REMEGEN(09995.HK):CONTINUOUS SALES RECOVERY
REMEGEN(09995.HK):CONTINUOUS SALES RECOVERY
emeGen reported 9M23 revenue of Rmb769m (+35% YoY) and net losses of Rm1.03bn, with revenue of Rmb347m (+58% YoY) and net losses of Rmb327m in 3Q23, in line with our expectation. The company's revenue growth is mainly driven by the sales ramp up of RC18 (telitacicept) and RC48 (disitamab vedotin).
eMeGen公佈的9M23年收入爲人民幣7.69億元（同比增長35％），淨虧損爲10.3億令吉，收入爲3.47億元人民幣（同比增長58％），淨虧損爲3.27億元人民幣，符合我們的預期。該公司的收入增長主要是由RC18（telitacicept）和RC48（disitamab vedotin）的銷售增長推動的。
Its R&D expenses reached Rmb858m (+30% YoY) and its selling expenses reached Rmb540m (+94% YoY) in 9M23. As the end of September 2023, the company has cash of c.Rmb800m on hand. We maintain our EPS forecast of -Rmb2.11 in 23E, -Rmb0.79 in 24E, and Rmb0.30 in 25E. We maintain our target price of HK$59. With 37% upside, we maintain our BUY rating.
在9M23，其研發費用達到人民幣8.58億元（同比增長30％），其銷售費用達到人民幣5.4億元（同比增長94％）。截至2023年9月底，該公司手頭有約8億元人民幣的現金。我們將23E的每股收益維持在-2.11元人民幣的預測，在24E中爲-0.79元人民幣，在25E中爲0.30元人民幣。我們維持59港元的目標價。憑藉37％的上漲空間，我們維持買入評級。
Sales ramp up with multiple pivotal trials of RC18 in China. Now, the company has established a sales team of over 700 people for RC18, covering over 2,300 hospitals and over 23,000 doctors. RemeGen has submitted the NDA of RC18 for the treatment of RA to the CDE in this August. In addition, RC18's full clinical data for RA will be published at 2023 ACR Meeting. In addition, RC18 is now under multiple phase III clinical trials and completed the FPI in 2Q23 in China, including MG, pSS and IgAN. In terms of the development of RC18 in overseas market, it is now under a global multi-center phase III study for SLE in the US. In addition, as for the treatment of MG, the company has obtained the orphan drug and fast-track designations in the US and the phase III clinical trial has been initiated. Meanwhile, RC18 has received the FDA's consensus for phase III study for IgAN and pSS in the US.
隨着RC18在中國的多項關鍵試驗，銷量增加。現在，該公司已經爲RC18建立了一支由700多人組成的銷售團隊，覆蓋2300多家醫院和23,000多名醫生。RemeGen已於今年8月向CDE提交了用於治療類風疹的RC18的保密協議。此外，RC18的RA完整臨床數據將在2023年ACR會議上公佈。此外，RC18目前正在進行多項III期臨床試驗，並於23年第二季度在中國完成了FPI，包括MG、PSs和iGaN。就RC18在海外市場的發展而言，它目前正在美國進行一項針對系統性紅斑狼瘡的全球多中心III期研究。此外，在治療MG方面，該公司已在美國獲得孤兒藥和快速通道稱號，並已啓動III期臨床試驗。同時，RC18已獲得美國食品藥品管理局的共識，將在美國進行IGaN和PS的III期研究。
Global trials of RC48 ongoing. As of 9M23, its oncology sales team has c.600 team members, covering over 2,000 hospitals and over 24,000 doctors. In terms of development of RC48 in China, as for UC, the company is carrying out earlier line treatments including first line, neoadjuvant and NMIBC, etc. Now, RC48's combo with PD-1 for 1L UC is under phase III clinical trial with patient enrollment ongoing. In addition, the company has completed patient enrollment of the phase II study of RC48's combo with PD-1 for MIBC. As for the GC, the company has obtained the IND approval from the NMPA for RC48's combo with PD-1 and Herceptin for 1L HER2-expressing GC. In addition, the company has submitted the IND application to the NMPA for RC48's combo with Akeso's cadonilimab for 2L GC. As for the BC, the company will focus on earlier line treatment and HER2-low expressing trails. RC48 is now under three phase II clinical trials for neoadjuvant HER2 expressing BC in China. In addition, as for the RC48's global development, RC48 is under phase III trial of RC48's combo with Keytruda for 1L UC and pivotal study of RC48's monotherapy for 2L UC.
RC48的全球試驗正在進行中。截至9M23，其腫瘤學銷售團隊擁有約600名團隊成員，覆蓋2,000多家醫院和24,000多名醫生。在中國研發RC48方面，與UC一樣，該公司正在進行早期的一線治療，包括一線、新輔助和NMIBC等。現在，RC48與PD-1的組合治療1L UC正在進行III期臨床試驗，患者招募工作正在進行中。此外，該公司已經完成了RC48與PD-1聯合治療MIBC的II期研究的患者入組。至於GC，該公司已獲得國家藥監局批准使用RC48與PD-1和Herceptin組合用於表達1L HER2的GC。此外，該公司已向NMPA提交了IND申請，要求將RC48與Akeso的cadonilimab組合用於2L GC。至於不列顛哥倫比亞省，該公司將專注於早期的線路治療和HER2低表達量試驗。RC48目前正在中國進行三項表達BC的新輔助HER2的II期臨床試驗。此外，至於RC48的全球發展，RC48正在對RC48與Keytruda聯合治療1L UC的III期試驗以及RC48對2L UC的單一療法進行關鍵研究。
Updates of other pipeline products. RC88 (mesothelin ADC) is under phase II trial for gynecological tumors in China. RC118 (Claudin18.2 ADC) has completed the phase I dosage escalation study for monotherapy. In addition, RC28 (VEGF/FGF) is now under phase III clinical trials for treatment of wAMD and DME in China while DR is under phase II clinical trial.
其他管道產品的更新。RC88（mesothelin ADC）正在中國進行婦科腫瘤的二期試驗。RC118（Claudin18.2 ADC）已經完成了單一療法的第一期劑量遞增研究。此外，RC28（VEGF/FGF）目前正在中國進行治療WamD和DME的III期臨床試驗，而DR正在進行二期臨床試驗。
Maintain BUY. We maintain our EPS forecast of -Rmb2.11 in 23E, -Rmb0.79 in 24E, and Rmb0.30 in 25E.
維持買入。我們將23E的每股收益維持在-2.11元人民幣的預測，在24E中爲-0.79元人民幣，在25E中爲0.30元人民幣。
We maintain our target price of HK$59. With 37% upside, we maintain our BUY rating.
我們維持59港元的目標價。憑藉37％的上漲空間，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 of key products after being included into the NRDL.
風險：關鍵產品線研發失敗；關鍵產品線競爭加劇；關鍵產品被納入NRDL後的銷售增長低於預期。
譯文內容由第三人軟體翻譯。