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君實生物-B(1877.HK):特瑞普利單抗全年銷售額7.74億元,第四季度銷售額環比增長約14%,維持“強烈推薦”投資評級
格隆匯 03-04 08:31

機構:方正證券

評級:強烈推薦

公司3月2日發佈2019年業績快報,全年實現收入7.75億元,歸母淨利潤-7.47億元。核心產品特瑞普利單抗2019年全年實現銷售收入7.74億元,第四季度的銷售收入為2.48億元,較第三季度的2.18億元環比增長約14%。同時,公司發佈《首次公開發行股票並在科創板上市申請文件的第二輪審核問詢函的回覆》,科創板上市穩步推進。

公司特瑞普利單抗上市後迅速打開市場,同時公司持續大舉投入研發,特瑞普利單抗的新適應症和其他在研產品研發進展順利,近期公佈的特瑞普利單抗二線治療尿路上皮癌臨牀數據優異,預計獲批成功率高,未來在這一適應症上有望成為領先的產品之一。我們看好公司核心產品特瑞普利單抗不斷在新的適應症取得進展,同時銷售額保持快速增長。公司作為國內新興創新藥企中的佼佼者之一,未來成長潛力大,維持“強烈推薦”投資評級。

特瑞普利單抗上市第一年即實現了7.74億元銷售收入,第四季度收入增速加快。預計2020年有望實現約70%增長,維持產品頂峯銷售額超過50億元的判斷。

特瑞普利單抗2019年正式上市銷售10個月,四個季度的銷售額分別為0.78億元、2.30億元、2.18億元和2.48億元。由於上市早期補充庫存需求較大,以及三季度恆瑞醫藥卡瑞利珠單抗單抗上市的影響,特瑞普利單抗第三季度銷售環比略有下滑,而第四季度環比增長即達到了14%,上升勢頭良好。展望2020年,我們預計隨着公司在更多醫院的進院環節取得進展,並進一步擴大銷售團隊,有望進一步擴大市場覆蓋面。同時,鼻咽癌、尿路上皮癌等多個適應症的臨牀試驗數據發佈,為特瑞普利單抗不斷打開新的市場。預計特瑞普利單抗將實現快速增長,預計2020年有望實現約70%增長,維持頂峯銷售額超過50億元的判斷。今年底,公司在上海臨港新建的30,000L抗體生產線也有望投入商業化生產,支持未來產品持續放量。

特瑞普利單抗各項臨牀試驗正在穩步推進,阿達木單抗生物類似藥有望於年內獲批,PCSK9單抗正在進行臨牀II期試驗,臨牀III期試驗有望於今年上半年啟動。

特瑞普利單抗單藥二線治療鼻咽癌和二線治療尿路上皮癌都預計將在近期提交上市申請,有望今年獲批;一線聯合化療治療驅動基因陰性的非小細胞肺癌、一線聯合化療治療食管癌、EGFR-TKI耐藥後的非小細胞肺癌和一線聯合白蛋白紫杉醇治療三陰性乳腺癌都有望在明年完成臨牀III期試驗,輔助治療肝癌有望在2022年完成臨牀III期試驗。

盈利預測:公司現階段研發投入大,特瑞普利單抗仍在銷量爬坡,短期尚無法盈利。預計公司2019-2021年收入分別為7.35億元、12.95億元和17.45億元。我們看好公司核心產品特瑞普利單抗不斷在新的適應症取得進展,同時銷售額保持快速增長,未來成長潛力大,維持“強烈推薦”投資評級。

風險提示:產品研發進度不及預期、臨牀試驗結果不及預期、競爭格局變化超出預期、醫保和進院等市場準入進展不及預期、產品降價幅度超出預期、產能擴展進度不及預期、對外合作項目進展不及預期、海外市場拓展不及預期

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