Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2024 Financial and Operational Results
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Company achieved
$57.2 million in total net revenue and$55.0 million in net product revenue for the second quarter of 2024, representing year-over-year growth of approximately 38% and 34% respectively
-
Company generated approximately
$15.8 million in free cash flow in the second quarter and had cash, cash equivalents, restricted cash and investments of$330.7 million as ofJune 30, 2024
- Company announces development strategy for AUR200, its potential next generation pipeline asset for autoimmune diseases targeting BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)
-
Company narrows 2024 net product revenue guidance range to
$210 to$220 million
Conference call to be hosted today at
Total net revenue was
Net product revenue was
“Our quarter-over-quarter growth in the second quarter is a result of our continued focus on commercial execution and business fundamentals. We are well prepared as we exit the first half of 2024, with upcoming innovative commercial initiatives targeting rheumatologists, the advancement of our AUR200 pipeline asset, and the anticipated approval of LUPKYNIS® in
The Company anticipates Japanese regulatory authorities' approval of LUPKYNIS in the second half of this year, based on the JNDA that Otsuka filed in
Additionally, the Company is moving forward with development of its pipeline asset AUR200, a differentiated, potential next generation therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
“We are thrilled to advance AUR200, which has the potential to serve as a best-in-class treatment in disease areas with high unmet need. We intend to develop it in disease states where there are currently few market entrants, including exploring one larger indication and one fast-to-market smaller indication that meets the FDA criteria for orphan and rare diseases,” said Dr.
First patients are expected to enter the Phase 1 Single Ascending Dose (SAD) study of AUR200 in the third quarter of 2024. Data from the SAD study, including safety, tolerability, pharmacokinetics, and biomarkers, is anticipated in the first half of 2025. The Company anticipates funding this development program with available cash flow, which is not anticipated to impact previously announced post restructuring operating expense targets. As previously reported, the Company expects to recognize
For the fiscal year 2024, the Company is narrowing its net product revenue guidance range to
Second Quarter 2024 Highlights
In the second quarter of 2024 the Company:
-
Achieved 22% growth in patients on LUPKYNIS therapy, with approximately 2,336 patients on therapy as of
June 30, 2024 , compared to 1,911 as ofJune 30, 2023 . - Added 428 PSFs and approximately 127 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy in the second quarter, compared to 451 PSFs in the prior year second quarter.
-
Added approximately 538 PSFs and approximately 155 new patients from restarts and the hospital channel from
April 1, 2024 , throughJuly 31, 2024 . - Sustained conversion rates, with approximately 85% of PSFs converted to patients on therapy.
- Sustained time to convert, with approximately 60% of patients on therapy by 20 days.
- Maintained high overall adherence rate at approximately 88%.
- Continued strong persistency, with approximately 56% of patients remaining on therapy at 12 months, 51% at 15 months, and 46% at 18 months.
Financial Results for the Three and Six Months Ended
Total net revenue was
Net product revenue was
The
License, collaboration and royalty revenue was
Total cost of sales and operating expenses, inclusive of a restructuring charge in the second quarter of 2024, were
Cost of sales were
Gross margin was approximately 84% and 96% for the three months ended
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, net was
Interest income was
Interest expense was
For the three months ended
Financial Liquidity at
As of
Cash generated from operations and non-GAAP free cash flow generated 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 Aurinia’s liquidity that, when viewed with the Company’s GAAP results, provides a more complete understanding of factors and trends affecting Aurinia’s cash flows. The Company believes 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, the Company believes it is important to view free cash flow as a complement to its 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 and six months ended
Conference Call Details
Aurinia will host a conference call and webcast today,
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
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; challenges in the conduct of clinical trials; 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
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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(unaudited) |
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|
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||
ASSETS |
|
|
|
|
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Current assets |
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
$ |
33,407 |
|
$ |
48,875 |
Short-term investments |
|
|
297,068 |
|
|
301,614 |
Accounts receivable, net |
|
|
25,522 |
|
|
24,089 |
Inventories, net |
|
|
38,853 |
|
|
39,705 |
Prepaid expenses |
|
|
7,840 |
|
|
9,486 |
Other current assets |
|
|
6,976 |
|
|
1,031 |
Total current assets |
|
|
409,666 |
|
|
424,800 |
|
|
|
|
|
||
Non-current assets |
|
|
|
|
||
Long-term investments |
|
|
199 |
|
|
201 |
Other non-current assets |
|
|
867 |
|
|
1,517 |
Property and equipment, net |
|
|
3,043 |
|
|
3,354 |
Acquired intellectual property and other intangible assets, net |
|
|
4,621 |
|
|
4,977 |
Finance right-of-use asset, net |
|
|
100,845 |
|
|
108,715 |
Operating right-of-use assets, net |
|
|
4,288 |
|
|
4,498 |
Total assets |
|
$ |
523,529 |
|
$ |
548,062 |
|
|
|
|
|
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LIABILITIES |
|
|
|
|
||
Current liabilities |
|
|
|
|
||
Accounts payable and accrued liabilities |
|
|
56,460 |
|
|
54,389 |
Deferred revenue |
|
|
4,367 |
|
|
4,813 |
Other current liabilities |
|
|
1,162 |
|
|
2,388 |
Finance lease liability |
|
|
13,906 |
|
|
14,609 |
Operating lease liabilities |
|
|
1,008 |
|
|
989 |
Total current liabilities |
|
|
76,903 |
|
|
77,188 |
|
|
|
|
|
||
Non-current liabilities |
|
|
|
|
||
Finance lease liability |
|
|
64,923 |
|
|
75,479 |
Operating lease liabilities |
|
|
6,146 |
|
|
6,530 |
Deferred compensation and other non-current liabilities |
|
|
10,941 |
|
|
10,911 |
Total liabilities |
|
|
158,913 |
|
|
170,108 |
SHAREHOLDER’S EQUITY |
|
|
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|
||
Common shares - no par value, unlimited shares authorized, 142,984 and 143,833 shares issued and
|
|
|
1,205,554 |
|
|
1,200,218 |
Additional paid-in capital |
|
|
112,270 |
|
|
120,788 |
Accumulated other comprehensive loss |
|
|
(859) |
|
|
(730) |
Accumulated deficit |
|
|
(952,349) |
|
|
(942,322) |
Total shareholders' equity |
|
|
364,616 |
|
|
377,954 |
Total liabilities and shareholders' equity |
|
$ |
523,529 |
|
$ |
548,062 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except per share data) |
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Three months ended |
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Six months ended |
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2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
(unaudited) |
||||||||||
Revenue |
|
|
|
|
|
|
|
|
||||
Product revenue, net |
|
$ |
55,028 |
|
$ |
41,100 |
|
$ |
103,101 |
|
$ |
75,437 |
License, collaboration and royalty revenue |
|
|
2,164 |
|
|
394 |
|
|
4,394 |
|
|
466 |
Total revenue, net |
|
|
57,192 |
|
|
41,494 |
|
|
107,495 |
|
|
75,903 |
Operating expenses |
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
8,909 |
|
|
1,563 |
|
|
16,661 |
|
|
1,984 |
Selling, general and administrative |
|
|
44,934 |
|
|
47,081 |
|
|
92,629 |
|
|
97,205 |
Research and development |
|
|
4,080 |
|
|
12,650 |
|
|
9,631 |
|
|
25,808 |
Restructuring expenses |
|
|
1,072 |
|
|
— |
|
|
7,755 |
|
|
— |
Other income, net |
|
|
(290) |
|
|
(3,630) |
|
|
(4,415) |
|
|
(3,340) |
Total cost of sales and operating expenses |
|
|
58,705 |
|
|
57,664 |
|
|
122,261 |
|
|
121,657 |
Loss from operations |
|
|
(1,513) |
|
|
(16,170) |
|
|
(14,766) |
|
|
(45,754) |
Interest expense |
|
|
(1,198) |
|
|
(65) |
|
|
(2,481) |
|
|
(65) |
Interest income |
|
|
4,189 |
|
|
4,101 |
|
|
8,715 |
|
|
7,915 |
Net income (loss) before income taxes |
|
|
1,478 |
|
|
(12,134) |
|
|
(8,532) |
|
|
(37,904) |
Income tax expense (benefit) |
|
|
756 |
|
|
(642) |
|
|
1,495 |
|
|
(206) |
Net income (loss) |
|
$ |
722 |
|
$ |
(11,492) |
|
$ |
(10,027) |
|
$ |
(37,698) |
|
|
|
|
|
|
|
|
|
||||
Net income (loss) per share: |
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
0.01 |
|
$ |
(0.08) |
|
$ |
(0.07) |
|
$ |
(0.26) |
Diluted |
|
$ |
0.01 |
|
$ |
(0.08) |
|
$ |
(0.07) |
|
$ |
(0.26) |
|
|
|
|
|
|
|
|
|
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Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
||||
Basic |
|
|
143,327 |
|
|
142,777 |
|
|
143,507 |
|
|
142,904 |
Diluted |
|
|
144,110 |
|
|
142,777 |
|
|
143,507 |
|
|
142,904 |
|
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||
|
|
Six Months Ended |
||||
|
|
|
2024 |
|
|
2023 |
(in thousands) |
|
(unaudited) |
||||
Cash flows from operating activities |
|
|
|
|
||
Net loss |
|
$ |
(10,027) |
|
$ |
(37,698) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
||
Depreciation and amortization |
|
|
9,690 |
|
|
1,436 |
Net amortization of premiums and discounts on short-term investments |
|
|
(6,331) |
|
|
(5,599) |
Share-based compensation expense |
|
|
14,323 |
|
|
21,735 |
Foreign exchange on finance lease liability |
|
|
(5,705) |
|
|
417 |
Other, net |
|
|
275 |
|
|
(3,652) |
Net changes in operating assets and liabilities |
|
|
|
|
||
Accounts receivable, net |
|
|
(1,433) |
|
|
(6,016) |
Inventories, net |
|
|
852 |
|
|
(8,403) |
Prepaid expenses and other current assets |
|
|
(4,305) |
|
|
2,374 |
Non-current operating assets |
|
|
(12) |
|
|
(16) |
Accounts payable, accrued and other liabilities |
|
|
283 |
|
|
1,245 |
Operating lease liabilities |
|
|
(365) |
|
|
(319) |
Net cash used in operating activities |
|
|
(2,755) |
|
|
(34,496) |
Cash flows from investing activities |
|
|
|
|
||
Purchase of investments |
|
|
(318,126) |
|
|
(256,439) |
Proceeds from investments |
|
|
328,877 |
|
|
288,291 |
Upfront lease payment |
|
|
(44) |
|
|
(11,864) |
Purchase of property and equipment |
|
|
— |
|
|
(524) |
Capitalized patent costs |
|
|
(96) |
|
|
(212) |
Net cash provided by investing activities |
|
|
10,611 |
|
|
19,252 |
Cash flows from financing activities |
|
|
|
|
||
Repurchase of common shares |
|
|
(18,435) |
|
|
— |
Principal portion of finance lease payments |
|
|
(6,001) |
|
|
— |
Proceeds from exercise of stock options and employee share purchase plan |
|
|
1,112 |
|
|
2,779 |
Cash (used in) provided by financing activities |
|
|
(23,324) |
|
|
2,779 |
Net decrease in cash, cash equivalents and restricted cash |
|
|
(15,468) |
|
|
(12,465) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
48,875 |
|
|
94,172 |
Cash, cash equivalents and restricted cash, end of period |
|
$ |
33,407 |
|
$ |
81,707 |
|
|
|
|
|
||
Reconciliation of free cash flow(1) |
|
|
|
|
||
Net cash used in operating activities |
|
$ |
(2,755) |
|
$ |
(34,496) |
Purchases of property and equipment |
|
|
— |
|
|
(524) |
Free cash flow |
|
$ |
(2,755) |
|
$ |
(35,020) |
(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/20240801207622/en/
Media and Investor Inquiries:
Corporate Communications and Investor Relations, Aurinia
achristopher@auriniapharma.com
ir@auriniapharma.com
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