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Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2024 Financial and Operational Results

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Aurinia Pharmaceuticals reported strong Q2 2024 financial results, with total net revenue of $57.2 million, up 38% year-over-year. Net product revenue reached $55.0 million, a 34% increase. The company generated $15.8 million in free cash flow and had $330.7 million in cash and investments as of June 30, 2024. Aurinia narrowed its 2024 net product revenue guidance to $210-$220 million. The company also announced plans to advance AUR200, a potential next-generation therapy for autoimmune diseases. LUPKYNIS showed strong growth with 2,336 patients on therapy, a 22% increase from the previous year. Aurinia expects Japanese regulatory approval for LUPKYNIS in the second half of 2024.

Aurinia Pharmaceuticals ha riportato risultati finanziari solidi per il secondo trimestre del 2024, con entrate nette totali di 57,2 milioni di dollari, in aumento del 38% rispetto all'anno precedente. Le entrate nette da prodotto hanno raggiunto i 55,0 milioni di dollari, con un incremento del 34%. L'azienda ha generato 15,8 milioni di dollari in flusso di cassa libero e aveva 330,7 milioni di dollari in contanti e investimenti al 30 giugno 2024. Aurinia ha ristretto la sua guida per le entrate nette da prodotto del 2024 a 210-220 milioni di dollari. L'azienda ha anche annunciato piani per sviluppare AUR200, una potenziale terapia di nuova generazione per le malattie autoimmuni. LUPKYNIS ha mostrato una forte crescita con 2.336 pazienti in terapia, un aumento del 22% rispetto all'anno precedente. Aurinia prevede l'approvazione normativa giapponese per LUPKYNIS nel secondo semestre del 2024.

Aurinia Pharmaceuticals reportó resultados financieros sólidos para el segundo trimestre de 2024, con ingresos netos totales de 57,2 millones de dólares, un aumento del 38% en comparación con el año anterior. Los ingresos netos por producto alcanzaron los 55,0 millones de dólares, un incremento del 34%. La empresa generó 15,8 millones de dólares en flujo de caja libre y tuvo 330,7 millones de dólares en efectivo e inversiones hasta el 30 de junio de 2024. Aurinia ajustó su proyección de ingresos netos por producto para 2024 a 210-220 millones de dólares. La compañía también anunció planes para avanzar en AUR200, una terapia potencial de próxima generación para enfermedades autoinmunes. LUPKYNIS mostró un sólido crecimiento con 2,336 pacientes en terapia, un aumento del 22% con respecto al año anterior. Aurinia espera la aprobación regulatoria japonesa para LUPKYNIS en la segunda mitad de 2024.

Aurinia Pharmaceuticals는 2024년 2분기 강력한 재무 결과를 보고하며, 총 순수익은 5720만 달러로 전년 대비 38% 증가했습니다. 제품 순수익은 5500만 달러에 달하며, 34% 증가했습니다. 회사는 1580만 달러의 자유 현금 흐름을 창출했으며, 2024년 6월 30일 기준으로 3억 3070만 달러의 현금과 투자를 보유하고 있었습니다. Aurinia는 2024년 제품 순수익 전망을 2억 1000만-2억 2000만 달러로 좁혔습니다. 회사는 자가면역 질환을 위한 차세대 치료제인 AUR200의 개발 계획도 발표했습니다. LUPKYNIS는 2,336명의 환자가 치료 중으로 전년 대비 22% 증가하는 강력한 성장을 보였습니다. Aurinia는 2024년 하반기 일본의 규제 승인을 예상하고 있습니다.

Aurinia Pharmaceuticals a annoncé de solides résultats financiers pour le deuxième trimestre 2024, avec des revenus nets totaux de 57,2 millions de dollars, en hausse de 38 % par rapport à l'année précédente. Les revenus nets des produits ont atteint 55,0 millions de dollars, soit une augmentation de 34 %. L'entreprise a généré 15,8 millions de dollars de flux de trésorerie libre et disposait de 330,7 millions de dollars en espèces et investissements au 30 juin 2024. Aurinia a réduit son prévision pour les revenus nets des produits de 2024 à 210-220 millions de dollars. La société a également annoncé des plans pour faire avancer AUR200, une thérapie potentielle de prochaine génération pour les maladies auto-immunes. LUPKYNIS a montré une forte croissance avec 2 336 patients sous traitement, soit une augmentation de 22 % par rapport à l'année précédente. Aurinia s'attend à obtenir l'approbation réglementaire japonaise pour LUPKYNIS au second semestre 2024.

Aurinia Pharmaceuticals berichtete über starke Finanzergebnisse für das zweite Quartal 2024, mit Gesamtnettoeinnahmen von 57,2 Millionen Dollar, was einem Anstieg von 38 % im Vergleich zum Vorjahr entspricht. Die Netto-Produkteinnahmen beliefen sich auf 55,0 Millionen Dollar, ein Anstieg um 34 %. Das Unternehmen generierte 15,8 Millionen Dollar an freiem Cashflow und verfügte zum 30. Juni 2024 über 330,7 Millionen Dollar in Bargeld und Investitionen. Aurinia hat die Prognose für die Netto-Produkteinnahmen 2024 auf 210-220 Millionen Dollar eingegrenzt. Das Unternehmen kündigte zudem Pläne zur Weiterentwicklung von AUR200 an, einer potenziellen Therapiegeneration für Autoimmunerkrankungen. LUPKYNIS zeigte ein starkes Wachstum mit 2.336 Patienten in Therapie, was einem Anstieg von 22 % im Vergleich zum Vorjahr entspricht. Aurinia erwartet die japanische Zulassung für LUPKYNIS in der zweiten Hälfte des Jahres 2024.

Positive
  • Total net revenue increased 38% year-over-year to $57.2 million
  • Net product revenue grew 34% to $55.0 million
  • Generated $15.8 million in free cash flow
  • Cash and investments of $330.7 million as of June 30, 2024
  • Narrowed 2024 net product revenue guidance to $210-$220 million
  • 22% growth in patients on LUPKYNIS therapy, reaching 2,336 patients
  • Maintained high overall adherence rate at approximately 88%
  • Strong persistency with 56% of patients remaining on therapy at 12 months
Negative
  • Gross margin decreased to 84% from 96% in Q2 2023
  • Restructuring expenses of $1.1 million in Q2 2024
  • Interest expense increased to $1.2 million from $0.1 million in Q2 2023

Insights

Aurinia Pharmaceuticals' Q2 2024 results demonstrate strong financial performance and operational progress. The company reported $57.2 million in total net revenue, a 38% year-over-year increase, driven by $55.0 million in net product revenue, up 34% from the previous year. This growth is primarily attributed to increased LUPKYNIS sales and market penetration.

Key financial highlights include:

  • Generated $15.8 million in free cash flow, a significant improvement from cash used in the same period last year
  • Cash position of $330.7 million as of June 30, 2024
  • Narrowed 2024 net product revenue guidance to $210-$220 million
  • Gross margin of 84%, down from 96% in Q2 2023 due to increased costs associated with the monoplant facility

The company's focus on commercial execution and cost management is evident, with SG&A expenses decreasing year-over-year. The anticipated $50-$55 million in annual cost savings following restructuring should further improve profitability. However, investors should monitor the impact of increased costs related to the monoplant facility on gross margins.

Aurinia's strong cash position and positive free cash flow provide financial flexibility for pipeline development and potential portfolio diversification. The share repurchase program, with $18.6 million spent to date, demonstrates confidence in the company's long-term prospects.

Aurinia's Q2 results highlight significant progress in both commercial and clinical aspects. The 22% growth in patients on LUPKYNIS therapy, reaching approximately 2,336 patients, indicates strong market adoption and physician acceptance. This growth, coupled with high conversion rates (85%) and persistency (56% at 12 months), suggests LUPKYNIS is meeting an important medical need in lupus nephritis treatment.

The company's pipeline development strategy for AUR200 is particularly intriguing. Targeting both BAFF and APRIL, this potential next-generation therapy for autoimmune diseases could address high unmet needs. The dual-pronged development approach - exploring one larger indication and one fast-to-market smaller indication meeting orphan and rare disease criteria - is a smart strategy to balance risk and potential market opportunity.

Key clinical milestones to watch:

  • First patients entering Phase 1 Single Ascending Dose study of AUR200 in Q3 2024
  • Data from the SAD study expected in H1 2025
  • Potential approval of LUPKYNIS in Japan in H2 2024

The anticipated Japanese approval could open up a significant new market, with a $10 million milestone payment and low double-digit royalties expected. This geographic expansion, combined with the advancing pipeline, positions Aurinia well for future growth in the autoimmune disease space.

  • Company achieved $57.2 million in total net revenue and $55.0 million in net product revenue for the second quarter of 2024, representing year-over-year growth of approximately 38% and 34% respectively
  • Company generated approximately $15.8 million in free cash flow in the second quarter and had cash, cash equivalents, restricted cash and investments of $330.7 million as of June 30, 2024
  • Company announces development strategy for AUR200, its potential next generation pipeline asset for autoimmune diseases targeting BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)
  • Company narrows 2024 net product revenue guidance range to $210 to $220 million

Conference call to be hosted today at 8:30 a.m. ET

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the second quarter and six months ended June 30, 2024. Amounts are expressed in U.S. dollars.

Total net revenue was $57.2 million for the three months ended June 30, 2024, and $41.5 million for the same period in 2023, representing growth of approximately 38%. Year to date total net revenue was $107.5 million for the six months ended June 30, 2024, compared to $75.9 million for the same period in 2023, representing growth of approximately 42%.

Net product revenue was $55.0 million for the three months ended June 30, 2024, and $41.1 million for the same period in 2023, representing growth of approximately 34%. Net product revenue was $103.1 million for the six months ended June 30, 2024, and $75.4 million for the same period in 2023, representing growth of approximately 37%. Net product revenue in the second quarter included sales of semi-finished product to Otsuka Pharmaceutical Co., Ltd. (Otsuka) for distribution in Europe and in anticipation of product approval in Japan.

“Our quarter-over-quarter growth in the second quarter is a result of our continued focus on commercial execution and business fundamentals. We are well prepared as we exit the first half of 2024, with upcoming innovative commercial initiatives targeting rheumatologists, the advancement of our AUR200 pipeline asset, and the anticipated approval of LUPKYNIS® in Japan. Additionally, achieving positive free cash flow ahead of our initial projections further strengthens our financial position and allows more flexibility to explore opportunities to diversify our portfolio,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia.

The Company anticipates Japanese regulatory authorities' approval of LUPKYNIS in the second half of this year, based on the JNDA that Otsuka filed in November 2023 for approval of LUPKYNIS to treat adults with LN. Upon approval, the Company expects to receive a milestone payment of $10 million with low double-digit royalties on net sales once launched.

Additionally, the Company is moving forward with development of its pipeline asset AUR200, a differentiated, potential next generation therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).

“We are thrilled to advance AUR200, which has the potential to serve as a best-in-class treatment in disease areas with high unmet need. We intend to develop it in disease states where there are currently few market entrants, including exploring one larger indication and one fast-to-market smaller indication that meets the FDA criteria for orphan and rare diseases,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.

First patients are expected to enter the Phase 1 Single Ascending Dose (SAD) study of AUR200 in the third quarter of 2024. Data from the SAD study, including safety, tolerability, pharmacokinetics, and biomarkers, is anticipated in the first half of 2025. The Company anticipates funding this development program with available cash flow, which is not anticipated to impact previously announced post restructuring operating expense targets. As previously reported, the Company expects to recognize $50 to $55 million in annual cost savings following the restructuring, with approximately 75% of that recognized in 2024.

For the fiscal year 2024, the Company is narrowing its net product revenue guidance range to $210 to $220 million, from the previously established range of $200 to $220 million. The guidance range is based on assumptions regarding historical run rates for patient start forms (PSF), patients restarting therapy, hospital fills, conversion rates, time to convert, persistency, and pricing.

Second Quarter 2024 Highlights

In the second quarter of 2024 the Company:

  • Achieved 22% growth in patients on LUPKYNIS therapy, with approximately 2,336 patients on therapy as of June 30, 2024, compared to 1,911 as of June 30, 2023.
  • Added 428 PSFs and approximately 127 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy in the second quarter, compared to 451 PSFs in the prior year second quarter.
  • Added approximately 538 PSFs and approximately 155 new patients from restarts and the hospital channel from April 1, 2024, through July 31, 2024.
  • Sustained conversion rates, with approximately 85% of PSFs converted to patients on therapy.
  • Sustained time to convert, with approximately 60% of patients on therapy by 20 days.
  • Maintained high overall adherence rate at approximately 88%.
  • Continued strong persistency, with approximately 56% of patients remaining on therapy at 12 months, 51% at 15 months, and 46% at 18 months.

Financial Results for the Three and Six Months Ended June 30, 2024

Total net revenue was $57.2 million and $41.5 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Total net revenue was $107.5 million and $75.9 million for the six months ended June 30, 2024 and June 30, 2023, respectively.

Net product revenue was $55.0 million and $41.1 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Net product revenue was $103.1 million and $75.4 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to an increase in sales of LUPKYNIS to the Company’s two main specialty pharmacies, driven predominantly by further penetration of the LN market. Additionally, Aurinia had sales of semi-finished product to Otsuka as Otsuka continues to commercialize in its territories.

The U.S. penetration can be demonstrated by a total of approximately 2,336 patients on therapy as of June 30, 2024, compared to approximately 1,911 patients on therapy as of June 30, 2023. Additionally, the 12-month persistency rate has increased to 56% at June 30, 2024 from approximately 54% at June 30, 2023.

License, collaboration and royalty revenue was $2.2 million and $0.4 million for the three months ended June 30, 2024 and June 30, 2023, respectively. License, collaboration and royalty revenue was $4.4 million and $0.5 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to manufacturing services revenue from Otsuka related to shared capacity services that commenced in late June 2023.

Total cost of sales and operating expenses, inclusive of a restructuring charge in the second quarter of 2024, were $58.7 million and $57.7 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Total cost of sales and operating expenses inclusive of a restructuring charge were $122.3 million and $121.7 million for the six months ended June 30, 2024 and June 30, 2023, respectively. Further breakdown of cost of sales and operating expense drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $8.9 million and $1.6 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Cost of sales were $16.7 million and $2.0 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The increase is primarily due to the amortization of the monoplant finance right of use asset, which was placed into service in late June 2023, semi-finished product sales to Otsuka and increased sales of LUPKYNIS (voclosporin).

Gross margin was approximately 84% and 96% for the three months ended June 30, 2024 and June 30, 2023, respectively. Gross margin was approximately 85% and 97% for the six months ended June 30, 2024 and June 30, 2023, respectively.

SG&A expenses, inclusive of share-based compensation, were $44.9 million and $47.1 million for the three months ended June 30, 2024 and June 30, 2023, respectively. SG&A expenses, inclusive of share-based compensation, were $92.6 million and $97.2 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The decrease is primarily due to lower employee and overhead costs as a result of a reduction in general and administrative headcount, which occurred late in the first quarter of 2024 partially offset by an increase in legal fees.

Non-cash SG&A share-based compensation expense included within SG&A expenses was $8.1 million and $9.8 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Non-cash SG&A share-based compensation expense included within SG&A expenses was $15.6 million and $17.4 million for the six months ended June 30, 2024 and June 30, 2023, respectively.

R&D expenses, inclusive of share-based compensation expense, were $4.1 million and $12.7 million for the three months ended June 30, 2024 and June 30, 2023, respectively. R&D expenses, inclusive of share-based compensation expense, were $9.6 million and $25.8 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The primary drivers for the decrease were lower employee costs due to a reduction in headcount, which occurred late in the first quarter of 2024, a decrease of CRO and developmental expenses related to ceasing development of Aurinia’s AUR300 program and timing of expenses related to AUR200.

Non-cash R&D share-based compensation expense included within R&D expense was $0.1 million and $2.1 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Non-cash R&D share-based compensation expense included within R&D expense was $(2.1) million and $3.7 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The non-cash R&D share-based compensation credit in the six months ended June 30, 2024 is due to the reversals of expense for forfeitures related to a reduction in headcount in the first quarter of 2024.

Restructuring expenses were approximately $1.1 million and nil for the three months ended June 30, 2024 and June 30, 2023, respectively. Restructuring expenses were approximately $7.8 million and nil for the six months ended June 30, 2024 and June 30, 2023, respectively. Restructuring expenses primarily included employee severance, one-time benefit payments and contract termination expenses.

Other income, net was $0.3 million and $3.6 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Other income, net was $4.4 million and $3.3 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The change is primarily driven by changes in the fair value assumptions related to Aurinia’s deferred compensation liability and the foreign exchange remeasurement of the monoplant lease liability, which commenced in June 2023 and is denominated in CHF.

Interest income was $4.2 million and $4.1 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Interest income was $8.7 million and $7.9 million for the six months ended June 30, 2024 and June 30, 2023, respectively.

Interest expense was $1.2 million and $0.1 million for the three months ended June 30, 2024 and June 30, 2023, respectively. Interest expense was $2.5 million and $0.1 million for the six months ended June 30, 2024 and June 30, 2023, respectively. The interest expense is due to the monoplant finance lease, which commenced in June 2023.

For the three months ended June 30, 2024, Aurinia recorded net income of $0.7 million or $0.01 net income per common share, as compared to a net loss of $11.5 million or $(0.08) net loss per common share for the three months ended June 30, 2023. For the six months ended June 30, 2024, Aurinia recorded a net loss of $10.0 million or $(0.07) net loss per common share, as compared to a net loss of $37.7 million or $(0.26) net loss per common share for the three months ended June 30, 2023.

Financial Liquidity at June 30, 2024

As of June 30, 2024, Aurinia had cash, cash equivalents, restricted cash and investments of $330.7 million compared to $350.7 million at December 31, 2023. The decrease is primarily related to the continued investment in commercialization activities and post approval commitments of our approved drug, LUPKYNIS, monoplant payments, share repurchases and restructuring related payments, partially offset by an increase in cash receipts from sales of LUPKYNIS and cash payments from Otsuka.

Cash generated from operations and non-GAAP free cash flow generated were $15.8 million for the three months ended June 30, 2024 compared to cash used in operations of $2.8 million and non-GAAP free cash flow used of $3.0 million for the three months ended June 30, 2023. Cash used in operations and non-GAAP free cash flow used were $2.8 million for the six months ended June 30, 2024 compared to cash used in operations of $34.5 million and non-GAAP free cash flow used of $35.0 million for the six months ended June 30, 2023.

Free cash flow is a non-GAAP financial measure calculated by subtracting purchases of property and equipment from net cash provided by or used in operating activities. Free cash flow reflects a view of Aurinia’s liquidity that, when viewed with the Company’s GAAP results, provides a more complete understanding of factors and trends affecting Aurinia’s cash flows. The Company believes it is a more conservative measure of cash flow since capital expenditures are necessary for ongoing operations. Free cash flow has limitations due to the fact that it does not represent the residual cash flow available for discretionary expenditures. For example, free cash flow does not incorporate the principal portion of payments made or expected to be made on finance lease obligations. Therefore, the Company believes it is important to view free cash flow as a complement to its entire consolidated statements of cash flows.

A reconciliation of free cash flow to its most directly comparable GAAP measure, net cash provided by or used in operating activities, is set out in the Condensed Consolidated Statement of Cash Flows included at the end of this press release.

Share Repurchase Program

As previously announced, Aurinia’s Board of Directors approved a share repurchase program of up to $150 million common shares of the Company. Canadian securities regulators also granted exemptive relief for the Company’s share repurchase program, authorizing the Company to purchase up to 15 percent of its issued and outstanding shares in any 12-month period for up to 36 months. Through July 31, 2024 Aurinia has repurchased 3.4 million shares for approximately $18.6 million at an average cost of $5.36. The Company expects to fund any future discretionary share repurchases from cash flows from operations and cash currently on hand.

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

Conference Call Details

Aurinia will host a conference call and webcast today, August 1, 2024, at 8:30 AM ET to discuss the quarter and six months ended June 30, 2024, financial results. The link to the audio webcast is available here or on Aurinia’s corporate website at www.auriniapharma.com under “News/Events” through the Investors section. To join the conference call, please dial +1 (866) 682-6100 / +1 (862) 298-0702 (Toll-free U.S. & Canada). A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes.

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. The Company’s head office is in Edmonton, Alberta, with its U.S. commercial office in Rockville, Maryland. The Company focuses its development efforts globally.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia’s expectation to recognize $50 to $55 million in annual cost savings following its corporate restructuring, with approximately 75% of that recognized in 2024; Aurinia’s estimates as to annual net product revenue from sales of LUPKYNIS in the range of $210 to $220 million in 2024; Aurinia’s expectations to achieve several key milestones in the second half of 2024; Aurinia’s belief that AUR200 has the potential to serve as a best-in-class treatment in disease areas with high unmet need; the anticipated timing of approval of voclosporin in Japan; the anticipated timeline for the development plan for AUR200, including manner of funding, and timing first patients enrolled in, and timing of data read out for, studies; and Aurinia’s estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who have developed LN at time of SLE diagnosis. It is possible that such results or conclusions may change. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. The Company has made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; the number, and timing of receipt, of PSFs and their rate of conversion into patients on therapy; assumptions relating to pricing for LUPKYNIS and patient persistency on the product; that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia’s assumptions relating to regulatory review processes and timelines; Aurinia’s assumptions relating to the clinical development opportunities for its pipeline products; Aurinia’s assumptions relating to the capital required to fund operations; the assumption that Aurinia’s current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia’s cash for operations; assumptions related to timing of interactions with regulatory bodies; and that Aurinia’s third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

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

 

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

(unaudited)

 

June 30,
2024

 

December 31,
2023

 

 

 

 

 

ASSETS

 

 

 

 

Current assets

 

 

 

 

Cash, cash equivalents and restricted cash

 

$

33,407

 

$

48,875

Short-term investments

 

 

297,068

 

 

301,614

Accounts receivable, net

 

 

25,522

 

 

24,089

Inventories, net

 

 

38,853

 

 

39,705

Prepaid expenses

 

 

7,840

 

 

9,486

Other current assets

 

 

6,976

 

 

1,031

Total current assets

 

 

409,666

 

 

424,800

 

 

 

 

 

Non-current assets

 

 

 

 

Long-term investments

 

 

199

 

 

201

Other non-current assets

 

 

867

 

 

1,517

Property and equipment, net

 

 

3,043

 

 

3,354

Acquired intellectual property and other intangible assets, net

 

 

4,621

 

 

4,977

Finance right-of-use asset, net

 

 

100,845

 

 

108,715

Operating right-of-use assets, net

 

 

4,288

 

 

4,498

Total assets

 

$

523,529

 

$

548,062

 

 

 

 

 

LIABILITIES

 

 

 

 

Current liabilities

 

 

 

 

Accounts payable and accrued liabilities

 

 

56,460

 

 

54,389

Deferred revenue

 

 

4,367

 

 

4,813

Other current liabilities

 

 

1,162

 

 

2,388

Finance lease liability

 

 

13,906

 

 

14,609

Operating lease liabilities

 

 

1,008

 

 

989

Total current liabilities

 

 

76,903

 

 

77,188

 

 

 

 

 

Non-current liabilities

 

 

 

 

Finance lease liability

 

 

64,923

 

 

75,479

Operating lease liabilities

 

 

6,146

 

 

6,530

Deferred compensation and other non-current liabilities

 

 

10,941

 

 

10,911

Total liabilities

 

 

158,913

 

 

170,108

SHAREHOLDER’S EQUITY

 

 

 

 

Common shares - no par value, unlimited shares authorized, 142,984 and 143,833 shares issued and
outstanding at June 30, 2024 and December 31, 2023, respectively

 

 

1,205,554

 

 

1,200,218

Additional paid-in capital

 

 

112,270

 

 

120,788

Accumulated other comprehensive loss

 

 

(859)

 

 

(730)

Accumulated deficit

 

 

(952,349)

 

 

(942,322)

Total shareholders' equity

 

 

364,616

 

 

377,954

Total liabilities and shareholders' equity

 

$

523,529

 

$

548,062

 

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

 

 

Three months ended

 

Six months ended

 

 

June 30,

 

June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(unaudited)

Revenue

 

 

 

 

 

 

 

 

Product revenue, net

 

$

55,028

 

$

41,100

 

$

103,101

 

$

75,437

License, collaboration and royalty revenue

 

 

2,164

 

 

394

 

 

4,394

 

 

466

Total revenue, net

 

 

57,192

 

 

41,494

 

 

107,495

 

 

75,903

Operating expenses

 

 

 

 

 

 

 

 

Cost of sales

 

 

8,909

 

 

1,563

 

 

16,661

 

 

1,984

Selling, general and administrative

 

 

44,934

 

 

47,081

 

 

92,629

 

 

97,205

Research and development

 

 

4,080

 

 

12,650

 

 

9,631

 

 

25,808

Restructuring expenses

 

 

1,072

 

 

 

 

7,755

 

 

Other income, net

 

 

(290)

 

 

(3,630)

 

 

(4,415)

 

 

(3,340)

Total cost of sales and operating expenses

 

 

58,705

 

 

57,664

 

 

122,261

 

 

121,657

Loss from operations

 

 

(1,513)

 

 

(16,170)

 

 

(14,766)

 

 

(45,754)

Interest expense

 

 

(1,198)

 

 

(65)

 

 

(2,481)

 

 

(65)

Interest income

 

 

4,189

 

 

4,101

 

 

8,715

 

 

7,915

Net income (loss) before income taxes

 

 

1,478

 

 

(12,134)

 

 

(8,532)

 

 

(37,904)

Income tax expense (benefit)

 

 

756

 

 

(642)

 

 

1,495

 

 

(206)

Net income (loss)

 

$

722

 

$

(11,492)

 

$

(10,027)

 

$

(37,698)

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

$

(0.08)

 

$

(0.07)

 

$

(0.26)

Diluted

 

$

0.01

 

$

(0.08)

 

$

(0.07)

 

$

(0.26)

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

Basic

 

 

143,327

 

 

142,777

 

 

143,507

 

 

142,904

Diluted

 

 

144,110

 

 

142,777

 

 

143,507

 

 

142,904

 

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

(in thousands)

 

(unaudited)

Cash flows from operating activities

 

 

 

 

Net loss

 

$

(10,027)

 

$

(37,698)

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

 

 

 

 

Depreciation and amortization

 

 

9,690

 

 

1,436

Net amortization of premiums and discounts on short-term investments

 

 

(6,331)

 

 

(5,599)

Share-based compensation expense

 

 

14,323

 

 

21,735

Foreign exchange on finance lease liability

 

 

(5,705)

 

 

417

Other, net

 

 

275

 

 

(3,652)

Net changes in operating assets and liabilities

 

 

 

 

Accounts receivable, net

 

 

(1,433)

 

 

(6,016)

Inventories, net

 

 

852

 

 

(8,403)

Prepaid expenses and other current assets

 

 

(4,305)

 

 

2,374

Non-current operating assets

 

 

(12)

 

 

(16)

Accounts payable, accrued and other liabilities

 

 

283

 

 

1,245

Operating lease liabilities

 

 

(365)

 

 

(319)

Net cash used in operating activities

 

 

(2,755)

 

 

(34,496)

Cash flows from investing activities

 

 

 

 

Purchase of investments

 

 

(318,126)

 

 

(256,439)

Proceeds from investments

 

 

328,877

 

 

288,291

Upfront lease payment

 

 

(44)

 

 

(11,864)

Purchase of property and equipment

 

 

 

 

(524)

Capitalized patent costs

 

 

(96)

 

 

(212)

Net cash provided by investing activities

 

 

10,611

 

 

19,252

Cash flows from financing activities

 

 

 

 

Repurchase of common shares

 

 

(18,435)

 

 

Principal portion of finance lease payments

 

 

(6,001)

 

 

Proceeds from exercise of stock options and employee share purchase plan

 

 

1,112

 

 

2,779

Cash (used in) provided by financing activities

 

 

(23,324)

 

 

2,779

Net decrease in cash, cash equivalents and restricted cash

 

 

(15,468)

 

 

(12,465)

Cash, cash equivalents and restricted cash, beginning of period

 

 

48,875

 

 

94,172

Cash, cash equivalents and restricted cash, end of period

 

$

33,407

 

$

81,707

 

 

 

 

 

Reconciliation of free cash flow(1)

 

 

 

 

Net cash used in operating activities

 

$

(2,755)

 

$

(34,496)

Purchases of property and equipment

 

 

 

 

(524)

Free cash flow

 

$

(2,755)

 

$

(35,020)

(1) Free cash flow is a non-GAAP financial measure and is calculated as net cash provided by or used in operating activities reduced by purchases of property and equipment.

 

Media and Investor Inquiries:

Andrea Christopher

Corporate Communications and Investor Relations, Aurinia

achristopher@auriniapharma.com

ir@auriniapharma.com

Source: Aurinia Pharmaceuticals Inc.

FAQ

What was Aurinia Pharmaceuticals' total net revenue for Q2 2024?

Aurinia Pharmaceuticals reported total net revenue of $57.2 million for Q2 2024, representing a 38% year-over-year growth.

How many patients were on LUPKYNIS therapy as of June 30, 2024?

As of June 30, 2024, approximately 2,336 patients were on LUPKYNIS therapy, showing a 22% growth compared to the same period in 2023.

What is Aurinia's updated net product revenue guidance for 2024?

Aurinia narrowed its 2024 net product revenue guidance range to $210 to $220 million, from the previously established range of $200 to $220 million.

What is the status of LUPKYNIS approval in Japan for Aurinia (AUPH)?

Aurinia anticipates Japanese regulatory authorities' approval of LUPKYNIS in the second half of 2024, based on the JNDA filed by Otsuka in November 2023.

What is Aurinia's (AUPH) cash position as of June 30, 2024?

As of June 30, 2024, Aurinia had cash, cash equivalents, restricted cash and investments of $330.7 million.

Aurinia Pharmaceuticals Inc

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Biotechnology
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