Jakafi Net Revenue

FY 2024

$2.71B to $2.75B " "

$2.74B to $2.77B " "

raised

Other Hematology/Oncology

FY 2024

Guidance reiterated, no numeric "

$310M to $320M "

no prior guidance

R&D

FY 2024

$1.76B to $1.80B "

$2.54B to $2.59B "

raised

COGS and SG&A

FY 2024

Guidance reiterated, no numeric "

Guidance reiterated, no numeric "

no change

Jakafi revenue growth and patent expiration

Previously: Q2 revenue $706M (3% YoY growth), Q1 revenue $572M (5% YoY increase), Q4 2023 revenue $695M (7% YoY). Patent expiration consistently mentioned, with plans for XR formulation; LOE discussions ongoing. " " " " " " " " " " " "

Net product revenue: $741M (16% YoY increase). Company highlighted 2029 patent expiration and remains confident in pipeline to mitigate future LOE. Raised full-year 2024 guidance to $2.74–$2.77B. " " "

Consistent recurring topic with continued bullish sentiment on growth and pipeline strategy to offset LOE.

Opzelura commercialization and pricing

Previously: Q2 revenue $122M (52% YoY), Q1 impacted by cyberattack and deductible resets, Q4 at $109M (78% YoY). Formulary gains (e.g., CVS) and modest discussions on potential discounts but focus on driving net sales. " " " " " " " " "

$139M in net product revenues (Q3), up 52% YoY, driven by atopic dermatitis and vitiligo uptake; Europe contributed $20M. Emphasis on coverage and access, no major concerns about pricing pressures explicitly mentioned. " " "

Repeated focus on growth, with confidence in global launches; stable sentiment on gross-to-net dynamics.

CDK2 inhibitor development in oncology

Previously: Q2 highlight of data to be presented at ESMO; Q1 dose optimization ongoing; Q4 early clinical activity with partial responses. " " " " "

Promising clinical activity in Cyclin E1-overexpressing tumors (ovarian/endometrial). Planning registrational studies in 2025, discussing single-arm vs. randomized trials ex-U.S.. " "

Momentum growing; sentiment remains bullish with clear path to pivotal studies.

Povorcitinib in hidradenitis suppurativa (HS)

Previously: Q2 data showed 29% HiSCR100 at week 52, Phase III enrollment ongoing; Q1 mention of Phase II success and plan for Phase III; Q4 updates on 52-week data and strong efficacy signals. " " "

Phase III (STOP-HS1 & STOP-HS2) enrolling well, with data expected early 2025. Phase II showed up to 29% HiSCR100 by week 52, highlighting potential best-in-disease profile. "

Consistent optimism; remains a key pipeline asset with potential for significant impact in HS market.

Niktimvo, tafasitamab, and retifanlimab

Previously: Q2 emphasised tafasitamab potential in follicular lymphoma and retifanlimab in anal carcinoma/lung cancer. Niktimvo not mentioned in Q1 or Q4 references. " " "

Collective revenue potential of $800M or more by 2029, with planned availability in 2025 leveraging existing commercial infrastructure. " "

New combined revenue guidance for three products, positive sentiment on near-term launches.

Regulatory uncertainties for pivotal programs

Previously: Q2 references to FDA review timelines for axatilimab; Q1 note on BLA acceptance for axatilimab; Q4 mention of multiple pending regulatory decisions but no detailed uncertainties. " " "

Mentioned STOP-HS Phase III data (povorcitinib) needed for NDA filing; ruxolitinib cream in pediatric AD awaiting approval (2025). CDK2 registrational studies in 2025. Overall cautious but positive on timelines. " " " "

Ongoing watchful approach; timelines remain mostly on track; sentiment cautious but constructive.

High R&D expenses impacting margins

Previously: Q2 approach was project-specific; Q1 cited $429M R&D spend; Q4 at $444M. Company has repeatedly noted high R&D is strategic, expecting better cost control once pivotal studies conclude. " " " "

$573M in GAAP R&D (Q3), reflecting a $100M milestone and late-stage programs. Adjusted R&D up 26% YoY. Company sees expenses moderating after key programs wrap, improving future margins. "

Remains a recurring pressure on margins, but intentional and expected to normalize with pipeline maturity.

BET inhibitor pipeline progress

Previously: Q2 pledged Phase III progress; Q1 and Q4 showed early efficacy and safety data, decreasing AML-transformation concerns. " " " "

Reiterated Phase III plans after seeing spleen volume reduction, symptom improvements, and continuous dosing advantage over competitor. Update expected later in 2024. " "

Steady progress; sentiment is positive with a clear path to pivotal trials.

Axatilimab for chronic GVHD

Previously: Q2 BLA filed and priority review accepted for third-line cGVHD, FDA decision anticipated Aug 2024; Q1, Q4 pointed to potential approval in late 2024. " " "

Nearing completion of third-line cGVHD development, with references to winding down clinical activities. "

Consistent references; remains a notable upcoming launch with stable optimism.