Aurinia Reports First Quarter 2022 Financial and Operational Results
Aurinia Pharmaceuticals (NASDAQ: AUPH) reported net revenues of $21.6 million for Q1 2022, significantly up from $914,000 in Q1 2021, driven by strong demand for LUPKYNIS following its FDA approval in January 2021. The company maintains its revenue guidance of $115-$135 million for 2022, reflecting a growth of over 150-200% compared to 2021. Despite a net loss of $37.6 million for the quarter, improvements in patient start forms and an upcoming EMA review for LUPKYNIS are promising milestones. Aurinia's cash reserves stood at $418.8 million as of March 31, 2022.
- Net revenues increased to $21.6 million for Q1 2022 from $914,000 in Q1 2021.
- Maintained revenue guidance of $115-$135 million for 2022, reflecting significant growth potential.
- Improvement in patient start forms, with 647 recorded in 2022 YTD.
- High patient retention rate with approximately 70% remaining on treatment at 6 months post-start.
- Q1 2022 net loss of $37.6 million, though improved from $50.4 million in Q1 2021.
- Operating expenses rose to $59.5 million from $51.5 million YoY, mainly due to increased commercialization costs.
Continued increases in LUPKYNIS™ (voclosporin) Patients on Treatment and Patient Start Forms; Steady Conversion Rates and Payor Coverage
EMA review of LUPKYNIS remains on track with decision expected in 2H 2022
Conference call to be hosted today at
Net product revenues were
“As previously reported on our fourth quarter call, LUPKYNIS revenues in the first quarter were impacted by care disruptions to both patients and the healthcare system caused by the COVID-19 Omicron variant. We are quite pleased that exiting the quarter, as Omicron abated, we began to see a significant increase in prescribing, patient starts, and refills, leading to a monthly record for received patient start forms and patient starts in March,” said
For fiscal year 2022, the Company maintains its net revenue guidance of
First Quarter 2022 and Recent Highlights & Upcoming Milestones:
- Aurinia added 461 patient start forms (PSFs) during the first quarter 2022, as compared to 257 in the first quarter 2021.
-
As of
Friday, May 6, 2022 , the Company recorded 647 total PSFs sinceJanuary 1, 2022 . -
PSF conversion rates are now at
80% after 90 days; confirmed patient access to LUPKYNIS through payors and plans remains steady representing about90% ofU.S. total lives. -
There were approximately 1,071 patients on LUPKYNIS therapy at
March 31, 2022 , compared with 884 at the end of 2021. At 6 months post-treatment-start, an average of approximately70% of patients remain on treatment. -
Per recent healthcare provider (HCP) surveys, unaided brand awareness of LUPKYNIS is over
70% while aided brand awareness is over90% and intent to use in the next 3 months is over70% , the highest level since launch. -
The first presentations of final AURORA 2 continuation study data are expected at the 59th
European Renal Association (ERA) Congress and at theEuropean Congress of Rheumatology at the end of May, 2022 and at theEuropean Alliance of Associations for Rheumatology (EULAR) 2022 in June. Submission of a manuscript with the full results is expected in the second half of 2022. - With the start of the year, the Aurinia commercial team initiated several new HCP and patient-targeted marketing programs that include the AURORA 2 data and patient brand ambassadors.
-
Regulatory review of the
European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with aEuropean Commission (EC) approval decision expected in second half of 2022. - Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry is continuing.
Financial Liquidity at
As of
Aurinia believes that it has sufficient financial resources to fund its current 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 research and development (R&D) programs, investing in its pipeline and operating activities for at least the next few years.
Financial Results for the Quarter Ended
Total net revenue was
Total cost of sales and operating expenses for the quarter ended
Cost of sales were
Gross margin for the quarters ended
Selling, general and administrative (SG&A) expenses were
Non-cash SG&A share-based compensation expense for the quarters ended
R&D expenses were
Non-cash R&D share-based compensation expense for the quarters ended
For the quarter ended
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 progression of systemic lupus erythematosus (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 |
|
$ |
132,542 |
|
$ |
231,900 |
Short-term investments |
|
|
286,210 |
|
|
234,178 |
Accounts receivable, net |
|
|
20,401 |
|
|
15,414 |
Inventories, net |
|
|
26,266 |
|
|
19,326 |
Prepaid expenses and other current assets |
|
|
12,199 |
|
|
12,506 |
Total current assets |
|
|
477,618 |
|
|
513,324 |
|
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Non-current assets |
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Other non-current assets |
|
|
11,838 |
|
|
11,838 |
Property and equipment, net |
|
|
4,332 |
|
|
4,418 |
Acquired intellectual property and other intangible assets, net |
|
|
7,882 |
|
|
8,404 |
Right-of-use assets |
|
|
5,232 |
|
|
5,383 |
Total assets |
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|
506,902 |
|
|
543,367 |
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LIABILITIES |
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Current liabilities |
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|
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Accounts payable and accrued liabilities |
|
|
32,327 |
|
|
34,947 |
Other current liabilities |
|
|
502 |
|
|
4,640 |
Operating lease liabilities |
|
|
1,009 |
|
|
1,059 |
Total current liabilities |
|
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33,838 |
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40,646 |
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Non-current liabilities |
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Deferred compensation and other non-current liabilities |
|
|
17,379 |
|
|
15,950 |
Operating lease liabilities |
|
|
7,562 |
|
|
7,680 |
Total liabilities |
|
|
58,779 |
|
|
64,276 |
SHAREHOLDER’S EQUITY |
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Common shares - no par value, unlimited shares authorized, 141,742 and 141,600 shares issued and outstanding at |
|
|
1,178,807 |
|
|
1,177,051 |
Additional paid-in capital |
|
|
64,686 |
|
|
59,014 |
Accumulated other comprehensive loss |
|
|
(1,618) |
|
|
(852) |
Accumulated deficit |
|
|
(793,752) |
|
|
(756,122) |
Total shareholders' equity |
|
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448,123 |
|
|
479,091 |
Total liabilities and shareholders’ equity |
|
$ |
506,902 |
|
$ |
543,367 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
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Three months ended |
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2022 |
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2021 |
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(unaudited) |
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Revenue |
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Product revenue, net |
|
$ |
21,492 |
|
$ |
884 |
License and collaboration revenue |
|
|
133 |
|
|
30 |
Total revenue, net |
|
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21,625 |
|
|
914 |
Operating expenses |
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|
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Cost of sales |
|
|
256 |
|
|
48 |
Selling, general and administrative |
|
|
45,197 |
|
|
39,805 |
Research and development |
|
|
12,620 |
|
|
9,833 |
Other expense, net |
|
|
1,434 |
|
|
1,771 |
Total cost of sales and operating expenses |
|
|
59,507 |
|
|
51,457 |
Loss from operations |
|
|
(37,882) |
|
|
(50,543) |
Interest income |
|
|
262 |
|
|
172 |
Net loss before income taxes |
|
|
(37,620) |
|
|
(50,371) |
Income tax expense |
|
|
10 |
|
|
8 |
Net loss |
|
$ |
(37,630) |
|
$ |
(50,379) |
Basic and diluted loss per share |
|
$ |
(0.27) |
|
$ |
(0.40) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
141,675 |
|
|
127,401 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220510005408/en/
Investor/Media Contact:
Corporate Communications, Aurinia
dlynch@auriniapharma.com
Source:
FAQ
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