In FY20, Co. started to generate revenue, ~RMB1bn of licence fee income from EQRx out-licensing deal
Co. guided an eventful 2021E (i.e. 4-5 NDA approvals; 5+ NDA filings; Pfizer collaboration advancement; 2 “pipeline 2.0” INDs)
Co. is an overlooked biotech name w/ NT approval catalysts (i.e. PD-L1 for 1L NSCLC) and global commercialization potential. BUY
Licence fee income help contracted adj. net loss in FY20
CStone started to generate revenue in FY20 (~RMB1bn vs. nil in FY19), attributed to licence fee income from EQRx collaboration for ex-China rights of its sugemalimab and CS1003 (αPD-1)。 R&D expenses were RMB1.4bn, largely remain flat with 2019. Adj. net loss (excluding the share-based payment and non-recurring items) contracted by ~47% to RMB1bn in FY20, mainly thanks to out-licencing revenue contribution.
Transition from biotech towards biopharma in 2021E
Co. on Mar 24 won its first NDA approval (pralsetinib, a RET inhibitor, for 2L RET fusion+ NSCLC) from CDE. Co. highlighted it is well-prepared for the looming commercialization, supported by 1) a full-fledged commercial team (>300 ppl) to cover >100 core cities and >400 hospitals, reflecting ~80% of precision medicines addressable market, per mgmt. est.; 2) growing precision medicine awareness in China, thanks to updated treatment guideline (CSCO20) and years of marketing efforts by other precision medicines (i.e. EGFR+, ALK+ drugs); 3) a feasible market access strategy via Sinopharm collaboration and next NRDL negotiation.
Further, mgmt. aims to nab 4 addition NDA approvals during 21E, with two avapritinib approvals in the near term plus sugemalimab and ivosidenib approvals in 2H21E. We reckon Co. to achieve RMB146mn/746mn product sales (incl: PD-L1 royalty income from Pfizer) over 2021E/22E.
“Pipeline 2.0” edging to clinical stages
Co. expects 2 IND submissions for in-licensed candidates from its “pipeline 2.0” (BIC and FIC assets) in 2H20E, namely CS5001 (a ROR1 ADC) and CS2006 (a multi-specific molecule targeting PD-L1x4- 1BBxHSA)。 Co. also stated multiple in-house “2.0” candidates progressing in preclinical phase and targeted 1-2 INDs/yr. We believe its “pipeline 2.0” strategy will help Co. to stand out in crowded PD-1/L1 ground in China.
Maintain BUY, SOTP-based TP updated to HKD19.1
We trimmed SOTP-based TP to HKD19.1 from HKD21.8 to reflect a lower PD-L1 ASP assumption based on peers’ PD-1 NRDL negotiation results. Co. is at the forefront of transformation from a biotech to a multi- commercial products biopharma. Maintain BUY.