HENLIUS BIOTECH(2696.HK):ANTICIPATING SUSTAINED PROFITABILITY
HENLIUS BIOTECH(2696.HK):ANTICIPATING SUSTAINED PROFITABILITY
Profit turnaround driven by core business operations. Henliu's FY23 revenue increased 67.8% YoY to RMB5.40bn, driven by strong sales of HANQUYOU (trastuzumab biosimilar) and serplulimab (PD-1). HANQUYOU recorded RMB2.74bn revenue in FY23, +58% YoY. We think HANQUYOU may be free from VBP risks in 2024 due to relatively moderate competition landscape for Herceptin biosimilars. GP margin (as % of product sales) increased to 83.0% in FY23, vs 80.7% in FY22. Selling expense ratio (as % of product sales) decreased to 38.5% in FY23, from 39.2% in FY22, and admin ratio decreased from 13.2% in FY22 to 8.4% in FY23, showing improving operating efficiency. R&D expense decreased 20% YoY to RMB1.12bn in FY23. In FY23, Henlius recorded c. RMB1.05bn operating cash inflows, and achieved net profit of RMB546mn, marking the Company's first profitable year in its history. We believe that the net profit was primarily derived from its core operations, namely the promotion of drugs. Thus, we are confident that this profitability will be sustainable in the coming years. As of end 2023, Henlius had RMB989mn cash reserves.
由核心業務運營推動的利潤週轉。恒流23財年收入同比增長67.8％，達到54.0億元人民幣，這得益於HANQUYOU（曲妥珠單抗生物仿製藥）和serplulimab（PD-1）的強勁銷售。漢趣優在23財年錄得27.4億元人民幣的收入，同比增長58％。我們認爲，由於赫賽汀生物仿製藥的競爭格局相對溫和，HANQUYOU在2024年可能沒有VBP風險。GP利潤率（佔產品銷售的百分比）在23財年增至83.0％，而22財年的80.7％。銷售費用比率（佔產品銷售的百分比）從22財年的39.2％降至23財年的38.5％，管理比率從22財年的13.2％下降到23財年的8.4％，這表明運營效率有所提高。23財年研發支出同比下降20％，至11.2億元人民幣。在23財年，Henlius記錄了約10.5億元人民幣的運營現金流入，實現了5.46億元人民幣的淨利潤，這是該公司歷史上第一個盈利的年度。我們認爲，淨利潤主要來自其核心業務，即藥品推廣。因此，我們相信，這種盈利能力在未來幾年將是可持續的。截至2023年底，Henlius擁有人民幣9.89億元的現金儲備。
Serplulimab (PD-1) has global potential thanks its superior profile in SCLC and CRC. The sales of serplulimab was RMB1.12bn in FY23, with 2H23 sales remaining stable (+1% HoH). This stability is notable even amidst a challenging period for the industry in China, attributable to the drug's differentiated profile in SCLC. The NDA for serplulimab as a first-line treatment for ES-SCLC was accepted by the EMA in Mar 2023, with the approval expected in 3Q24. In the US, Henlius is conducting a bridging study of serplulimab for 1L ES-SCLC, with data release and BLA submission expected by end-2024. Henlius has recently released encouraging data of serplulimab in 1L mCRC, especially in the underserved MSS CRC (CMBI report, link). A Ph3 trial in Asia, combining serplulimab with HLX04 and chemotherapy for first-line mCRC, is set to commence.
Serplulimab（PD-1）具有全球潛力，這要歸功於其在小細胞肺癌和結直腸癌中的卓越表現。serplulimab在23財年的銷售額爲11.2億元人民幣，下半年的銷售額保持穩定（同比增長1％）。即使在中國該行業面臨挑戰的時期，這種穩定性仍然顯而易見，這要歸因於該藥物在SCLC中的差異化特徵。作爲ES-SCLC一線治療的serplulimab的保密協議已於2023年3月被EMA接受，預計將在24年第三季度獲得批准。在美國，Henlius正在對用於1L ES-SCLC的serplulimab進行橋接研究，預計將在2024年底之前發佈數據並提交BLA。Henlius最近發佈了令人鼓舞的1L mCRC中serplulimab的數據，尤其是在服務不足的MSS CRC中（CMBI報告，鏈接）。在亞洲進行的一項Ph3試驗即將開始，該試驗將serplulimab與 HLX04 以及一線mCRC的化療相結合。
Promising innovative assets with global BD potential. HLX22 (a novel HER2 mAb) in combo with HANQUYOU and chemo had demonstrated overwhelming PFS signals in 1L GC compared with the current SoC (CMBI report, link). We expect Henlius to start a global Ph3 trial of HLX22 + HANQUYOU + chemo as a first-line treatment for GC, with Keytruda in the control arms. Henlius has developed a differentiated ADC platform leveraging MediLink's payload-linker technology which enables selective release of payload in tumor microenvironment. Based on this platform, HLX42 (EGFR ADC) has recently completed FPI in China, and also received a fast track designation from FDA for EGFR-TKI resistant NSCLC. HLX42 showed promising potential in post osimertinib EGFRm NSCLC in preclinical studies. HLX43 (PD-L1 ADC) started a Ph1 study in China in late 2023 with US IND approved as well. We think Henlius is likely to achieve global BD deals for its differentiated innovative assets, such as HLX22, HLX42 and HLX43.
具有全球BD潛力的有前途的創新資產。與當前的 SoC 相比，HLX22（一種新型 HER2 mAb）與 HANQUYOU 和化療聯合使用，在 1L 氣相色譜中表現出壓倒性的 PFS 信號（CMBI 報告，鏈接）。我們預計，Henlius將啓動一項全球Ph3試驗，將HLX22 + HANQUYOU +化療作爲氣相色譜的一線治療方法，Keytruda處於控制區。Henlius利用MediLink的有效載荷鏈接器技術開發了差異化的ADC平台，該平台可以在腫瘤微環境中選擇性釋放有效載荷。基於該平台，HLX42（表皮生長因子ADC）最近在中國完成了FPI，並且還獲得了美國食品藥品管理局對EGFR-TKI耐藥非小細胞肺癌的快速通道認證。在臨床前研究中，HLX42 在奧美替尼後 eGFrm NSCLC 中顯示出廣闊的潛力。HLX43（PD-L1 ADC）於2023年底在中國啓動了Ph1研究，並獲得了美國IND的批准。我們認爲，Henlius很可能會就其差異化創新資產（例如 HLX22、HLX42 和 HLX43）達成全球業務發展協議。
Maintain BUY. We expect Henlius to file NDAs in the US for HLX14 in 3Q24 and for HLX11 in end 2024. HLX11 may become the first pertuzumab biosimilar in the US/EU. We maintain our DCF-based TP unchanged at HK$18.67 (WACC 11.46%, terminal growth 2%).
維持買入。我們預計 Henlius 將於 24 年第 3 季度在美國提交 HLX14 的保密協議，並在 2024 年底提交 HLX11 的保密協議。HLX11 可能成爲美國/歐盟第一款帕妥珠單抗生物仿製藥。我們將基於差價合約的目標股維持在18.67港元不變（WACC爲11.46％，最終增長2％）。
譯文內容由第三人軟體翻譯。