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Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2023 Financial and Operational Results, Q2 Net Revenue Up 47% YoY to $41.5 Million
Friday, August 25, 2023Company Profile | Follow Company
Net revenue increased to $41.5 million for second quarter of 2023; 47% over the prior year second quarter
Increases 2023 revenue guidance range to $150 - $160 million from net product sales of LUPKYNIS® (voclosporin)
Victoria, BC, August 25, 2023--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today issued its financial results for the three and six months ended June 30, 2023. Amounts are expressed in U.S. dollars.
Total net revenue was $41.5 million for the three months ended June 30, 2023, compared to $28.2 million in the prior year three months ended June 30, 2022, representing growth of approximately 47% year over year.
Year to date net revenue increased to $75.9 million for the six months ended June 30, 2023 compared to $49.8 million for the same time period for 2022, representing growth of approximately 52% period over period.
Peter Greenleaf, Chief Executive Officer, Director, Aurinia Pharmaceuticals Inc.
"We are extremely pleased with our results in the second quarter of 2023. Building on three successful quarters in a row, this represents our most successful quarter to date from a net revenue perspective," said Peter Greenleaf, President, and Chief Executive Officer of Aurinia.
"Strong commercial execution continues as we see further utilization of LUPKYNIS (voclosporin) across the lupus nephritis marketplace. Moreover, we are excited by the depth of usage in nephrology and the continued expansion into rheumatology. Our marketing and selling efforts continue to produce patient start forms (PSFs), patients on therapy (POT), wallets shipped, and net product revenue at or near all-time highs."
For the fiscal year 2023, the Company is increasing its net product revenue guidance to a range of $150 - $160 million for net product sales of LUPKYNIS. The guidance range is based on assumptions regarding PSF run rates, consistent conversion rates, time to convert, persistency, and pricing.
Second Quarter 2023 and Recent Highlights
LUPKYNIS Product Performance Highlights
Financial Results for the Three and Six Months Ended June 30, 2023
Total net revenue was $41.5 million and $28.2 million for the three months ended June 30, 2023 and June 30, 2022, respectively. Total net revenue was $75.9 million and $49.8 million for the six months ended June 30, 2023 and June 30, 2022, respectively. The increase is primarily due to an increase in net product revenue from our two main customers for LUPKYNIS driven predominantly by further penetration in the LN market.
Total cost of sales and operating expenses for the three months ended June 30, 2023 and June 30, 2022 were $57.7 million and $64.2 million, respectively. Total cost of sales and operating expenses for the six months ended June 30, 2023 and June 30, 2022 were $121.7 million and $123.7 million, respectively. Further breakdown of operating expense drivers and fluctuations are highlighted in the following paragraphs.
Cost of sales were $1.6 million for the three months ended June 30, 2023 and June 30, 2022. Cost of sales were $2.0 million and $1.9 million for the six months ended June 30, 2023 and June 30, 2022, respectively. Cost of sales for both periods ended June 30, 2023 and June 30, 2022 remained consistent due to an increase of revenues, offset by a write down of FDA process validation batches that occurred during the second quarter of 2022.
Gross margin for the three months ended June 30, 2023 and June 30, 2022 was approximately 96% and 94%, respectively. Gross margin for the six months ended June 30, 2023 and June 30, 2022 was approximately 97% and 96% respectively.
Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $47.1 million and $51.5 million for the three months ended June 30, 2023 and June 30, 2022, respectively. SG&A expenses, inclusive of share-based compensation, were $97.2 million and $96.7 million for the six months ended June 30, 2023 and June 30, 2022, respectively. The primary drivers for the decrease in SG&A expense for the three months ended June 30, 2023 compared to the same period ended June 30, 2022 was a decrease in professional fees and services, including legal fees incurred during the respective quarters, with respect to litigation matters that were taking place in the three months ended June 30, 2022. For the six months ended June 30, 2023 compared to the same period ended June 30, 2022, the increase was due to an increase in share-based compensation expense and marketing expenses offset by a decrease in professional fees and services which includes legal fees.
Non-cash SG&A share-based compensation expense included within SG&A expenses was $9.8 million and $8.9 million for the three months ended June 30, 2023 and June 30, 2022, respectively. Non-cash SG&A share-based compensation expense included within SG&A expenses, was $17.4 million and $14.9 million for the six months ended June 30, 2023 and June 30, 2022, respectively.
Research and development (R&D) expenses, inclusive of share-based compensation, were $12.7 million and $11.5 million for the three months ended June 30, 2023 and June 30, 2022, respectively. R&D expenses, inclusive of share-based compensation expense, were $25.8 million and $24.1 million for the six months ended June 30, 2023 and June 30, 2022, respectively. The primary drivers for the increase for the three and six months ended June 30, 2023 as compared to the same periods ended June 30, 2022, were an increase in salaries and related employee benefit costs, share-based compensation expense and clinical supply and distribution as the Company advances its AUR200 and AUR300 programs and fulfills the post approval FDA commitments related to LUPKYNIS. The increase was partially offset by a decrease in contract research organization costs related to the completion of the AURORA 2 continuation study and drug interaction study, which were substantially completed in 2022.
Non-cash R&D share-based compensation expense included with R&D expense was $2.1 million and $1.1 million for the three months ended June 30, 2023 and June 30, 2022, respectively. Non-cash R&D share-based compensation expense included with R&D expenses was $3.7 million and $2.0 million for the six months ended June 30, 2023 and June 30, 2022, respectively.
Other (income) expense, net was $(3.6) million and $(0.5) million for the three months ended June 30, 2023 and June 30, 2022, respectively. Other (income) expense, net was $(3.3) million and $1.0 million for the six months ended June 30, 2023 and June 30, 2022, respectively. The increase in other income is primarily related to change in fair value assumptions driven predominantly by rising interest rates related to our deferred compensation liability coupled with the foreign exchange gain related to our monoplant finance liability.
Interest expense was $0.1 million for the three and six months ended June 30, 2023 due to the commencement of the monoplant finance lease during the second quarter of 2023. We did not incur interest expense during 2022.
Interest income was $4.1 million and $0.5 million for the three months ended June 30, 2023 and June 30, 2022, respectively. Interest income was $7.9 million and $0.7 million for the six months ended June 30, 2023 and June 30, 2022, respectively. The increase between periods is due to higher yields on our investments as a result of increased interest rates.
For the three months ended June 30, 2023, Aurinia recorded a net loss of $11.5 million or $0.08 net loss per common share, as compared to a net loss of $35.5 million or $0.25 net loss per common share for the three months ended June 30, 2022. For the six months ended June 30, 2023, Aurinia recorded a net loss of $37.7 million or $0.26 net loss per common share, as compared to a net loss of $73.1 million or $0.52 net loss per common share for the six months ended June 30, 2022.
Financial Liquidity at June 30, 2023
As of June 30, 2023, Aurinia had cash, cash equivalents and restricted cash and short-term investments of $350.7 million compared to $389.4 million at December 31, 2022. The decrease is primarily related to the continued investment in commercialization activities and post approval commitments of our approved drug, LUPKYNIS, inventory purchases, advancement of our pipeline and the second capital expenditure payment for the monoplant, 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, such as FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, advancing its R&D programs and funding its working capital obligations for at least the next few years.
About Lupus Nephritis
Lupus Nephritis is a serious manifestation of systemic lupus erythematosus (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, lupus nephritis can lead to permanent and irreversible tissue damage within the kidney. Black and Asian people with SLE are four times more likely to develop lupus nephritis and Hispanic people are approximately twice as likely to develop the disease compared to White people with SLE. Black and Hispanic people with SLE also tend to develop lupus nephritis earlier and have poorer outcomes, compared to White people with SLE.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with a high unmet medical need that are impacted by autoimmune, kidney and rare diseases. 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 Edmonton, Alberta, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | ||||||||
(unaudited) | June 30, | December 31, | ||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash, cash equivalents and restricted cash | $ | 81,707 | $ | 94,172 | ||||
Short-term investments | 269,006 | 295,218 | ||||||
Accounts receivable, net | 19,499 | 13,483 | ||||||
Inventories, net | 33,155 | 24,752 | ||||||
Prepaid expenses | 11,332 | 13,580 | ||||||
Other current assets | 1,208 | 1,334 | ||||||
Total current assets | 415,907 | 442,539 | ||||||
Non-current assets | ||||||||
Other non-current assets | 1,518 | 13,339 | ||||||
Property and equipment, net | 3,650 | 3,650 | ||||||
Acquired intellectual property and other intangible assets, net | 5,683 | 6,425 | ||||||
Finance right-of-use asset, net | 117,428 | — | ||||||
Operating right-of-use assets, net | 4,714 | 4,907 | ||||||
Total assets | $ | 548,900 | $ | 470,860 | ||||
LIABILITIES | ||||||||
Current liabilities | ||||||||
Accounts payable and accrued liabilities | 41,375 | 39,990 | ||||||
Deferred revenue | 3,228 | 3,148 | ||||||
Other current liabilities | 2,088 | 2,033 | ||||||
Finance lease liability | 14,016 | — | ||||||
Operating lease liabilities | 954 | 936 | ||||||
Total current liabilities | 61,661 | 46,107 | ||||||
Non-current liabilities | ||||||||
Finance lease liability | 79,422 | — | ||||||
Operating lease liabilities | 6,814 | 7,152 | ||||||
Deferred compensation and other non-current liabilities | 8,711 | 12,166 | ||||||
Total liabilities | 156,608 | 65,425 | ||||||
SHAREHOLDER'S EQUITY | ||||||||
Common shares - no par value, unlimited shares authorized, 143,369 and 142,268 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 1,196,480 | 1,185,309 | ||||||
Additional paid-in capital | 98,832 | 85,489 | ||||||
Accumulated other comprehensive loss | (1,020 | ) | (1,061 | ) | ||||
Accumulated deficit | (902,000 | ) | (864,302 | ) | ||||
Total shareholders' equity | 392,292 | 405,435 | ||||||
Total liabilities and shareholders' equity | $ | 548,900 | $ | 470,860 |
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
||||||||||||||||
|
|
Three months ended |
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Six months ended |
||||||||||||
|
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June 30, |
|
June 30, |
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
|
|
(unaudited) |
||||||||||||||
Revenue |
|
|
|
|
|
|
|
|
||||||||
Product revenue, net |
|
$ |
41,100 |
|
|
$ |
28,148 |
|
|
$ |
75,437 |
|
|
$ |
49,640 |
|
License, royalty and collaboration revenue |
|
|
394 |
|
|
|
43 |
|
|
|
466 |
|
|
|
176 |
|
Total revenue, net |
|
|
41,494 |
|
|
|
28,191 |
|
|
|
75,903 |
|
|
|
49,816 |
|
Operating expenses |
|
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
|
1,563 |
|
|
|
1,599 |
|
|
|
1,984 |
|
|
|
1,855 |
|
Selling, general and administrative |
|
|
47,081 |
|
|
|
51,532 |
|
|
|
97,205 |
|
|
|
96,729 |
|
Research and development |
|
|
12,650 |
|
|
|
11,525 |
|
|
|
25,808 |
|
|
|
24,145 |
|
Other (income) expense, net |
|
|
(3,630 |
) |
|
|
(476 |
) |
|
|
(3,340 |
) |
|
|
958 |
|
Total cost of sales and operating expenses |
|
|
57,664 |
|
|
|
64,180 |
|
|
|
121,657 |
|
|
|
123,687 |
|
Loss from operations |
|
|
(16,170 |
) |
|
|
(35,989 |
) |
|
|
(45,754 |
) |
|
|
(73,871 |
) |
Interest expense |
|
|
(65 |
) |
|
|
— |
|
|
|
(65 |
) |
|
|
— |
|
Interest income |
|
|
4,101 |
|
|
|
483 |
|
|
|
7,915 |
|
|
|
745 |
|
Net loss before income taxes |
|
|
(12,134 |
) |
|
|
(35,506 |
) |
|
|
(37,904 |
) |
|
|
(73,126 |
) |
Income tax (benefit) expense |
|
|
(642 |
) |
|
|
9 |
|
|
|
(206 |
) |
|
|
19 |
|
Net loss |
|
$ |
(11,492 |
) |
|
$ |
(35,515 |
) |
|
$ |
(37,698 |
) |
|
$ |
(73,145 |
) |
Basic and diluted loss per share |
|
$ |
(0.08 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.52 |
) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
142,777 |
|
|
|
141,726 |
|
|
|
142,904 |
|
|
|
141,734 |
|
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, 2023 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, 2022, 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.
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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