Aurinia Reports Second Quarter and Six Months 2022 Financial and Operational Results
Aurinia Pharmaceuticals reported a net revenue of $28.2 million for Q2 2022, significantly up from $6.6 million in Q2 2021. The company maintains its 2022 revenue guidance of $115-$135 million, mainly from its drug, LUPKYNIS® (voclosporin). The patient treatment count has risen to 1,274, with strong conversion rates and payor coverage. However, the net loss for the quarter was $35.5 million, an improvement from a $47 million loss in the prior year. Aurinia also reported $391.7 million in cash and investments as of June 30, 2022, ensuring adequate liquidity for upcoming operations.
- Net revenue increased to $28.2 million for Q2 2022, up from $6.6 million in Q2 2021.
- Maintains 2022 net revenue guidance range of $115-$135 million driven by LUPKYNIS.
- Increased patient count on LUPKYNIS therapy to 1,274 by June 30, 2022, up from 1,071 in Q1 2022.
- High patient retention rates: approximately 70% at 6 months and 60% at 9 months post-treatment.
- Reported $391.7 million in cash and investments, ensuring financial stability.
- Net loss for Q2 2022 was $35.5 million, though improved from $47 million in Q2 2021.
- Total operating expenses increased to $64.2 million for Q2 2022, up from $53.8 million in Q2 2021.
- SG&A expenses rose to $51.5 million for Q2 2022, reflecting increased share-based compensation.
Net revenue increased to
Continued increases in LUPKYNIS Patients on Treatment; Steady Conversion Rates and Payor Coverage
EMA review of LUPKYNIS remains on track with decision expected by the end of Q3 2022
Conference call to be hosted today at
Second Quarter 2022 and Recent Highlights & Upcoming Milestones
-
Net product revenues were
for the quarter ended$28.2 million June 30, 2022 , compared to for the same period ended$6.6 million June 30, 2021 .-
Aurinia added 409 patient start forms (PSFs) during the second quarter 2022, as compared to 415 in the second quarter of 2021. As of
Friday, July 29, 2022 , the Company recorded 981 total PSFs sinceJanuary 1, 2022 . - PSF conversion rates after 90 days and confirmed patient access remain at peak levels since launch.
-
There were approximately 1,274 patients on LUPKYNIS therapy at
June 30, 2022 , compared with 1,071 atMarch 31, 2022 . -
At 6 months post-treatment-start, an average of approximately
70% of patients remain on treatment; and at 9 months, approximately60% of patients are still on treatment.
-
Aurinia added 409 patient start forms (PSFs) during the second quarter 2022, as compared to 415 in the second quarter of 2021. As of
-
Received positive CHMP opinion for LUPKYNIS® (voclosporin) for the treatment of adults with active lupus nephritis in
Europe . Regulatory review of theEuropean Medicines Agency (EMA) marketing authorization application (MAA) remains on track with aEuropean Commission (EC) approval decision expected by the end of the third quarter of 2022. -
The first presentations of final AURORA 2 continuation study data were presented at the following medical meetings:
-
59th
European Renal Association (ERA) Congress ; -
the
European Congress of Rheumatology ; -
the
European Alliance of Associations for Rheumatology (EULAR); and, - Submission of a manuscript with the full results is expected in the second half of 2022.
-
59th
- Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry continue as planned.
-
The Company received notice regarding the
U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review (IPR) filed bySun Pharmaceuticals , directed atU.S. Patent No. 10,286,036. This patent is related to the LUPKYNIS dosing protocol for lupus nephritis. A determination on patentability, relative to the IPR, is expected on or prior toJuly 26, 2023 .
Financial Results for the Quarter and Six Months Ended
Total net revenue was
Total cost of sales and operating expenses for the quarters ended
Cost of sales were
Gross margin for the quarters ended
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 quarters ended
Research and Development (R&D) expenses, inclusive of share-based compensation, were
Non-cash R&D share-based compensation expense included above for the quarters ended
For the quarter ended
Financial Liquidity at
As 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, conducting planned R&D programs and investing in its pipeline and operating activities 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
Conference Call Details
Aurinia will host a conference call and webcast to discuss the quarter ended
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE 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; 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 COVID-19 pandemic 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 available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
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(unaudited) |
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ASSETS |
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Current assets |
|
|
|
|
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Cash, cash equivalents and restricted cash |
|
$ |
151,632 |
|
|
$ |
231,900 |
|
Short-term investments |
|
|
240,104 |
|
|
|
234,178 |
|
Accounts receivable, net |
|
|
18,173 |
|
|
|
15,414 |
|
Inventories, net |
|
|
25,863 |
|
|
|
19,326 |
|
Prepaid expenses and other current assets |
|
|
17,421 |
|
|
|
12,506 |
|
Total current assets |
|
|
453,193 |
|
|
|
513,324 |
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Non-current assets |
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|
|
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Other non-current assets |
|
|
12,355 |
|
|
|
11,838 |
|
Property and equipment, net |
|
|
4,183 |
|
|
|
4,418 |
|
Acquired intellectual property and other intangible assets, net |
|
|
7,338 |
|
|
|
8,404 |
|
Right-of-use assets, net |
|
|
5,079 |
|
|
|
5,383 |
|
Total assets |
|
|
482,148 |
|
|
|
543,367 |
|
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LIABILITIES |
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Current liabilities |
|
|
|
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Accounts payable and accrued liabilities |
|
|
32,380 |
|
|
|
34,947 |
|
Other current liabilities |
|
|
1,293 |
|
|
|
4,640 |
|
Operating lease liabilities |
|
|
953 |
|
|
|
1,059 |
|
Total current liabilities |
|
|
34,626 |
|
|
|
40,646 |
|
|
|
|
|
|
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Non-current liabilities |
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|
|
|
||||
Deferred compensation and other non-current liabilities |
|
|
16,323 |
|
|
|
15,950 |
|
Operating lease liabilities |
|
|
7,431 |
|
|
|
7,680 |
|
Total liabilities |
|
|
58,380 |
|
|
|
64,276 |
|
SHAREHOLDER’S EQUITY |
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Common shares - no par value, unlimited shares authorized, 141,892 and 141,600 shares issued and outstanding at |
|
|
1,180,884 |
|
|
|
1,177,051 |
|
Additional paid-in capital |
|
|
74,004 |
|
|
|
59,014 |
|
Accumulated other comprehensive loss |
|
|
(1,853 |
) |
|
|
(852 |
) |
Accumulated deficit |
|
|
(829,267 |
) |
|
|
(756,122 |
) |
Total shareholders' equity |
|
|
423,768 |
|
|
|
479,091 |
|
Total liabilities and shareholders’ equity |
|
$ |
482,148 |
|
|
$ |
543,367 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
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Three months ended |
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Six months ended |
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2022 |
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2021 |
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2022 |
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2021 |
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(unaudited) |
|
(unaudited) |
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Revenue |
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Product revenue, net |
|
$ |
28,148 |
|
|
$ |
6,591 |
|
|
$ |
49,640 |
|
|
$ |
7,475 |
|
License and collaboration revenue |
|
|
43 |
|
|
|
29 |
|
|
|
176 |
|
|
|
59 |
|
Total revenue, net |
|
|
28,191 |
|
|
|
6,620 |
|
|
|
49,816 |
|
|
|
7,534 |
|
Operating expenses |
|
|
|
|
|
|
|
|
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Cost of sales |
|
|
1,599 |
|
|
|
308 |
|
|
|
1,855 |
|
|
|
356 |
|
Selling, general and administrative |
|
|
51,532 |
|
|
|
44,322 |
|
|
|
96,729 |
|
|
|
84,127 |
|
Research and development |
|
|
11,525 |
|
|
|
10,091 |
|
|
|
24,145 |
|
|
|
19,924 |
|
Other (income) expense, net |
|
|
(476 |
) |
|
|
(967 |
) |
|
|
958 |
|
|
|
804 |
|
Total cost of sales and operating expenses |
|
|
64,180 |
|
|
|
53,754 |
|
|
|
123,687 |
|
|
|
105,211 |
|
Loss from operations |
|
|
(35,989 |
) |
|
|
(47,134 |
) |
|
|
(73,871 |
) |
|
|
(97,677 |
) |
Interest income |
|
|
483 |
|
|
|
142 |
|
|
|
745 |
|
|
|
314 |
|
Net loss before income taxes |
|
|
(35,506 |
) |
|
|
(46,992 |
) |
|
|
(73,126 |
) |
|
|
(97,363 |
) |
Income tax expense |
|
|
9 |
|
|
|
18 |
|
|
|
19 |
|
|
|
26 |
|
Net loss |
|
$ |
(35,515 |
) |
|
$ |
(47,010 |
) |
|
$ |
(73,145 |
) |
|
$ |
(97,389 |
) |
Basic and diluted loss per share |
|
$ |
(0.25 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.76 |
) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
141,726 |
|
|
|
128,222 |
|
|
|
141,734 |
|
|
|
127,814 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005355/en/
Investor/Media Contact:
Vice President, Investor Relations, Aurinia
dsheel@auriniapharma.com
Source:
FAQ
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