Latest news with #LUPKYNIS
National Post
22-05-2025
- Health
- National Post
New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis
Article content ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS ® (voclosporin), mycophenolate mofetil (MMF), and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. Article content The analysis assessed the achievement of urine protein creatine ratio (UPCR) targets of ≤0.4 g/g, ≤0.3 g/g, ≤0.2 g/g (classified as ultra-low UPCR), and ≤0.1 g/g in LN patients treated with LUPKYNIS-based triple immunosuppressive therapy compared to patients in the control group. Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). Patients in the triple immunosuppressive therapy group also achieved higher rates of all other UPCR targets compared to patients in the control group. Adverse event rates were comparable in both groups. Article content 'It is widely known that no level of proteinuria is safe for nephrons and that early reductions in proteinuria are predictive of better long-term kidney outcomes. Yet, UPCR endpoints have varied widely across clinical trials and in clinical practice,' said lead study author Maria Dall'Era, M.D., Professor of Medicine in the Division of Rheumatology, University of California, San Francisco. 'This analysis shows that achieving UPCR targets of ≤0.4 g/g may be a feasible goal and that a voclosporin-based triple immunosuppressive therapy regimen can reduce proteinuria to profoundly low levels in a proportion of patients.' Article content An additional post-hoc analysis from the AURORA 1 study evaluated lipidomic profiles in LN patients based on achievement of proteinuria reductions, including ultra-low UPCR, at Week 52. The analysis found a distinct lipidomic profile in patients who achieved ultra-low UPCR. This analysis builds upon a previous analysis of AURORA 1 in which patients who received triple immunosuppressive therapy with LUPKYNIS achieved significantly greater improvements in total and low-density lipoprotein (LDL) cholesterol compared to those in the control group. While further research is needed to clarify the role of certain lipids in the biochemistry of LN patients, these preliminary findings suggest that attaining ultra-low UPCR targets may provide additional benefits to LN patients and contribute to modification of cardiovascular disease risk. Article content An analysis of real-world baseline data from ENLIGHT-LN, a U.S.-based prospective, observational registry of adult LN patients treated with LUPKYNIS, was also presented at LUPUS 2025. 'The data presented at LUPUS 2025 highlight the critical role of LUPKYNIS in improving health outcomes for LN patients. Early reduction of proteinuria to the lowest possible levels and long-term preservation of kidney health are key goals of LN therapy. These data provide compelling evidence that LUPKYNIS-based therapy can achieve significantly lower UPCR targets, potentially reducing the risk of significant kidney damage and other comorbidities,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. Article content Title: Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome Authors: Farsad Afshinnia, Subramaniam Pennathur, Michelle Zubrycki, Linda Rehaume, Lucy Hodge Date: Thursday, May 22 Time: 12:10 – 1:10 PM ET Abstract Number: 252 Article content About LUPKYNIS Article content LUPKYNIS is a second generation calcineurin inhibitor with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of triple immunosuppressive therapy with LUPKYNIS, mycophenolate mofetil, and low-dose glucocorticoids to preserve kidney health in lupus nephritis patients without reliance on chronic high-dose glucocorticoids. It is the only clinical program in lupus nephritis to include three years of triple immunosuppressive therapy. Article content About Aurinia Article content Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). Article content LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Article content Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. Article content CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. Article content WARNINGS AND PRECAUTIONS Article content Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Article content Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Article content Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Article content Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. Article content Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms. Article content Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically. Article content QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. Article content Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. Article content Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Article content Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. Article content ADVERSE REACTIONS Article content The most common adverse reactions (≥3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Article content SPECIFIC POPULATIONS Article content Pregnancy: Avoid use of LUPKYNIS. Article content Lactation: Consider the mother's clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Article content Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Article content Dall'Era M. et al. Achievement of Proteinuria Less Than 0.4 G/G in the Phase 3 AURORA 1 Study of Voclosporin in Lupus Nephritis. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Geraldino-Pardilla L. et al. Baseline Demographics, Clinical Characteristics, and Treatment Regimens of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Afshinnia F. et al. Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Arriens C. et al. Arthritis Care & Research. Vol. 75, No. 7, July 2023, pp 1399–1408. Article content Article content Article content Article content Article content Contacts Article content Article content
Business Wire
22-05-2025
- Health
- Business Wire
New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS ® (voclosporin), mycophenolate mofetil (MMF), and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. The analysis assessed the achievement of urine protein creatine ratio (UPCR) targets of ≤0.4 g/g, ≤0.3 g/g, ≤0.2 g/g (classified as ultra-low UPCR), and ≤0.1 g/g in LN patients treated with LUPKYNIS-based triple immunosuppressive therapy compared to patients in the control group. Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). Patients in the triple immunosuppressive therapy group also achieved higher rates of all other UPCR targets compared to patients in the control group. Adverse event rates were comparable in both groups. 'It is widely known that no level of proteinuria is safe for nephrons and that early reductions in proteinuria are predictive of better long-term kidney outcomes. Yet, UPCR endpoints have varied widely across clinical trials and in clinical practice,' said lead study author Maria Dall'Era, M.D., Professor of Medicine in the Division of Rheumatology, University of California, San Francisco. 'This analysis shows that achieving UPCR targets of ≤0.4 g/g may be a feasible goal and that a voclosporin-based triple immunosuppressive therapy regimen can reduce proteinuria to profoundly low levels in a proportion of patients.' An additional post-hoc analysis from the AURORA 1 study evaluated lipidomic profiles in LN patients based on achievement of proteinuria reductions, including ultra-low UPCR, at Week 52. The analysis found a distinct lipidomic profile in patients who achieved ultra-low UPCR. This analysis builds upon a previous analysis of AURORA 1 in which patients who received triple immunosuppressive therapy with LUPKYNIS achieved significantly greater improvements in total and low-density lipoprotein (LDL) cholesterol compared to those in the control group. While further research is needed to clarify the role of certain lipids in the biochemistry of LN patients, these preliminary findings suggest that attaining ultra-low UPCR targets may provide additional benefits to LN patients and contribute to modification of cardiovascular disease risk. An analysis of real-world baseline data from ENLIGHT-LN, a U.S.-based prospective, observational registry of adult LN patients treated with LUPKYNIS, was also presented at LUPUS 2025. 'The data presented at LUPUS 2025 highlight the critical role of LUPKYNIS in improving health outcomes for LN patients. Early reduction of proteinuria to the lowest possible levels and long-term preservation of kidney health are key goals of LN therapy. These data provide compelling evidence that LUPKYNIS-based therapy can achieve significantly lower UPCR targets, potentially reducing the risk of significant kidney damage and other comorbidities,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. Following is the complete guide to Aurinia's accepted abstracts at LUPUS 2025: Title: Achievement of Proteinuria Less Than 0.4 G/G in the Phase 3 AURORA 1 Study of Voclosporin in Lupus Nephritis Authors: Maria Dall'Era, Brad Rovin, Salem Almaani, Lily Cipolla, Vanessa Birardi, Ernie Yap Date: Thursday, May 22 Time: 2:20 PM ET Abstract Number: 232 Title: Baseline Demographics, Clinical Characteristics, and Treatment Regimens of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry Authors: Laura Geraldino-Pardilla, Leanna Wise, Mohammad Kamgar, Niloofar Nobakht, Lily Cipolla, Lucy Hodge, Keelin Da'Lee Poster Session: Lupus Nephritis-Clinical Date/Time: On display for duration of meeting Abstract Number: 249 Title: Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome Authors: Farsad Afshinnia, Subramaniam Pennathur, Michelle Zubrycki, Linda Rehaume, Lucy Hodge Date: Thursday, May 22 Time: 12:10 – 1:10 PM ET Abstract Number: 252 About LUPKYNIS LUPKYNIS is a second generation calcineurin inhibitor with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of triple immunosuppressive therapy with LUPKYNIS, mycophenolate mofetil, and low-dose glucocorticoids to preserve kidney health in lupus nephritis patients without reliance on chronic high-dose glucocorticoids. It is the only clinical program in lupus nephritis to include three years of triple immunosuppressive therapy. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. IMPORTANT SAFETY INFORMATION Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. WARNINGS AND PRECAUTIONS Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms. Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically. QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. ADVERSE REACTIONS The most common adverse reactions (≥3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. SPECIFIC POPULATIONS Pregnancy: Avoid use of LUPKYNIS. Lactation: Consider the mother's clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS. References Dall'Era M. et al. Achievement of Proteinuria Less Than 0.4 G/G in the Phase 3 AURORA 1 Study of Voclosporin in Lupus Nephritis. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Geraldino-Pardilla L. et al. Baseline Demographics, Clinical Characteristics, and Treatment Regimens of an Initial Cohort of Patients Receiving Voclosporin for Lupus Nephritis in the Enlight-LN Registry. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Afshinnia F. et al. Attainment of Ultra-Low Levels of UPCR in the AURORA 1 Study Associated with Alterations in the Circulating Lipidome. Presented at LUPUS 2025 Congress, 2025, Toronto, CA. Arriens C. et al. Arthritis Care & Research. Vol. 75, No. 7, July 2023, pp 1399–1408.
Yahoo
13-05-2025
- Business
- Yahoo
Aurinia Pharmaceuticals Inc (AUPH) Q1 2025 Earnings Call Highlights: Strong Revenue Growth and ...
Total Revenue: $62.5 million, up 24% from $50.3 million in Q1 2024. Net Product Sales of LUPKYNIS: $60 million, up 25% from $48.1 million in Q1 2024. Cash Flow from Operations: $1.3 million, compared to negative $18.6 million in Q1 2024. Excluding restructuring payments, cash flow was $12.4 million. Cash, Cash Equivalents, and Investments: $312.9 million as of March 31, 2025, down from $358.5 million on December 30, 2024. Share Repurchase: 5.8 million shares repurchased for $47.4 million in Q1 2025. Cost of Revenue: $8.6 million, up from $7.8 million in Q1 2024. Gross Margin: 86%, compared to 85% in Q1 2024. Total Operating Expenses: $40.6 million, down from $63.6 million in Q1 2024. Net Income: $23.3 million or $0.17 per share, compared to a net loss of $10.7 million or $0.07 per share in Q1 2024. Warning! GuruFocus has detected 4 Warning Sign with DOLE. Release Date: May 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) reported a 24% increase in total revenue for Q1 2025, reaching $62.5 million compared to $50.3 million in Q1 2024. Net product sales of LUPKYNIS increased by 25% to $60 million in Q1 2025, driven by increased penetration in lupus nephritis treatment. The company generated positive cash flow from operations of $1.3 million in Q1 2025, a significant improvement from a negative cash flow of $18.6 million in Q1 2024. Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) has a strong cash position with $312.9 million in cash, cash equivalents, restricted cash, and investments as of March 31, 2025. The company is on track to report initial results from the Phase 1 study of AUR200, a dual BAFF/APRIL inhibitor, later this quarter, indicating progress in their pipeline development. Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) experienced a decrease in cash, cash equivalents, restricted cash, and investments from $358.5 million in December 2024 to $312.9 million in March 2025. The company repurchased 5.8 million of its common shares for $47.4 million, which could impact cash reserves. Total operating expenses were $40.6 million in Q1 2025, although reduced from $63.6 million in Q1 2024, still represent a significant cost. Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) faces challenges from ANDA filers challenging the validity of its 2037 dosing protocol patent, posing potential future risks. The company is involved in ongoing patent litigation, which could lead to uncertainties and potential financial implications. Q: Can you discuss the quarterly sales cadence for LUPKYNIS and what's driving sales growth? A: Peter Greenleaf, President and CEO, explained that the sales growth is driven by a combination of new patient additions, persistency, and improved time to getting patients on the drug. The company is focusing on educating rheumatologists, which has shown positive results in prescribing trends. Historical patterns suggest a lift in sales towards the end of the year. Q: What are the expectations for the second quarter and the rest of the year based on historical trends? A: Peter Greenleaf noted that historically, the second and third quarters have been softer due to the summer, with a rise in the fourth quarter. The guidance range for the year is based on these historical trends, and the company is optimistic about maintaining growth. Q: How is Aurinia addressing the ANDA filers challenging the 2037 dosing protocol patent? A: Peter Greenleaf stated that Aurinia has filed patent infringement lawsuits against all ANDA filers and intends to vigorously defend its patents. The company is focused on ensuring the longevity of LUPKYNIS as a priority. Q: What is Aurinia's exposure to potential new federal government policies, such as tariffs and MFN legislation? A: Peter Greenleaf explained that the API for LUPKYNIS is manufactured in Switzerland, but several years' worth of product is stockpiled in the US, minimizing tariff impact. The company is monitoring potential changes in transfer pricing and government reimbursement policies closely. Q: Can you provide more details on the AUR200 Phase 1 study and its competitive positioning? A: Peter Greenleaf mentioned that the single ascending dose data for AUR200 will be reported by the end of June. The study will provide insights into pharmacokinetics and pharmacodynamics, which will help assess its competitive positioning against other APRIL/BAFF inhibitors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Business Wire
12-05-2025
- Business
- Business Wire
Aurinia Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three months ended March 31, 2025. First Quarter 2025 Financial Results Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024. License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia's collaboration partner, Otsuka, was $2.5 million, up 14% from $2.2 million in the same period of 2024. Net Income (Loss): For the three months ended March 31, 2025, net income (loss) was $23.3 million, compared to $(10.7) million in the same period of 2024. Cash Flow Provided by (Used in) Operating Activities: For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025. Cash Position As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million, compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million. Full Year 2025 Total Revenue and Net Product Sales Guidance For 2025, Aurinia is reiterating its established total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million. 'We are pleased to report continued positive growth and momentum for LUPKYNIS in the first quarter of 2025 and are looking forward to a strong performance this year,' stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. 'Following the recent update to the American College of Rheumatology lupus nephritis treatment guideline, which recommends the incorporation of drugs like LUPKYNIS into first-line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm. We also remain on track to report initial results from our Phase 1 study of AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), later this quarter.' Webcast & Conference Call Details A webcast and conference call will be hosted today, May 12, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: LUPKYNIS net product sales, the timing of clinical study results and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at and on Aurinia's website at (in thousands) December 31, 2024 (Unaudited) ASSETS Current assets: Cash, cash equivalents and restricted cash $ 66,428 $ 83,433 Short-term investments 246,473 275,043 Accounts receivable, net 40,350 36,544 Inventory, net 46,195 39,228 Prepaid expenses and deposits 5,535 11,219 Other current assets 781 1,129 Total current assets 405,762 446,596 Finance right-of-use lease assets 87,577 92,072 Intangible assets, net 4,158 4,355 Operating right-of-use lease assets 3,954 4,068 Property and equipment, net 2,576 2,731 Other noncurrent assets 823 823 Total assets $ 504,850 $ 550,645 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,220 $ 5,187 Accrued expenses 42,353 64,971 Finance lease liabilities, current portion 14,508 14,046 Deferred revenue 4,594 11,002 Operating lease liabilities, current portion 1,036 1,026 Other current liabilities 1,695 1,531 Total current liabilities 68,406 97,763 Finance lease liabilities, less current portion 56,828 58,554 Deferred revenue, less current portion 12,450 1,699 Deferred compensation and other noncurrent liabilities 11,438 9,408 Operating lease liabilities, less current portion 5,538 5,743 Total liabilities 154,660 173,167 Shareholders' equity Common shares - no par value, unlimited shares authorized, 137,747 and 140,883 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 1,163,262 1,187,696 Additional paid-in capital 100,979 126,999 Accumulated other comprehensive loss (825 ) (647 ) Accumulated deficit (913,226 ) (936,570 ) Total shareholders' equity 350,190 377,478 Total liabilities and shareholders' equity $ 504,850 $ 550,645 Expand AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY (Unaudited) (in thousands, except per share data) Three months ended March 31, 2025 2024 Revenue Net product sales $ 59,971 $ 48,073 License, collaboration and royalty revenue 2,494 2,230 Total revenue 62,465 50,303 Operating expenses Cost of revenue 8,574 7,752 Selling, general and administrative 20,339 47,695 Research and development 5,743 5,551 Restructuring 1,533 6,683 Other expense (income), net 4,429 (4,125 ) Total operating expenses 40,618 63,556 Income (loss) from operations 21,847 (13,253 ) Interest income 3,569 4,526 Interest expense (1,067 ) (1,283 ) Net income (loss) before income taxes 24,349 (10,010 ) Income tax expense 1,005 739 Net income (loss) $ 23,344 $ (10,749 ) Earnings (loss) per share Basic $ 0.17 $ (0.07 ) Diluted $ 0.16 $ (0.07 ) Shares used in computing earnings (loss) per share Basic 138,917 144,013 Diluted 143,199 144,013 Expand AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY (Unaudited) (in thousands) Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net income (loss) $ 23,344 $ (10,749 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Share-based compensation (3,409 ) 5,737 Amortization and depreciation 4,856 4,847 Foreign exchange loss (gain) on revaluation of finance lease liability (Monoplant) 1,812 (6,025 ) Net amortization of premiums and discounts on investments (2,656 ) (3,206 ) Other, net 2,325 1,559 Net changes in operating assets and liabilities: Accounts receivable, net (3,806 ) (4,820 ) Inventory, net (6,967 ) (56 ) Prepaid expenses and other current assets 6,033 873 Other noncurrent operating assets — 17 Accounts payable (974 ) 1,345 Accrued expenses and other liabilities (23,405 ) (7,936 ) Deferred revenue 4,342 (3 ) Operating lease liabilities (195 ) (181 ) Net cash provided by (used in) operating activities 1,300 (18,598 ) Cash flows from investing activities: Proceeds from the sale and maturities of investments 123,035 170,505 Purchases of investments (91,986 ) (121,260 ) Purchase of property, equipment and intangible assets (17 ) (12 ) Net cash provided by investing activities 31,032 49,233 Cash flows from financing activities: Repurchase of common shares (46,921 ) (12,301 ) Principal portion of finance lease payments (2,771 ) (2,778 ) Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs and performance awards 9,288 5,524 Taxes paid related to net settlement of exercises of stock options and vesting of RSUs and performance awards (8,933 ) (5,496 ) Net cash used in financing activities (49,337 ) (15,051 ) Net (decrease) increase in cash, cash equivalents and restricted cash (17,005 ) 15,584 Cash, cash equivalents and restricted cash, beginning of the period 83,433 48,875 Cash, cash equivalents and restricted cash, end of the period $ 66,428 $ 64,459 Expand
Malaysian Reserve
09-05-2025
- Health
- Malaysian Reserve
LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows
As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ — DelveInsight's 'LUPKYNIS Market Size, Forecast, and Market Insight Report' highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Drug Name LUPKYNIS (voclosporin) Molecule type Small molecule Developer Aurinia Pharmaceuticals/Otsuka Pharmaceutical Approval year US: 2021; EU: 2022; JP: 2024 Primary Indication Lupus nephritis Mechanism of action Calcineurin-inhibitor immunosuppressant Route of administration Oral Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents 1 Report Introduction 2 LUPKYNIS: Aurinia Pharmaceuticals/Otsuka Pharmaceutical 2.1 Product Overview 2.2 Other Development Activities 2.3 Clinical Development 2.4 Clinical Trials Information 2.5 Safety and Efficacy 2.6 Product Profile 2.7 Market Assessment 2.7.1 The 7MM Analysis 2.7.1.1 Cost Assumptions and Rebate 2.7.1.2 Pricing Trends 2.7.1.3 Analogue Assessment 2.7.1.4 Launch Year and Therapy Uptake 2.7.2 The United States Market Analysis 2.7.3 EU4 and the United Kingdom Market Analysis 2.7.3.1 Germany 2.7.3.2 France 2.7.3.3 Italy 2.7.3.4 Spain 2.7.3.5 UK 2.7.4 Japan Market Analysis 2.8 Market Drivers 2.9 Market Barriers 2.10 SWOT Analysis 3 Key Cross of Marketed Competitors of LUPKYNIS 4 Key Cross of Emerging Competitors of LUPKYNIS Related Reports Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content:
