3Q major products rev grew to USD334mn, topped CMS est./StreetAccount consensus by 8%/7%
Next key catalysts for BRUKINSA: 1) PDUFA date for CLL in Jan 20th 2023; 2) full data of ALPINE study at upcoming medical conf.
We maintain SOTP-based TP at USD400. Maintain BUY as our top pick on Co.’s strong growth, multiple catalysts and BD capabilities
Continuing its strong performance
BRUKINSA 3Q revenue grew 136% yoy globally to USD155.5mn (+21% qoq), led by strong growth in U.S. (+221% to USD108.1mn), ROW (USD7.9mn vs. nearly nil last year) and China (+23% to USD39.5mn).
The strong BRUKINSA sales in U.S and ROW. was fuelled by 1) greater new patient share in MCL thanks to rising acceptance by clinicians and insurers in the U.S., 2) expansion globally in new geographies (i.e. EU and 6 Latin American countries) and indications; Tislelizumab 3Q sales grew 66% yoy (22% qoq) to USD128.2mn (~RMB878mn) driven by new patient demand from broader indication inclusion in NRDL. We reckon tislelizumab continued its lead in PD-1 sales for the second consecutive quarter, which might be the new normal for the domestic PD-1 landscape.
Major In-licensed products delivered soft 3Q results (+7% yoy to ~USD50mn), o/w robust Amgen in-licence portfolio (USD27.5mn, +32% yoy) and weak BMS in-licensed products (USD22.4mn, -13.8% yoy). Co. remained adj. loss-making but narrower to USD349mn in 3Q (USD381mn/USD360mn in 1Q/2Q), reflecting strong sales and continuing downward trend of SG&A ratio.
Major catalysts in 4Q22E-23E
Tislelizumab: 1) release of rescheduled PDUFA date for 2L ESCC in '22/23E; 2) multiple BLA filings in U.S./EU during '22-23E, including NSCLC/ESCC/GC/HCC; 3) sBLA approval of 1L ESCC in China in '23E; Zanubrutinib: 1) key data presentation for MAGNOLIA study at ASH2022 (Dec 10-14); 2) FDA sNDA approval for CLL/SLL, w/ PDUFA data on Jan 20th, 2023; 3) full data for ph3 ALPINE global head-to-head trial in r/r CLL/SLL at an upcoming medical congress.
Maintain BUY with SOTP-based TP remained at USD400
We upgraded FY22E rev forecast by ~5% but left our FY23E projection and SOTP TP unchanged. We retained 20% BD premium on top of its derived equity valuation given Co.’s BD capability (cash-rich position of USD4.3bn in YE22E and proven track records) and potential global M&A recovery in 2H22E/23E to help restore market sentiment. Investment risks: clinical delay/failure, lower-than-expected sales, regulatory risks.
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