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Aurinia Pharmaceuticals Reports First Quarter 2023 Financial and Operational Results, Q1 Revenue up 59% YoY to US $34.4 Million
Monday, May 8, 2023Company Profile | Follow Company
$34.4 million in net revenue for the first quarter of 2023; an increase of 59% over the first quarter of the prior year
Increases 2023 revenue guidance range to $135 - $155 million from net product sales of LUPKYNIS
Significant progress across Commercial, R&D and Intellectual Property
Victoria, BC, May 8, 2023--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today issued its financial results for first quarter ended March 31, 2023. Amounts are expressed in U.S. dollars.
Total net revenue was $34.4 million for the quarter ended March 31, 2023, compared to $21.6 million in the prior year quarter ended March 31, 2022, representing significant growth of 59% year over year.
Total net product revenue was $34.3 million for the quarter ended March 31, 2023, compared to $21.5 million in the prior year quarter ended March 31, 2022.
Peter Greenleaf, Chief Executive Officer, Director, Aurinia Pharmaceuticals Inc.
"We are very pleased with our results in the first quarter of 2023 as it represents our most successful quarter to date," said Peter Greenleaf, President, and Chief Executive Officer of Aurinia. "With our continued focus on commercial execution, we saw the impact of our marketing and selling efforts directly in the quarter. This, coupled with the recent release of the renal biopsy data, and the newly issued method of use patent serve to further substantiate LUPKYNIS in the LN market."
For the fiscal year 2023, the Company is increasing its net product revenue guidance to a range of $135 - $155 million from $120 - $140 million for net product sales of LUPKYNIS. The guidance range is based on assumptions regarding historical patient start form (PSF) run rates, consistent conversion rates, time to convert, persistency, and pricing.
First Quarter 2023 and Recent Highlights
Financial Results for the Three Months Ended March 31, 2023
Total net revenue was $34.4 million and $21.6 million for the three months ended March 31, 2023 and March 31, 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 March 31, 2023 and March 31, 2022 were $64.0 million and $59.5 million, respectively. Further breakdown of operating expense drivers and fluctuations are highlighted in the following paragraphs.
Cost of sales were $0.4 million and $0.3 million for the three months ended March 31, 2023 and March 31, 2022, respectively. The increase is primarily due to an increase in product related revenue, as gross margin was approximately 99% for the periods ended March 31, 2023 and March 31, 2022.
Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $50.1 million and $45.2 million for the three months ended March 31, 2023 and March 31, 2022, respectively. The increase is primarily related to an increase in professional fees and services related to marketing and pharmacovigilance, share-based compensation expense and travel and related costs.
Non-cash SG&A share-based compensation expense included above for the three months ended March 31, 2023 and March 31, 2022 was $7.6 million and $6.0 million, respectively.
Research and development (R&D) expenses, inclusive of share-based compensation, were $13.2 million and $12.6 million for the three months ended March 31, 2023 and March 31, 2022, respectively. The increase is primarily related to an increase in salaries and related employee benefit costs and share-based compensation expense 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, which was completed in 2022.
Non-cash R&D share-based compensation expense included above for the three months ended March 31, 2023 and March 31, 2022 was $1.6 million and $1.0 million, respectively.
Interest income was $3.8 million and $0.3 million for the three months ended March 31, 2023 and March 31, 2022, respectively. The increase is due to higher yields on our investments as a result of increased interest rates.
For the three months ended March 31, 2023, Aurinia recorded a net loss of $26.2 million or $0.18 net loss per common share, as compared to a net loss of $37.6 million or $0.27 net loss per common share for the quarter ended March 31, 2022.
Financial Liquidity at March 31, 2023
As of March 31, 2023, Aurinia had cash, cash equivalents and restricted cash and short-term investments of $361.5 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 and advancement of our pipeline, 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, advancing its R&D programs and funding its working capital obligations for at least the next few years.
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
March 31, |
|
December 31, |
||||
|
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(unaudited) |
|
|
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ASSETS |
|
|
|
|
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Current assets |
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
89,001 |
|
|
$ |
94,172 |
|
Short-term investments |
|
|
272,533 |
|
|
|
295,218 |
|
Accounts receivable, net |
|
|
19,046 |
|
|
|
13,483 |
|
Inventories, net |
|
|
31,745 |
|
|
|
24,752 |
|
Prepaid expenses |
|
|
10,096 |
|
|
|
13,580 |
|
Other current assets |
|
|
1,227 |
|
|
|
1,334 |
|
Total current assets |
|
|
423,648 |
|
|
|
442,539 |
|
|
|
|
|
|
||||
Non-current assets |
|
|
|
|
||||
Other non-current assets |
|
|
13,357 |
|
|
|
13,339 |
|
Property and equipment, net |
|
|
3,842 |
|
|
|
3,650 |
|
Acquired intellectual property and other intangible assets, net |
|
|
6,101 |
|
|
|
6,425 |
|
Right-of-use assets, net |
|
|
4,813 |
|
|
|
4,907 |
|
Total assets |
|
|
451,761 |
|
|
|
470,860 |
|
|
|
|
|
|
||||
LIABILITIES |
|
|
|
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Current liabilities |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
|
35,965 |
|
|
|
39,990 |
|
Deferred revenue |
|
|
3,157 |
|
|
|
3,148 |
|
Other current liabilities |
|
|
1,979 |
|
|
|
2,033 |
|
Operating lease liabilities |
|
|
945 |
|
|
|
936 |
|
Total current liabilities |
|
|
42,046 |
|
|
|
46,107 |
|
|
|
|
|
|
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Non-current liabilities |
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|
|
|
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Deferred compensation and other non-current liabilities |
|
|
12,321 |
|
|
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12,166 |
|
Operating lease liabilities |
|
|
6,986 |
|
|
|
7,152 |
|
Total liabilities |
|
|
61,353 |
|
|
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65,425 |
|
SHAREHOLDER'S EQUITY |
|
|
|
|
||||
Common shares - no par value, unlimited shares authorized, 143,029 and 142,268 |
|
|
1,193,019 |
|
|
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1,185,309 |
|
Additional paid-in capital |
|
|
88,885 |
|
|
|
85,489 |
|
Accumulated other comprehensive loss |
|
|
(988 |
) |
|
|
(1,061 |
) |
Accumulated deficit |
|
|
(890,508 |
) |
|
|
(864,302 |
) |
Total shareholders' equity |
|
|
390,408 |
|
|
|
405,435 |
|
Total liabilities and shareholders' equity |
|
$ |
451,761 |
|
|
$ |
470,860 |
|
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|
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Three months ended |
||||||
|
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March 31, |
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2023 |
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|
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2022 |
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(unaudited) |
||||||
Revenue |
|
|
|
|
||||
Product revenue, net |
|
$ |
34,337 |
|
|
$ |
21,492 |
|
License, royalty and collaboration revenue |
|
|
72 |
|
|
|
133 |
|
Total revenue, net |
|
|
34,409 |
|
|
|
21,625 |
|
Operating expenses |
|
|
|
|
||||
Cost of sales |
|
|
421 |
|
|
|
256 |
|
Selling, general and administrative |
|
|
50,124 |
|
|
|
45,197 |
|
Research and development |
|
|
13,158 |
|
|
|
12,620 |
|
Other expense, net |
|
|
290 |
|
|
|
1,434 |
|
Total cost of sales and operating expenses |
|
|
63,993 |
|
|
|
59,507 |
|
Loss from operations |
|
|
(29,584 |
) |
|
|
(37,882 |
) |
Interest income |
|
|
3,814 |
|
|
|
262 |
|
Net loss before income taxes |
|
|
(25,770 |
) |
|
|
(37,620 |
) |
Income tax expense |
|
|
436 |
|
|
|
10 |
|
Net loss |
|
$ |
(26,206 |
) |
|
$ |
(37,630 |
) |
Basic and diluted loss per share |
|
$ |
(0.18 |
) |
|
$ |
(0.27 |
) |
Weighted-average common shares outstanding used in computation of basic and |
|
|
142,641 |
|
|
|
141,675 |
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.
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 March 31, 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, 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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