Aurinia Pharmaceuticals Reports First Quarter 2024 Financial and Operational Results
Aurinia Pharmaceuticals Inc. reported $50.3 million in total net revenue and $48.1 million in net product revenue for the first quarter of 2024, with a year-over-year growth of approximately 46% and 40% respectively. The company achieved significant milestones like FDA approval for LUPKYNIS and plans to reach positive free cash flows in Q2 2024. The 2024 net product revenue guidance is $200 to $220 million. Financially, total net revenue increased, operating expenses decreased, and the company maintained a strong liquidity position.
Achieved $50.3 million in total net revenue and $48.1 million in net product revenue for the first quarter of 2024, with significant year-over-year growth.
Aurinia reached key milestones like FDA approval for LUPKYNIS and plans to achieve positive free cash flows in Q2 2024, ahead of projections.
The 2024 net product revenue guidance of $200 to $220 million indicates a strong outlook for the company.
Total net revenue increased, operating expenses decreased, and the company maintained a robust liquidity position.
The restructuring resulted in a one-time charge of approximately $7 million, impacting the financials in the first quarter of 2024.
Despite the positive revenue growth, the company recorded a net loss of $10.7 million for the three months ended March 31, 2024.
Gross margin decreased to approximately 85% compared to 99% for the three months ended March 31, 2023, affecting the profitability margin.
Insights
-
Achieved
in total net revenue and$50.3 million in net product revenue for the first quarter of 2024, representing year over year growth of approximately$48.1 million 46% and40% respectively, and extending the trend of consistent growth in LUPKYNIS® (voclosporin) sales - Rapidly completed restructuring while maintaining focus on commercial execution
-
Ahead of prior projections, Company expects to be cash flow positive, excluding share repurchases, in second quarter 2024, with estimated cost savings of
to$50 annually$55 million -
Company reiterates 2024 net product revenue guidance of
to$200 $220 million
Conference call to be hosted today at 8:30 a.m. ET
Total net revenue was
Aurinia rapidly completed its corporate restructuring in the first quarter, reducing employee headcount by approximately
“We are pleased to be on track to reach positive free cash flows, excluding share repurchases, in the second quarter of 2024, ahead of prior projections, further strengthening our financial position, and with further balance sheet growth, allowing more strategic flexibility for the Company,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “We recently achieved several key milestones, including FDA approval of a label update for LUPKYNIS which now includes long-term efficacy data from our AURORA Clinical Program. We have also launched an innovative new marketing campaign to further educate rheumatologists on the seriousness of lupus nephritis and the urgent need for appropriate treatment. This momentum demonstrates our full commitment to solid execution and driving growth, as we continue in our work of delivering LUPKYNIS to patients in need.”
Earlier this week, Aurinia announced that the FDA has approved a label update for LUPKYNIS that provides physicians with important information to treat and manage their lupus nephritis (LN) patients. Notably, the updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year. The label now includes long-term data from a post-hoc analysis of the AURORA 2 extension study showing that patients receiving LUPKYNIS achieved sustained complete renal response at every time point assessed through three years, compared to mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. Additionally, the updated label now requires quarterly, rather than monthly kidney function assessment after the first year of treatment. The safety profile of LUPKYNIS in the updated label remains unchanged and is aligned with the safety findings in the AURORA Clinical Program.
Aurinia recently launched “Know the Signs,” a disease state education campaign designed to increase awareness among rheumatologists around the severity of LN, the critical need to prioritize kidney health for people with systemic lupus erythematosus (SLE), and to increase screening for LN among people with SLE.
In addition to the Company’s operational execution, Aurinia has also released its 2023 ESG report, which details the holistic approach the Company takes to address environmental, social and governance priorities, including energy and emissions, addressing barriers to care among LN patients, (Diversity, Equity and Inclusion) DE&I practices, employee engagement, and risk management. The full report is available here.
For the fiscal year 2024, the Company maintains its established net product revenue guidance for a range of
First Quarter 2024 and Recent Highlights
- There were approximately 2,178 patients on LUPKYNIS therapy as of March 31, 2024, compared to 1,731 as of March 31, 2023.
- In the first quarter, the Company added 448 patient start forms and approximately 148 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy, compared to 466 PSFs in the prior year first quarter, representing significant year-over-year growth.
- From January 1, 2024, through April 28, 2024, the Company added approximately 582 PSFs and approximately 170 new patients from restarts and the hospital channel.
-
Conversion rates were sustained, with approximately
85% of PSFs converted to patients on therapy. -
Time to convert was sustained with approximately
60% of patients on therapy by 20 days. -
The overall adherence rate remained high at approximately
87% through the first quarter of 2024. -
Persistency continues to improve, with approximately
56% of patients remaining on therapy at 12 months,50% at 15 months, and46% at 18 months.
Financial Results for the Three Months Ended March 31, 2024
Total net revenue was
This penetration can be demonstrated by a total of 2,178 patients on therapy as of March 31, 2024, compared to 1,731 patients on therapy as of March 31, 2023. The increase in patients was driven by 448 additional patients start forms and 148 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy during the three months ended March 31, 2024, compared to 466 PSFs received during the three months ended March 31, 2023. Additionally, our 12-month persistency rate has increased to
License, collaboration and royalty revenue was
Total cost of sales and operating expenses, inclusive of a one-time restructuring charge in Q1 2024, were
Cost of sales were
Gross margin was approximately
SG&A expenses, inclusive of share-based compensation, were
Non-cash SG&A share-based compensation expense included within SG&A expenses was
R&D expenses, inclusive of share-based compensation expense, were
Non-cash R&D share-based compensation expense included within R&D expense was
Restructuring expenses were approximately
Other (income) expense, net was
Interest income was
For the three months ended March 31, 2024, Aurinia recorded a net loss of
Financial Liquidity at March 31, 2024
As of March 31, 2024, Aurinia had cash, cash equivalents and restricted cash and investments of
Cash used in operations and non-GAAP free cash flow used were
Free cash flow is a non-GAAP financial measure calculated by subtracting purchases of property and equipment from net cash provided by or used in operating activities. Free cash flow reflects a view of our liquidity that, when viewed with our GAAP results, provides a more complete understanding of factors and trends affecting our cash flows. We believe it is a more conservative measure of cash flow since capital expenditures are necessary for ongoing operations. Free cash flow has limitations due to the fact that it does not represent the residual cash flow available for discretionary expenditures. For example, free cash flow does not incorporate the principal portion of payments made or expected to be made on finance lease obligations. Therefore, we believe it is important to view free cash flow as a complement to our entire consolidated statements of cash flows.
A reconciliation of free cash flow to its most directly comparable GAAP measure, net cash provided by or used in operating activities, is set out in the Condensed Consolidated Statement of Cash Flows included at the end of this press release.
Share Repurchase Program
As previously announced, Aurinia’s Board of Directors approved a share repurchase program of up to
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, 2024 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, 2023, 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 March 31, 2024 financial results today, Thursday, May 2, 2024 at 8:30 a.m. ET. The link to the audio webcast is available here or on Aurinia’s corporate website at www.auriniapharma.com under “News/Events” through the Investors section. To join the conference call, please dial +1 (877) 407-9170 / +1 201-493-6756 (Toll-free
About Lupus Nephritis
Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. 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) |
|
March 31, 2024 |
|
December 31, 2023 |
||||
|
|
|
|
|
||||
ASSETS |
|
|
|
|
||||
Current assets |
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
64,459 |
|
|
$ |
48,875 |
|
Short-term investments |
|
|
255,453 |
|
|
|
301,614 |
|
Accounts receivable, net |
|
|
28,909 |
|
|
|
24,089 |
|
Inventories, net |
|
|
39,761 |
|
|
|
39,705 |
|
Prepaid expenses |
|
|
7,646 |
|
|
|
9,486 |
|
Other current assets |
|
|
1,995 |
|
|
|
1,031 |
|
Total current assets |
|
|
398,223 |
|
|
|
424,800 |
|
|
|
|
|
|
||||
Non-current assets |
|
|
|
|
||||
Long-term investments |
|
|
199 |
|
|
|
201 |
|
Other non-current assets |
|
|
1,502 |
|
|
|
1,517 |
|
Property and equipment, net |
|
|
3,198 |
|
|
|
3,354 |
|
Acquired intellectual property and other intangible assets, net |
|
|
4,760 |
|
|
|
4,977 |
|
Finance right-of-use asset, net |
|
|
104,358 |
|
|
|
108,715 |
|
Operating right-of-use assets, net |
|
|
4,394 |
|
|
|
4,498 |
|
Total assets |
|
$ |
516,634 |
|
|
$ |
548,062 |
|
|
|
|
|
|
||||
LIABILITIES |
|
|
|
|
||||
Current liabilities |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
|
50,270 |
|
|
|
54,389 |
|
Deferred revenue |
|
|
4,909 |
|
|
|
4,813 |
|
Other current liabilities |
|
|
1,150 |
|
|
|
2,388 |
|
Finance lease liability |
|
|
13,724 |
|
|
|
14,609 |
|
Operating lease liabilities |
|
|
999 |
|
|
|
989 |
|
Total current liabilities |
|
|
71,052 |
|
|
|
77,188 |
|
|
|
|
|
|
||||
Non-current liabilities |
|
|
|
|
||||
Finance lease liability |
|
|
67,475 |
|
|
|
75,479 |
|
Operating lease liabilities |
|
|
6,339 |
|
|
|
6,530 |
|
Deferred compensation and other non-current liabilities |
|
|
12,292 |
|
|
|
10,911 |
|
Total liabilities |
|
|
157,158 |
|
|
|
170,108 |
|
SHAREHOLDER’S EQUITY |
|
|
|
|
||||
Common shares - no par value, unlimited shares authorized, 143,690 and 143,833 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively |
|
|
1,207,982 |
|
|
|
1,200,218 |
|
Additional paid-in capital |
|
|
105,419 |
|
|
|
120,788 |
|
Accumulated other comprehensive loss |
|
|
(854 |
) |
|
|
(730 |
) |
Accumulated deficit |
|
|
(953,071 |
) |
|
|
(942,322 |
) |
Total shareholders' equity |
|
|
359,476 |
|
|
|
377,954 |
|
Total liabilities and shareholders' equity |
|
$ |
516,634 |
|
|
$ |
548,062 |
|
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES |
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(in thousands, except per share data) |
||||||||
|
|
Three months ended |
||||||
|
|
March 31, |
||||||
|
|
2024 |
|
2023 |
||||
|
(unaudited) |
|||||||
Revenue |
|
|
|
|
||||
Product revenue, net |
|
$ |
48,073 |
|
|
$ |
34,337 |
|
License, collaboration and royalty revenue |
|
|
2,230 |
|
|
|
72 |
|
Total revenue, net |
|
|
50,303 |
|
|
|
34,409 |
|
Operating expenses |
|
|
|
|
||||
Cost of sales |
|
|
7,752 |
|
|
|
421 |
|
Selling, general and administrative |
|
|
47,695 |
|
|
|
50,124 |
|
Research and development |
|
|
5,551 |
|
|
|
13,158 |
|
Restructuring expenses |
|
|
6,683 |
|
|
|
— |
|
Other (income) expense, net |
|
|
(4,125 |
) |
|
|
290 |
|
Total cost of sales and operating expenses |
|
|
63,556 |
|
|
|
63,993 |
|
Loss from operations |
|
|
(13,253 |
) |
|
|
(29,584 |
) |
Interest expense |
|
|
(1,283 |
) |
|
|
— |
|
Interest income |
|
|
4,526 |
|
|
|
3,814 |
|
Net loss before income taxes |
|
|
(10,010 |
) |
|
|
(25,770 |
) |
Income tax expense |
|
|
739 |
|
|
|
436 |
|
Net loss |
|
$ |
(10,749 |
) |
|
$ |
(26,206 |
) |
Basic and diluted loss per share |
|
$ |
(0.07 |
) |
|
$ |
(0.18 |
) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
144,013 |
|
|
|
142,641 |
|
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES |
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
|
|
Three Months Ended March 31, |
||||||
|
|
2024 |
|
2023 |
||||
(in thousands) |
|
(unaudited) |
||||||
Cash flows used in operating activities: |
|
|
|
|
||||
Net loss |
|
$ |
(10,749 |
) |
|
$ |
(26,206 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
||||
Depreciation and amortization |
|
|
4,847 |
|
|
|
717 |
|
Net amortization of premiums and discounts on short-term investments |
|
|
(3,206 |
) |
|
|
(2,611 |
) |
Share-based compensation expense |
|
|
5,737 |
|
|
|
9,467 |
|
Foreign exchange on finance lease liability |
|
|
(6,025 |
) |
|
|
— |
|
Other, net |
|
|
1,559 |
|
|
|
217 |
|
Net changes in operating assets and liabilities |
|
|
|
|
||||
Accounts receivable, net |
|
|
(4,820 |
) |
|
|
(5,559 |
) |
Inventories, net |
|
|
(56 |
) |
|
|
(6,993 |
) |
Prepaid expenses and other current assets |
|
|
873 |
|
|
|
3,588 |
|
Non-current operating assets |
|
|
17 |
|
|
|
(17 |
) |
Accounts payable, accrued and other liabilities |
|
|
(6,594 |
) |
|
|
(4,117 |
) |
Operating lease liabilities |
|
|
(181 |
) |
|
|
(156 |
) |
Net cash used in operating activities |
|
|
(18,598 |
) |
|
|
(31,670 |
) |
Cash flows used in investing activities: |
|
|
|
|
||||
Purchase of investments |
|
|
(121,260 |
) |
|
|
(142,397 |
) |
Proceeds from investments |
|
|
170,505 |
|
|
|
167,766 |
|
Purchase of property and equipment |
|
|
— |
|
|
|
(347 |
) |
Capitalized patent costs |
|
|
(12 |
) |
|
|
(162 |
) |
Net cash provided by investing activities |
|
|
49,233 |
|
|
|
24,860 |
|
Cash flows from financing activities |
|
|
|
|
||||
Repurchase of common shares, net of transaction costs |
|
|
(12,301 |
) |
|
|
— |
|
Finance lease payments |
|
|
(2,778 |
) |
|
|
— |
|
Proceeds from exercise of stock options |
|
|
28 |
|
|
|
1,639 |
|
Cash (used in) provided by financing activities |
|
|
(15,051 |
) |
|
|
1,639 |
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
15,584 |
|
|
|
(5,171 |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
48,875 |
|
|
|
94,172 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
64,459 |
|
|
$ |
89,001 |
|
|
|
|
|
|
||||
Reconciliation of free cash flow(1) |
|
|
|
|
||||
Net cash used in operating activities |
|
$ |
(18,598 |
) |
|
$ |
(31,670 |
) |
Purchases of property and equipment |
|
|
— |
|
|
|
(347 |
) |
Free cash flow |
|
$ |
(18,598 |
) |
|
$ |
(32,017 |
) |
(1) Free cash flow is a non-GAAP financial measure and is calculated as net cash provided by or used in operating activities reduced by purchases of property and equipment. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240502430931/en/
Media and Investor Inquiries:
Andrea Christopher
Corporate Communications and Investor Relations, Aurinia
achristopher@auriniapharma.com
ir@auriniapharma.com
Source: Aurinia Pharmaceuticals Inc.
FAQ
What were Aurinia Pharmaceuticals' total net revenue and net product revenue for the first quarter of 2024?
What is the 2024 net product revenue guidance provided by Aurinia Pharmaceuticals?
What significant milestone did Aurinia achieve related to LUPKYNIS in 2024?