Aurinia Pharmaceuticals Inc (AUPH) Stock Analysis

LUPKYNIS (voclosporin), the only FDA-approved oral therapy for adult lupus nephritis, generated $271.3 million in net product sales for Aurinia Pharmaceuticals in 2025 — a 25% increase from $216.2 million in 2024 — with operating cash flows of $135.7 million, up 206% year over year. Aurinia commercializes LUPKYNIS directly in the United States and supplies product to Otsuka Pharmaceutical Co., Ltd. for Japan, the European Union, the United Kingdom, and Switzerland under a collaboration agreement signed in December 2020. The company held $398.0 million in cash, equivalents, and investments at December 31, 2025, and repurchased 12.2 million shares for $98.2 million during the year.

Aurinia sells LUPKYNIS in the U.S. through two specialty pharmacies and a specialty distributor, with payer coverage from commercial plans and government programs including Medicaid and Medicare. Outside the U.S., Otsuka has obtained regulatory approval in Japan, the EU, the UK, and Switzerland; Aurinia earns royalties of 10% to 20% on Otsuka Territory net sales. Manufacturing is entirely outsourced: Lonza is the sole supplier of voclosporin drug substance at a dedicated Monoplant facility, Catalent Pharma Solutions is the sole supplier of voclosporin capsules, and a sole supplier handles blistering and packaging of U.S. commercial cartons. In the U.S., LUPKYNIS competes against BENLYSTA (belimumab, marketed by GSK plc) and GAZYVA (obinutuzumab, marketed by Genentech, Inc.), both injectable therapies, as well as off-label use of mycophenolate mofetil and corticosteroids. In February and March 2025, eight generic companies including Hikma, Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Sandoz filed ANDAs challenging the 2037 dosing patents; Aurinia filed patent infringement complaints against each, triggering a Hatch-Waxman 30-month regulatory stay.