AP
Aurinia Pharmaceuticals Inc. (AUPH)·Q3 2025 Earnings Summary
Executive Summary
- Strong Q3 print with broad-based beats and a guidance raise: total revenue $73.5M (+8% YoY; +4.9% QoQ) and diluted EPS $0.23 (+130% YoY), both above S&P Global consensus; management raised 2025 total revenue to $275–$280M and LUPKYNIS net product sales to $265–$270M . Revenue actual $73.5M vs $67.7M consensus; EPS $0.23 vs $0.16 consensus (beats) (Values retrieved from S&P Global)*.
- Growth driven by LUPKYNIS net product sales $70.6M (+27% YoY; +6% QoQ), offsetting lower license/collaboration revenue (lap of $10M 2024 Japan milestone) .
- Margins expanded materially (operating margin ~40.5%; net margin ~42.9%), aided by sharply lower SG&A post 2024 restructuring, and interest income tailwind .
- Strategic update: FDA information request on LUPKYNIS yielded additional analyses showing a statistically significant reduction in renal-related events or death; Aritinercept (dual BAFF/APRIL) advancing to clinical studies in two autoimmune diseases by year-end 2025, with more program detail in early 2026 .
What Went Well and What Went Wrong
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What Went Well
- LUPKYNIS unit economics and execution: Net product sales +27% YoY to $70.6M, driving total revenue and EPS beats; management raised FY revenue and sales guidance for the second time in 2025 . CEO: “LUPKYNIS sales experienced continued momentum…” .
- Increased clinical and real-world evidence: New analyses suggest a statistically significant reduction in risk of renal-related events or death, reinforcing LUPKYNIS’ profile . CMO: “LUPKYNIS… was associated with a statistically significant and clinically meaningful 53% reduction in the risk of renal-related events or death” .
- Operating leverage and cash generation: Operating cash flow $44.5M in Q3 (+162% YoY) and strong YTD cash flow; share count reduced (12.2M shares repurchased YTD for $98.2M), with cash and investments at $351.8M .
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What Went Wrong
- Contract/other revenue headwind: License/collaboration/royalty revenue fell to $2.8M from $12.3M YoY due to prior-year $10M Japan milestone, masking underlying sales growth in total revenue .
- Continued competitive and formulary backdrop: Q&A flagged clinician adoption dynamics versus newly approved/expected B‑cell agents (e.g., GAZYVA), necessitating continued education and differentiation on speed of response .
- Regulatory/legal overhangs persist: FDA information request adds attention (albeit data favorable), and ANDA/IP litigation timelines remain protracted; management will not provide frequent updates .
Financial Results
Headline metrics vs prior periods and vs estimates
Revenue breakdown
Profitability and margins
Key KPIs
Notes: Q3 2024 license revenue included a $10M milestone in Japan; YoY comps reflect this headwind . Gross margin for Q2 is company-stated; Q3/Q3’24 margins are derived from reported revenue and cost of revenue .
Guidance Changes
Context: Initial 2025 guide reiterated at Q1 ($250–$260M total; $240–$250M LUPKYNIS) . Raised at Q2 and again at Q3 reflecting sustained demand momentum .
Earnings Call Themes & Trends
Management Commentary
- “LUPKYNIS sales experienced continued momentum following last year’s update to the American College of Rheumatology lupus nephritis treatment guidelines… We are increasing total revenue guidance… to $275 million to $280 million and net product sales guidance… to $265 million to $270 million.” — Peter Greenleaf, CEO .
- “Excluding the one-time milestone, total revenue increased by 27%… Net product sales… were $70.6 million, up 27%… Diluted EPS was $0.23, up 130%.” — Joe Miller, CFO .
- “New analyses… show that LUPKYNIS also was associated with a statistically significant and clinically meaningful reduction in the risk of renal-related events or death…” — Greg Keenan, CMO ; see detailed tables in slides .
- “Aurinia plans to initiate clinical studies of aritinercept in two autoimmune diseases by the end of 2025.” — Management .
Q&A Highlights
- Adoption dynamics vs B‑cell agents: Management underscored complementarity and LUPKYNIS’ faster achievement of therapeutic goals vs B‑cell modulators; rheumatology prescriber base and hospital channel continue to expand .
- Outlook into Q4 and 2026: Confidence in continued momentum; raised guidance reflects trends; more AUR200 details in early 2026 .
- FDA information request: Company responded with favorable data; cannot predict further questions but views the exchange positively .
- Aritinercept dosing/program: 150 mg will be among doses in MAD; once‑monthly dosing supported by PD; indications to be disclosed with program updates in 2026 .
- Persistence: Upward trend in patient persistency, helped by long‑term safety/efficacy and biopsy substudy data .
Estimates Context
- Q3 2025 vs S&P Global consensus: Revenue $73.5M actual vs $67.7M consensus (beat by ~$5.8M); EPS $0.23 vs $0.16 consensus (beat by $0.07) (Values retrieved from S&P Global)*.
- Prior quarters: Q2 revenue $70.0M vs $63.8M consensus; EPS $0.16 vs $0.147 consensus (beats). Q1 revenue $62.5M vs $61.1M; EPS $0.16 vs $0.10 (beats) (Values retrieved from S&P Global)*.
Consensus detail
Note: * Values retrieved from S&P Global.
Key Takeaways for Investors
- Beat-and-raise quarter: Solid top-line and EPS beats with a second FY guidance raise should support positive estimate revisions and multiple support (Values retrieved from S&P Global)*.
- Quality of growth: Underlying demand reflected in +27% LUPKYNIS sales; YoY revenue growth understated by prior‑year Japan milestone in license revenue .
- Margin inflection: Significant operating and net margin expansion from SG&A resets and scale; cash generation supports continued buybacks and pipeline funding .
- Clinical/practice tailwinds: ACR guideline inclusion continues to aid adoption across rheumatology and hospital channels .
- Risk watch: Competitive LN agents (B‑cell pathway) are coming; management positioning emphasizes speed of response and complementarity .
- Regulatory update: FDA information request outcome appears favorable; additional LN outcomes analyses bolster durability narrative .
- Pipeline catalyst path: Aritinercept to enter two autoimmune indications by YE25 with early 2026 program disclosure—watch for dose selection/MAD data and indication reveals .
Appendix: Additional Supporting Data and References
- Q3 2025 financial statements and press release excerpts (revenue breakout, EPS, cash flow, balance sheet, guidance) .
- Q2 2025 and Q1 2025 baselines (revenue, EPS, guidance progression, buybacks) .
- Earnings call commentary and Q&A (adoption, competition, FDA request, AUR200 plans) .
- LUPKYNIS clinical analyses (renal-related events/death reduction) and Aritinercept SAD data (IgA/IgM/IgG reductions) .
- Related press releases (ACR/ASN data presentations) .