Aurinia Pharmaceuticals Inc.
For the period ended Jun 30, 2025. Filed Jul 31, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Jul 31, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001600620-25-000049
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001600620-25-000092
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 53 previous paragraphs and 56 current paragraphs.
30 unchanged; 22 reworded; 3 added; 1 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
On June 30, 2025, Aurinia announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept. The Company plans to initiate clinical studies with aritinercept in at least two autoimmune diseases in the second half of the year.
Current report
For the three and six months ended June 30, 2025, cost of revenue was $7.1 million and $15.7 million, respectively, compared to $8.9 million and $16.7 million, respectively, for the same periods in 2024. The decrease for both periods is primarily a result of a decrease in sales of LUPKYNIS inventory to Otsuka, which has a low gross margin.
Current report
During the three and six months ended June 30, 2025, the increase in R&D non-personnel expense was primarily as a result of development activities for aritinercept and voclosporin.
Removed paragraphs (1)
Previous report
For the three months ended March 31, 2025, cost of revenue was $8.6 million, compared to $7.8 million in the same period in 2024. The increase is primarily due to an increase in Aurinia’s net sales of LUPKYNIS in the U.S. and net sales of LUPKYNIS inventory to Otsuka.
Reworded paragraphs (22)
Previous wording
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (“LN”). Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Current wording
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (“LN”). Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Previous wording
For the three months ended March 31, 2025, net product sales were $60.0 million, up 25% from $48.1 million in the same period of 2024.
Current wording
For the three and six months ended June 30, 2025, net product sales were $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55.0 million and $103.1 million, respectively, for the same periods in 2024.
Previous wording
For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.
Current wording
For the six months ended June 30, 2025, cash flow provided by (used in) operating activities was $45.5 million, compared to $(2.8) million in the same period of 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57.0 million for the six months ended June 30, 2025.
Previous wording
As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million.
Current wording
As of June 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $315.1 million compared to $358.5 million at December 31, 2024. For the six months ended June 30, 2025, the Company repurchased 11.2 million of its common shares for $90.8 million.
Previous wording
Comparison of the Three Months ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months ended June 30, 2025 and 2024
Previous wording
The following table sets forth our results of operations for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table sets forth our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Aurinia sells LUPKYNIS to two specialty pharmacies and a specialty distributor in the U.S., and Aurinia sells LUPKYNIS inventory to its collaboration partner, Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), for the European and Japanese market. The two specialty pharmacies, specialty distributor and Otsuka are considered our customers for accounting purposes.
Current wording
Aurinia sells LUPKYNIS to two specialty pharmacies and a specialty distributor in the U.S., and Aurinia sells LUPKYNIS inventory to its collaboration partner, Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), for the Japan, the European Union (the “E.U.”), the U.K., Switzerland, Russia, Norway, Belarus, Iceland, Liechtenstein and Ukraine markets (collectively, the “Otsuka Territories”). The two specialty pharmacies, specialty distributor and Otsuka are considered our customers for accounting purposes.
Previous wording
For the three months ended March 31, 2025, net product sales were $60.0 million, up 25% from $48.1 million in the same period in 2024. The increase is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies, driven by further LN market penetration.
Current wording
For the three and six months ended June 30, 2025, net product sales were $66.6 million and $126.5 million, respectively, compared to $55.0 million and $103.1 million, respectively, for the same periods in 2024. The increase for both periods is primarily due to an increase in the number of LUPKYNIS cartons sold to specialty pharmacies, driven by further LN market penetration.
Previous wording
License, collaboration and royalty revenue consists of revenue from a collaboration and licensing agreement with Otsuka to develop and commercialize oral voclosporin in Japan, the European Union (the “E.U.”), the U.K., Switzerland, Russia, Norway, Belarus, Iceland, Liechtenstein and Ukraine (collectively, the “Otsuka Territories”) in exchange for: (i) a $50 million upfront cash payment; (ii) regulatory and commercial milestone payments; and (iii) royalties ranging from 10% to 20% on net sales in the Otsuka Territories. Otsuka has obtained regulatory approval of LUPKYNIS in Japan, the E.U., the U.K. and Switzerland.
Current wording
License, collaboration and royalty revenue consists of revenue from a collaboration and licensing agreement with Otsuka to develop and commercialize oral voclosporin in the Otsuka Territories in exchange for: (i) a $50 million upfront cash payment; (ii) regulatory and commercial milestone payments; and (iii) royalties ranging from 10% to 20% on net sales in the Otsuka Territories. Otsuka has obtained regulatory approval of LUPKYNIS in Japan, the E.U., the U.K. and Switzerland.
Previous wording
For the three months ended March 31, 2025, license, collaboration, and royalty revenue was $2.5 million, up 14% from $2.2 million in the same period in 2024. The increase is primarily due to manufacturing services provided to Otsuka for sharing the capacity of the Monoplant.
Current wording
For the three and six months ended June 30, 2025, license, collaboration, and royalty revenue was $3.4 million and $5.9 million, respectively, compared to $2.2 million and $4.4 million, respectively, for the same periods in 2024. The increase for both periods is primarily a result of an increase in manufacturing services provided to Otsuka in the current year.
Previous wording
In December 2020, Aurinia entered into a manufacturing services agreement with Lonza Ltd. for the construction of the Monoplant. The construction of the Monoplant began in January 2021 and manufacturing of voclosporin began in late June 2023. The Monoplant is equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacturing of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand. Aurinia pays a quarterly fixed facility fee of 3.6 million Swiss Francs (approximately $4.0 million) for the exclusive right to use the Monoplant through March 31, 2030.
Current wording
In December 2020, Aurinia entered into a manufacturing services agreement with Lonza Ltd. for the construction of the Monoplant. The construction of the Monoplant began in January 2021 and manufacturing of voclosporin began in late June 2023. The Monoplant is equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacturing of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand. Aurinia pays a quarterly fixed facility fee of 3.6 million Swiss Francs for the exclusive right to use the Monoplant through March 31, 2030.
Previous wording
For the three months ended March 31, 2025, gross margin was 86%, compared to 85% in the same period in 2024.
Current wording
For the three and six months ended June 30, 2025, gross margin was 90% and 88%, respectively, compared to 84% and 85%, respectively, for the same periods in 2024.
Previous wording
The following table summarizes our SG&A expense for three months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our SG&A expense for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
The decrease in SG&A personnel expense was primarily a result of lower employee-related costs, including the reversal of non-cash, share-based compensation expense related to forfeited, unvested equity awards, resulting from our strategic restructuring efforts in 2024. The decrease in SG&A non-personnel expense was primarily a result of lower overhead, marketing, travel, sponsorship and trade show costs resulting from our strategic restructuring efforts in 2024.
Current wording
During the three and six months ended June 30, 2025, the decrease in SG&A personnel expense was primarily the result of lower employee-related costs, including the reversal of non-cash, share-based compensation expense related to forfeited, unvested equity awards, resulting from our strategic restructuring efforts in 2024.
Previous wording
We expect our SG&A expense to remain low in 2025 as compared to 2024 as we realize the full benefits of our strategic restructuring efforts.
Current wording
We expect our SG&A expense to remain lower in 2025 as compared to 2024 as we realize the full benefits of our strategic restructuring efforts.
Previous wording
The following table summarizes our R&D expense for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our R&D expense for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
The decrease in R&D personnel-expense was primarily a result of lower employee-related costs as a result of a reduction of headcount from our strategic restructuring efforts in 2024, offset by an increase in share-based compensation as a result of a reversal in the prior year of non-cash, share-based compensation expense related to forfeited, unvested equity awards related to the 2024 restructuring. The increase in R&D non-personnel expense was primarily a result of clinical development for our AUR200 program and post-approval obligations with the FDA related to LUPKYNIS.
Current wording
During the three and six months ended June 30, 2025, the increase in R&D personnel-expense was primarily as a result of an increase in share-based compensation due to a reversal in the prior year of non-cash, share-based compensation expense related to forfeited, unvested equity awards related to the February 2024 restructuring. During the six months ended June 30, 2025, the increase in personnel expense was partially offset by lower employee headcount in 2025, resulting from our strategic restructuring efforts in 2024.
Previous wording
We expect our R&D expenses to increase for the foreseeable future as we advance AUR200 through clinical development and continue to meet our post-approval obligations with the FDA related to LUPKYNIS.
Current wording
We expect our R&D expenses to increase for the foreseeable future as we continue our development activities.
Previous wording
Restructuring expense consists primarily of one-time termination benefits to affected employees, including severance and health care benefits, contract terminations and other costs related to our strategic restructuring efforts in 2024. On February 15, 2024, we announced a strategic restructuring that reduced headcount by approximately 25% and discontinued Aurinia’s AUR300 development program. On November 7, 2024, we announced another strategic restructuring that further reduced headcount by approximately 45% to sharpen the Company's focus on continued LUPKYNIS growth and the development of AUR200.
Current wording
Restructuring expense consists primarily of one-time termination benefits to affected employees, including severance and health care benefits, contract terminations and other costs related to our strategic restructuring efforts in 2024. On February 15, 2024, we announced a strategic restructuring that reduced headcount by approximately 25% and discontinued Aurinia’s AUR300 development program. On November 7, 2024, we announced another strategic restructuring that further reduced headcount by approximately 45% to sharpen the Company's focus on continued LUPKYNIS growth and the development of aritinercept. The Company's restructuring activities were substantially completed in the first half of 2025.
Previous wording
For the three months ended March 31, 2025 and 2024, restructuring expense was $1.5 million, and $6.7 million, respectively.
Current wording
For the three and six months ended June 30, 2025, restructuring expense was $0.1 million and $1.6 million, respectively compared to $1.1 million and $7.8 million, respectively for the same periods in 2024.
Previous wording
For the three months ended March 31, 2025, other expense (income), net was $4.4 million, compared to $(4.1) million in the same period in 2024. The change is primarily due to: (i) changes in the foreign exchange remeasurement of the finance lease liability recognized in connection with the Monoplant, which is denominated in Swiss Francs; and (ii) changes in the fair value assumptions related to our deferred compensation liability.
Current wording
For the three and six months ended June 30, 2025, other expense (income), net was $9.2 million and $13.7 million, respectively, compared to $(0.3) million and $(4.4) million, respectively, for the same periods in 2024. The change is primarily due to: (i) changes in the foreign exchange remeasurement of the finance lease liability recognized in connection with the Monoplant, which is denominated in Swiss Francs; and (ii) changes in the fair value assumptions related to our deferred compensation liability.
Previous wording
As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million. For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period in 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.
Current wording
As of June 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $315.1 million compared to $358.5 million at December 31, 2024. For the six months ended June 30, 2025, the Company repurchased $11.2 million of its common shares for $90.8 million, including commissions and excise tax. For the six months ended June 30, 2025, cash flow provided by (used in) operating activities was $45.5 million, compared to $(2.8) million in the same period in 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57.0 million for the six months ended June 30, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
During the three and six months ended June 30, 2025, the decrease in SG&A non-personnel expense was primarily as a result of lower overhead, marketing, travel, sponsorship and trade show costs resulting from our strategic restructuring efforts in 2024.