君實生物-B(1877.HK):拓益上市首年銷售7.75億元,持續快速放量,維持“買入”評級
機構:中泰證券
評級:買入
投資要點
事件:2020年3月3日,公司發佈2019年業績快報。預計2019年實現營業收入7.75億元,同比增長26,375.48%;實現歸母淨利潤-7.47億元,同比下降3.39%;實現扣非歸母淨利潤-7.76億元,同比下降9.90%。
特瑞普利單抗(PD-1單抗/拓益)上市首年銷售7.75億元,大品種快速放量。2019年特瑞普利單抗(拓益)實現銷售額7.75億元,四個季度銷售額分別為7812萬元(2月底開售)、2.3億元、2.2億元和2.5億元,銷售數量分別為1.4萬支、4.0萬支、3.8萬支和4.3萬支。雖然2019年以來同類產品陸續上市,但PD-1單抗臨牀療效好、整體市場潛力大,公司依靠良好的療效、安全性和定價策略實現平穩持續較快放量。我們看好PD-1單抗作為腫瘤免疫檢查點藥物的革命性魅力,看好未來醫保持續對於此類創新藥的支持。特瑞普利單抗作為國產首個PD-1單抗,除已獲批上市的療既往標準治療失敗後的局部進展或轉移性黑色素瘤適應症外,同步開展超過20項臨牀試驗,其中11項關鍵註冊臨牀針對多項拓展適應症如非小細胞肺癌(EGFR陰性)一線治療,非小細胞肺癌(EGFR陽性、TKI治療失敗)一線治療,食管癌一線治療,鼻咽癌一線治療,鼻咽癌二線治療,肝細胞癌輔助治療,三陰性乳腺癌一線治療,尿路上皮癌二線治療,黑色素瘤一線治療。我們預計特瑞普利單抗銷售額2023年有望達到52億,2028年有望達到103億。
公司深耕生物藥研發領域,2019年自主研發和外部引進均取得一定進展。自主研發的全球首個抗BTLA單抗獲得FDA和中國臨牀試驗批准,阿達木單抗申報生產獲得受理,抗IL-17A單抗獲批臨牀。發揮優勢快速引進產品,受讓蘇州潤佳的CDK抑制劑、PI3K-ɑ抑制劑的50%權益,引入Anwita創新產品IL-21融合蛋白等。
盈利預測與投資建議:參考業績快報,我們上調公司2019-2021年營業收入分別為7.75、12.16、17.75億元人民幣,增速分別為由負轉正、56.9%、46.0%;歸母淨利潤分別為-7.76、-6.32、-4.68億元人民幣。公司作為國產PD-1單抗頭部梯隊企業具備先發優勢,多適應症快速推進,維持“買入”評級。
風險提示
事件:核心品種拓益銷售放量不及預期的風險,品種降價超過預期的風險,在研產品進度不及預期進而影響DCF模型估值的風險,預測前提不及預期導致市場容量測算出現偏差的風險,政策不確定性的風險。

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