REMEGEN(09995.HK):SALES RAMP UP WITH R&D ACHIEVEMENTS
REMEGEN(09995.HK):SALES RAMP UP WITH R&D ACHIEVEMENTS
RemeGen reported 2023 revenue of Rmb1.08bn (+40% YoY) and net losses of Rm1.51bn (vs -Rmb999m in 2022), in line with our expectation. The revenue growth is mainly driven by the sales ramp up of RC18 (telitacicept) and RC48 (disitamab vedotin). Its R&D expenses reached Rmb1.31bn (+33% YoY) and its selling expenses reached Rmb775m (+76% YoY) in 2023. Considering the sales ramp up of core products and R&D investments of innovative pipelines, we lower our EPS forecast of from -Rmb0.79 to -Rmb2.02 in 24E, from Rmb0.30 to -Rmb1.09 in 25E, and forecast Rmb0.21 in 26E. We lower our target price from HK$59 to HK$47. With 72% upside, we maintain our BUY rating.
榮興通訊報告稱，2023年收入爲10.8億元人民幣（同比增長40％），淨虧損爲151億令吉（2022年爲-9.99億元人民幣），符合我們的預期。收入增長主要是由RC18（telitacept）和RC48（disitamab vedotin）的銷售增長推動的。2023年，其研發費用達到13.1億元人民幣（同比增長33％），銷售費用達到7.75億元人民幣（同比增長76％）。考慮到核心產品銷售的增長和創新管道的研發投資，我們將24E的每股收益預測從-Rmb0.79下調至-2.02元人民幣，25E的每股收益從0.30元下調至-1.09元人民幣，並預測26E的每股收益爲0.21元人民幣。我們將目標價格從59港元下調至47港元。上行空間爲72％，我們維持買入評級。
Expecting new indications of RC18 to be launched. With a sales team of c.700 people for RC18, RC18 has been listed in over 800 hospitals. As for the SLE in China, the company received the full approval by the NMPA in November 2023. In addition, RemeGen has submitted the NDA of RC18 for the treatment of RA to the NMPA in August 2023, which is expected to receive the approval in 2024E. In addition, RC18 is under phase III trial for MG in China with the patient enrollment completed in end-2023. RC18 is also under phase III clinical trials in China for pSS and IgAN, with the enrollment expected to be completed in 2024E. In terms of the development in overseas market, RC18 is now under a global multi-center phase III trial for SLE in the US. In addition, FDA has approved the phase III trial of RC18 for MG, with the fast-track designation in 2023.
預計RC18將推出新的跡象。RC18的銷售團隊約有700人，已在800多家醫院上市。至於中國的系統性紅斑狼瘡，該公司於2023年11月獲得了國家藥監局的全面批准。此外，榮昌生物已於2023年8月向國家藥監局提交了治療類風溼關節炎的RC18的保密協議，預計將在2024E獲得批准。此外，RC18正在中國進行MG的III期試驗，患者入組已於2023年底完成。RC18還在中國進行PS和IGaN的三期臨床試驗，預計註冊將於2024E完成。在海外市場的發展方面，RC18目前正在美國進行系統性紅斑狼瘡的全球多中心三期試驗。此外，美國食品和藥物管理局已批准MG的RC18的三期試驗，並將於2023年獲得快速通道認證。
Multiple studies of RC48 under development. In 2023, RC48 has been listed in over 650 hospitals, with a sales team of over 600 people. In terms of RC48's clinical trials in China, the company is carrying out earlier line treatments including first line, neoadjuvant and NMIBC for UC. Now, RC48's combo with PD-1 for 1L UC is under phase III clinical trial with patient enrollment ongoing. In addition, RC48's combo with toripalimab is under phase II trial for perioperative MIBC. As for the GC, the company plans the earlier line treatment studies. RC48's combo with PD-1 and chemotherapy or with PD-1 and Herceptin for 1L HER2- expressing GC is under phase II trial. As for the BC, the company focuses on earlier line treatment and HER2-low expressing trails. In addition, as for the RC48's global development by Pfizer/Seagen, RC48 is under phase III trial of RC48's combo with Keytruda for 1L UC, with patient enrolment ongoing. RC48's monotherapy for 2L UC is under pivotal phase II trial.
對RC48的多項研究正在開發中。2023年，RC48已在650多家醫院上市，銷售團隊超過600人。就RC48在中國的臨床試驗而言，該公司正在進行早期的線路治療，包括用於UC的一線、新輔助和NMIBC。現在，RC48與PD-1聯合治療1L UC的藥物正在進行三期臨床試驗，患者入組仍在進行中。此外，RC48與託利單抗的組合正在進行圍手術期MIBC的II期試驗。至於氣相色譜，該公司計劃進行早期的生產線處理研究。RC48與PD-1和化療或與PD-1和赫賽汀聯合用於1L HER2表達 GC 的組合正在進行二期試驗。至於不列顛哥倫比亞省，該公司專注於早期的線路處理和HER2-Low表達路線。此外，至於輝瑞/西根在全球開發的RC48，RC48正在對RC48與Keytruda聯合用於1L UC的III期試驗，患者入組仍在進行中。RC48的2L UC單一療法正在進行關鍵的II期試驗。
Active development of other ADC pipelines. The company has received the IND approval from NMPA for phase I/II trail of RC88 (mesothelin ADC)'s combo with sintilimab for advanced solid tumors in 2023, with the enrolment of first patient. In addition, the company has received the IND approval from FDA for a phase II trial of RC88 for gynecologic cancers. In addition, RC118 (Claudin18.2 ADC) is now under Phase I clinical trial in patients with Claudin18.2-positive locally advanced unresectable or metastatic malignant solid tumors in China. Meanwhile, RC248 (DR5 ADC) is under phase I dosage escalation stage for various tumors, with the enrolment of first patient.
積極開發其他 ADC 管道。該公司已獲得國家藥監局的臨床試驗批准，將於2023年進行RC88（間皮素ADC）與辛替利單抗聯合治療晚期實體瘤的I/II期試驗，並將招募首位患者。此外，該公司已獲得美國食品藥品管理局的IND批准，用於對婦科癌症進行RC88的二期試驗。此外，RC118（Claudin18.2 ADC）目前正在中國進行鍼對Claudin18.2陽性局部晚期不可切除或轉移性惡性實體瘤患者的I期臨床試驗。同時，針對各種腫瘤，RC248（DR5 ADC）處於I期劑量遞增階段，第一位患者入組。
Maintain BUY. Considering the sales ramp up of core products and R&D investments of innovative pipelines, we lower our EPS forecast of from -Rmb0.79 to -Rmb2.02 in 24E, from Rmb0.30 to -Rmb1.09 in 25E, and forecast Rmb0.21 in 26E. We lower our target price from HK$59 to HK$47. With 72% upside, we maintain our BUY rating.
維持買入。考慮到核心產品銷售的增長和創新管道的研發投資，我們將24E的每股收益預測從-Rmb0.79下調至-2.02元人民幣，25E的每股收益從0.30元下調至-1.09元人民幣，並對26E的預測爲0.21元人民幣。我們將目標價格從59港元下調至47港元。上行空間爲72％，我們維持買入評級。
Risks: R&D failure of key pipeline; rising competitions of key pipeline; lower-than-expected sales ramp-up.
風險：關鍵管道研發失敗；關鍵管道競爭加劇；銷售增長低於預期。
譯文內容由第三人軟體翻譯。