# Aurinia Pharmaceuticals Inc.: Form 10-Q for the period ended Sep 30, 2025

- Company: [Aurinia Pharmaceuticals Inc.](/companies/auph.md) (CIK 1600620)
- Form: 10-Q
- Filed: 2025-11-04
- Accepted by EDGAR: Nov 4, 2025, 06:06 ET
- Period: 2025-09-30
- Accession: 0001600620-25-000106
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1600620/000160062025000106/auph-20250930.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1600620/000160062025000106/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2025-09-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2025-07-01 to 2025-09-30 | $73.5m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 9 months, 2025-01-01 to 2025-09-30 | $205.9m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Cost of revenue | 3 months, 2025-07-01 to 2025-09-30 | $8.2m | us-gaap:CostOfRevenue |
| Cost of revenue | 9 months, 2025-01-01 to 2025-09-30 | $23.9m | us-gaap:CostOfRevenue |
| Research and development | 3 months, 2025-07-01 to 2025-09-30 | $8.4m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months, 2025-01-01 to 2025-09-30 | $21.6m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2025-07-01 to 2025-09-30 | $29.7m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months, 2025-01-01 to 2025-09-30 | $71.7m | us-gaap:OperatingIncomeLoss |
| Interest expense | 3 months, 2025-07-01 to 2025-09-30 | $1.1m | us-gaap:InterestExpenseNonoperating |
| Interest expense | 9 months, 2025-01-01 to 2025-09-30 | $3.3m | us-gaap:InterestExpenseNonoperating |
| Income tax | 3 months, 2025-07-01 to 2025-09-30 | $411.0k | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 9 months, 2025-01-01 to 2025-09-30 | $2.1m | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2025-07-01 to 2025-09-30 | $31.6m | us-gaap:NetIncomeLoss |
| Net income | 9 months, 2025-01-01 to 2025-09-30 | $76.4m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2025-07-01 to 2025-09-30 | $0.23 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 9 months, 2025-01-01 to 2025-09-30 | $0.55 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2025-07-01 to 2025-09-30 | $0.24 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 9 months, 2025-01-01 to 2025-09-30 | $0.57 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2025-07-01 to 2025-09-30 | 136,008,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 9 months, 2025-01-01 to 2025-09-30 | 138,959,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 9 months, 2025-01-01 to 2025-09-30 | $90.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Share repurchases | 9 months, 2025-01-01 to 2025-09-30 | $98.2m | us-gaap:PaymentsForRepurchaseOfCommonStock |
| Cash and equivalents | at 2025-09-30 | $72.9m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2025-09-30 | $438.7m | us-gaap:AssetsCurrent |
| Total assets | at 2025-09-30 | $527.5m | us-gaap:Assets |
| Current liabilities | at 2025-09-30 | $76.2m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2025-09-30 | $161.8m | us-gaap:Liabilities |
| Shareholders' equity | at 2025-09-30 | $365.8m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 18,682 characters.

*You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (the “Quarterly Report”) and our audited financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission on February 27, 2025 (the “Form 10-K”) and with applicable Canadian securities regulatory authorities.*

*This Quarterly Report contains “forward-looking statements” within the meaning of U.S. federal securities laws and "forward-looking information" within the meaning of Canadian securities laws, and such statements may involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this Quarterly Report, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, future expenses, business trends and other information referred to under this section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “anticipate,” “target,” “forecast” or the negative of these terms and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Forward-looking statements are also based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.*

*We discuss a number of risks, uncertainties and other factors in greater detail under the heading “Risk Factors” in Part I, Item 1A of the Form 10-K as well as in Part II, Item 1A of this Quarterly Report. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this filing. You should read this discussion completely and with the understanding that our actual future results may be materially different from what we expect. We hereby qualify our forward-looking statements by our cautionary statements. Except as required by law, we assume no obligation to update our forward-looking statements publicly, or to update the reasons that actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.*

### Overview

#### Background

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. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.

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 two autoimmune diseases by the end of 2025.

#### Net Product Sales

For the three and nine months ended September 30, 2025, net product sales were $70.6 million and $197.2 million, up 27% and 24%, respectively, from $55.5 million and $158.6 million, respectively, for the same periods in 2024.

#### Cash Flows from Operating Activities

For the nine months ended September 30, 2025, cash flows from operating activities were $90.0 million, compared to $14.3 million for the same period of 2024. Excluding $11.6 million of cash payments made in connection with the November 2024 restructuring, cash flows from operating activities were $101.6 million for the nine months ended September 30, 2025.

#### Cash Position

As of September 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $351.8 million compared to $358.5 million at December 31, 2024. For the nine months ended September 30, 2025, the Company repurchased 12.2 million of its common shares for $98.2 million.

### Results of Operations

### Comparison of the Three and Nine Months ended September 30, 2025 and 2024

The following table sets forth our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

| Revenue | Three Months Ended September 30, 2025 | 2024 | Change | Nine Months Ended September 30, 2025 | 2024 | Change |
| --- | ---: | ---: | ---: | ---: | ---: | ---: |
| Net product sales | **$70,627** | $55,503 | $15,124 | **$197,172** | $158,604 | $38,568 |
| License, collaboration and royalty revenue | **2,841** | 12,268 | (9,427) | **8,769** | 16,662 | (7,893) |
| Total revenue | **73,468** | 67,771 | 5,697 | **205,941** | 175,266 | 30,675 |
| Operating expenses |  |  |  |  |  |  |
| Cost of revenue | **8,177** | 6,035 | 2,142 | **23,866** | 22,696 | 1,170 |
| Selling, general and administrative | **26,182** | 42,367 | (16,185) | **72,539** | 134,996 | (62,457) |
| Research and development | **8,435** | 3,047 | 5,388 | **21,610** | 12,678 | 8,932 |
| Restructuring | **—** | — | — | **1,647** | 7,755 | (6,108) |
| Other expense, net | **929** | 4,574 | (3,645) | **14,604** | 159 | 14,445 |
| Total operating expenses | **43,723** | 56,023 | (12,300) | **134,266** | 178,284 | (44,018) |
| Income (loss) from operations | **29,745** | 11,748 | 17,997 | **71,675** | (3,018) | 74,693 |
| Interest income | **3,316** | 4,267 | (951) | **10,075** | 12,982 | (2,907) |
| Interest expense | **(1,099)** | (1,208) | 109 | **(3,283)** | (3,689) | 406 |
| Net income before income taxes | **31,962** | 14,807 | 17,155 | **78,467** | 6,275 | 72,192 |
| Income tax expense | **411** | 457 | (46) | **2,059** | 1,952 | 107 |
| Net income | **$31,551** | $14,350 | $17,201 | **$76,408** | $4,323 | $72,085 |

#### Net Product Sales

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”), in 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.

For the three and nine months ended September 30, 2025, net product sales were $70.6 million and $197.2 million, respectively, compared to $55.5 million and $158.6 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.

#### License, Collaboration and Royalty Revenue

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.

License, collaboration and royalty revenue also consists of revenue from a commercial supply agreement with Otsuka to provide manufacturing and other services, including sharing the capacity of a dedicated manufacturing facility at Lonza Ltd. (the “Monoplant”), Aurinia’s contract manufacturing partner for voclosporin.

For the three and nine months ended September 30, 2025, license, collaboration, and royalty revenue was $2.8 million and $8.8 million, respectively, compared to $12.3 million and $16.7 million, respectively, for the same periods in 2024. The decrease for both periods is primarily due to a $10.0 million one-time milestone that Aurinia recognized as revenue in the third quarter of 2024 for the approval of LUPKYNIS for the treatment of LN by the Japanese Ministry of Health, Labour, and Welfare.

#### Cost of Revenue

Cost of revenue consists primarily of expense associated with: (i) amortization of the finance lease right-of-use asset recognized in connection with the Monoplant; (ii) manufacturing; and (iii) shipping, storage and distribution.

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.

For the three and nine months ended September 30, 2025, cost of revenue was $8.2 million and $23.9 million, respectively, compared to $6.0 million and $22.7 million, respectively, for the same periods in 2024. The increase for the three months ended September 30, 2025 is primarily due to the timing of Aurinia's sales of LUPKYNIS inventory to Otsuka. The increase for the nine months ended September 30, 2025 is primarily due to an increase in Aurinia's net sales of LUPKYNIS in the U.S.

For the three and nine months ended September 30, 2025, gross margin was 89% and 88%, respectively, compared to 91% and 87%, respectively, for the same periods in 2024.

#### Selling, General and Administrative Expense

Selling, general and administrative (“SG&A”) expense consists of personnel and non-personnel expenses to support growing sales of LUPKYNIS. Personnel-related expense includes salaries, incentive pay, benefits and share-based compensation for personnel engaged in sales, finance and administrative functions. Non-personnel-related expense includes: (i) selling, patient services, pharmacovigilance, marketing, advertising, travel, sponsorships and trade shows; and (ii) other general and administrative costs, including consulting, legal, patent, insurance, accounting, information technology and facilities.

The following table summarizes our SG&A expense for the three and nine months ended September 30, 2025 and 2024 (in thousands):

| Personnel expense: | Three Months Ended September 30, 2025 | 2024 | Change | Nine Months Ended September 30, 2025 | 2024 | Change |
| --- | ---: | ---: | ---: | ---: | ---: | ---: |
| Salaries, incentive pay and benefits | **$10,449** | $17,563 | $(7,114) | **$32,593** | $57,493 | $(24,900) |
| Share-based compensation | **5,387** | 7,812 | (2,425) | **6,751** | 23,427 | (16,676) |
| Total personnel expense | **15,836** | 25,375 | (9,539) | **39,344** | 80,920 | (41,576) |
| Non-personnel expense: |  |  |  |  |  |  |
| Professional fees and services | **6,445** | 7,504 | (1,059) | **19,587** | 26,745 | (7,158) |
| Travel, sponsorship and trade shows | **1,012** | 2,282 | (1,270) | **3,729** | 7,124 | (3,395) |
| Marketing and advertising | **605** | 4,505 | (3,900) | **2,423** | 12,009 | (9,586) |
| Other | **2,284** | 2,701 | (417) | **7,456** | 8,198 | (742) |
| Total non-personnel expense | **10,346** | 16,992 | (6,646) | **33,195** | 54,076 | (20,881) |
| Total SG&A expense | **$26,182** | $42,367 | $(16,185) | **$72,539** | $134,996 | $(62,457) |

For the three and nine months ended September 30, 2025, the decrease in SG&A personnel expense was primarily due to lower employee-related costs resulting from our strategic restructuring efforts in 2024.

For the three and nine months ended September 30, 2025, the decrease in SG&A non-personnel expense was primarily due to lower marketing, professional fees and services and other overhead resulting from our strategic restructuring efforts in 2024.

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.

#### Research and Development Expense

Research and development (“R&D”) expense consists of personnel and non-personnel expenses. Personnel-related expense includes salaries, incentive pay, benefits and share-based compensation for personnel engaged in research and development functions. Non-personnel-related expense includes subcontractors and materials used for R&D activities, including development, clinical trials, clinical supply and distribution, and other professional services.

The following table summarizes our R&D expense for the three and nine months ended September 30, 2025 and 2024 (in thousands):

| Personnel expense: | Three months ended September 30, 2025 | 2024 | Change | Nine Months Ended September 30, 2025 | 2024 | Change |
| --- | ---: | ---: | ---: | ---: | ---: | ---: |
| Salaries, incentive pay and benefits | **$2,630** | $900 | $1,730 | **$5,314** | $5,240 | $74 |
| Share-based compensation | **327** | 306 | 21 | **755** | (1,773) | 2,528 |
| Total personnel expense | **2,957** | 1,206 | 1,751 | **6,069** | 3,467 | 2,602 |
| Non-personnel expense: |  |  |  |  |  |  |
| Clinical supply and distribution | **2,267** | 354 | 1,913 | **7,277** | 2,353 | 4,924 |
| Contract research organizations and developmental expenses | **3,134** | 1,380 | 1,754 | **8,005** | 6,486 | 1,519 |
| Other | **77** | 107 | (30) | **259** | 372 | (113) |
| Total non-personnel expense | **5,478** | 1,841 | 3,637 | **15,541** | 9,211 | 6,330 |
| Total R&D expense | **$8,435** | $3,047 | $5,388 | **$21,610** | $12,678 | $8,932 |

For the three months ended September 30, 2025, the increase in R&D personnel-expense was primarily due to an increase in employee-related costs to support development activities. During the nine months ended September 30, 2025, the increase in R&D personnel expense was primarily due to an increase in share-based compensation due to a reversal in the prior year of non-cash, share-based compensation expense in the first quarter of 2024 related to forfeited, unvested equity awards from our strategic restructuring efforts in February 2024.

For the three and nine months ended September 30, 2025, the increase in R&D non-personnel expense was primarily as a result of development activities.

We expect our R&D expenses to increase for the foreseeable future as we continue our development activities.

#### Restructuring Expense

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. In February 2024, we announced a strategic restructuring that reduced headcount by approximately 25% and discontinued Aurinia’s AUR300 development program. In November 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.

For the three and nine months ended September 30, 2025, restructuring expense was nil and $1.6 million, respectively compared to nil and $7.8 million, respectively for the same periods in 2024.

#### Other Expense, Net

For the three and nine months ended September 30, 2025, other expense, net was $0.9 million and $14.6 million, respectively, compared to $4.6 million and $0.2 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.

### Liquidity and Capital Resources

As of September 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $351.8 million compared to $358.5 million at December 31, 2024. For the nine months ended September 30, 2025, the Company repurchased $12.2 million of its common shares for $98.2 million, including commissions. For the nine months ended September 30, 2025, cash flows from operating activities were $90.0 million, compared to $14.3 million for the same period in 2024. Excluding $11.6 million of cash payments made in connection with the November 2024 restructuring, cash flows from operating activities were $101.6 million for the nine months ended September 30, 2025.

Based on our current operating plans and projections, the Company expects to fund future operations with existing cash on hand or future cash flows from operating activities.

The amount and timing of additional future funding needs, if any, will depend on many factors, including the success of our commercialization efforts for LUPKYNIS and our ability to control expenses. If necessary, we intend to raise additional capital through equity or debt financings. We can provide no assurance that additional financing will be available to us on favorable terms, or at all.

### Critical Accounting Estimates

There have been no material changes to our critical accounting policies and significant judgments and estimates as described in our Annual Report on Form 10-K for the year ended December 31, 2024.

### Off‑Balance Sheet Arrangements

During the periods presented, we did not have, nor do we currently have, any off‑balance sheet arrangements as such term is defined in Item 303(a)(4)(ii) of Regulation S-K under the Securities Act.

### Contractual Obligations

There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024.

## Market risk

As filed, 187 characters.

There have been no material changes to our quantitative and qualitative disclosures about market risks as described in our Annual Report on Form 10-K for the year ended December 31, 2024.

## Controls and procedures

As filed, 1,201 characters.

### Evaluation of Disclosure Controls and Procedures

Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of September 30, 2025, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

### Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the most recent quarter that has materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

## Risk factors

As filed, 2,715 characters.

Under Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024, we identified important factors that could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Quarterly Report. There has been no material change in our risk factors subsequent to the filing of our prior reports referenced above, other than as set out below. However, the risks described in our reports are not the only risks we face. Additional risks and uncertainties that we currently deem to be immaterial or not currently known to us, as well as other risks reported from time to time in our reports to the SEC, also could cause our actual results to differ materially from our anticipated results or other expectations.

***Changes or developments in U.S. economic laws or policies, including the reaction of other countries thereto, may have a material adverse effect on our business***

The U.S. federal government has announced that it has commenced a national security investigation of imports of “pharmaceuticals and pharmaceutical ingredients.” Depending on the findings of its investigation, the U.S. federal government could implement additional measures against the import of pharmaceuticals and pharmaceutical ingredients. The degree and extent of those measures or other measures the U.S. federal government could implement (such as pricing restrictions, tariffs or other trade restrictions or deterrents on foreign companies doing business outside of the U.S.) are unknown. Aurinia is an Alberta, Canada incorporated company, and we manufacture and import certain products in our supply chain into the U.S. primarily from Switzerland. If implemented, and depending on the degree and extent (including how directly they relate to our operations) of any changes or developments in U.S. economic laws or policies, additional measures against “pharmaceuticals and pharmaceutical ingredients” could have a material adverse effect on Aurinia’s business.

In addition, we sell encapsulated voclosporin to our collaboration partner, Otsuka, which Otsuka then sells to customers in its territories. Certain international governments have responded to other recent related economic policies announced by the U.S. with retaliatory action. If a government in one of the Otsuka Territories implemented a retaliatory action, such as a tariff, on the import of pharmaceutical products from the U.S., this could have a material adverse effect on Otsuka's voclosporin business which, in turn, could have a material adverse effect on our business.

Filed Nov 4, 2025.
Source: SEC EDGAR, the filing index for accession 0001600620-25-000106. Last ingested by Listed: Oct 30, 2026, 08:08 ET. No prices; not investment advice.