Akebia Therapeutics (AKBA) investor relations material

Strategic focus and capital allocation

• Emphasis on driving lead product Vafseo to become standard of care in dialysis-related anemia, supported by ongoing Phase IV and 3b trials.

• Continued commitment to kidney disease with pipeline expansion, including praliciguat, AKB-097, and AKB-9090 for acute kidney injury.

• Small-scale investments in non-kidney disease areas, such as ARDS and retinopathy of prematurity, to explore future growth opportunities.

Vafseo clinical and commercial trajectory

• Vafseo demonstrated statistically significant reductions in mortality and hospitalization in a 3,500-patient Phase III trial, with economic analysis showing an 8% decrease in hospitalizations and a 15% cost reduction.

• Data presented at major nephrology conferences and pending publication in a top-tier journal, supporting broader physician education.

• TIW (three times weekly) dosing under study, with ongoing VOCAL and VOICE trials expected to further validate ease of use and clinical benefits.

• Post-TDAPA, pricing strategy aligns with ESA benchmarks, targeting a $1 billion market opportunity with potential for $500+ million in annual revenue.

• Anticipates a temporary revenue dip post-TDAPA but expects volume growth and data-driven adoption to offset declines.

Pipeline development and growth drivers

• Praliciguat in Phase II for FSGS, leveraging prior data in diabetic kidney disease and animal models, with unique mechanism and ongoing enrollment.

• AKB-097, a tissue-targeted complement inhibitor, entering a basket study for IgAN, lupus nephritis, and C3G, aiming for best-in-class efficacy and safety.

• Basket study expected to generate data in 2027, with prioritization based on efficacy signals across indications.

• Additional pipeline assets in early-stage development, with focus on rare kidney diseases and potential expansion to other indications.