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Aurinia Reports Second Quarter and Six Months 2022 Financial and Operational Results
Wednesday, August 10, 2022Company Profile | Follow Company
Victoria, BC, August 10, 2022--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today issued its financial results for the second quarter ended June 30, 2022. Amounts, unless specified otherwise, are expressed in U.S. dollars.
Second Quarter 2022 and Recent Highlights & Upcoming Milestones
Financial Results for the Quarter and Six Months Ended June 30, 2022
Total net revenue was $28.2 million and $6.6 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Total net revenue was $49.8 million and $7.5 million for the six months ended June 30, 2022 and June 30, 2021, respectively.
The company's net revenues primarily consisted of product revenue, net of adjustments, for LUPKYNIS following FDA approval in late January 2021. Revenue growth is attributed to further progress in the launch of LUPKYNIS, driven by further penetration in the lupus nephritis market coupled with improvements in a number of key revenue driving metrics as noted above. No product sales commenced and no product marketing was permitted prior to January 22, 2021.
Total cost of sales and operating expenses for the quarters ended June 30, 2022 and June 30, 2021 were $64.2 million and $53.8 million, respectively. Total cost of sales and operating expenses were $123.7 million and $105.2 million for the six months ended June 30, 2022 and June 30, 2021, respectively. Further breakdown of operating expenses drivers and fluctuations are highlighted in the following paragraphs.
Cost of sales were $1.6 million and $0.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Cost of sales were $1.9 million and $0.4 million for the six months ended June 30, 2022 and June 30, 2021, respectively. The increase for both periods was primarily due to an increase in product revenue coupled with safety stock reserves.
Gross margin for the quarters ended June 30, 2022 and June 30, 2021 was approximately 94% and 95% respectively. Gross margin for the six months ended June 30, 2022 and June 30, 2021 was approximately 96% and 95% respectively.
Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $51.5 million and $44.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, SG&A expenses, inclusive of share-based compensation, were $96.7 million and $84.1 million, respectively. The primary drivers for the increase for both periods ended June 30, 2022 as compared to June 30, 2021 were an increase in share-based compensation expense, corporate legal matters and increased investment in infrastructure to support the commercialization of LUPKYNIS.
Non-cash SG&A share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $8.9 million and $6.5 million, respectively. Non-cash SG&A share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $14.9 million and $13.2 million, respectively. The increase in share-based compensation is primarily due to an increase in annual grants in 2022 coupled with the full year expense impact from prior year grants.
Research and Development (R&D) expenses, inclusive of share-based compensation, were $11.5 million and $10.1 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, R&D expenses, inclusive of share-based compensation expense, were $24.1 million and $19.9 million, respectively. The primary drivers for the increase for both periods were due to an increase in CRO and developmental expenses related to AUR200 and AUR300.
Non-cash R&D share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $1.1 million for both periods. Non-cash R&D share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $2.0 million and $2.2 million, respectively.
For the quarter ended June 30, 2022, Aurinia recorded a net loss of $35.5 million or $0.25 net loss per common share, as compared to a net loss of $47.0 million or $0.37 net loss per common share for the quarter ended June 30, 2021. For the six months ended June 30, 2022, Aurinia recorded a net loss of $73.1 million or $0.52 net loss per common share, as compared to a net loss of $97.4 million or $0.76 net loss per common share for the six months ended June 30, 2021.
Financial Liquidity at June 30, 2022
As of June 30, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $391.7 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, advancement of our pipeline and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.
Aurinia believes that it has sufficient financial resources to fund its operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, conducting planned R&D programs and investing in its pipeline and operating activities for at least the next few years.
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.
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 ended June 30, 2022 in the Company's Quarterly Report on Form 10-Q, which will be accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.
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 estimates as to annual net revenue; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia being confident that it is well-poised for growth; Aurinia's belief that it has sufficient financial resources to fund its current plans; the expected timing for the EMA CHMP opinion and EMA decision relating to the EMA MAA; and the planned timing for reporting top-line results from the ongoing AURORA-2 continuation study. [ MORE ] |
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