Summary

• Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company.
• Aurinia Submits Ind Application to Us Food & Drug Administration for Aur 200.
• In 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult lupus nephritis patients.

Aurinia Pharmaceuticals (Nasdaq: AUPH) is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with high unmet medical needs that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis.

Recent Developments

Aurinia Submits Ind Application to Us Food & Drug Administration for Aur 200¹

December 20, 2023; Aurinia Pharmaceuticals Inc announced the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia plans to initiate a Phase 1 study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of AUR200 in healthy volunteers.

AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). BAFF and APRIL play important roles in regulating B-cell survival and differentiation.

Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (Nda) For Lupkynis® (Voclosporin) In Japan²

November 13, 2023; Aurinia Pharmaceuticals Inc. announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN). LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys. In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN and it is currently available in the U.S. under the brand name LUPKYNIS®.

Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia is eligible to receive a payment of $10 million upon approval in Japan along with low double-digit royalties on net sales once launched.

Financial Highlights

Fourth Quarter Full-Year 2023 Results³

January 5, 2024; Preliminary unaudited net product revenue was approximately $42 million for the three months ended December 31, 2023, and $28.3 million for the same period in 2022, representing growth of approximately 49%. Preliminary unaudited net product revenue was approximately $159 million for the full year, and $103.5 million for the same period in 2022, representing growth of approximately 53%.

Preliminary unaudited total net revenue was approximately $45 million for the three months ended December 31, 2023 and $28.4 million for the same period 2022, representing growth of approximately 59%. Preliminary unaudited total net revenue was approximately $176 million for the year and $134.0 million for the same period 2022, representing growth of approximately 31%.

The Company had unaudited cash, cash equivalents, restricted cash and investments of approximately $351 million as of December 31, 2023. The Company is expecting to become cash flow positive on a go forward basis in the second half of 2024.

Full Year 2022 Results

Total net revenue were $134.0 million and $45.6 million for the years ended December 31, 2022 and 2021, respectively. The company's total net revenue during 2022 increased primarily as a result of net product revenue from its two main customers for LUPKYNIS driven predominantly by further penetration in the LN market, as well as the recognition of a $30.0 million milestone payment from Otsuka following the EC granting marketing authorization of LUPKYNIS in September 2022. Revenues from its two main customers in the U.S. accounted for approximately 45% and 35%, respectively, of its total revenues for the year ended December 31, 2022.

Cost of sales were $5.7 million and $1.1 million for the years ended December 31, 2022 and 2021. Gross margin for the years ended December 31, 2022 and 2021 was approximately 96% and 98%, respectively. SG&A expenses increased to $196.4 million for the year ended December 31, 2022 compared to $173.5 million for the year ended December 31, 2021. R&D expenses decreased to $45.0 million for the year ended December 31, 2022 compared to $51.1 million for the year ended December 31, 2021.

As of December 31, 2022, the company had cash, cash equivalents and restricted cash of $94.2 million and short-term investments of $295.2 million compared to cash, cash equivalents and restricted cash of $231.9 million and short-term investments of $234.2 million at December 31, 2021. Cash, cash equivalents and restricted cash and investments are primarily held in U.S. dollars. As of December 31, 2022 and 2021, the company had working capital of $396.4 million and $472.7 million, respectively.

Company Overview

Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by autoimmune, kidney and rare diseases with a high unmet medical need. In January 2021, the company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active LN. The company continue to conduct pre-clinical, clinical and regulatory activities to support the LUPKYNIS development program as well as its other assets. The company engaged with Otsuka Pharmaceutical Co., Ltd. as a collaboration partner for the development and commercialization of LUPKYNIS in the European Union (EU) and Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.⁴

As of December 31, 2022, the company employed approximately 300 employees in the United States, Canada, and the United Kingdom. Aurinia has two wholly-owned subsidiaries: Aurinia Pharma U.S., Inc., (Delaware incorporated) and Aurinia Pharma Limited (United Kingdom incorporated).

Product Pipeline

Company History

References

1. ^ https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/311/aurinia-submits-ind-application-to-us-food-drug
2. ^ https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/310/aurinia-pharmaceuticals-announces-collaboration-partner
3. ^ https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/312/aurinia-provides-preliminary-unaudited-fourth-quarter-and
4. ^ https://fintel.io/doc/sec-aurinia-pharmaceuticals-inc-1600620-10k-2023-february-28-19416-1248