Vamil Divan

Chris Boshoff provided comprehensive detail on which datasets will be presented at ADA (VESPER-1/2/3) and clarified amylin mono data would come in H2.

Boshoff noted VESPA-3 used only two step-up doses versus typical four to five; Phase III VESPA-6 will test different titrations plus 9.6mg monthly; expects updated amylin combo data and potentially GIPR antagonist Phase II data at ADA.

Malik confirmed strong demand growth and market share leadership but acknowledged volume offset by two GTN headwinds: IRA manufacturer rebates and new payer contracting in Q3; competition from Attruby taking some first-line treatment-naive share.

Malik attributed Q3 Padcev softness to Q2 distribution model transition (drop ship to wholesaler) creating one-time Q2 inventory build; expects return to growth in Q4; MIBC approval could add 22,000 patients to addressable population.

Denton reaffirmed steadfast commitment to maintaining and growing dividend, citing improved operating margin performance and cash flow yield.

Malik explained Q1 weakness from lower winter wave, treated over 750,000 patients; baseline assumes two annual COVID waves; Alexandre noted international Comirnaty beat consensus by $130 million.

Boshoff highlighted best-in-class Serotype 3 immunogenicity in PCV-25, noted pediatric study ongoing with additional data expected later in year, and mentioned 30-plus candidate in preclinical.

Boshoff confirmed cancer cachexia Phase 3 starting but disclosed termination of cardiovascular study, directly addressing the enrollment change question.

Cavanaugh said Q3 INLEXZO sales were north of $90 million and sized the expansion populations behind a $5 billion-plus platform.

Cavanaugh declined to disclose ICOTYDE sales this year and said disclosure should come next year.

Jennifer Taubert said INLEXZO beat consensus, more than doubled sequentially, and leads novel agents in new-patient share; John Reed detailed SunRISe program.

Taubert confirmed very robust interest and enthusiasm. Permanent J-code anticipated beginning of Q2 in April timeframe as utilization catalyst. Sunrise 5 (BCG experienced) data and submission listed for 2026 events. Reaffirmed $5 billion plus peak sales conviction.

Taubert cited very positive clinician reception and initial insertions underway. J-code reimbursement expected April as uptake catalyst. Reed detailed broad Phase III program across BCG settings.

Reed confirmed 4804 Phase IIb readout mid-year for both UC and Crohn's. Noted early Phase IIa showed unprecedented combination potential. Icotrokinra positive UC proof-of-concept data coming at congress.

Moore clarified consensus estimates rose by about $2B of the $4B gap since 2023 EBR. Wolk emphasized they remain bullish, consensus just caught up. Taubert confirmed CARVYKTI as $5B+ asset.

Robert Michael expressed disappointment but noted conservative planning. Jeff Stewart confirmed no meaningful interaction between therapeutic and cosmetic pricing despite formulaic NDC linkage. Scott Reents outlined Skyrizi/Rinvoq pricing: low single-digit headwinds in 2026 and beyond. 2025 was unique with H1 favorability netting to roughly flat for Skyrizi and slightly down for Rinvoq.

Rob Michael confirmed combined 2025 guidance raised $1.7B+ since 2027 targets set. Cited underappreciated areas: immunology innovation beyond Skyrizi/Rinvoq (combos, oral peptides, B-cell depletion), neuroscience franchise breadth, and oncology pipeline depth. Jeff Stewart reported BOTOX share in low 60s, Juvederm stable in mid-40s. New BOTOX consumer campaign and HA filler sentiment campaign deployed.

Jeff Stewart positioned alopecia areata as part of Rinvoq's third wave (after rheumatology and IBD), overlapping with derm/rheum call points. Combined next-wave indications (alopecia, GCA, lupus, vitiligo, HS) add ~$2B peak sales. Aesthetics practices seeing stable conditions but dermal filler sentiment shifting toward natural look.

Scott Reents confirmed ~$30M tariff impact on aesthetics absorbed in guidance. Jeff Stewart reported one market share point recovery in US toxins and stable filler share; China share gaining on new approvals.

Jeff Stewart confirmed consistent low single-digit price concessions from formulary rebating with one-time Part D adjustment. Rob Michael reinforced volume-driven growth strategy.

Carrie Strom acknowledged share loss but noted the reversion to the original Alle program in January was greeted with very positive response from customers.

Dean Li emphasized the need for clinically meaningful endpoints beyond just PVR reduction, signaling that time to clinical worsening will be central to Phase III discussions with FDA.

Caroline said US growth depends heavily on ACIP dosing outcome; ex-US opportunity is in private-market mid-adult (27-45) cohort as public programs mature.

Rob said ex-US WINREVAIR growth was masked by a pricing adjustment; contracting in Germany is off to a good start with reimbursement expansion expected in H2.

Rob said BD strategy is unchanged though seller price expectations have not yet aligned; on MFN pricing, he emphasized PBM reform and global pricing fairness.

Caroline confirmed normal WINREVAIR inventory and a Part D redesign-related channel adjustment; Dean declined to commit on CADENCE readthrough.

Divan questioned confidence in the flat 7,000 new-starts assumption; Lewis confirmed it is all organic and expects it to hold, with room to rise.

Management declined to provide quarterly guidance but emphasized organic demand growth expected sequentially. Noted enthusiasm but cited only 2 quarters of data as reason for caution on guidance revision.

CEO expressed confidence in overcoming orphan exclusivity. CMO detailed three pathways: superiority in efficacy, safety, or impact on patient care. Highlighted once-daily dosing and dose titration as potential advantages for showing superiority over existing orphan-designated treatments.

Management provided detailed overview of BiRCh trial design, endpoints, and powering. Compared to Optinose studies showing treatment effects of 0.7-0.9 points.