Aurinia Pharmaceuticals Reports First Quarter 2023 Financial and Operational Results
Increases 2023 revenue guidance range to
Significant progress across Commercial, R&D and Intellectual Property
Conference call to be hosted today at 8:30 a.m. ET
Total net revenue was
“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
First Quarter 2023 and Recent Highlights
- There were approximately 1,731 patients on LUPKYNIS therapy at March 31, 2023, compared with 1,071 at March 31, 2022.
-
Aurinia added 466 PSFs during the three months ended March 31, 2023, compared to 461 during the three months ended March 31, 2022, and 406 in the three months ended December 31, 2022. An increase of
1% and15% , respectively. - Through Friday, April 28, 2023, the Company recorded 604 PSFs since January 1, 2023.
-
Conversion rates remain consistent with the prior quarter, with approximately
85% of PSFs converted to patients on therapy. -
Time to conversion remains consistent with the prior quarter, with 30- and 60-day conversion rates holding near their best levels since launch; with the large majority (
61% ) of patients on therapy by 20 days. -
Persistency rates at 12 months and 15 months improved over prior periods, with approximately
51% and47% remaining on therapy, respectively. At 18 months post-treatment start, an average of approximately41% of patients remain on treatment. - Announced promising top line results from the renal biopsy sub-study of the AURORA trial demonstrating that LUPKYNIS-treated patients showed histologic activity improvement with stable chronicity scores similar to active control arm of mycophenolate mofetil (MMF) and low dose steroids alone. These results have the potential to further differentiate LUPKYNIS from first generation calcineurin inhibitors, which are known to cause histologic kidney changes over time.
-
Received issuance of new and refined method of use patent (
U.S. Patent No. 11,622,991) for LUPKYNIS for an improved protocol for the treatment of LN. - Announced that Grammy Award winning singer Toni Braxton, who has been living with lupus since 2008, is the new spokesperson for our Get Uncomfortable patient campaign, which launched in October 2022.
- Released Aurinia’s inaugural Environmental, Social, and Governance (ESG) report.
- Received a positive recommendation from The United Kingdom’s National Institute for Health and Care Excellence (NICE) that LUPKYNIS can be used in combination with MMF to treat patients with LN.
-
Received regulatory approval for LUPKYNIS in
Switzerland .
Financial Results for the Three Months Ended March 31, 2023
Total net revenue was
Total cost of sales and operating expenses for the three months ended March 31, 2023 and March 31, 2022 were
Cost of sales were
Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were
Non-cash SG&A share-based compensation expense included above for the three months ended March 31, 2023 and March 31, 2022 was
Research and development (R&D) expenses, inclusive of share-based compensation, were
Non-cash R&D share-based compensation expense included above for the three months ended March 31, 2023 and March 31, 2022 was
Interest income was
For the three months ended March 31, 2023, Aurinia recorded a net loss of
Financial Liquidity at March 31, 2023
As of March 31, 2023, Aurinia had cash, cash equivalents and restricted cash and short-term investments of
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.
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.
Conference Call Details
Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2023 financial results today, Thursday, May 4, 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 +1 (888) 645-4404 (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.sedar.com or the
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
March 31,
|
|
December 31,
|
||||
|
|
(unaudited) |
|
|
||||
ASSETS |
|
|
|
|
||||
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 |
|
|
|
|
||||
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 |
|
|
|
|
|
|
||||
Non-current liabilities |
|
|
|
|
||||
Deferred compensation and other non-current liabilities |
|
|
12,321 |
|
|
|
12,166 |
|
Operating lease liabilities |
|
|
6,986 |
|
|
|
7,152 |
|
Total liabilities |
|
|
61,353 |
|
|
|
65,425 |
|
SHAREHOLDER’S EQUITY |
|
|
|
|
||||
Common shares - no par value, unlimited shares authorized, 143,029 and 142,268
|
|
|
1,193,019 |
|
|
|
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)
|
|
Three months ended |
||||||
|
|
March 31, |
||||||
|
|
|
2023 |
|
|
|
2022 |
|
|
|
(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 |
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Investor/Media:
Aurinia@westwicke.com
Source: Aurinia Pharmaceuticals Inc.