Aurinia Pharmaceuticals Inc. Q4 FY2024 earnings call

• Focused on commercial execution and operational efficiency, achieving growth in total revenue and LUPKYNIS sales.
• Key growth drivers for LUPKYNIS include expanding base at academic medical centers and lupus centers, leveraging new ACR lupus nephritis treatment guidelines, reinforcing AURORA clinical program data, and improving continuity of care for patients.
• Cash flow from operations improved in 2024, with $30.1M in Q4 2024 and $44.4M for the full year. Ended 2024 with $358.5M in cash, equivalents, restricted cash, and investments.
• Advancing AUR200, a Phase 1 study initiated in September 2024 with initial results expected in Q2 2025.

For the fourth quarter of 2024, total revenue was $59.9 million. LUPKYNIS net product sales were $57.6 million, up 36% from the same period in 2023. For the full-year 2024, total revenue was $235.1 million, with LUPKYNIS net product sales at $216.2 million, a 36% increase from 2023. LUPKYNIS net product sales contributed significantly to the overall revenue growth, driven by increased market penetration in lupus nephritis.

• Expect total revenue for 2025 in the range of $250 million to $260 million.
• Net product sales of LUPKYNIS expected to be in the range of $240 million to $250 million for 2025.

• Competition from Lotus Pharmaceuticals, which filed an NDA for a product related to LUPKYNIS.
• Uncertainties regarding patent defense and potential generic competition for LUPKYNIS, with the earliest generic entry potentially in the first half of 2028.
• Risks associated with the clinical development of AUR200, including uncertainties in trial outcomes and data interpretation.

Q: Could you provide more details on maximizing LUPKYNIS opportunity with the current sales force and how ACR guidelines are impacting this, and on the AUR200 Phase 1 study results expected in Q2 2025?

A: Focus on rheumatology, high prescribing SLE/LN offices, and hospital segments. AUR200 Phase 1 study will provide pharmacodynamics and pharmacokinetic data, informing the MAD study.

Q: How is LUPKYNIS growth expected beyond 2025 and on AUR200's MAD study timeline?

A: Historical trends guide LUPKYNIS growth; wait for AUR200 Phase 1 data to inform MAD study timeline.

Q: About the 2025 guidance being conservative and LUPKYNIS exclusivity protection and generic timeline?

A: Guidance based on current market insights; LUPKYNIS has Orange Book exclusivity until 2028, with robust patent portfolio to defend.

Q: Reason for not reporting PSS in Q4 2024 and AUR200's potency implications?

A: Historical results provide enough insight; AUR200's lower KD and IC50 suggest potential for lower/fewer doses.

Q: Impact of ACR guidelines on prescriber behavior and AUR200's longer-term timeline?

A: ACR guidelines drive early diagnosis and treat-to-target, with impact on prescriber behavior; wait for AUR200 Phase 1 data to inform longer-term timeline.