SIMCERE PHARMACEUTICAL(2096.HK):INNOVATIVE DRUGS CONTRIBUTING MAJORITY OF SALES
SIMCERE PHARMACEUTICAL(2096.HK):INNOVATIVE DRUGS CONTRIBUTING MAJORITY OF SALES
In 1H23, Simcere reported RMB3.38bn (+25% YoY) revenue from drug sales and promotion services. Revenue from innovative drugs increased 37% YoY to RMB2.41bn (accounting for 71% of 1H23 total revenue, vs 65% in FY22 and 62% in FY21). In 1H23, revenue from oncology, autoimmune and other fields recorded 35%, 30%, and 63% YoY growth, respectively, while the sales of CNS products decreased 1.5% YoY in 1H23. The GP margin decreased to 75.8% in 1H23 from 79.4% in 1H22, mainly due to the reduced proportion of sales from high-margin Sanbexin, and relatively high manufacturing cost of Xiannuoxin (3CL) at the initial commercialization stage. Operating cash outflows in 1H23 was RMB82mn, compared to cash inflow of RMB685mn in 1H22, mainly due to the raw material stocking for Xiannuoxin in 1H23. R&D ratio decreased to 36.9% in 1H23 from 38.0% in FY22, and SG&A ratio also fell to 44.5% from 45.1% for the same period. Simcere recorded an attributable net profit of RMB2.27bn in 1H23 (incl. RMB1.14bn from fair value change of investment portfolio and RMB0.79bn from disposal of subsidiaries), while the core net profit was stable (RMB395mn in 1H23 vs RMB393mn in 1H22).
23年上半年，先聲藥業公佈的藥品銷售和促銷服務收入爲33.8億元人民幣（同比增長25％）。創新藥物收入同比增長37％，達到24.1億元人民幣（佔23上半年總收入的71％，而22財年爲65％，2021財年爲62％）。23年上半年，腫瘤學、自身免疫和其他領域的收入分別同比增長35％、30％和63％，而中樞神經系統產品的銷售額在23年上半年同比下降1.5％。GP利潤率從22年上半年的79.4％降至23年上半年的75.8％，這主要是由於高利潤率的三百信的銷售比例降低，以及先諾新（3CL）在初始商業化階段的製造成本相對較高。23年上半年的經營現金流出爲8.2億元人民幣，而22年上半年的現金流入爲6.85億元人民幣，這主要是由於Xiannuoxin在23年上半年的原材料庫存。研發比率從22財年的38.0％降至23年上半年的36.9％，銷售和收購比率也從同期的45.1％降至44.5％。先聲藥業在23年上半年的應占淨利潤爲22.7億元人民幣（包括投資組合公允價值變動產生的11.4億元人民幣和出售子公司所得的79.9億元人民幣），而核心淨利潤保持穩定（23年上半年爲3.95億元人民幣，而上半年爲3.93億元人民幣）。
Oncology business recorded growth recovery. The sales of Endostar in 1H23 increased 51% YoY to RMB434mn. According to 3D Medicines, Enweida (PD-L1) realized RMB353mn sales in 1H23 (+70% YoY). Cosela was at early stage of sales ramp-up, and may obtain approval for domestic production in 1Q24, which will boost the GP margin for the product. We expect Cosela to be added to the NRDL for ES-SCLC in early 2024. In addition, the Ph3 trial of Cosela in TNBC will release data in 1H24. The Company is also exploring the potential of Cosela in combination with ADC or IO drugs. Besides the commercialized assets, the Company recently in- licensed CMAB009 (EGFR) which is currently under the NDA review by CDE for CRC. CMAB009 could potentially become the first domestic EGFR mAb in China.
腫瘤業務實現增長復甦。23年上半年，Endostar的銷售額同比增長51％，達到4.34億元人民幣。根據3D Medicines的數據，恩威達（PD-L1）在23年上半年實現了3.53億元人民幣的銷售額（同比增長70％）。Cosela還處於銷售增長的早期階段，可能會在24年第一季度獲得國內生產的批准，這將提高該產品的GP利潤率。我們預計，Cosela將在2024年初加入ES-SCLC的NRDL。此外，TNBC對Cosela的Ph3試驗將在24年上半年發佈數據。該公司還在探索Cosela與ADC或IO藥物聯合使用的潛力。除了商業化資產外，該公司最近還獲得了 CMAB009（EGFR）許可，CDE目前正在接受CRC的保密協議審查。CMAB009 有可能成爲中國首款國產表皮生長因子單抗。
Non-oncology portfolio continues to grow. In the CNS field, sales of Sanbexin remained stable YoY in 1H23 at RMB1.03bn (22% market share of stroke injection), with a significant 33% increase in patient numbers offsetting the 32% price cut due to NRDL renewal effective in Mar 2023.The NDA of Sanbexin sublingual tablet for acute ischemic stroke (AIS) was accepted by CDE in Jun 2023. Upon the approval expected in 1H24, the tablet will become a sequential therapy of Sanbexin injection and provide better flexibility for stroke treatment. Additionally, Sanbexin is assessed in a Ph2 trial for hemorrhagic stroke. Daridorexant, a differentiated anti- insomnia drug potentially with better safe profile and no withdrawal symptom, has recently obtained Ph1+3 IND approval in China, which could lead to an NDA in 2024. Meanwhile, Xiannuoxin (3CL) has filed the full approval application, being the first COVID-19 small molecule drug in China to apply for full approval in China.
非腫瘤產品組合持續增長。在中樞神經系統領域，三貝欣的銷售額在23年上半年保持同比穩定，爲10.3億元人民幣（中風注射的市場份額爲22％），患者人數大幅增長33％，抵消了2023年3月生效的NRDL續訂所導致的32％的降價。三貝心舌下片治療急性缺血性中風（AIS）的保密協議於2023年6月被CDE接受。預計在24年上半年獲得批准後，該片劑將成爲Sanbexin注射液的連續療法，併爲中風治療提供更好的靈活性。此外，在一項出血性中風的Ph2試驗中對Sanbexin進行了評估。Daridorexant是一種差異化的抗失眠藥物，其安全性可能更好，沒有戒斷症狀，最近已在中國獲得Ph1+3 IND批准，這可能會導致在2024年獲得NDA的批准。同時，Xiannuoxin（3CL）已提交全面批准申請，這是中國第一款在中國申請全面批准的 COVID-19 小分子藥物。
Maintain BUY. To factor in the challenging business environment in China, we revise our DCF-based TP from HK$12.12 to HK$8.15 (WACC: 11.1%, terminal growth rate 3.0%), implying 27x/17x FY23/24 PE.
維持買入。考慮到中國充滿挑戰的商業環境，我們將基於DCF的目標價從12.12港元修改爲8.15港元（WACC：11.1％，終端增長率3.0％），這意味着23/24財年的市盈率爲27倍/17倍。
譯文內容由第三人軟體翻譯。