Aurinia Pharmaceuticals(AUPH)

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Aurinia Discloses 2023 Year-End Financial and Operational Results, Announces Corporate Actions Focused on Enhancing Shareholder Value
Businesswire· 2024-02-15 11:00
ROCKVILLE, Maryland & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today provided an update on its 2023 fourth quarter and full year business performance, as well as a corporate update regarding the Company’s strategic review. This includes corporate actions designed to enhance shareholder value, including an exclusive focus on driving commercial execution of the LUPKYNIS® (voclosporin) business, and a significant share repurchase program. Effecti ...
Aurinia Pharmaceuticals(AUPH) - 2023 Q4 - Annual Report
2024-02-14 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________ Form 10-K ___________________________________________________________________________________ ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______ ...
Aurinia Pharmaceuticals (AUPH) Expected to Beat Earnings Estimates: What to Know Ahead of Q4 Release
Zacks Investment Research· 2024-02-08 16:05
Wall Street expects flat earnings compared to the year-ago quarter on higher revenues when Aurinia Pharmaceuticals (AUPH) reports results for the quarter ended December 2023. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on February 15, 2024, might help the stock move higher if these key nu ...
Kane Biotech Announces Special Meeting of Shareholders
Newsfilter· 2024-01-18 21:30
Company Overview - Kane Biotech Inc. is a biotechnology company focused on the research, development, and commercialization of technologies and products aimed at preventing and removing microbial biofilms [3] - The company holds a portfolio of 80 patents and patents pending, along with trade secrets and trademarks [3] - Kane Biotech's product offerings include StrixNB™, DispersinB®, Aledex™, and several others [3] Leadership Update - A special meeting of shareholders is scheduled for February 20, 2024, to consider the election of Dr. Robert Huizinga as an additional director [1] - Dr. Huizinga has extensive experience in the pharmaceutical industry, having previously served as Executive Vice-President of Aurinia Pharmaceuticals Inc., where he led the clinical development of voclosporin, achieving first-year sales of $100 million USD [2] - He has been a member of Kane Biotech's Scientific Advisory Board since 2018 [2]
Aurinia Pharmaceuticals(AUPH) - 2023 Q3 - Earnings Call Transcript
2023-11-02 16:06
Financial Data and Key Metrics Changes - Aurinia achieved $40.8 million in LUPKYNIS net product revenue for Q3 2023, a 60% increase compared to Q3 2022 [6] - Year-to-date LUPKYNIS net product revenue reached $116.2 million, representing a 55% increase year-over-year [6] - Total revenue for Q3 2023 was $154.5 million, including a $10 million milestone from Otsuka Pharmaceuticals [7] - The company narrowed its 2023 net product revenue guidance from $150 million to $160 million to a new range of $155 million to $160 million [6] Business Line Data and Key Metrics Changes - Patient start forms (PSFs) totaled 436 in Q3 2023, a 17% increase from the prior year's third quarter [7] - Approximately 90% of patients with a submitted PSF received actual treatment, with 65% starting therapy within 20 days [8] - The 12-month persistency rate for patients on therapy is around 54%, with 15-month persistency at about 48% and 18-month persistency at 43% [8] Market Data and Key Metrics Changes - The company reported approximately 4,000 patients treated with LUPKYNIS since its launch [8] - Aurinia's strategy focuses on educating healthcare providers and patients to increase screening and treatment for lupus nephritis [9][10] Company Strategy and Development Direction - Aurinia aims to activate three main levers for growth: educating healthcare providers, activating patient advocacy, and clinically differentiating LUPKYNIS [9] - The company is leveraging data from the AURORA trial and the AURORA II extension study to promote LUPKYNIS [9][16] - Aurinia is actively working with Otsuka to expand LUPKYNIS's market presence outside the U.S., having secured approvals in several European countries [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong results and momentum in the first three quarters of 2023 [33] - The company is focused on delivering LUPKYNIS to patients and driving results in key global markets [33] - Management is committed to a strategic review process to explore options for enhancing shareholder value [21] Other Important Information - As of September 30, 2023, Aurinia had cash and investments totaling $338.5 million, down from $389.4 million at the end of 2022 [22] - The company recorded a net loss of $13.4 million for Q3 2023, compared to a net loss of $9 million in Q3 2022 [31] Q&A Session Summary Question: Feedback from prescribers on patient persistency - Management noted encouraging feedback regarding persistency rates and emphasized the importance of maintaining therapy to control the inflammatory process [37] Question: Trends in diagnosis rates - Management indicated that qualitative data suggests an increase in diagnosis rates, but quantitative data is not yet available [39] Question: Higher cost of goods sold (COGS) - Management explained that the increase in COGS was due to full absorption of the model plant facility, which is partially reimbursed by Otsuka [41] Question: New guidance rationale - Management tightened the revenue guidance range conservatively based on new patient starts and historical performance [44] Question: Trends in prescribers - Management reported double-digit increases in both volume of prescribing and the number of prescribers [46] Question: Expectations for 2024 - Management plans to provide guidance for 2024 around the time of the JPMorgan conference, maintaining consistency with previous years [49] Question: Impact of EULAR guidelines - Management expressed hope that upcoming KDIGO and ACR guidelines will align with EULAR guidelines, promoting aggressive use of novel therapies [63] Question: Discontinuation rates - Management clarified that higher discontinuation rates were due to a mix of patients who had been on therapy longer, not seasonal factors [66] Question: Changes in prescriber trends - Management noted improvements in the percentage of repeat prescribers, indicating a positive trend in prescribing behavior [69]
Aurinia Pharmaceuticals(AUPH) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements and management's analysis of its financial condition and results [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of shareholders' equity, and statements of cash flows, along with detailed notes explaining the company's accounting policies, financial instruments, and specific asset/liability components [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's financial position, including assets, liabilities, and equity **Condensed Consolidated Balance Sheets (in thousands):** | Metric | September 30, 2023 | December 31, 2022 | | :------------------------------------- | :------------------- | :------------------ | | Total Assets | $555,013 | $470,860 | | Total Liabilities | $163,136 | $65,425 | | Total Shareholders' Equity | $391,877 | $405,435 | | Cash, cash equivalents and restricted cash | $46,397 | $94,172 | | Accounts receivable, net | $37,946 | $13,483 | | Inventories, net | $32,820 | $24,752 | | Finance right-of-use asset, net | $113,069 | — | | Current Finance lease liability | $13,328 | — | | Non-current Finance lease liability | $72,193 | — | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance, detailing revenue, expenses, and net loss **Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands):** | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total Revenue, Net | $54,515 | $55,779 | $130,418 | $105,595 | | Product Revenue, Net | $40,781 | $25,502 | $116,218 | $75,142 | | License, Royalty and Collaboration Revenue | $13,734 | $30,277 | $14,200 | $30,453 | | Loss from operations | $(16,263) | $(9,499) | $(62,017) | $(83,370) | | Net Loss | $(13,447) | $(8,989) | $(51,145) | $(82,134) | | Basic and diluted loss per share | $(0.09) | $(0.06) | $(0.36) | $(0.58) | [Condensed Consolidated Statements of Shareholders' Equity (Three Months Ended September 30, 2023 and September 30, 2022)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(three%20months)) This section details changes in shareholders' equity for the three-month periods, including net loss and share-based compensation **Shareholders' Equity (in thousands) - Three Months Ended September 30:** | Metric | September 30, 2023 | September 30, 2022 | | :--------------------------- | :------------------- | :------------------- | | Total Shareholders' Equity | $391,877 | $423,425 | | Net Loss | $(13,447) | $(8,989) | | Share-based compensation | $11,808 | $8,320 | [Condensed Consolidated Statements of Shareholders' Equity (Nine Months Ended September 30, 2023 and September 30, 2022)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(nine%20months)) This section details changes in shareholders' equity for the nine-month periods, including net loss and share-based compensation **Shareholders' Equity (in thousands) - Nine Months Ended September 30:** | Metric | September 30, 2023 | September 30, 2022 | | :--------------------------- | :------------------- | :------------------- | | Total Shareholders' Equity | $391,877 | $423,425 | | Net Loss | $(51,145) | $(82,134) | | Share-based compensation | $33,543 | $25,398 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash flows from operating, investing, and financing activities over specific periods **Condensed Consolidated Statements of Cash Flows (in thousands) - Nine Months Ended September 30:** | Metric | 2023 | 2022 | | :-------------------------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(47,773) | $(89,979) | | Net cash provided by (used in) investing activities | $(449) | $(57,614) | | Cash provided by financing activities | $447 | $1,745 | | Net decrease in cash, cash equivalents and restricted cash | $(47,775) | $(145,848) | | Cash, cash equivalents and restricted cash, end of period | $46,397 | $86,052 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements [1. Organization and Description of Business](index=8&type=section&id=1.%20Organization%20and%20Description%20of%20Business) This note describes the company's core business, key product, and development pipeline - Aurinia Pharmaceuticals Inc. is a biopharmaceutical company focused on autoimmune, kidney, and rare diseases[20](index=20&type=chunk) - LUPKYNIS® (voclosporin), the first U.S. FDA-approved oral therapy for active lupus nephritis (LN), was introduced in January 2021[20](index=20&type=chunk) - The company collaborates with Otsuka Pharmaceutical Co., Ltd. for LUPKYNIS® development and commercialization in the EU, Japan, and other territories[20](index=20&type=chunk) - Novel assets AUR200 and AUR300 are in pre-clinical development, with projected FDA submissions in 2023 and 2024, respectively[20](index=20&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and policies for financial statement preparation - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[22](index=22&type=chunk) - The company believes it has sufficient resources (**$338.5 million** in cash, cash equivalents, restricted cash, and investments as of September 30, 2023) to fund operations for at least the next few years[26](index=26&type=chunk) - Major customers include two main U.S. commercial sales customers for LUPKYNIS® and Otsuka for collaboration revenue[26](index=26&type=chunk) **Percentage of Total Revenues, Net from Main Customers:** | Revenue Type | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Product revenue, net | 77% | 48% | 90% | 74% | | License, royalty and collaboration revenue | 21% | 52% | 9% | 26% | [3. Fair Value Measurements](index=10&type=section&id=3.%20Fair%20Value%20Measurements) This note details valuation methodologies and inputs for financial assets measured at fair value **Financial Assets Measured at Fair Value (in thousands):** | Category | September 30, 2023 | December 31, 2022 | | :------------------------------------- | :------------------- | :------------------ | | Total financial assets | $338,491 | $389,390 | | Level 1 (Cash, cash equivalents and restricted cash) | $46,397 | $94,172 | | Level 2 (Corporate bonds, Commercial paper, Treasury bills/bonds) | $292,094 | $295,218 | - No credit loss allowance was recorded as of September 30, 2023, or December 31, 2022, as unrealized losses are considered temporary[41](index=41&type=chunk) [4. Cash, Cash Equivalents, Restricted Cash and Investments](index=12&type=section&id=4.%20Cash%2C%20Cash%20Equivalents%2C%20Restricted%20Cash%20and%20Investments) This note provides a breakdown of the company's liquid assets and investment portfolio **Cash, Cash Equivalents, Restricted Cash and Investments (in thousands):** | Metric | September 30, 2023 | December 31, 2022 | | :-------------------------------------------------- | :------------------- | :------------------ | | Total cash, cash equivalents, restricted cash and investments | $338,491 | $389,390 | | Available-for-sale debt securities | $292,094 | $295,218 | | Unrealized gains on available-for-sale securities, net of tax (Q3) | $73 | $326 | | Unrealized gains on available-for-sale securities, net of tax (YTD) | $114 | $(675) | | Total unrealized losses on investments | $(144) | $(256) | [5. Inventories, net](index=12&type=section&id=5.%20Inventories%2C%20net) This note details the composition of the company's inventory, including raw materials, work in process, and finished goods **Components of Inventory, Net (in thousands):** | Component | September 30, 2023 | December 31, 2022 | | :-------------------- | :------------------- | :------------------ | | Raw materials | $1,985 | $2,217 | | Work in process | $29,639 | $21,059 | | Finished goods, net of reserve | $1,196 | $1,476 | | Total inventories, net | $32,820 | $24,752 | - Reserves for finished goods inventories were approximately **$1.1 million** as of September 30, 2023, down from **$3.9 million** as of December 31, 2022, primarily related to potential inventory obsolescence[49](index=49&type=chunk) [6. Prepaid Expenses](index=13&type=section&id=6.%20Prepaid%20Expenses) This note presents the breakdown of various prepaid assets held by the company **Prepaid Expenses (in thousands):** | Component | September 30, 2023 | December 31, 2022 | | :-------------------- | :------------------- | :------------------ | | Prepaid assets | $7,288 | $5,451 | | Prepaid deposits | $6,922 | $6,330 | | Prepaid insurance | $1,948 | $1,799 | | Total prepaid expenses | $16,158 | $13,580 | [7. Intangible Assets](index=13&type=section&id=7.%20Intangible%20Assets) This note provides information on the company's intangible assets, such as patents and acquired intellectual property **Intangible Assets, Net (in thousands):** | Component | September 30, 2023 | December 31, 2022 | | :--------------------------------------------- | :------------------- | :------------------ | | Patents | $515 | $307 | | Acquired intellectual property and reacquired rights | $4,588 | $5,288 | | Internal-use software implementation costs | $158 | $830 | | Total intangible assets, net | $5,261 | $6,425 | - Amortization expense was approximately **$0.5 million** for both Q3 2023 and Q3 2022, and **$1.4 million** for YTD 2023 compared to **$1.6 million** for YTD 2022[54](index=54&type=chunk) [8. Property and Equipment, net](index=14&type=section&id=8.%20Property%20and%20Equipment%2C%20net) This note details the company's property and equipment, net of accumulated depreciation **Property and Equipment, Net (in thousands):** | Component | September 30, 2023 | December 31, 2022 | | :-------------------------- | :------------------- | :------------------ | | Construction in progress | — | $255 | | Leasehold improvements | $3,243 | $2,978 | | Office equipment | $631 | $645 | | Furniture | $1,141 | $976 | | Computer equipment | $235 | $251 | | Less accumulated depreciation | $(1,754) | $(1,455) | | Total property and equipment, net | $3,496 | $3,650 | [9. Lease Obligations](index=14&type=section&id=9.%20Lease%20Obligations) This note describes the company's lease arrangements, especially the finance lease for its manufacturing facility - The company entered into a finance lease for a dedicated manufacturing facility (monoplant) in Visp, Switzerland, with the lease commencement occurring in Q2 2023[59](index=59&type=chunk)[61](index=61&type=chunk) - At lease inception, an ROU asset of approximately **$117.6 million** and a corresponding lease liability of **$94.1 million** were recorded for the monoplant[61](index=61&type=chunk) **Monoplant Finance Lease (in thousands):** | Metric | September 30, 2023 | | :-------------------------- | :------------------- | | ROU asset, net | $113,100 | | Lease liability | $85,500 | | ROU amortization (Q3 2023) | $4,400 | | ROU amortization (YTD 2023) | $4,600 | | Interest expense (Q3 2023) | $1,400 | | Interest expense (YTD 2023) | $1,500 | - Operating lease costs for all leases were **$0.2 million** for Q3 2023 and **$0.6 million** for YTD 2023[58](index=58&type=chunk) [10. Accounts Payable and Accrued Liabilities](index=16&type=section&id=10.%20Accounts%20Payable%20and%20Accrued%20Liabilities) This note provides a breakdown of the company's current liabilities, such as employee and commercial accruals **Accounts Payable and Accrued Liabilities (in thousands):** | Component | September 30, 2023 | December 31, 2022 | | :------------------------------------- | :------------------- | :------------------ | | Employee accruals | $18,177 | $20,214 | | Commercial accruals | $13,437 | $8,620 | | Accrued R&D projects | $5,678 | $5,350 | | Trade payables | $8,854 | $3,087 | | Other accrued liabilities | $5,938 | $2,094 | | Income taxes payable | $225 | $625 | | Total accounts payable and accrued liabilities | $52,309 | $39,990 | [11. Deferred Compensation and Other Non-current Liabilities](index=16&type=section&id=11.%20Deferred%20Compensation%20and%20Other%20Non-current%20Liabilities) This note details the company's non-current liabilities, mainly deferred compensation arrangements **Other Non-current Liabilities (in thousands):** | Metric | September 30, 2023 | December 31, 2022 | | :------------------------------------- | :------------------- | :------------------ | | Deferred compensation and other non-current liabilities | $10,340 | $12,166 | - The balance primarily includes deferred compensation arrangements for certain former executive officers, contingent on future events[71](index=71&type=chunk) [12. License and Collaboration Agreements](index=16&type=section&id=12.%20License%20and%20Collaboration%20Agreements) This note outlines the key terms and financial impacts of the company's licensing and collaboration agreements - The collaboration and license agreement with Otsuka for LUPKYNIS® includes an upfront cash payment of **$50.0 million** (2020), potential regulatory and pricing approval milestones up to **$50.0 million**, and tiered royalties (10-20%) on net product sales[72](index=72&type=chunk) - A **$30.0 million** regulatory milestone from Otsuka was recognized in 2022 following EC marketing authorization of LUPKYNIS®[74](index=74&type=chunk) - A **$10.0 million** pricing and reimbursement milestone was recognized as collaboration revenue in Q3 2023[74](index=74&type=chunk) **License, Royalty and Collaboration Revenue from Otsuka (in thousands):** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | $12,700 | $30,200 | | Nine months ended September 30 | $13,200 | $30,400 | - AUR300 was secured through a global licensing and research agreement with Riptide Bioscience, Inc., involving a **$6.0 million** upfront license fee (2021) and a **$4.0 million** milestone payment (Q1 2022)[76](index=76&type=chunk) [13. Net Loss per Common Share](index=17&type=section&id=13.%20Net%20Loss%20per%20Common%20Share) This note presents the calculation of basic and diluted net loss per common share **Net Loss per Common Share:** | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net loss (in thousands) | $(13,447) | $(8,989) | $(51,145) | $(82,134) | | Weighted average common shares outstanding (in thousands) | 142,847 | 141,856 | 143,085 | 141,831 | | Net loss per common share | $(0.09) | $(0.06) | $(0.36) | $(0.58) | - Diluted net loss per share is the same as basic net loss per share because the company was in a loss position for all periods presented[77](index=77&type=chunk) **Anti-dilutive Securities (in thousands) - Nine Months Ended September 30:** | Security Type | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Stock options | 12,400 | 14,299 | | Unvested performance awards | 921 | — | | Unvested restricted stock units | 6,968 | 2,098 | | Total anti-dilutive securities | 20,289 | 16,397 | [14. Share-based Compensation](index=18&type=section&id=14.%20Share-based%20Compensation) This note details share-based compensation expense and activity for stock options and restricted stock units **Share-based Compensation Expense (in thousands):** | Expense Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $1,975 | $1,489 | $5,679 | $3,531 | | Selling, general and administrative | $9,560 | $6,625 | $26,969 | $21,480 | | Capitalized under inventories | $273 | $206 | $895 | $387 | | Total share-based compensation expense | $11,808 | $8,320 | $33,543 | $25,398 | - As of September 30, 2023, there was **$39.2 million** of unrecognized share-based compensation expense related to unvested awards, expected to be recognized over approximately 1.4 years[94](index=94&type=chunk) **Stock Option Activity (in thousands, except price) - Nine Months Ended September 30, 2023:** | Activity | Number of Shares | Weighted Average Exercise Price ($) | | :--------------------------- | :--------------- | :---------------------------------- | | Outstanding - December 31, 2022 | 13,295 | 12.09 | | Granted | 675 | 9.68 | | Exercised | (558) | 5.27 | | Forfeited | (1,012) | 14.11 | | Outstanding - September 30, 2023 | 12,400 | 12.10 | **RSU and PA Activity (in thousands, except price) - Nine Months Ended September 30, 2023:** | Activity | Number of Shares | Weighted Average Fair Value Price ($) | | :--------------------------- | :--------------- | :------------------------------------ | | Outstanding - December 31, 2022 | 1,980 | 10.84 | | Granted | 6,775 | 9.04 | | Vested | (569) | 11.71 | | Forfeited | (297) | 9.31 | | Outstanding - September 30, 2023 | 7,889 | 9.29 | [15. Income Taxes](index=20&type=section&id=15.%20Income%20Taxes) This note provides information on the company's income tax expense and related considerations **Income Tax Expense (in thousands):** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | $298 | $954 | | Nine months ended September 30 | $92 | $973 | - The 2023 income tax expense is primarily due to current period tax not offset by a tax benefit, as losses were fully offset by a valuation allowance in significant jurisdictions and withholding taxes on foreign income[95](index=95&type=chunk) [16. Related Party Transactions](index=20&type=section&id=16.%20Related%20Party%20Transactions) This note discloses transactions and balances with entities or individuals considered related parties - ILJIN is considered a related party due to equity ownership over 5%, with **$0.5 million** payable as of September 30, 2023, due to a milestone[96](index=96&type=chunk) - Dr. Robert T. Foster, a Board member, is a related party with **$0.5 million** in current and **$6.4 million** in non-current liabilities as of September 30, 2023, related to former employee benefit obligations[97](index=97&type=chunk) [17. Commitments and Contingencies](index=20&type=section&id=17.%20Commitments%20and%20Contingencies) This note outlines potential future obligations and uncertainties, including legal proceedings - The company may be subject to claims and legal proceedings in the normal course of business, but management believes the ultimate resolution will not have a material adverse effect on its consolidated financial position[98](index=98&type=chunk) - No material changes to commitments and contingencies from previously described in the Annual Report on Form 10-K for 2022[98](index=98&type=chunk) [18. Other Funding Commitments](index=20&type=section&id=18.%20Other%20Funding%20Commitments) This note describes the company's agreements with third parties for services and funding commitments - The company enters into agreements with contract research organizations, contract manufacturing organizations, and other third parties for services[99](index=99&type=chunk) - These agreements generally provide for termination upon notice, with specified amounts due upon termination, and actual payments are uncertain and contingent upon service initiation and completion[101](index=101&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, discussing revenue drivers, expense changes, liquidity, and capital resources. It highlights the performance of LUPKYNIS®, pipeline advancements, and strategic initiatives [Overview](index=22&type=section&id=Overview) This section introduces the company's business, key product, and development pipeline - Aurinia is a fully integrated biopharmaceutical company focused on therapies for autoimmune, kidney, and rare diseases[104](index=104&type=chunk) - LUPKYNIS® (voclosporin) is the first U.S. FDA-approved oral therapy for active lupus nephritis (LN), launched in January 2021[104](index=104&type=chunk) - LUPKYNIS® is an orally administered calcineurin inhibitor (CNI) immunosuppressant that improves near and long-term outcomes in LN when used in combination with mycophenolate mofetil (MMF) and steroids[104](index=104&type=chunk) - Novel assets AUR200 and AUR300 are in pre-clinical development, with projected FDA submissions for AUR200 in 2023 and AUR300 in 2024[106](index=106&type=chunk) [Recent Developments](index=23&type=section&id=Recent%20Developments) This section highlights significant recent events, including clinical study results, patent grants, and board actions - The AURORA Renal Biopsy Sub-Study showed LUPKYNIS® led to significantly earlier and greater reductions in proteinuria while maintaining stable renal function[107](index=107&type=chunk) - A new U.S. Patent (No. 11,622,991) for LUPKYNIS®'s unique dosing regimen was issued, potentially providing patent protection until 2037[108](index=108&type=chunk) - The Board of Directors initiated an exploration of strategic alternatives on June 29, 2023[109](index=109&type=chunk) - New board appointments include Dr. Karen Smith, Jeffrey A. Bailey, and Dr. Robert T. Foster, bringing expertise in biopharma leadership, commercial strategy, and M&A[109](index=109&type=chunk) [Policies and Significant Judgments and Estimates](index=23&type=section&id=Policies%20and%20Significant%20Judgments%20and%20Estimates) This section confirms consistency of critical accounting policies and estimates with prior reports - There have been no material changes to the company's critical accounting policies and significant judgments and estimates as described in its Annual Report on Form 10-K for the year ended December 31, 2022[110](index=110&type=chunk) [Product Revenues](index=23&type=section&id=Product%20Revenues) This section details the recognition and estimation of net product revenue from LUPKYNIS® sales - LUPKYNIS® is sold primarily to specialty pharmacies and specialty distributors in the United States, with revenue recognized upon delivery to the customer[111](index=111&type=chunk) - Product sales are recorded at the net sales price, which includes estimates of variable consideration for discounts and allowances, calculated using the expected value method[111](index=111&type=chunk)[112](index=112&type=chunk) - Estimates for variable consideration are based on historical data, including patient mix and inventory not yet dispensed, with no material adjustments as of September 30, 2023[113](index=113&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in revenues and expenses [Total Revenue, Net](index=25&type=section&id=Total%20Revenue%2C%20Net) This section provides an overview of the company's total net revenue and its primary sources **Total Net Revenue (in thousands):** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | $54,515 | $55,779 | | Nine months ended September 30 | $130,418 | $105,595 | - The majority of revenue comes from two main U.S. commercial customers for LUPKYNIS® and the collaboration partnership with Otsuka[117](index=117&type=chunk) [Product Revenue, Net](index=25&type=section&id=Product%20Revenue%2C%20Net) This section analyzes changes in net product revenue, driven by LUPKYNIS® sales and market penetration **Net Product Revenue (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :------- | | Three months ended September 30 | $40,781 | $25,502 | +$15,279 | | Nine months ended September 30 | $116,218 | $75,142 | +$41,076 | - The increase is primarily due to further penetration of the LN market, evidenced by **436 additional prescriptions (PSFs)** in Q3 2023 and **1,353 additional PSFs** in YTD 2023 compared to the prior year[119](index=119&type=chunk) - Approximately **1,939 patients** were on therapy as of September 30, 2023, up from **1,354 patients** as of September 30, 2022[119](index=119&type=chunk) [License, Royalty and Collaboration Revenue](index=25&type=section&id=License%20Royalty%20and%20Collaboration%20Revenue) This section details fluctuations in revenue derived from licensing, royalty, and collaboration agreements **License, Royalty and Collaboration Revenue (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :--------- | | Three months ended September 30 | $13,734 | $30,277 | $(16,543) | | Nine months ended September 30 | $14,200 | $30,453 | $(16,253) | - The decrease is primarily due to the recognition of a **$30.0 million** regulatory milestone from Otsuka in September 2022, partially offset by a **$10.0 million** pricing and reimbursement milestone recognized in September 2023[120](index=120&type=chunk) [Cost of Sales](index=25&type=section&id=Cost%20of%20Sales) This section explains the factors contributing to changes in the cost of goods sold **Cost of Sales (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :------- | | Three months ended September 30 | $6,769 | $2,447 | +$4,322 | | Nine months ended September 30 | $8,753 | $4,302 | +$4,451 | - The increase is primarily due to increased sales of LUPKYNIS® and the amortization of the monoplant finance right-of-use asset, which was placed into service in late June 2023[121](index=121&type=chunk)[123](index=123&type=chunk) [Gross Margin](index=26&type=section&id=Gross%20Margin) This section presents the company's gross margin percentages for the reported periods **Gross Margin:** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | 88% | 96% | | Nine months ended September 30 | 93% | 96% | [Selling, General and Administrative Expenses](index=26&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) This section analyzes changes in selling, general, and administrative expenses, including professional fees and share-based compensation **Selling, General and Administrative Expenses (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :--------- | | Three months ended September 30 | $47,759 | $52,169 | $(4,410) | | Nine months ended September 30 | $144,964 | $148,898 | $(3,934) | - The decrease for both periods was primarily due to a reduction in professional fees and services (including legal fees) and other corporate costs (including rent and insurance), partially offset by an increase in share-based compensation expense[126](index=126&type=chunk)[127](index=127&type=chunk) [Research and Development Expenses](index=26&type=section&id=Research%20and%20Development%20Expenses) This section details changes in research and development expenditures, driven by pipeline advancements and study completions **Research and Development Expenses (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :------- | | Three months ended September 30 | $13,605 | $10,973 | +$2,632 | | Nine months ended September 30 | $39,413 | $35,118 | +$4,295 | - The increase was primarily driven by higher CRO and developmental costs as the company advances its preclinical assets and an increase in share-based compensation expense[129](index=129&type=chunk)[130](index=130&type=chunk) - This increase was partially offset by decreased costs associated with the completion of the AURORA 2 continuation study and drug interaction study in 2022[130](index=130&type=chunk) [Other (Income) Expense, net](index=27&type=section&id=Other%20(Income)%20Expense%2C%20net) This section explains the components and fluctuations of other income and expense items **Other (Income) Expense, Net (in thousands):** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | $2,645 | $(311) | | Nine months ended September 30 | $(695) | $647 | - Changes are primarily related to expenses incurred for shareholder matters, foreign exchange gains on the revaluation of the monoplant finance lease liability, and changes in fair value assumptions for deferred compensation liability[131](index=131&type=chunk) [Interest Expense](index=27&type=section&id=Interest%20Expense) This section details the interest expense incurred, primarily from the monoplant finance lease **Interest Expense (in thousands):** | Period | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Three months ended September 30 | $1,400 | — | | Nine months ended September 30 | $1,465 | — | - The interest expense is due to the commencement of the monoplant finance lease during the three months ended June 30, 2023[132](index=132&type=chunk) [Interest Income](index=27&type=section&id=Interest%20Income) This section explains the increase in interest income due to higher yields on investments **Interest Income (in thousands):** | Period | 2023 | 2022 | Change | | :------------------------------------- | :--------- | :--------- | :------- | | Three months ended September 30 | $4,514 | $1,464 | +$3,050 | | Nine months ended September 30 | $12,429 | $2,209 | +$10,220 | - The increase for both periods is due to higher yields on investments as a result of increased interest rates[133](index=133&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial resources, including cash, investments, and working capital, and their sufficiency **Liquidity and Capital Resources (in thousands):** | Metric | September 30, 2023 | December 31, 2022 | | :------------------------------------- | :------------------- | :------------------ | | Cash, cash equivalents and restricted cash | $46,400 | $94,200 | | Investments | $292,100 | $295,200 | | Working capital | $352,600 | $396,400 | - The decrease in cash, cash equivalents, restricted cash, and investments is primarily related to continued investment in commercialization activities, post-approval commitments for LUPKYNIS®, inventory purchases, pipeline advancement, and monoplant payments, partially offset by increased cash receipts from LUPKYNIS® sales[134](index=134&type=chunk) - The company believes its cash position is sufficient to fund current plans for at least the next few years, including commercial activities, R&D programs, and working capital obligations[135](index=135&type=chunk) [Cash Flow Summary](index=28&type=section&id=Cash%20Flow%20Summary) This section provides a summary of cash flows from operating, investing, and financing activities **Cash Flow Summary (in thousands) - Nine Months Ended September 30:** | Activity | 2023 | 2022 | | :------------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(47,773) | $(89,979) | | Net cash used in investing activities | $(449) | $(57,614) | | Cash provided by financing activities | $447 | $1,745 | | Net decrease in cash and cash equivalents | $(47,775) | $(145,848) | - The decrease in net cash used in operating activities is primarily due to an increase in cash receipts from LUPKYNIS® sales[138](index=138&type=chunk) - The decrease in cash used in investing activities was primarily related to the timing of investment purchases and the second capital expenditure payment for the monoplant, offset by proceeds from investment maturities[139](index=139&type=chunk) [Off‑Balance Sheet Arrangements](index=28&type=section&id=Off%E2%80%91Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements - The company did not have, nor does it currently have, any off-balance sheet arrangements[140](index=140&type=chunk) [Contractual Obligations](index=28&type=section&id=Contractual%20Obligations) This section states that there have been no material changes to the company's contractual obligations - There have been no material changes outside the ordinary course of business to the company's contractual obligations and commitments as described in its Annual Report on Form 10-K for the year ended December 31, 2022[141](index=141&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risks](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) This section details the company's exposure to various market risks, including interest rate risk, foreign currency risk, inflation risk, and credit risk, and outlines the strategies employed to manage these exposures [Interest Rate Risk](index=28&type=section&id=Interest%20Rate%20Risk) This section discusses the company's exposure to interest rate fluctuations on its investment portfolio - The company's investment portfolio of **$338.5 million** (as of September 30, 2023) earns interest at various rates, exposing it to cash flow interest rate risk[143](index=143&type=chunk) - A hypothetical **100 basis point decrease** in interest rates on investments would result in **$3.0 million** less interest annually[144](index=144&type=chunk) - The investment policy limits investments to highly rated debt and money market instruments, with restrictions on maturities and concentrations[143](index=143&type=chunk) [Foreign Currency Risk](index=29&type=section&id=Foreign%20Currency%20Risk) This section outlines the company's exposure to foreign currency fluctuations, especially for its finance lease liability - The company is exposed to foreign currency risk, primarily with the Canadian dollar, Swiss Franc, Euro, and Great British Pound[145](index=145&type=chunk) - An **$85.5 million** finance lease liability related to the monoplant is exposed to Swiss Franc fluctuations; a **10% fluctuation** would result in an approximate **$8.6 million** change in valuation[145](index=145&type=chunk) - Approximately **$7.0 million** in foreign denominated third-party payables are subject to foreign exchange fluctuations, with a **10% change** impacting amounts due by **$0.7 million**[145](index=145&type=chunk) [Inflation Risk](index=29&type=section&id=Inflation%20Risk) This section describes how inflation impacts the company's operating costs and investment portfolio - Increasing inflation affects the company by raising costs for labor, commercial support, manufacturing, and clinical trial expenditures[147](index=147&type=chunk) - Inflation also impacts government rebates due to the consumer price index (CPI) penalty[147](index=147&type=chunk) - The investment portfolio may experience realized losses if investments are sold before maturity due to market volatility caused by increased interest rates[147](index=147&type=chunk) [Credit Risk](index=29&type=section&id=Credit%20Risk) This section details the company's exposure to credit risk from cash, investments, and accounts receivable - The company's exposure to credit risk consists of cash and cash equivalents, investments, and accounts receivable[148](index=148&type=chunk) - Accounts receivable from its two main U.S. customers for LUPKYNIS® and the Otsuka collaboration accounted for approximately **97%** of net trade accounts receivable as of September 30, 2023[149](index=149&type=chunk) - The company monitors economic conditions and customer creditworthiness, and has not experienced any issues with collectability or recorded any allowance for doubtful accounts in Q3 2023[149](index=149&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and procedures and any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=30&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[151](index=151&type=chunk) [Changes in Internal Control over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes to the company's internal control over financial reporting - There has been no change in the company's internal control over financial reporting during the quarter ended September 30, 2023, that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting[152](index=152&type=chunk) PART II. OTHER INFORMATION This section provides additional information not covered in financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) This section updates on legal proceedings, specifically a shareholder class action lawsuit, and reiterates the company's defense commitment - A purported shareholder class action complaint, Ortmann v. Aurinia Pharmaceuticals, Inc. et al., was filed on April 15, 2022, alleging materially false and misleading statements regarding financial guidance and commercial prospects[155](index=155&type=chunk) - The company filed a motion to dismiss the amended complaint on October 20, 2023, and intends to vigorously defend itself[155](index=155&type=chunk) - Litigation can have an adverse impact due to defense and settlement costs, as well as diversion of management resources[154](index=154&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors from the 10-K, noting the Ukraine conflict's impact and clarifying LUPKYNIS® activity metric limitations - No material change in risk factors since the 2022 Annual Report on Form 10-K, except for the ongoing armed conflict in Ukraine and its potential adverse effects on business, operations, and financial condition[156](index=156&type=chunk)[157](index=157&type=chunk) - Metrics relating to LUPKYNIS® activity (prescriptions/PSFs, conversion rates, persistency rates, patients on therapy) are not directly indicative of current or future financial performance due to various factors outside the company's control, including insurance coverage, cancellations, and discontinuations[157](index=157&type=chunk)[158](index=158&type=chunk) - Revenue from main customers does not necessarily correlate to PSF numbers, meaning revenue could fluctuate contrary to PSF trends[159](index=159&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states no unregistered sales of equity securities or use of proceeds were reported for the period - None to report[160](index=160&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states no defaults upon senior securities were reported for the period - None to report[160](index=160&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states no mine safety disclosures were reported for the period - None to report[160](index=160&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) This section states no other information is reported for the period - None to report[160](index=160&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, agreements, and certifications - Exhibits include Articles of Amalgamation, Amended and Restated By-Law No. 2, and a Cooperation Agreement dated September 21, 2023[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer are included pursuant to the Sarbanes-Oxley Act of 2002[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Schema Documents are also filed[169](index=169&type=chunk) [Signatures](index=35&type=section&id=Signatures) This section contains official signatures of the company's principal executive and financial officers, certifying report accuracy - The report was signed by Peter Greenleaf, Chief Executive Officer, and Joseph Miller, Chief Financial Officer, on November 1, 2023[171](index=171&type=chunk)
Aurinia Pharmaceuticals(AUPH) - 2023 Q2 - Earnings Call Transcript
2023-08-03 16:32
Financial Data and Key Metrics Changes - Aurinia Pharmaceuticals reported net product revenues of $41.1 million for Q2 2023, a 46% increase compared to Q2 2022 and a 20% increase over Q1 2023, bringing year-to-date revenues to $75.4 million, up over 52% from the same period in 2022 [5][21] - Total net revenue for Q2 2023 increased 47% to $41.5 million from $28.2 million in Q2 2022, and for the six months ended June 30, 2023, total net revenue increased 52% to $75.9 million from $49.8 million in the prior year [21][22] - The company recorded a net loss of $11.5 million or $0.08 per share for Q2 2023, compared to a net loss of $35.5 million or $0.25 per share for Q2 2022 [28] Business Line Data and Key Metrics Changes - The number of patient start forms (PSFs) totaled 451 in Q2 2023, a 10% increase over Q2 2022, with a conversion rate of 89% from PSFs to therapy, marking an all-time high [14][15] - The 12-month persistency rate for patients on LUPKYNIS improved from 51% to 54% in Q2 2023, indicating better retention [16] Market Data and Key Metrics Changes - The company has seen significant launch momentum for LUPKYNIS outside the U.S., with launches in Germany, Austria, Sweden, Finland, and Norway, and recent approvals in Switzerland, the U.K., and Italy [18] - The awareness campaign "Get Uncomfortable" reached over 750 million people, significantly increasing patient engagement and education [8] Company Strategy and Development Direction - Aurinia's strategy focuses on three main areas: driving patient awareness, clinically differentiating LUPKYNIS, and ensuring patient access to therapy [7] - The company is increasing its net product revenue guidance for 2023 from $135 million to $155 million to a new range of $150 million to $160 million [17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of seasonality on patient flow during summer months but expressed confidence in returning to growth patterns in Q3 and Q4 [33][35] - The company is actively exploring strategic alternatives, including potential sales, in response to shareholder requests, emphasizing a commitment to fiduciary responsibilities [59][60] Other Important Information - Aurinia had cash and equivalents of $350.7 million as of June 30, 2023, down from $389.4 million at the end of 2022, primarily due to investments in commercialization and R&D [20][21] - The company is on track to file an IND for AUR200 by the end of the year and is advancing its lupus nephritis registry [17][18] Q&A Session Summary Question: What strategies are in place to mitigate seasonality impacts? - Management noted that summer months typically see a dip in patient flow due to asymptomatic conditions and staff vacations, but they are implementing targeted marketing initiatives to maintain patient engagement [33][35] Question: Will the biopsy data be submitted to the FDA? - Management confirmed that they have submitted a package of data to the FDA, including biopsy data, but a timeline for label updates is still under negotiation [37][39] Question: What are the underlying drivers for the recent revenue guidance increase? - Management highlighted that metrics such as patient conversion rates and persistency have reached all-time highs, contributing to revenue growth despite a slight decline in PSFs [41][42] Question: What proportion of prescribers are repeat prescribers? - Management did not provide specific percentages but emphasized the importance of increasing both the number of prescribers and the depth of prescribing [69] Question: What are patients saying about remaining on therapy longer? - Management indicated that patient feedback is generally positive, with ongoing efforts to enhance patient education and support for long-term therapy adherence [70]
Aurinia Pharmaceuticals(AUPH) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
PART I. FINANCIAL INFORMATION This section provides a comprehensive overview of the company's unaudited financial statements and management's analysis [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited consolidated financial statements, including balance sheets, income, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)%20as%20of%20June%2030%2C%202023%20and%20December%2031%2C%202022) This section details the company's financial position, including assets, liabilities, and equity, as of June 30, 2023, and December 31, 2022 | Metric | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------------------ | :--------------------------- | :------------------------------- | | Total Assets | $548,900 | $470,860 | | Total Liabilities | $156,608 | $65,425 | | Total Shareholders' Equity | $392,292 | $405,435 | | Current Assets | $415,907 | $442,539 | | Current Liabilities | $61,661 | $46,107 | | Finance right-of-use asset, net | $117,428 | — | | Finance lease liability (current & non-current) | $93,438 | — | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(unaudited)%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202023%20and%20June%2030%2C%202022) This section presents the company's revenues, expenses, and net loss for the three and six months ended June 30, 2023 and 2022 Three Months Ended June 30 | Metric | June 30, 2023 (in thousands) | June 30, 2022 (in thousands) | Change (YoY) | | :--------------------------- | :--------------------------- | :--------------------------- | :----------- | | Total Revenue, net | $41,494 | $28,191 | +$13,303 (+47.2%) | | Loss from operations | $(16,170) | $(35,989) | +$19,819 (Improved) | | Net loss | $(11,492) | $(35,515) | +$24,023 (Improved) | | Basic and diluted loss per share | $(0.08) | $(0.25) | +$0.17 (Improved) | Six Months Ended June 30 | Metric | June 30, 2023 (in thousands) | June 30, 2022 (in thousands) | Change (YoY) | | :--------------------------- | :--------------------------- | :--------------------------- | :----------- | | Total Revenue, net | $75,903 | $49,816 | +$26,087 (+52.4%) | | Loss from operations | $(45,754) | $(73,871) | +$28,117 (Improved) | | Net loss | $(37,698) | $(73,145) | +$35,447 (Improved) | | Basic and diluted loss per share | $(0.26) | $(0.52) | +$0.26 (Improved) | - Interest income increased significantly due to higher yields on investments: * 3 months: **$4,101k (2023)** vs **$483k (2022)** * 6 months: **$7,915k (2023)** vs **$745k (2022)**[10](index=10&type=chunk) [Condensed Consolidated Statements of Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(unaudited)%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202023%20and%20June%2030%2C%202022) This section outlines changes in shareholders' equity, including common shares and share-based compensation, for the periods ended June 30, 2023 and 2022 | Metric | June 30, 2023 (in thousands) | June 30, 2022 (in thousands) | | :--------------------------- | :--------------------------- | :--------------------------- | | Total Shareholders' Equity | $392,292 | $423,768 | | Common Shares Issued and Outstanding | 143,369 | 141,892 | | Share-based compensation (3 months) | $12,268 | $10,055 | | Share-based compensation (6 months) | $21,735 | $17,078 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)%20for%20the%20six%20months%20ended%20June%2030%2C%202023%20and%20June%2030%2C%202022) This section details cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 and 2022 Six Months Ended June 30 | Cash Flow Activity | June 30, 2023 (in thousands) | June 30, 2022 (in thousands) | Change (YoY) | | :------------------------------------------ | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(34,496) | $(74,617) | +$40,121 (Improved) | | Net cash provided by (used in) investing activities | $19,252 | $(7,396) | +$26,648 (Shift to provided) | | Cash provided by financing activities | $2,779 | $1,745 | +$1,034 (Increased) | | Net decrease in cash, cash equivalents and restricted cash | $(12,465) | $(80,268) | +$67,803 (Reduced decrease) | | Cash, cash equivalents and restricted cash, end of period | $81,707 | $151,632 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Organization and Description of Business](index=8&type=section&id=1.%20Organization%20and%20Description%20of%20Business) This note describes Aurinia Pharmaceuticals Inc.'s core business, product offerings, and strategic collaborations - Aurinia Pharmaceuticals Inc. is a fully integrated biopharmaceutical company focused on autoimmune, kidney, and rare diseases[22](index=22&type=chunk) - **LUPKYNIS (voclosporin)** was introduced in January 2021 as the first U.S. FDA-approved oral therapy for adult patients with active lupus nephritis (LN)[22](index=22&type=chunk) - The company collaborates with Otsuka Pharmaceutical Co., Ltd. for LUPKYNIS development and commercialization in the EU, Japan, UK, and other territories[22](index=22&type=chunk) - **AUR200** and **AUR300** are in pre-clinical development, with Investigational New Drug Applications (INDs) projected for submission in **2023** and **2024**, respectively[22](index=22&type=chunk) - The European Commission granted marketing authorization for LUPKYNIS on **September 15, 2022**[23](index=23&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and policies applied in preparing the condensed consolidated financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[24](index=24&type=chunk) - The company's functional currency is U.S. dollars[27](index=27&type=chunk) - As of June 30, 2023, the company had **$350.7 million** in cash, cash equivalents, restricted cash, and investments, believing it has sufficient resources to fund operations for at least the next few years[28](index=28&type=chunk) - Revenues from the two main U.S. customers accounted for approximately **98% of total revenues** for the three and six months ended June 30, 2023[29](index=29&type=chunk) - Product revenues are recognized when the customer obtains control of the product, typically upon delivery[32](index=32&type=chunk) Accounts Receivable, Net | Date | Amount (in thousands) | | :---------------- | :-------------------- | | June 30, 2023 | $19,500 | | December 31, 2022 | $13,500 | - The company adopted ASU No. 2021-10 (Government Assistance) effective **January 1, 2022**, with no material impact on the financial statements[38](index=38&type=chunk) [3. Fair Value Measurements](index=11&type=
Aurinia Pharmaceuticals(AUPH) - 2023 Q1 - Earnings Call Transcript
2023-05-04 17:08
Start Time: 08:30 January 1, 0000 9:27 AM ET Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q1 2023 Earnings Conference Call May 04, 2023, 08:30 AM ET Company Participants Peter Greenleaf - President and CEO Joe Miller - CFO Jamie Harrell - Head of IR Conference Call Participants Olivia Brayer - Cantor Fitzgerald Farzin Haque - Jefferies Stacy Ku - TD Cowen Justin Kim - Oppenheimer Ed Arce - H.C. Wainwright David Martin - Bloom Burton Will Soghikian - SVB Securities Sahil Dhingra - RBC Capital Markets Operator ...
Aurinia Pharmaceuticals(AUPH) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________________________________ FORM 10-Q _____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |------------------------------------------------------------------|---------------------- ...