Financial Data and Key Metrics Changes - For Q3 2024, total net revenue was $67.8 million, a 24% increase from $54.5 million in Q3 2023 [6][16] - Net product revenue for Q3 2024 was $55.5 million, up 36% from $40.8 million in Q3 2023 [6][17] - Cash flow from operations was approximately $17 million in Q3 2024, compared to a cash outflow of $13.3 million in Q3 2023 [7][16] - The company recorded a net income of $14.4 million, or $0.10 per share, compared to a net loss of $13.4 million, or $0.09 per share, in Q3 2023 [22] Business Line Data and Key Metrics Changes - The company added 364 PSFs and 146 new patients in Q3 2024, totaling 510, a 17% increase from 436 PSFs in Q3 2023 [8] - Total patients on LUPKYNIS therapy grew by 25%, reaching approximately 2,422 patients as of September 30, 2024, compared to 1,939 patients a year earlier [8] Market Data and Key Metrics Changes - The Japanese regulatory approval of LUPKYNIS triggered a $10 million milestone payment, with expectations of low double-digit royalties on net sales once launched in Japan [11] - Presentations at the American Society of Nephrology Kidney Week highlighted LUPKYNIS's role in treating lupus nephritis, particularly in affected populations [11][12] Company Strategy and Development Direction - The company is restructuring operations to enhance commercial and R&D efforts, aiming for a more focused operational strategy [13] - The restructuring will involve a workforce reduction of approximately 45%, with expected annualized cash-based operating expense savings of over $40 million [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business despite the restructuring, reaffirming 2024 revenue guidance [25] - The company anticipates continued growth driven by patient restarts and hospital-based sales, with a focus on maintaining high persistency rates [31] Other Important Information - The gross margin for Q3 2024 was 91%, compared to 88% in Q3 2023, while the gross margin for the first nine months of 2024 was 87%, down from 93% in the same period of 2023 [20] - Research and development expenses significantly decreased due to headcount reductions and the cessation of the AUR300 development program [21] Q&A Session Summary Question: Insights on restructuring and competitive positioning for AUR200 - Management clarified that the restructuring is based on a thorough review of business drivers and is not a sign of lack of confidence in the business [25][26] Question: Commentary on fourth quarter sales and guidance - Management feels comfortable with the current guidance range and noted potential factors affecting sales, including year-end insurance changes and holiday impacts [30] Question: Insights from the ENLIGHT-LN study on lupus nephritis treatment - Management indicated that the restart phenomenon is influenced by physician practices and guidelines, with expectations for increased persistency in treatment [31][32] Question: Dose levels and safety considerations for AUR200 - Management stated that dosing strategies will be determined through ongoing clinical studies, with a focus on balancing efficacy and safety [34] Question: Commentary on PSFs and sales environment - Management acknowledged the importance of PSFs but emphasized the need to consider restarts and hospital sales as part of the overall growth strategy [39]

分组1 - Aurinia Pharmaceuticals reported quarterly earnings of $0.10 per share, exceeding the Zacks Consensus Estimate of $0.02 per share, compared to a loss of $0.09 per share a year ago, representing an earnings surprise of 400% [1] - The company posted revenues of $67.77 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 14.74%, and compared to year-ago revenues of $54.52 million [2] - Aurinia has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates four times in the same period [2] 分组2 - The stock has underperformed the market, losing about 16.4% since the beginning of the year, while the S&P 500 gained 24.3% [3] - The current consensus EPS estimate for the coming quarter is $0.11 on revenues of $68.33 million, and for the current fiscal year, it is $0.04 on revenues of $235.59 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 33% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]

Financial Performance - Total net revenue for Q3 2024 was $67.8 million, a 24.3% increase from $54.5 million in Q3 2023[119] - Product revenue for Q3 2024 was $55.5 million, up from $40.8 million in Q3 2023, representing a 36.1% increase[117] - Net income for Q3 2024 was $14.4 million, compared to a net loss of $13.4 million in Q3 2023, marking a significant turnaround[117] - Total net revenue for the nine months ended September 30, 2024, was $175.3 million, an increase of 34.4% from $130.4 million in the same period of 2023[119] - Net product revenue increased to $55.5 million for the three months ended September 30, 2024, compared to $40.8 million for the same period in 2023, and $158.6 million for the nine months ended September 30, 2024, compared to $116.2 million in 2023[121] Expenses and Cost Management - Operating expenses decreased to $56.0 million in Q3 2024 from $70.8 million in Q3 2023, a reduction of 20.9%[117] - SG&A expenses decreased to $42.4 million for the three months ended September 30, 2024, from $47.8 million in 2023, and to $135.0 million for the nine months ended September 30, 2024, from $145.0 million in 2023[128] - R&D expenses were $3.0 million for the three months ended September 30, 2024, down from $13.6 million in 2023, and $12.7 million for the nine months ended September 30, 2024, compared to $39.4 million in 2023[129] Strategic Restructuring - The company anticipates a one-time restructuring charge of approximately $15 to $19 million in Q4 2024, with expected annualized cash savings of over $40 million post-restructuring[107] - The workforce will be reduced by approximately 45% as part of the strategic restructuring to focus on LUPKYNIS growth and AUR200 development[107] Product Development and Market Performance - The average annualized net realizable revenue per patient for LUPKYNIS is estimated to be between $70,000 and $75,000[105] - The company recognized a $10 million milestone payment as collaboration revenue following the approval of LUPKYNIS in Japan[109] - The company is developing AUR200, a potential next-generation therapy for autoimmune diseases, with the first participant dosed in a Phase 1 study[108] - The number of patients on therapy increased to approximately 2,422 as of September 30, 2024, from approximately 1,939 as of September 30, 2023, with a 12-month persistency rate rising to 57% from 54%[122] Revenue Sources and Trends - The percentage of total net revenues from the two main specialty pharmacies was 81% for the three months ended September 30, 2024, up from 77% in 2023, and 87% for the nine months ended September 30, 2024, down from 90% in 2023[120] - License, collaboration, and royalty revenues were $12.3 million for the three months ended September 30, 2024, compared to $13.7 million in 2023, and $16.7 million for the nine months ended September 30, 2024, compared to $14.2 million in 2023[123] Financial Position and Cash Flow - Cash, cash equivalents, and restricted cash as of September 30, 2024, were approximately $37.1 million, down from $48.9 million at December 31, 2023, while investments increased to $311.6 million from $301.8 million[134] - Net cash provided by operating activities was $14.3 million for the nine months ended September 30, 2024, compared to net cash used of $47.8 million in 2023[137] - As of September 30, 2024, approximately 3.4 million common shares were repurchased for $18.6 million under the approved share repurchase program[141] Risk Factors - The company is exposed to foreign currency risk primarily with the Swiss franc, Canadian dollar, and Great Britain Pound, which could affect operating and financial results[149] - Inflation has been volatile and may continue to increase costs related to labor, manufacturing, and clinical trials, impacting overall financial performance[151] - The company does not believe that sudden changes in market interest rates would significantly affect its results of operations or cash flows due to the short-term nature of its investments[148] Other Financial Insights - The company had an $80.7 million finance lease liability related to the monoplant as of September 30, 2024, with a 10% fluctuation in the Swiss franc potentially causing an $8.1 million fluctuation in the lease liability valuation[150] - The company has not recognized any allowance for credit losses related to accounts receivable during the quarter ended September 30, 2024, indicating no issues with collectability[153] - The company's investment policy limits investments to highly rated financial institutions and aims for an overall rating of A-1 or higher by Standard & Poor's[152] - The timing between revenue recognition for product sales and receipt of payment is not significant, with standard credit terms ranging from 30 to 45 days[153] - There were no material impacts from foreign currency fluctuations on the company's financial condition or results of operations as of September 30, 2024[150] - The company monitors economic conditions and the creditworthiness of its main specialty pharmacies and collaboration partners[153]

Financial Performance - Total net revenue for Q3 2024 was $67.8 million, a 24% increase year-over-year, while net product revenue was $55.5 million, reflecting a 36% growth[1][6][7] - The company achieved $158.6 million in net product revenue for the nine months ended September 30, 2024, a 36% increase from $116.2 million in the same period of 2023[1][7] - Total revenue for the three months ended September 30, 2024, was $67,771,000, a 24% increase from $54,515,000 in the same period of 2023[28] - Product revenue for the nine months ended September 30, 2024, reached $158,604,000, compared to $116,218,000 for the same period in 2023, reflecting a 36% increase[28] - Net income for the three months ended September 30, 2024, was $14,350,000, compared to a net loss of $13,447,000 in the same period of 2023[28] - The company recorded a net income of $14.4 million or $0.10 per share for Q3 2024, compared to a net loss of $(13.4) million or $(0.09) per share in Q3 2023[1][15][16] - The company reported a basic net income per share of $0.10 for the three months ended September 30, 2024, compared to a loss of $0.09 per share in the same period of 2023[28] Cash Flow and Expenses - Cash flow from operations for Q3 2024 was $17.0 million, compared to a cash outflow of $(13.3) million in Q3 2023[1][18] - Operating expenses for the three months ended September 30, 2024, totaled $56,023,000, down from $70,778,000 in the same period of 2023, representing a 21% decrease[28] - SG&A expenses decreased to $42.4 million in Q3 2024 from $47.8 million in Q3 2023, primarily due to lower employee-related costs[1][12] - Research and development expenses for the three months ended September 30, 2024, were $3,047,000, significantly lower than $13,605,000 in the same period of 2023[28] - The company had a net cash provided by operating activities of $14,274,000 for the nine months ended September 30, 2024, compared to a net cash used of $47,773,000 in the same period of 2023[29] Market and Product Development - LUPKYNIS market penetration in the U.S. grew by 25% year-over-year, with 2,422 patients on therapy as of September 30, 2024[1][8] - AUR200, a new therapy for autoimmune diseases, began Phase 1 study in September 2024, with initial results expected in the first half of 2025[1][4] - License, collaboration, and royalty revenues included a $10 million milestone payment from Otsuka Pharmaceutical for LUPKYNIS approval in Japan[1][9] Assets and Liabilities - Cash, cash equivalents, and restricted cash decreased to $37,142,000 as of September 30, 2024, from $48,875,000 at the end of 2023[26] - Total current assets increased to $440,459,000 as of September 30, 2024, compared to $424,800,000 at the end of 2023, marking a 4% increase[26] - Total liabilities decreased to $161,359,000 as of September 30, 2024, from $170,108,000 at the end of 2023, indicating a 5% reduction[26] Future Outlook - The company anticipates a one-time restructuring charge of $15 to $19 million in Q4 2024, with expected annualized cash-based operating expense savings of over $40 million post-restructuring[1][22] - The gross margin for Q3 2024 was 91%, up from 88% in Q3 2023[1][11]

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - Three small biotech stocks have been highlighted positively, showing upward movement due to favorable news, indicating they currently possess strong momentum [1] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade discussions and weekly market commentary [1] Group 2 - The analyst has disclosed a beneficial long position in the shares of AUPH, CORT, and VRDN, indicating a vested interest in these stocks [2] - The article expresses the author's personal opinions and does not represent any business relationship with the companies mentioned [2]

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH ) is a biopharmaceutical company focused on autoimmune diseases. Currently, AUPH’s hit product is LUPKYNIS, which is indicated for managing lupus nephritis [LN]. LN is a complication of systemic lupus erythematosus [SLE]. Thus, LUPKYNIS is an FDA-approved treatment for LN that offersMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in compu ...

When I last covered Aurinia Pharmaceuticals (NASDAQ: AUPH ) (TSX: AUP:CA ) in May, I rated the company a buy, as sales of Lupkynis seemed to have renewed growth. In the past two months, AUPH has; restructured its board, made movesScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure: I/we ha ...

Aurinia Pharmaceuticals, Inc. (NASDAQ:AUPH) Q2 2024 Earnings Conference Call August 1, 2024 8:30 AM ET Company Participants Andrea Christopher - Head, Corporate Communications & IR Peter Greenleaf - President, CEO & Director Greg Keenan - Chief Medical Officer Joe Miller - CFO Conference Call Participants Joseph Schwartz - Leerink Partners Stacy Ku - TD Cowen Ed Arce - H.C. Wainwright & Co. Operator Good day, ladies and gentlemen. Welcome to Aurinia Pharmaceuticals Second Quarter 2024 Earnings Call. [Operat ...

Aurinia Pharmaceuticals (AUPH) came out with quarterly earnings of $0.02 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to loss of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 100%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.17 per share when it actually produced a loss of $0.03, delivering a surprise of 82.35%.Over the last four quarters, ...

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |------------------------------------------------------------------|----------------------- ...