Aurinia Pharmaceuticals Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Aurinia Pharmaceuticals Inc. has filed its 2023 10-K report detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

Aurinia Pharmaceuticals Inc. (AUPH) filed a Annual Report (10-K) with the SEC on February 15, 2024. Aurinia Pharmaceuticals Inc. filed its 2023 Form 10-K on February 15, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is in Pharmaceutical Preparations (SIC 2834). Aurinia Pharmaceuticals Inc. is headquartered in Edmonton, Alberta, Canada. The filing includes financial data for the fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking Aurinia Pharmaceuticals Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Aurinia's financial health, operational activities, and strategic direction for the past fiscal year, crucial for investors to assess performance and future prospects. The detailed financial statements and risk factors within the report are essential for understanding the company's market position, revenue streams, and potential challenges in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Aurinia Pharmaceuticals Inc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as detailed in its risk factors section.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Aurinia's performance and future growth potential, particularly concerning its product pipeline and market penetration.

Key Numbers

• 2023-12-31 — Fiscal Year End (The report covers the fiscal year ending on this date.)
• 2024-02-15 — Filing Date (The date the 10-K was filed with the SEC.)
• 2023 — Reporting Period (The primary fiscal year for which the report is filed.)
• 2022 — Prior Fiscal Year (Financial data for this year is included for comparison.)
• 2021 — Earlier Fiscal Year (Financial data for this year is included for comparison.)

Key Players & Entities

• Aurinia Pharmaceuticals Inc. (company) — Filer of the 10-K report.
• 2023-12-31 (date) — Fiscal year end date covered by the report.
• 2024-02-15 (date) — Filing date of the 10-K report.
• Edmonton (location) — City of the company's business and mailing address.
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations.

FAQ

Risk Factors

• Customer Concentration Risk [high — market]: The company's revenue is significantly dependent on a small number of customers, specifically two specialty pharmacies in the US, posing a risk if these relationships are disrupted.

Industry Context

Aurinia Pharmaceuticals operates within the pharmaceutical industry, focusing on the development and commercialization of treatments for autoimmune diseases.

Regulatory Implications

The pharmaceutical industry is subject to extensive regulation by health authorities like the FDA and EMA, impacting drug approval, marketing, and post-market surveillance.

What Investors Should Do

1. Analyze the detailed financial statements for revenue trends, profitability, and cash flow.
2. Review the risk factors section, particularly customer concentration, for potential business impacts.
3. Assess management's discussion and analysis for strategic priorities and outlook.

Key Dates

• 2024-02-15: 10-K Filing — Official filing of the annual report for fiscal year 2023.
• 2023-12-31: Fiscal Year End — End date of the reporting period covered by the 10-K.

Year-Over-Year Comparison

This is the initial 10-K filing provided for analysis; no prior filing data is available for comparison.

Key Financial Figures

• $ — rency of the United States, the term "CA$," refers to Canadian dollars, the lawfu
• $65,000 — revenue per patient to be approximately $65,000; our estimates as to the trajectory an
• $30.0 million — thern Ireland. The approval triggered a $30.0 million milestone payment to us, which was reco
• $10.0 million — secured. As a result, this triggered a $10.0 million milestone which was recognized as colla
• $11 — first quarter of 2024 of approximately $11 - $15 million and expected operational
• $15 million — quarter of 2024 of approximately $11 - $15 million and expected operational cost savings o
• $50 — erational cost savings of approximately $50 - $55 million annually, with approximat
• $55 million — nal cost savings of approximately $50 - $55 million annually, with approximately 75% of the

Filing Documents

• auph-20231231.htm (10-K) — 1863KB
• exhibit211listofsubsidiari.htm (EX-21.1) — 4KB
• exhibit231consentofindepen.htm (EX-23.1) — 1KB
• exhibit311certification302.htm (EX-31.1) — 10KB
• exhibit312certification302.htm (EX-31.2) — 11KB
• exhibit321certificationsox.htm (EX-32.1) — 5KB
• exhibit322certificationsox.htm (EX-32.2) — 5KB
• exhibit971incentivecompens.htm (EX-97.1) — 44KB
• auph-20231231_g1.jpg (GRAPHIC) — 49KB
• auph-20231231_g2.jpg (GRAPHIC) — 112KB
• auph-20231231_g3.jpg (GRAPHIC) — 194KB
• auph-20231231_g4.jpg (GRAPHIC) — 210KB
• auph-20231231_g5.jpg (GRAPHIC) — 232KB
• auph-20231231_g6.jpg (GRAPHIC) — 40KB
• consentfeb2024.jpg (GRAPHIC) — 56KB
• 0001600620-24-000012.txt (&nbsp;) — 11907KB
• auph-20231231.xsd (EX-101.SCH) — 57KB
• auph-20231231_cal.xml (EX-101.CAL) — 95KB
• auph-20231231_def.xml (EX-101.DEF) — 260KB
• auph-20231231_lab.xml (EX-101.LAB) — 850KB
• auph-20231231_pre.xml (EX-101.PRE) — 560KB
• auph-20231231_htm.xml (XML) — 1396KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 22 Item 1B. Unresolved Staff Comments 48

C

Item 1 C . C ybersecurity 48 Item 2.

Properties

Properties 50 Item 3.

Legal Proceedings

Legal Proceedings 50 Item 4. Mine Safety Disclosures 50 PART II. Item 5. Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities 51 Item 6. Reserved 52 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 52 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 60 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 62 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 63 Item 9A.

Controls and Procedures

Controls and Procedures 63 Item 9B. Other Information 64

Disclosure Regarding Foreign Jurisdictions the Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions the Prevent Inspections 64 PART III. Item 10. Directors, Executive Officers and Corporate Governance 65 Item 11.

Executive Compensation

Executive Compensation 65 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters 65 Item 13. Certain Relationships and Related Transactions and Director Independence 65 Item 14. Principal Accountant Fees and Services 65 PART IV. Item 15. Exhibits, Financial Statement Schedules 66

Form 10-K Summary

Item 16. Form 10-K Summary 66 PART I INTRODUCTION Unless the context otherwise requires, references in this Annual Report on Form 10-K for the year ended December 31, 2023, or this Annual Report, to "we", "us", "our" or similar terms, as well as references to "Aurinia" and "the Company," refer to Aurinia Pharmaceuticals Inc., together with our subsidiaries. We maintain our books and records in U.S. dollars, and prepare our financial statements in accordance with generally accepted accounting principles in the United States (U.S. GAAP) as issued by the Financial Accounting Standards Board (FASB). The terms "dollar," "U.S. dollar" or "

Business

Item 1. Business OVERVIEW Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, we introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active LN. We continue to conduct clinical and regulatory activities to support the LUPKYNIS development program. We contracted with Otsuka Pharmaceutical Co., Ltd. (Otsuka) as a collaboration partner for the development and commercialization of LUPKYNIS in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine (collectively, the Otsuka Territories). LUPKYNIS is an orally administered CNI immunosuppressant that has been demonstrated to improve near and long-term outcomes in LN when used in combination with mycophenolate mofetil (MMF) (although MMF is not currently approved as such) and steroids. By inhibiting calcineurin, LUPKYNIS reduces cytokine activation and blocks interleukin IL-2 expression and T-cell mediated immune responses. LUPKYNIS also potentially stabilizes podocytes, which can protect against proteinuria. Voclosporin, the active ingredient in LUPKYNIS, is made by a modification of a single amino acid of the cyclosporine molecule. The mechanism of action of LUPKYNIS has been validated with certain earlier generation CNIs for the prevention of rejection in patients undergoing solid organ transplants and in several autoimmune indications, including uveitis, keratoconjunctivitis sicca, psoriasis, rheumatoid arthritis, and for LN in Japan. We believe that LUPKYNIS possesses pharmacologic properties with the potential to demonstrate best-in-class differentiation. On September 15, 2022, the EC granted marketing authorization of LUPKYNIS. The centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and N

View Full Filing

View this 10-K filing on SEC EDGAR