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荣昌生物(688331):亏损缩窄趋势明显 RC18海外临床顺利推进

Rongchang Biotech (688331): The trend of narrowing losses is obvious, and RC18 overseas clinical trials are progressing smoothly

Description of the event

On October 29, 2024, Rongchang Biotech released the 2024 third quarter results report: 2024Q3 achieved revenue of 0.467 billion yuan in a single quarter (+34.6% YoY, +13.6% month-on-month), achieved net profit of -0.291 billion yuan (-0.327 billion yuan in Q3 last year), further narrowing in the single quarter; achieved operating income of 1.209 billion yuan (+57.1% YoY) in the first three quarters of 2024, achieving net profit to mother- -1.071 billion yuan (-1.031 billion yuan in the same period last year).

Incident comments

Revenue for the first three quarters increased 57% year over year, and the trend of narrowing losses in a single quarter was obvious. 2024Q3 achieved revenue of 0.467 billion yuan in a single quarter (+34.6% YoY, +13.6% month-on-month), and achieved net profit of -0.291 billion yuan (-0.327 billion yuan in Q3 last year), further narrowing in the single quarter; achieved operating income of 1.209 billion yuan (+57.1% YoY) in the first three quarters of 2024, achieving net profit to mother of -1.071 billion yuan (-1.031 billion yuan in the same period last year). Expense side: Sales expenses for the first three quarters were 0.623 billion yuan (cost ratio was 51.5%, 2024H1 sales expense ratio was 52.5%), R&D expenses were 1.153 billion yuan (cost rate 95.4%), and management expenses were 0.235 billion yuan (cost rate 19.4%). The sales cost control effect was remarkable.

RC18's marketing application for myasthenia gravis (MG) was accepted, and overseas clinical trials progressed smoothly. RC18 (bYS/April fusion protein) for myasthenia gravis (MG) indications was submitted and accepted in the priority review process in October 2024, and we estimate that it will be approved in the second half of 2025 as soon as possible; in addition, both phase III clinical trials of RC18 for dry syndrome (PSS) and IgA nephropathy have been completed and are awaiting follow-up. RC18 has begun screening patients for the second phase III clinical trial of SLE overseas, and is expected to achieve the first patient enrollment (FPI) in the near future; the global multi-center phase III clinical trial for MG has recently completed FPI and is currently continuing to be enrolled.

RC48 has been enrolled in phase III clinical trials for 1L urothelial cancer (UC) indications in China; phase III trials of 1L gastric cancer (GC) are still being prepared; the 2L marketing application for HER2-positive breast cancer (BC) with liver metastasis has been accepted and included in priority review, and the phase III clinical trial of 2L HER2 low expression breast cancer with a single drug is undergoing data cleaning. In addition, RC48 continues to be enrolled in two key or phase III clinical trials overseas, 2L UC and 1L UC.

RC28 has completed enrollment for DME Indication Phase III and is expected to submit a marketing application in mid-2025; domestic Phase III clinical enrollment for wAMD indications is expected to end in 2024Q4. In addition, clinical trials of the company's other early clinical varieties, including RC88 (MSLN ADC), RC148 (PD-1/VEGF), RC198 (IL-15/IL-15Rα), and RC248 (DR5 ADC) are also being successfully carried out, and we look forward to further clinical progress in the future.

Profit forecast: The company's net profit for 2024-2026 is expected to be -1.093 billion yuan, -0.458 billion yuan, and 0.819 billion yuan, respectively, corresponding EPS of -2.01 yuan, -0.84 yuan and 1.51 yuan, respectively, maintaining the “buy” rating.

The translation is provided by third-party software.


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