HANSOH PHARMA(3692.HK):STRONG SALES GROWTH OF INNOVATIVE DRUGS
HANSOH PHARMA(3692.HK):STRONG SALES GROWTH OF INNOVATIVE DRUGS
Strong sales growth of innovative drugs in 1H24. Hansoh reported
24年上半年創新藥物的銷售強勁增長。漢森報道說
RMB6.51bn revenue in 1H24, including US$185mn upfront payment from GSK regarding the out-licensing of HS-20093 (B7-H3 ADC). In 1H24, Hansoh recorded RMB5.10bn (+13.8% YoY) revenue from product sales, representing 48% of our previous FY24 estimate, in line with our expectations. In 1H24, 77% of the total revenue came from innovative drugs. Excluding collaboration revenue, the sales from innovative drugs recorded strong growth of +31.6% YoY in 1H24. In 1H24, the company's selling expense ratio as % of product sales decreased significantly to 33.7% from 37.5% in FY23, and the admin expense ratio also decreased from 7.5% in FY23 to 6.9% in 1H24, indicating improved cost efficiency. Hansoh continues to invest in R&D with the R&D cost increasing 29% YoY to RMB1.20bn, representing 23.4% of product sales. In 1H24, Hansoh realized RMB2.73bn net income, with plans to distribute ~40% as dividends.
24 年上半年的收入爲 65.1 億元人民幣,其中包括葛蘭素史克爲 HS-20093(B7-H3 ADC)的許可外包而支付的1.85億美元的預付款。在24年上半年,漢森的產品銷售收入爲51.0億元人民幣(同比增長13.8%),佔我們之前的24財年估計值的48%,符合我們的預期。在24年上半年,總收入的77%來自創新藥物。不包括合作收入,創新藥物的銷售在24年上半年實現了強勁的同比增長31.6%。在24財年上半年,該公司的銷售費用佔產品銷售的百分比從23財年的37.5%大幅下降至33.7%,管理費用比率也從23財年的7.5%下降至24年上半年的6.9%,這表明成本效率有所提高。漢森繼續投資研發,研發成本同比增長29%,達到12.0億元人民幣,佔產品銷售額的23.4%。在24年上半年,漢森實現了27.3億元人民幣的淨收入,並計劃將約40%的股息分配。
Expansion of aumolertinib's indications to drive growth. As an early-mover in
擴大aumolertinib的適應症以推動增長。作爲先行者
China's 3rd-generation EGFR-TKI market, Hansoh continues to expand aumolertinib's indications, with two additional NDAs of aumolertinib recently accepted by NMPA, including (1) adjuvant therapy after resection, and (2) maintenance therapy for locally advanced unresectable NSCLC without progression following chemoradiotherapy. With expected approvals by mid-2025 and the potential inclusion in the NRDL by early 2026, aumolertinib is poised to be the first domestic EGFR-TKI for these two indications. Additionally, we expect Hansoh to file another NDA of aumolertinib in combination with chemotherapy for 1L EGFRm NSCLC in 4Q24, differentiated from other domestic players. A Ph3 trial of aumolertinib + HS-10241 (cMET inhibitor) for EGFR-TKI resistant MET+ NSCLC is ongoing as well. With stable pricing and NRDL coverage for 1L and 2L indications through FY24, we expect aumolertinib's sales to grow 22% YoY to RMB4.38bn in FY24E. We expect aumolertinib's pricing to remain largely stable during the NRDL renewal in late 2024, and remain confident toward the management's target of aumolertinib's sales reaching RMB6.0bn in 2026.
作爲中國第三代EGFR-TKI市場,Hansoh繼續擴大aumolertinib的適應症,Aumolertinib的另外兩個新藥上市申請最近被國家藥監局接受,包括(1)切除後的輔助治療,以及(2)局部晚期不可切除的NSCLC的維持治療,在放化療後沒有進展的局部晚期非小細胞肺癌。奧樂替尼有望在2025年中期獲得批准,並有可能在2026年初被納入NRDL,有望成爲首款針對這兩個適應症的國內EGFR-TKI。此外,我們預計,漢索將在24年第四季度再次提交奧莫樂替尼與1L eGFrm NSCLC聯合化療的保密協議,這與其他國內公司不同。aumolertinib + HS-10241(cMet抑制劑)治療EGFR-TKI耐藥的MET+ NSCLC的Ph3試驗也在進行中。憑藉穩定的定價以及截至24財年的1升和2L適應症的NRDL覆蓋率,我們預計奧樂替尼在 FY24E 中的銷售額將同比增長22%,達到43.8億元人民幣。我們預計,在2024年底續訂NRDL期間,aumolertinib的定價將基本保持穩定,並對管理層2026年aumolertinib銷售額達到60億元人民幣的目標充滿信心。
Diversified pipeline of innovative drugs. HS-20093 (B7-H3 ADC) is leading the
多元化的創新藥物管道。HS-20093(B7-H3 ADC)處於領先地位
global development, with two Ph3 studies for SCLC already underway in China.
全球發展,中國已經在進行SCLC的兩項Ph3研究。
HS-20093 has demonstrated promising early signals in heavily treated SCLC patients, with 61.3% ORR, 5.9 months of mPFS and 9.8 months of mOS in the 8.0mg dose cohort in its Ph1 study (WCLC abstract, link), comparable to that of I- DXd (52.4% ORR, 5.6 months of mPFS and 12.2 months of OS; CMBI report, link), in our view. GSK has registered a global Ph1 trial for HS-20093, recently receiving BTD from the FDA. For HS-20089 (B7-H4 ADC), a Ph1 trial has been registered by GSK, with pivotal trials expected soon in China. We expect Hansoh to bring more ADC assets, including EGFR/cMet ADC, to clinical studies in 2H24 and beyond. HS-10374 (TYK2 inhibitor) is expected to enter Ph3 psoriasis study, with Ph2 data to be released in 2H24. Additionally, we expect HS-20094 (GLP- 1/GIP dual agonist) to enter Ph3 study for obesity in 2H24.
在我們看來,HS-20093 已在接受大量治療的小細胞肺癌患者中顯示出令人鼓舞的早期信號,在其Ph1研究(WCLC摘要,鏈接)的8.0mg劑量隊列中有61.3%的ORR,5.9個月的MPF和9.8個月的MO(WCLC摘要,鏈接),與I-dxD(52.4%的OR率,5.6個月的MPF和12.2個月的操作系統;CMBI報告,鏈接)相當。葛蘭素史克已經註冊了一項 HS-20093 的全球 Ph1 試驗,最近獲得了 FDA 的 BTD。對於 HS-20089(B7-H4 ADC),GsK已經註冊了一項Ph1試驗,預計不久將在中國進行關鍵試驗。我們預計,漢森將在24下半年及以後的臨床研究中引入更多的ADC資產,包括表皮生長因子/cMet ADC。HS-10374(TYK2抑制劑)有望進入Ph3銀屑病研究,Ph2數據將於24年下半年公佈。此外,我們預計 HS-20094(GLP-1/GIP 雙重激動劑)將在 24 年下半年進入肥胖症的 Ph3 研究。
Maintain BUY. For FY24E, we expect Hansoh's total revenue to increase 21% YoY to RMB12.23bn. Excluding the impact of collaboration revenue, we expect Hansoh's organic revenue to grow 14.3%/14.1% YoY in FY24E/25E. We expect Hansoh's net profit to increase 33.3% and decrease 25.1% YoY in FY24E and FY25E to RMB4.37bn/3.27bn, respectively. With the strong sales of innovative drugs, we raise our DCF-based TP to HK$24.11 from HK$22.06 (WACC: 8.52%, terminal growth rate: 3.5%).
維持買入。在 FY24E 方面,我們預計漢森的總收入將同比增長21%,達到122.3億元人民幣。不包括協作收入的影響,我們預計漢森在24E/25E財年的有機收入將同比增長14.3%/14.1%。我們預計,漢森的 FY24E 和 FY25E 淨利潤將分別增長33.3%和25.1%,至43.7億元人民幣/32.7億元。隨着創新藥物的強勁銷售,我們將基於DCF的目標從22.06港元提高至24.11港元(WACC:8.52%,終端增長率:3.55%)。
譯文內容由第三人軟體翻譯。