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    Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2024 Financial and Operational Results, Announces Strategic Restructuring to Sharpen Focus on Continued LUPKYNIS® Growth and AUR200 Development

    11/7/24 6:00:00 AM ET
    $AUPH
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $AUPH alert in real time by email
    • Achieved $67.8 million in total net revenue and $55.5 million in net product revenue for the third quarter of 2024, representing year-over-year growth of 24% and 36%, respectively
    • Generated $17.0 million in cash flow from operations in the third quarter and had cash, cash equivalents, restricted cash, and investments of $348.7 million as of September 30, 2024
    • Anticipates a one-time restructuring charge in the fourth quarter of 2024 of $15 to $19 million and estimates post-restructuring annualized cash-based operating expense savings of more than $40 million
    • Reiterates 2024 net product revenue guidance range of $210 to $220 million for fiscal year 2024

    Webcast and conference call to be hosted today at 8:30 a.m. ET

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company) today issued its financial results for the third quarter and nine months ended September 30, 2024. With continued strong commercial execution, the Company achieved significant year-over-year growth in total net revenue and net product revenue and $17.0 million in cash flow from operations in the third quarter. Having achieved $158.6 million in net product revenue for the nine months ended September 30, 2024, the Company is reiterating its net product revenue guidance range of $210 to $220 million for fiscal year 2024.

    Aurinia is implementing a strategic restructuring to sharpen the Company's focus on continued LUPKYNIS® growth and the rapid development of AUR200. This restructuring will result in a workforce reduction of approximately 45% and will focus the Company's LUPKYNIS commercial strategy on the highest growth drivers. The restructuring will also improve operational efficiency, with anticipated post-restructuring annualized cash-based operating expense savings of more than $40 million.

    "We are pleased to report continued strong momentum through the first nine months of the year," stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Going forward, our streamlined organization will enable us to lean further into key areas of the commercial LUPKYNIS business that have historically delivered optimal returns, while at the same time accelerating the development of our important pipeline product, AUR200."

    In the third quarter of 2024, the Company added 364 PSFs and 146 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy. Together, these total 510, which is 17% higher than the 436 PSFs in the third quarter of 2023. Conversion rates (PSFs converted to patients on therapy), time to conversion, and adherence rates remained consistent with the prior quarter.

    Recent Milestones Achieved

    • In September 2024, the first participant was dosed in a Phase 1 study of AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). The Company continues to expect to report initial results from this study in the first half of 2025.
    • In September 2024, the Japanese Ministry of Health, Labour, and Welfare approved LUPKYNIS, triggering the recognition of an additional $10 million milestone payment from Aurinia's collaboration partner, Otsuka Pharmaceutical Co., Ltd.

    Financial Results for the Three and Nine Months Ended September 30, 2024

    Total net revenue was $67.8 million for the three months ended September 30, 2024, and $54.5 million for the same period in 2023, representing growth of 24%. Year to date total net revenue was $175.3 million for the nine months ended September 30, 2024, compared to $130.4 million for the same period in 2023, representing growth of 34%.

    Net product revenue was $55.5 million for the three months ended September 30, 2024, and $40.8 million for the same period in 2023, representing growth of 36%. Net product revenue was $158.6 million for the nine months ended September 30, 2024, and $116.2 million for the same period in 2023, representing growth of 36%. The increase in both periods is primarily due to increased LUPKYNIS sales to the Company's two main specialty pharmacies, driven predominantly by further penetration of the lupus nephritis (LN) market. Additionally, for the nine months ended September 30, 2024, Aurinia had sales of semi-finished product to Otsuka to support continued commercialization in its territories.

    U.S. market penetration grew 25% year-over-year, with 2,422 patients on LUPKYNIS therapy as of September 30, 2024, compared to 1,939 as of September 30, 2023.

    License, collaboration, and royalty revenues were $12.3 million and $13.7 million for the three months ended September 30, 2024, and September 30, 2023, respectively, and $16.7 million and $14.2 million for the nine months ended September 30, 2024, and September 30, 2023, respectively. The revenue is primarily due to a $10.0 million milestone recognized in the third quarter of 2024 for the Japanese Ministry of Health, Labour, and Welfare approval of LUPKYNIS and a $10.0 million milestone recognized in the third quarter of 2023 for pricing and reimbursement approval, coupled with manufacturing services revenue from Otsuka related to shared capacity services that commenced in late June 2023.

    Cost of sales were $6.0 million and $6.8 million for the three months ended September 30, 2024, and September 30, 2023, respectively, and $22.7 million and $8.8 million for the nine months ended September 30, 2024, and September 30, 2023, respectively. The increase for the nine months ended September 30, 2024, is primarily due to the amortization of the monoplant finance right of use asset, which was placed into service in late June 2023 and therefore only partially impacted prior year results.

    Gross margin was 91% and 88% for the three months ended September 30, 2024, and September 30, 2023, respectively, and 87% and 93% for the nine months ended September 30, 2024, and September 30, 2023, respectively.

    SG&A expenses, inclusive of share-based compensation, were $42.4 million and $47.8 million for the three months ended September 30, 2024, and September 30, 2023, respectively, and $135.0 million and $145.0 million for the nine months ended September 30, 2024, and September 30, 2023, respectively. The decrease in both periods is primarily due to lower employee related costs, including share-based compensation and overhead costs, as a result of a reduction in general and administrative headcount, which occurred late in the first quarter of 2024.

    R&D expenses, inclusive of share-based compensation expense, were $3.0 million and $13.6 million for the three months ended September 30, 2024, and September 30, 2023, respectively, and $12.7 million and $39.4 million for the nine months ended September 30, 2024, and September 30, 2023, respectively. The primary drivers in both periods were lower employee costs due to a reduction in headcount late in the first quarter of 2024, a decrease of expenses related to ceasing Aurinia's AUR300 development program, and timing of expenses related to developing AUR200.

    Restructuring expenses were nil and $7.8 million for the three and nine months ended September 30, 2024, and nil for the three and nine months ended September 30, 2023. Restructuring expenses primarily included employee severance, one-time benefit payments, and contract termination expenses related to the restructuring, which occurred late in the first quarter of 2024.

    For the three months ended September 30, 2024, Aurinia recorded net income of $14.4 million or $0.10 net income per common share, as compared to a net loss of $(13.4) million or $(0.09) net loss per common share for the three months ended September 30, 2023. For the nine months ended September 30, 2024, Aurinia recorded a net income of $4.3 million or $0.03 net income per common share, as compared to a net loss of $(51.1) million or $(0.36) net loss per common share for the nine months ended September 30, 2023.

    Financial Liquidity at September 30, 2024

    As of September 30, 2024, Aurinia had cash, cash equivalents, restricted cash, and investments of $348.7 million, compared to $350.7 million at December 31, 2023.

    Cash flow from operations was $17.0 million for the three months ended September 30, 2024, compared to $(13.3) million for the three months ended September 30, 2023. Cash flow from operations was $14.3 million for the nine months ended September 30, 2024, compared to $(47.8) million for the nine months ended September 30, 2023.

    All amounts in this press release are expressed in U.S. dollars. This press release is intended to be read in conjunction with the Company's unaudited condensed consolidated financial statements and Management's Discussion and Analysis for the quarter and nine months ended September 30, 2024, in the Company's Quarterly Report on Form 10-Q and the Company's Annual Report on Form 10-K for the year ended December 31, 2023, including risk factors disclosed therein, which will be accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedarplus.ca or on EDGAR at www.sec.gov/edgar.

    Webcast & Conference Call Details

    The link to the audio webcast is available here. To join the conference call, please dial (800) 715-9871 / +1 (646) 307-1963. Conference ID: 6251719 or company name required for entry. A replay of the webcast will be available on Aurinia's website.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated 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 dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's anticipation of a one-time restructuring charge in the fourth quarter of 2024 of $15 to $19 million, with post-restructuring annualized cash-based operating expense savings of more than $40 million; Aurinia's estimates as to annual net product revenue from sales of LUPKYNIS in the range of $210 to $220 million in fiscal year 2024; Aurinia's estimate that it will reduce its workforce by approximately 45%; and Aurinia's expectation that its restructuring will further improve operational efficiency. It is possible that such results or conclusions may change. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. The Company has made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; the expected number of patient start forms, patients restarting therapy, and hospital fills, conversion rates and time to convert for patients; pricing for LUPKYNIS and patient persistency on the product; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; the clinical development opportunities for its pipeline products; Aurinia's assumptions relating to the capital required to fund operations; the timing and ability to execute on Aurinia's restructuring plans; the costs, benefits and scope of Aurinia's restructuring plans; that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; and that Aurinia's third party service providers will comply with their contractual obligations.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia's actual future financial and operational results may differ from its expectations; difficulties Aurinia may experience in completing the commercialization of LUPKYNIS; difficulties Aurinia may experience executing its restructuring program; challenges in the conduct of clinical studies; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for LUPKYNIS in a timely fashion; unknown impact and difficulties imposed by the widespread health concerns on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia's website at www.auriniapharma.com.

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

    (unaudited)

     

    September 30,

    2024

     

    December 31,

    2023

    ASSETS

     

     

     

     

    Current assets

     

     

     

     

    Cash, cash equivalents, and restricted cash

     

    $

    37,142

     

     

    $

    48,875

     

    Short-term investments

     

     

    311,605

     

     

     

    301,614

     

    Accounts receivable, net

     

     

    36,483

     

     

     

    24,089

     

    Inventories, net

     

     

    38,714

     

     

     

    39,705

     

    Prepaid expenses and deposits

     

     

    13,815

     

     

     

    9,486

     

    Other current assets

     

     

    2,700

     

     

     

    1,031

     

    Total current assets

     

     

    440,459

     

     

     

    424,800

     

     

     

     

     

     

    Non-current assets

     

     

     

     

    Long-term investments

     

     

    —

     

     

     

    201

     

    Other non-current assets

     

     

    868

     

     

     

    1,517

     

    Property and equipment, net

     

     

    2,887

     

     

     

    3,354

     

    Acquired intellectual property and other intangible assets, net

     

     

    4,509

     

     

     

    4,977

     

    Finance right-of-use assets, net

     

     

    96,459

     

     

     

    108,715

     

    Operating right-of-use assets, net

     

     

    4,179

     

     

     

    4,498

     

    Total assets

     

    $

    549,361

     

     

    $

    548,062

     

     

     

     

     

     

    LIABILITIES

     

     

     

     

    Current liabilities

     

     

     

     

    Accounts payable and accrued liabilities

     

     

    56,770

     

     

     

    54,389

     

    Deferred revenue

     

     

    4,304

     

     

     

    4,813

     

    Other current liabilities

     

     

    1,590

     

     

     

    2,388

     

    Finance lease liabilities

     

     

    14,927

     

     

     

    14,609

     

    Operating lease liabilities

     

     

    1,018

     

     

     

    989

     

    Total current liabilities

     

     

    78,609

     

     

     

    77,188

     

     

     

     

     

     

    Non-current liabilities

     

     

     

     

    Finance lease liabilities

     

     

    65,955

     

     

     

    75,479

     

    Operating lease liabilities

     

     

    5,951

     

     

     

    6,530

     

    Deferred compensation and other non-current liabilities

     

     

    10,844

     

     

     

    10,911

     

    Total liabilities

     

     

    161,359

     

     

     

    170,108

     

    SHAREHOLDER'S EQUITY

     

     

     

     

    Common shares - no par value, unlimited shares authorized, 143,109 and 143,833 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

     

     

    1,206,613

     

     

     

    1,200,218

     

    Additional paid-in capital

     

     

    119,773

     

     

     

    120,788

     

    Accumulated other comprehensive loss

     

     

    (385

    )

     

     

    (730

    )

    Accumulated deficit

     

     

    (937,999

    )

     

     

    (942,322

    )

    Total shareholders' equity

     

     

    388,002

     

     

     

    377,954

     

    Total liabilities and shareholders' equity

     

    $

    549,361

     

     

    $

    548,062

     

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share data)

     

     

     

    Three months ended

     

    Nine months ended

     

     

    September 30,

     

    September 30,

     

     

     

    2024

     

     

     

    2023

     

     

     

    2024

     

     

     

    2023

     

     

     

    (unaudited)

    Revenue

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    55,503

     

     

    $

    40,781

     

     

    $

    158,604

     

     

    $

    116,218

     

    License, collaboration, and royalty revenue

     

     

    12,268

     

     

     

    13,734

     

     

     

    16,662

     

     

     

    14,200

     

    Total revenue, net

     

     

    67,771

     

     

     

    54,515

     

     

     

    175,266

     

     

     

    130,418

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of sales

     

     

    6,035

     

     

     

    6,769

     

     

     

    22,696

     

     

     

    8,753

     

    Selling, general and administrative

     

     

    42,367

     

     

     

    47,759

     

     

     

    134,996

     

     

     

    144,964

     

    Research and development

     

     

    3,047

     

     

     

    13,605

     

     

     

    12,678

     

     

     

    39,413

     

    Restructuring expenses

     

     

    —

     

     

     

    —

     

     

     

    7,755

     

     

     

    —

     

    Other expense (income), net

     

     

    4,574

     

     

     

    2,645

     

     

     

    159

     

     

     

    (695

    )

    Total cost of sales and operating expenses

     

     

    56,023

     

     

     

    70,778

     

     

     

    178,284

     

     

     

    192,435

     

    Income (Loss) from operations

     

     

    11,748

     

     

     

    (16,263

    )

     

     

    (3,018

    )

     

     

    (62,017

    )

    Interest expense

     

     

    (1,208

    )

     

     

    (1,400

    )

     

     

    (3,689

    )

     

     

    (1,465

    )

    Interest income

     

     

    4,267

     

     

     

    4,514

     

     

     

    12,982

     

     

     

    12,429

     

    Net income (loss) before income taxes

     

     

    14,807

     

     

     

    (13,149

    )

     

     

    6,275

     

     

     

    (51,053

    )

    Income tax expense

     

     

    457

     

     

     

    298

     

     

     

    1,952

     

     

     

    92

     

    Net income (loss)

     

    $

    14,350

     

     

    $

    (13,447

    )

     

    $

    4,323

     

     

    $

    (51,145

    )

     

     

     

     

     

     

     

     

     

    Net income (loss) per share:

     

     

     

     

     

     

     

     

    Basic

     

    $

    0.10

     

     

    $

    (0.09

    )

     

    $

    0.03

     

     

    $

    (0.36

    )

    Diluted

     

    $

    0.10

     

     

    $

    (0.09

    )

     

    $

    0.03

     

     

    $

    (0.36

    )

     

     

     

     

     

     

     

     

     

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

     

    Basic

     

     

    143,051

     

     

     

    142,847

     

     

     

    143,353

     

     

     

    143,085

     

    Diluted

     

     

    145,651

     

     

     

    142,847

     

     

     

    145,010

     

     

     

    143,085

     

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

     

     

     

    Nine Months Ended

    September 30,

     

     

     

    2024

     

     

     

    2023

     

    (in thousands)

     

    (unaudited)

    Cash flows from operating activities

     

     

     

     

    Net income (loss)

     

    $

    4,323

     

     

    $

    (51,145

    )

    Adjustments to reconcile net loss to net cash used in operating activities

     

     

     

     

    Depreciation and amortization

     

     

    14,583

     

     

     

    6,698

     

    Net amortization of premiums and discounts on short-term investments

     

     

    (9,752

    )

     

     

    (8,836

    )

    Share-based compensation expense

     

     

    22,650

     

     

     

    33,543

     

    Foreign exchange on finance lease liability

     

     

    (718

    )

     

     

    (1,335

    )

    Other, net

     

     

    220

     

     

     

    (1,659

    )

    Net changes in operating assets and liabilities

     

     

     

     

    Accounts receivable, net

     

     

    (12,394

    )

     

     

    (24,463

    )

    Inventories, net

     

     

    991

     

     

     

    (8,984

    )

    Prepaid expenses and other current assets

     

     

    (6,001

    )

     

     

    (2,889

    )

    Non-current operating assets

     

     

    (12

    )

     

     

    (16

    )

    Accounts payable, accrued and other liabilities

     

     

    934

     

     

     

    11,812

     

    Operating lease liabilities

     

     

    (550

    )

     

     

    (499

    )

    Net cash provided by (used in) operating activities

     

     

    14,274

     

     

     

    (47,773

    )

    Cash flows from investing activities

     

     

     

     

    Purchase of investments

     

     

    (461,140

    )

     

     

    (379,213

    )

    Proceeds from investments

     

     

    461,448

     

     

     

    391,287

     

    Upfront lease payment

     

     

    (44

    )

     

     

    (11,864

    )

    Purchase of property and equipment

     

     

    —

     

     

     

    (419

    )

    Capitalized patent costs

     

     

    (225

    )

     

     

    (240

    )

    Net cash provided by (used in) investing activities

     

     

    39

     

     

     

    (449

    )

    Cash flows from financing activities

     

     

     

     

    Repurchase of common shares

     

     

    (18,435

    )

     

     

    —

     

    Principal portion of finance lease payments

     

     

    (8,959

    )

     

     

    (3,482

    )

    Proceeds from exercise of stock options and employee share purchase plan

     

     

    1,348

     

     

     

    3,929

     

    Cash (used in) provided by financing activities

     

     

    (26,046

    )

     

     

    447

     

    Net decrease in cash, cash equivalents, and restricted cash

     

     

    (11,733

    )

     

     

    (47,775

    )

    Cash, cash equivalents, and restricted cash, beginning of period

     

     

    48,875

     

     

     

    94,172

     

    Cash, cash equivalents, and restricted cash, end of period

     

    $

    37,142

     

     

    $

    46,397

     

     

     

     

     

     

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    Recent Analyst Ratings for
    $AUPH

    DatePrice TargetRatingAnalyst
    11/4/2022Outperform → Perform
    Oppenheimer
    5/5/2022$34.00 → $25.00Overweight
    Cantor Fitzgerald
    3/8/2022$30.00 → $22.00Outperform
    SVB Leerink
    3/1/2022$31.00 → $27.00Outperform
    RBC Capital
    2/23/2022$34.00 → $31.00Outperform
    RBC Capital
    12/10/2021$33.00 → $31.00Perform → Outperform
    Oppenheimer
    11/4/2021$32.00 → $33.00Perform
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    11/4/2021$35.00 → $40.00Buy
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    • New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis

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    • Amendment: SEC Form SC 13G/A filed by Aurinia Pharmaceuticals Inc

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    • SEC Form SC 13D filed by Aurinia Pharmaceuticals Inc

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    • Aurinia Pharma downgraded by Oppenheimer

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      11/4/22 7:15:31 AM ET
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    • Cantor Fitzgerald resumed coverage on Aurinia Pharma with a new price target

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    • SEC Form S-8 filed by Aurinia Pharmaceuticals Inc

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    • Aurinia Pharmaceuticals Inc filed SEC Form 8-K: Leadership Update, Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Submission of Matters to a Vote of Security Holders, Financial Statements and Exhibits

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    • SEC Form 10-Q filed by Aurinia Pharmaceuticals Inc

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    • SEC Form 4 filed by Director Nova Tina Susan

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    • Director Tang Kevin bought $12,713,126 worth of shares (1,600,000 units at $7.95) (SEC Form 4)

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    • Director Tang Kevin bought $10,822,000 worth of shares (1,200,000 units at $9.02) (SEC Form 4)

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    • Aurinia Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025

      Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) today announced financial results for the three months ended March 31, 2025. First Quarter 2025 Financial Results Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024. License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty

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    • Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025

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      2/27/25 6:00:00 AM ET
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