您的浏览器禁用了JavaScript(一种计算机语言,用以实现您与网页的交互),请解除该禁用,或者联系我们。 [伯恩斯坦]:BeOne Medicines:BTKi降价不太可能阻碍Brukinsa的份额增长;2025年第四季度后的模型更新(跑赢大盘) - 发现报告

BeOne Medicines:BTKi降价不太可能阻碍Brukinsa的份额增长;2025年第四季度后的模型更新(跑赢大盘)

2026-03-05 伯恩斯坦 睿扬
报告封面

Price Target 412.00 USD(414.00OLD) BeOne Medicines: BTKi price cuts unlikely to deter Brukinsa'sshare gain; model update post 4Q25 (Outperform) Brukinsa (almost) taking the throne of best-selling BTK inhibitor; upcoming IRA pricecuts unlikely to challenge its leadership.With $3.9Bn in 2025, Brukinsa came close toImbruvica ($4.0 Bn) and ahead of Calquence ($3.5Bn), and is on track to become the top-selling BTK with recent share developments. Its leadership comes from better efficacy(higher long term OS%) and safety (lower atrial fibrillation %). Importantly, BeOne managedto stay out of the CMS IRA price negotiations this Jan, while the other two BTK inhibitors aredue for c. 40% price cuts this year (Imbruvica) and in 2027 (Calquence).Though the WACprices of both would be more than 40% cheaper than Brukinsa post-IRA, to patients,the total OOP cap per year is the same for all BTK inhibitors at $2,100.Therefore, wethink the future price difference would not sway market share development, as the choice ofphysicians and patients is primarily on clinical benefits. B-cell market outlook:we have previously detailed the advantage of sonro over SoC fixedduration treatment V+O (cross-trial comps). BeOne appears undetered by the FDA approvalof V+A in Feb, and H2H trials for both combos are underway (the new Ph3 comparing againstV+A was initiated in Jan). If the better efficacy of sonro combos holds in Ph3, we expect tosee more patient share migrate to fixed duration treatments. We estimate the long-termpatient share of BTK continuous therapy to drop from half to 40%, but given the shorter DoTof fixed-duration treatments, the DoT-adjusted patient share of continuous therapy is stillexpected at c. 70% in 2033E. We increased Brukinsa peak sales to $6 Bn in 2033E (up from$5.2 Bn OLD), sonro $3.5 Bn (unchanged), and BGB-16673 (CDAC) $1.5 Bn (down from $2Bn OLD) - total B-cell products $11 Bn (unchanged). Solid tumors pipeline:CDK4 to enter 1L breast cancer. BeOne announced a Ph3 to testits CDK4 in combo with letrozole in 1L HR+ BC, H2H against SoC (CDK4/6 + letrozole)and same design as Pfizer’s FourLight-3 trial, making it the second CDK4 asset globally totrial in 1L. The Ph1 cohort of 1L patients will have readout in 1H26. As the great hopes forselective CDK4 inhibitors are their supposed safety benefits over CDK4/6. We like the lowneutropenia rate of BGB-43395 (8-12%), but its low cORR in 2L+ patients (11%) could be apain point - we look forward to seeing theefficacy of the 1L cohort in previous Ph1 trial,which will have readout in 1H26.(continued on the next page) DETAILS (continue)Other catalysts:IRAK4 CDAC: Ph1/2 RA trial readout in 2H26; B7H4 ADC: dose escalation readouts in1H26, Ph3trial initiation planned within NTM; GPC3x41BB: Ph2 trial initiation in 2H26. Model updates:1) B-cell malig. market model updates: we further segmented the patient population in TN CLL/SLL and R/R CLL/SLL, incorporated treatment duration impacts, and reassigned market share accordingly; however, total peak sales forthe three products remain largely unchanged at $11 Bn in 2033E, with our view on competitive landscape intact; 2) Marginupdates: we increased 2026-2027 OPEX margins in line with company’s guidance, with long-term assumptions remainunchanged; 3) Valuation updates: we updated the excess cash and number of shares outstanding to 2025 actual, with theupdated 1-y forward TP of $412 (-$2) per share using DCF, P/S and terminal P/E. BRUKINSA (ALMOST) TAKING THE THRONE OF BEST-SELLING BTK INHIBITOR; UPCOMING IRA PRICE CUTSUNLIKELY TO CHALLENGE ITS LEADERSHIP BeOne Medicines is increasingly positioned at the forefront of the global BTK inhibitor landscape, driven by the rapid ascentof zanubrutinib. Based on the IQVIA quarterly U.S. sales data, zanubrutinib’s market share grew rapidly, surpassing ibrutinib in3Q25 and continuing to rise to 30% in 4Q25. Globally, similar trend has been observed based on company reported annualsales, with zanubrutinib reaching parity with ibrutinib, position itself as one of the leading BTKis worldwide. The magnitude andpace of its share gain closely align with zanu’s differentiated clinical positioning, including favorable efficacy in CLL/SLL vs. itspeers, broader label expansion across key indications, and continued geographic penetration (Exhibit 1-Exhibit 2). EXHIBIT 1:The US BTKi market continues its steadyascent, with zanu maintaining its momentum andcapturing 30% share in 4Q25 We revisited the pricing of BTKi therapies - Ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib - all are covered underMedicare Part D. Approximately 70% of total product sales come from the Medicare channel, making these products highlyexposed to IRA pricing changes. Under the IRA (Inflation Reduction Act), signed in 2022 to lower prescription drug costs, ibrutinib and acalabrutinib have beenselected for price negotiation.Ibrutinib’s negotiated price will take effect in 2026, and acalabrutinib’s in 2027, withex