Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results
- Net product revenue increased by 60% in Q3 2023 compared to the same period last year.
- Total net revenue increased by 24% for the nine months ended September 30, 2023, compared to the prior year.
- Achieved a pricing and reimbursement milestone, receiving a $10 million payment from Otsuka Pharmaceutical Co. Ltd.
- Narrowed net product revenue guidance for 2023 to a range of $155 - $160 million.
- Full results from AURORA 2 demonstrated kidney preservation and additional efficacy of LUPKYNIS.
- Appointed three new directors to the Board of Directors.
- LUPKYNIS product performance showed an increase in patients on therapy, improved conversion rates, and higher adherence rates.
- None.
Net product revenue of
Total net revenue of
Achieved European pricing and reimbursement milestone triggering
Narrowing 2023 net product revenue guidance range to
Conference call to be hosted today at 8:30 a.m. ET
Net product revenue was
Total net revenue was
“We are very pleased with our overall results for the first nine months of the year. Reporting another strong quarter of results reinforces our ability to execute and deliver against key metrics. Our team continues to focus on business fundamentals and steady performance,” said Peter Greenleaf, President, and Chief Executive Officer of Aurinia. “We continue to deliver new data on LUPKYNIS and grow the overall LN market. In addition, we received a
For the fiscal year 2023, the Company is narrowing its net product revenue guidance to a range of
Third Quarter 2023 and Recent Highlights
- Full results from AURORA 2 (the long-term extension study of the Phase 3 AURORA trial) were published in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology, demonstrating kidney preservation over the 3-year study period as measured by eGFR (estimated glomerular filtration rate) along with additional efficacy, safety, and tolerability of LUPKYNIS over the study duration.
- A total of 14 LUPKYNIS clinical abstracts were accepted for presentation at the upcoming American Society of Nephrology and the American College of Rheumatology being held in November 2023. Led by several leading experts in nephrology and rheumatology, these presentations reinforce the long-term safety and efficacy profile of LUPKYNIS for the treatment of adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The robust set of data demonstrates Aurinia’s deep commitment to sustained research in autoimmune diseases, including lupus.
-
Received notification that the pricing and reimbursement milestone was secured. As a result, this triggered a
$10 million Scotland by the Scottish Medicines Consortium.
- Appointed three new directors to the Board of Directors - Dr. Karen Smith, Jeffrey Bailey, and Dr. Robert Foster.
LUPKYNIS Product Performance Highlights
-
There were approximately 1,939 patients on LUPKYNIS therapy at September 30, 2023, compared with 1,354 at September 30, 2022, representing an increase of approximately
43% year over year.
-
Aurinia added 436 patient start forms (PSFs) during the three months ended September 30, 2023, compared to 374 during the three months ended September 30, 2022, representing an increase of approximately
17% over the same period last year.
- Through the end of October 2023, the Company recorded approximately 1,510 PSFs since January 1, 2023.
-
Conversion rates remain consistent with approximately
90% of PSFs converted to patients on therapy.
-
Time to convert has improved to an all-time high with the large majority (
64% ) of patients on therapy by 20 days.
-
Adherence improved from
84% at September 30, 2022 to87% at September 30, 2023.
-
Persistency at 12 months has maintained at
54% ; and remained stable at further months on therapy:48% at 15 months and43% at 18 months.
Financial Results for the Three and Nine Months Ended September 30, 2023
Total net revenue was
Net product revenue was
License, royalty and collaboration revenue was
Total cost of sales and operating expenses were
Cost of sales were
Cost of sales were
Gross margin for the three months ended September 30, 2023 and September 30, 2022 was approximately
Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were
SG&A expenses, inclusive of share-based compensation, were
Non-cash SG&A share-based compensation expense included within SG&A expenses was
Research and development (R&D) expenses, inclusive of share-based compensation, were
R&D expenses, inclusive of share-based compensation expense, were
Non-cash R&D share-based compensation expense included with R&D expense was
Other (income) expense, net was
Other (income) expense, net was
Interest income was
For the three months ended September 30, 2023, Aurinia recorded a net loss of
Financial Liquidity at September 30, 2023
As of September 30, 2023, Aurinia had cash, cash equivalents and restricted cash and investments of
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.
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 September 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.
Conference Call Details
Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2023 financial results today, Thursday, November 2, 2023 at 8:30 a.m. ET. The audio webcast can be accessed under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial the corrected call-in number for participants +1 (877) 407-9170 / + 1 201-493-6756 (Toll-free
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
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
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
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; 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
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||||
(unaudited) |
|
September 30,
|
|
December 31, 2022 |
||||
|
|
|
|
|
||||
ASSETS |
|
|
|
|
||||
Current assets |
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
46,397 |
|
|
$ |
94,172 |
|
Short-term investments |
|
|
291,503 |
|
|
|
295,218 |
|
Accounts receivable, net |
|
|
37,946 |
|
|
|
13,483 |
|
Inventories, net |
|
|
32,820 |
|
|
|
24,752 |
|
Prepaid expenses |
|
|
16,158 |
|
|
|
13,580 |
|
Other current assets |
|
|
1,645 |
|
|
|
1,334 |
|
Total current assets |
|
|
426,469 |
|
|
|
442,539 |
|
|
|
|
|
|
||||
Non-current assets |
|
|
|
|
||||
Long-term investments |
|
|
591 |
|
|
|
— |
|
Other non-current assets |
|
|
1,518 |
|
|
|
13,339 |
|
Property and equipment, net |
|
|
3,496 |
|
|
|
3,650 |
|
Acquired intellectual property and other intangible assets, net |
|
|
5,261 |
|
|
|
6,425 |
|
Finance right-of-use asset, net |
|
|
113,069 |
|
|
|
— |
|
Operating right-of-use assets, net |
|
|
4,609 |
|
|
|
4,907 |
|
Total assets |
|
$ |
555,013 |
|
|
$ |
470,860 |
|
|
|
|
|
|
||||
LIABILITIES |
|
|
|
|
||||
Current liabilities |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
|
52,309 |
|
|
|
39,990 |
|
Deferred revenue |
|
|
4,662 |
|
|
|
3,148 |
|
Other current liabilities |
|
|
2,611 |
|
|
|
2,033 |
|
Finance lease liability |
|
|
13,328 |
|
|
|
— |
|
Operating lease liabilities |
|
|
980 |
|
|
|
936 |
|
Total current liabilities |
|
|
73,890 |
|
|
|
46,107 |
|
|
|
|
|
|
||||
Non-current liabilities |
|
|
|
|
||||
Finance lease liability |
|
|
72,193 |
|
|
|
— |
|
Operating lease liabilities |
|
|
6,713 |
|
|
|
7,152 |
|
Deferred compensation and other non-current liabilities |
|
|
10,340 |
|
|
|
12,166 |
|
Total liabilities |
|
|
163,136 |
|
|
|
65,425 |
|
SHAREHOLDER’S EQUITY |
|
|
|
|
||||
Common shares - no par value, unlimited shares authorized, 143,605 and 142,268 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively |
|
|
1,198,560 |
|
|
|
1,185,309 |
|
Additional paid-in capital |
|
|
109,711 |
|
|
|
85,489 |
|
Accumulated other comprehensive loss |
|
|
(947 |
) |
|
|
(1,061 |
) |
Accumulated deficit |
|
|
(915,447 |
) |
|
|
(864,302 |
) |
Total shareholders' equity |
|
|
391,877 |
|
|
|
405,435 |
|
Total liabilities and shareholders' equity |
|
$ |
555,013 |
|
|
$ |
470,860 |
|
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
||||||||||||||||
|
|
Three months ended |
|
Nine months ended |
||||||||||||
|
|
September 30, |
|
September 30, |
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
|
|
(unaudited) |
||||||||||||||
Revenue |
|
|
|
|
|
|
|
|
||||||||
Product revenue, net |
|
$ |
40,781 |
|
|
$ |
25,502 |
|
|
$ |
116,218 |
|
|
$ |
75,142 |
|
License, royalty and collaboration revenue |
|
|
13,734 |
|
|
|
30,277 |
|
|
|
14,200 |
|
|
|
30,453 |
|
Total revenue, net |
|
|
54,515 |
|
|
|
55,779 |
|
|
|
130,418 |
|
|
|
105,595 |
|
Operating expenses |
|
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
|
6,769 |
|
|
|
2,447 |
|
|
|
8,753 |
|
|
|
4,302 |
|
Selling, general and administrative |
|
|
47,759 |
|
|
|
52,169 |
|
|
|
144,964 |
|
|
|
148,898 |
|
Research and development |
|
|
13,605 |
|
|
|
10,973 |
|
|
|
39,413 |
|
|
|
35,118 |
|
Other (income) expense, net |
|
|
2,645 |
|
|
|
(311 |
) |
|
|
(695 |
) |
|
|
647 |
|
Total cost of sales and operating expenses |
|
|
70,778 |
|
|
|
65,278 |
|
|
|
192,435 |
|
|
|
188,965 |
|
Loss from operations |
|
|
(16,263 |
) |
|
|
(9,499 |
) |
|
|
(62,017 |
) |
|
|
(83,370 |
) |
Interest expense |
|
|
(1,400 |
) |
|
|
— |
|
|
|
(1,465 |
) |
|
|
— |
|
Interest income |
|
|
4,514 |
|
|
|
1,464 |
|
|
|
12,429 |
|
|
|
2,209 |
|
Net loss before income taxes |
|
|
(13,149 |
) |
|
|
(8,035 |
) |
|
|
(51,053 |
) |
|
|
(81,161 |
) |
Income tax expense |
|
|
298 |
|
|
|
954 |
|
|
|
92 |
|
|
|
973 |
|
Net loss |
|
$ |
(13,447 |
) |
|
$ |
(8,989 |
) |
|
$ |
(51,145 |
) |
|
$ |
(82,134 |
) |
Basic and diluted loss per share |
|
$ |
(0.09 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.58 |
) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
142,847 |
|
|
|
141,856 |
|
|
|
143,085 |
|
|
|
141,831 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231102070232/en/
Investor/Media Contact:
ir@auriniapharma.com
Source: Aurinia Pharmaceuticals Inc.
FAQ
What was Aurinia Pharmaceuticals' net product revenue for Q3 2023?
What was the total net revenue for the nine months ended September 30, 2023?
What triggered a $10 million payment to Aurinia Pharmaceuticals?
What is Aurinia Pharmaceuticals' net product revenue guidance for 2023?
What were the highlights of the AURORA 2 study?
Did Aurinia Pharmaceuticals make any changes to their Board of Directors?
What were the key highlights of LUPKYNIS product performance?
