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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 | --- | --- | --- | |------------------------------------------------------------------|---------------------- ...
Aurinia Pharmaceuticals (AUPH) Investor Presentation - Slideshow
2023-03-07 18:58
Corporate Presentation Cautionary statement regarding forward-looking information Certain statements made in this slide presentation 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 estimates as to its unaudited net revenues and produc ...
Aurinia Pharmaceuticals(AUPH) - 2022 Q4 - Earnings Call Transcript
2023-02-28 19:48
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q4 2022 Earnings Conference Call February 28, 2023 8:30 AM ET Company Participants Jamie Harrell - Director of Corporate Communications & Corporate Affairs Peter Greenleaf - President & Chief Executive Officer Joseph Miller - Chief Financial Officer Conference Call Participants Maurice Raycroft - Jefferies Olivia Brayer - Cantor Fitzgerald Stacy Ku - Cowen Ed Arce - H.C. Wainwright Joseph Schwartz - SVB Securities Justin Kim - Oppenheimer Operator Greetings, and we ...
Aurinia Pharmaceuticals(AUPH) - 2022 Q4 - Annual Report
2023-02-27 16:00
PART I [Business](index=7&type=section&id=Item%201.%20Business) Aurinia is a biopharmaceutical company focused on commercializing its primary product, LUPKYNIS®, for lupus nephritis while advancing its R&D pipeline [Overview and Strategy](index=7&type=section&id=Overview%20and%20Strategy) The company's strategy centers on maximizing the commercial value of its main product LUPKYNIS® through market education and strategic partnerships - Aurinia is a fully integrated biopharmaceutical company focused on therapies for autoimmune, kidney, and rare diseases with high unmet medical needs[22](index=22&type=chunk) - The company's primary product, LUPKYNIS (voclosporin), is the **first FDA-approved oral therapy** for adult patients with active lupus nephritis (LN), launched in January 2021[22](index=22&type=chunk) - Aurinia has a collaboration agreement with Otsuka Pharmaceutical Co, Ltd for the development and commercialization of LUPKYNIS in the European Union, Japan, and other territories[22](index=22&type=chunk) - The company's strategy includes educating physicians and patients about LN, ensuring adequate supply of LUPKYNIS, advancing its R&D pipeline (including AUR200 and AUR300), and evaluating external assets for acquisition[26](index=26&type=chunk)[27](index=27&type=chunk) [Recent Developments](index=8&type=section&id=Recent%20Developments) The company achieved key regulatory milestones in Europe, settled patent litigation, and secured a new method-of-use patent for LUPKYNIS® - On September 15, 2022, the European Commission (EC) granted marketing authorization for LUPKYNIS in the EU, triggering a **$30.0 million milestone payment** from Otsuka[28](index=28&type=chunk)[30](index=30&type=chunk) - On November 29, 2022, the UK's MHRA granted marketing authorization for LUPKYNIS in Great Britain[30](index=30&type=chunk) - In January 2023, Aurinia settled patent litigation with Sun Pharmaceuticals regarding U.S Patent No 10,286,036 and Sun's CEQUA® product[31](index=31&type=chunk) - In January 2023, the USPTO allowed a new method-of-use patent application for LUPKYNIS's unique dosing regimen, which could provide patent protection up to **2037**[31](index=31&type=chunk) [Market Potential and Commercialization](index=9&type=section&id=Market%20Potential%20and%20Commercialization) The company targets a significant U.S market for lupus nephritis, with an estimated average annualized net revenue of $65,000 per patient - The company estimates there are **80,000 to 120,000** SLE patients diagnosed with LN in the United States[32](index=32&type=chunk) - The wholesale acquisition cost (WAC) of a LUPKYNIS 'wallet' (60 capsules) is **$4,561** as of February 28, 2023[36](index=36&type=chunk) - Aurinia expects the average annualized net revenue per patient to be approximately **$65,000**, after accounting for rebates, discounts, and patient adherence[36](index=36&type=chunk) [Clinical and Regulatory](index=10&type=section&id=Clinical%20and%20Regulatory) LUPKYNIS received FDA approval in January 2021, and ongoing studies demonstrate a favorable long-term safety and efficacy profile - LUPKYNIS was approved by the FDA on January 22, 2021, in combination with a background immunosuppressive therapy regimen for adult patients with active LN[40](index=40&type=chunk) - The AURORA 2 continuation study showed a favorable risk/benefit profile over three years, with sustained efficacy and safety comparable to the initial AURORA 1 study[41](index=41&type=chunk) - The company initiated the ENLIGHT-LN registry to obtain long-term, real-world data on LUPKYNIS, with 42 sites activated towards a goal of 75[34](index=34&type=chunk) [Intellectual Property](index=11&type=section&id=Intellectual%20Property) Voclosporin's intellectual property is protected by a patent portfolio extending to at least 2027 for composition and 2037 for method-of-use - Patent protection for the composition of matter of voclosporin is anticipated to extend until at least **October 2027** in the U.S, Europe, and Japan[46](index=46&type=chunk) - U.S Patent No 10,286,036, with a term extending to **December 2037**, covers the specific LUPKYNIS dosing protocol for LN[47](index=47&type=chunk) - A newly allowed patent application in January 2023 further refines the method of using LUPKYNIS and has the potential to provide an additional layer of patent protection up to **2037**[48](index=48&type=chunk) [Manufacturing and Supply Chain](index=20&type=section&id=Manufacturing%20and%20Supply%20Chain) Aurinia relies on sole-source contract manufacturing organizations, including Lonza and Catalent, for its LUPKYNIS supply chain - The company uses contract manufacturing organizations (CMOs) for the manufacturing of LUPKYNIS[97](index=97&type=chunk) - Lonza is the sole supplier for the voclosporin drug substance A dedicated manufacturing facility (monoplant) is being built with Lonza in Switzerland, expected to be completed in 2023[98](index=98&type=chunk)[99](index=99&type=chunk) - Catalent Pharma Solutions is the sole supplier for the encapsulation of voclosporin 7.9 mg capsules[100](index=100&type=chunk) [Human Capital and Corporate Information](index=21&type=section&id=Human%20Capital%20and%20Corporate%20Information) The company employed approximately 300 people as of year-end 2022 and is preparing its first ESG report for 2023 - As of December 31, 2022, the company employed approximately **300 employees** in the United States, Canada, and the United Kingdom[104](index=104&type=chunk) - The company is preparing its first Environmental, Social and Governance (ESG) report, which is expected to be made public in 2023[111](index=111&type=chunk) - Aurinia is organized under the Business Corporations Act (Alberta) with its principal executive office in Victoria, British Columbia, and a U.S commercial office in Rockville, Maryland[112](index=112&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its dependence on a single product, commercialization challenges, intellectual property, and third-party manufacturing - The company's success is highly dependent on its ability to successfully commercialize its single approved product, LUPKYNIS, and it has **limited commercial sales experience**[115](index=115&type=chunk) - Aurinia relies on a limited number of customers, with two main customers accounting for approximately **45% and 35%** of total revenues in 2022[120](index=120&type=chunk) - The business is exposed to risks from unfavorable pricing regulations, third-party coverage, and reimbursement policies, which could be impacted by healthcare reform initiatives like the **Inflation Reduction Act**[128](index=128&type=chunk)[93](index=93&type=chunk) - The company relies exclusively on third-party manufacturers, including **Lonza as the sole source** for drug substance and **Catalent for encapsulation**, exposing it to supply chain risks[194](index=194&type=chunk)[195](index=195&type=chunk) - Aurinia is dependent on its partner, **Otsuka**, for the development and commercialization of LUPKYNIS in several key territories outside the United States[188](index=188&type=chunk) [Unresolved Staff Comments](index=52&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[265](index=265&type=chunk) [Properties](index=53&type=section&id=Item%202.%20Properties) Aurinia leases its principal R&D, administrative, and commercial office facilities in Canada and the United States - The company's headquarters is a leased **13,206 sq ft** facility in Victoria, British Columbia, which is on a month-to-month lease as of December 31, 2022[266](index=266&type=chunk) - The U.S commercial office is a leased **30,531 sq ft** space in Rockville, Maryland[266](index=266&type=chunk) [Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in patent litigation and a shareholder class action lawsuit - In January 2023, the company settled a patent infringement lawsuit with Sun Pharmaceuticals concerning Sun's CEQUA product[489](index=489&type=chunk) - A shareholder class action complaint was filed against the company in April 2022, alleging violations of federal securities laws The company intends to vigorously defend against this action[491](index=491&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's biopharmaceutical operations - Not applicable[267](index=267&type=chunk) PART II [Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities](index=54&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Shareholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common shares trade on Nasdaq under 'AUPH', and it does not anticipate paying cash dividends - The company's common shares trade on The Nasdaq Global Market under the symbol '**AUPH**'[270](index=270&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future, retaining funds for business development and commercialization of LUPKYNIS[276](index=276&type=chunk) - No securities were repurchased during the three months ended December 31, 2022[275](index=275&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Revenue grew significantly in 2022 driven by LUPKYNIS® sales and a milestone payment, leading to a reduced net loss despite higher operating expenses [Results of Operations](index=58&type=section&id=Results%20of%20Operations) Total net revenue increased to $134.0 million in 2022, driven by LUPKYNIS® sales and a milestone payment, narrowing the net loss to $108.2 million Comparison of Results of Operations (Years Ended Dec 31) | Financial Metric (in thousands) | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | **Total revenue, net** | **$134,030** | **$45,605** | **$88,425** | | Product revenue, net | $103,468 | $45,488 | $57,980 | | License and collaboration revenue | $30,562 | $117 | $30,445 | | **Total cost of sales and operating expenses** | **$245,500** | **$226,340** | **$19,160** | | Cost of sales | $5,664 | $1,091 | $4,573 | | Selling, general and administrative | $196,371 | $173,536 | $22,835 | | Research and development | $44,988 | $51,139 | $(6,151) | | **Net loss** | **$(108,180)** | **$(180,966)** | **$72,786** | - The increase in total net revenue was driven by higher LUPKYNIS sales and a **$30.0 million milestone payment** from Otsuka following EC marketing authorization[295](index=295&type=chunk) - The decrease in R&D expenses was primarily due to a **$10.0 million upfront license and milestone expense** for AUR300 in 2021 that did not recur in 2022[301](index=301&type=chunk) [Liquidity and Capital Resources](index=60&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended 2022 with $389.4 million in cash and investments, which is considered sufficient to fund operations for the next few years Cash and Investments (as of Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $94,172 | $231,900 | | Short-term investments | $295,218 | $234,178 | | **Total** | **$389,390** | **$466,078** | Summary of Cash Flows (Years Ended Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(79,529) | $(157,692) | | Net cash used in investing activities | $(60,632) | $(103,870) | | Net cash provided by financing activities | $2,433 | $221,112 | - The company believes its cash position as of December 31, 2022, is **sufficient to fund its current business plans** for at least the next few years[306](index=306&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=62&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to market risks including interest rate, foreign currency, inflation, and credit risk - A hypothetical **100 basis point change** in interest rates would result in a **$3.0 million fluctuation** in annual interest income from the company's investment portfolio[319](index=319&type=chunk) - Foreign currency risk is primarily from the Canadian dollar, Swiss Franc, and Great British Pound, but is considered low as the majority of cash and expenses are denominated in U.S dollars[320](index=320&type=chunk) - Inflation affects the company by increasing costs for labor, manufacturing, and clinical trials[321](index=321&type=chunk) - Credit risk is concentrated with two main customers, but the company has not experienced any issues with collectability[323](index=323&type=chunk) [Financial Statements and Supplementary Data](index=63&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements and supplementary data for the fiscal year ended December 31, 2022 [Consolidated Balance Sheets](index=80&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $470.9 million in 2022, primarily due to a reduction in cash, while total shareholders' equity fell to $405.4 million Consolidated Balance Sheet Data (as of Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | **Total Current Assets** | **$442,539** | **$513,324** | | Cash, cash equivalents and restricted cash | $94,172 | $231,900 | | Short-term investments | $295,218 | $234,178 | | Inventories, net | $24,752 | $19,326 | | **Total Assets** | **$470,860** | **$543,367** | | **Total Liabilities** | **$65,425** | **$64,276** | | **Total Shareholders' Equity** | **$405,435** | **$479,091** | [Consolidated Statements of Operations and Comprehensive Loss](index=82&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss improved significantly to $108.2 million in 2022 from $181.0 million in 2021, driven by strong revenue growth Consolidated Statement of Operations Data (Years Ended Dec 31) | (in thousands, except per share data) | 2022 | 2021 | | :--- | :--- | :--- | | Total revenue, net | $134,030 | $45,605 | | Total cost of sales and operating expenses | $245,500 | $226,340 | | Loss from operations | $(111,470) | $(180,735) | | **Net loss** | **$(108,180)** | **$(180,966)** | | **Basic and diluted loss per common share** | **$(0.76)** | **$(1.40)** | [Notes to Consolidated Financial Statements](index=85&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Key disclosures include revenue concentration, significant manufacturing commitments with Lonza, and details on a future finance lease for a new facility - Revenues from the two main U.S customers accounted for approximately **45% and 35%** of total revenues for 2022 The collaboration partner, Otsuka, accounted for approximately 20%[394](index=394&type=chunk) - The company has non-cancellable future manufacturing commitments of approximately **$29.3 million** with Lonza through 2024[492](index=492&type=chunk) - A future finance lease for a dedicated manufacturing facility (monoplant) with Lonza is expected to commence in 2023, with minimum lease payments totaling approximately **$85.0 million** through 2030[503](index=503&type=chunk) - As of Dec 31, 2022, the company has **$518.1 million** of Canadian net operating loss (NOL) carryforwards and **$10.1 million** of U.S federal NOL carryforwards[486](index=486&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2022 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[328](index=328&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022[329](index=329&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[332](index=332&type=chunk) PART III [Directors, Executive Compensation, Security Ownership, and Accountant Fees](index=67&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Required disclosures are incorporated by reference from the company's forthcoming 2023 Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, Certain Relationships, and Principal Accountant Fees and Services is **incorporated by reference** from the registrant's definitive proxy statement to be filed within 120 days of the fiscal year end[3](index=3&type=chunk)[336](index=336&type=chunk)[338](index=338&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=68&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the consolidated financial statements and exhibits filed as part of the annual report - This section contains the list of consolidated financial statements and exhibits filed with the Form 10-K[342](index=342&type=chunk)[343](index=343&type=chunk) [Form 10-K Summary](index=72&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has elected not to provide a summary for its Form 10-K - None[349](index=349&type=chunk)
Aurinia Pharmaceuticals(AUPH) - 2022 Q3 - Earnings Call Transcript
2022-11-03 15:53
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Peter Greenleaf - President & Chief Executive Officer Joe Miller - Chief Financial Officer Conference Call Participants Ed Arce - H.C. Wainwright Joseph Schwartz - SVB Securities Ken Cacciatore - Cowen & Company Justin Kim - Oppenheimer & Company Sahil Dhingra - RBC Capital Markets David Martin - Bloom Burton Maury Raycroft - Jefferies Operator Greetings, and welcome to Aurinia Pharma ...
Aurinia Pharmaceuticals(AUPH) - 2022 Q2 - Earnings Call Transcript
2022-08-04 16:02
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q2 2022 Earnings Conference Call August 4, 2022 8:30 AM ET Company Participants DeDe Sheel – Vice President-Investor Relations Peter Greenleaf – President and Chief Executive Officer Joe Miller – Chief Financial Officer Neil Solomons – Chief Medical Officer Conference Call Participants Ed Arce – HC Wainwright Justin Kim – Oppenheimer Olivia Brayer – Cantor Fitzgerald Sahil Dhingra – RBC Operator Greetings, and welcome to Aurinia Pharmaceuticals Second Quarter 2022 ...