughs such as PD-1. We maintain a “buy” rating.
Risk warning
Risk of clinical failure, risk of competition, risk of product sales falling short of expectations, policy risk.