Aurinia Reports Third Quarter and Nine Months 2022 Financial and Operational Results
Aurinia Pharmaceuticals announced Q3 2022 net revenue of $55.8 million, up from $14.7 million in Q3 2021. The revenue includes a $30 million milestone from Otsuka for LUPKYNIS® approval in Europe. The company adjusted its revenue guidance for 2022 to $100-105 million and projected $120-140 million for 2023. As of October 31, 2022, Aurinia reported approximately $400 million in cash and equivalents. Despite a slight decline in new patient start forms, the company achieved significant progress in commercialization and patient adherence.
- Q3 2022 net revenue increased to $55.8 million from $14.7 million in Q3 2021.
- Recognition of a $30 million milestone from Otsuka for LUPKYNIS approval.
- Adjusted revenue guidance for 2022 is now $100-105 million.
- Preliminary revenue guidance for 2023 estimated at $120-140 million.
- Approximately $400 million in cash and equivalents as of October 31, 2022.
- Positive growth in patient adherence and commercial metrics for LUPKYNIS.
- Slight decline in new patient start forms compared to the second quarter.
- Potentially reduced lupus nephritis diagnoses impacting new patient starts.
Net revenue of
Adjusts net product revenue guidance to
Issues preliminary net product revenue guidance for 2023 in the range of
Approximately
Conference call to be hosted today at
Total net revenue was
“During the third quarter, we demonstrated progress across many key commercial metrics for LUPKYNIS, including an increased total number of patients on therapy, improved patient start form conversion rates and processing speed, and sustained patient adherence, in comparison to the second quarter ended
Third Quarter 2022 and Recent Highlights
-
There were approximately 1,354 patients on LUPKYNIS therapy at
September 30, 2022 , compared with 1,274 atJune 30, 2022 . -
Aurinia added 374 patient start forms (PSFs) during the third quarter 2022, as compared to 412 in the third quarter of 2021. As of
Monday, October 31, 2022 , the Company recorded 1,357 total PSFs sinceJanuary 1, 2022 . - PSF conversion rates after 90 days, adherence rates and confirmed patient access remain at peak levels since launch.
-
Persistency rates at 6 months and at 9 months remain reasonable consistent with prior periods, at approximately,
70% and60% , respectively. At 12 months post-treatment-start, an average of approximately50% of patients remain on treatment. -
The
European Commission (EC) granted Marketing Authorization for LUPKYNIS to Otsuka for the treatment of adults with active lupus nephritis inEurope inSeptember 2022 . The centralized marketing authorization is valid in allEuropean Union (EU) member states as well as inIceland ,Liechtenstein ,Norway andNorthern Ireland .-
The Company recognized a one-time
EC approval-related milestone in connection with its collaboration and licensing agreement with its partner$30.0 million Otsuka Pharmaceuticals Co., Ltd. , during the quarter, which was subsequently received onOctober 31, 2022 . In addition to the milestone, the Company began recognizing revenue for the supply of product and certain reimbursable collaboration activities under a cost-plus arrangement. Going forward the Company will be eligible to receive further payments tied to additional regulatory and reimbursement milestones, along with low double digit royalties on future net sales.
-
The Company recognized a one-time
-
Additional clinical data, including updates from AURORA 1 and AURORA 2, are expected to be presented at upcoming conferences, including LUPUS, the
American College of Rheumatology Convergence 2022, and, theAmerican Society of Nephrology . - Key ongoing clinical updates for LUPKYNIS include the advancement of both the VOCAL pediatric study and the ENLIGHT-LN registry. With the registry, which we just initiated at the beginning of the year, we now have 38 activated sites toward our goal of having 75 sites total. As a reminder, we plan to leverage real-world data collected from this study to gain further knowledge about patients taking LUPKYNIS and help clinicians and payers to improve patient care and ensure access to therapy. We also remain on track to meet our post approval FDA commitments.
As previously reported, on
Financial Results for the Three and Nine Months Ended
Total net revenue was
Total cost of sales and operating expenses for the three months ended
Cost of sales were
Gross margin for the three months 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 three months 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 three months ended
Interest income was
For the three months 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, 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
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 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
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 |
|
$ |
86,052 |
|
|
$ |
231,900 |
|
Short-term investments |
|
|
290,592 |
|
|
|
234,178 |
|
Accounts receivable, net |
|
|
41,771 |
|
|
|
15,414 |
|
Inventories, net |
|
|
25,320 |
|
|
|
19,326 |
|
Prepaid expenses |
|
|
12,159 |
|
|
|
11,710 |
|
Other current assets |
|
|
3,808 |
|
|
|
796 |
|
Total current assets |
|
|
459,702 |
|
|
|
513,324 |
|
|
|
|
|
|
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Non-current assets |
|
|
|
|
||||
Other non-current assets |
|
|
13,049 |
|
|
|
11,838 |
|
Property and equipment, net |
|
|
3,758 |
|
|
|
4,418 |
|
Acquired intellectual property and other intangible assets, net |
|
|
6,839 |
|
|
|
8,404 |
|
Right-of-use assets, net |
|
|
4,945 |
|
|
|
5,383 |
|
Total assets |
|
|
488,293 |
|
|
|
543,367 |
|
|
|
|
|
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LIABILITIES |
|
|
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Current liabilities |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
|
40,123 |
|
|
|
34,947 |
|
Other current liabilities |
|
|
724 |
|
|
|
4,640 |
|
Operating lease liabilities |
|
|
918 |
|
|
|
1,059 |
|
Total current liabilities |
|
|
41,765 |
|
|
|
40,646 |
|
|
|
|
|
|
||||
Non-current liabilities |
|
|
|
|
||||
Deferred compensation and other non-current liabilities |
|
|
15,833 |
|
|
|
15,950 |
|
Operating lease liabilities |
|
|
7,270 |
|
|
|
7,680 |
|
Total liabilities |
|
|
64,868 |
|
|
|
64,276 |
|
SHAREHOLDER’S EQUITY |
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Common shares - no par value, unlimited shares authorized, 142,110 and 141,600 shares issued and outstanding at |
|
|
1,184,020 |
|
|
|
1,177,051 |
|
Additional paid-in capital |
|
|
79,188 |
|
|
|
59,014 |
|
Accumulated other comprehensive loss |
|
|
(1,527 |
) |
|
|
(852 |
) |
Accumulated deficit |
|
|
(838,256 |
) |
|
|
(756,122 |
) |
Total shareholders' equity |
|
|
423,425 |
|
|
|
479,091 |
|
Total liabilities and shareholders’ equity |
|
$ |
488,293 |
|
|
$ |
543,367 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
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Three months ended |
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Nine months ended |
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2022 |
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2021 |
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2022 |
|
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|
2021 |
|
|
|
(unaudited) |
|
(unaudited) |
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Revenue |
|
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|
|
|
|
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|
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Product revenue, net |
|
$ |
25,502 |
|
|
$ |
14,638 |
|
|
$ |
75,142 |
|
|
$ |
22,113 |
|
License and collaboration revenue |
|
|
30,277 |
|
|
|
29 |
|
|
|
30,453 |
|
|
|
88 |
|
Total revenue, net |
|
|
55,779 |
|
|
|
14,667 |
|
|
|
105,595 |
|
|
|
22,201 |
|
Operating expenses |
|
|
|
|
|
|
|
|
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Cost of sales |
|
|
2,447 |
|
|
|
254 |
|
|
|
4,302 |
|
|
|
610 |
|
Selling, general and administrative |
|
|
52,169 |
|
|
|
44,645 |
|
|
|
148,898 |
|
|
|
128,772 |
|
Research and development |
|
|
10,973 |
|
|
|
20,066 |
|
|
|
35,118 |
|
|
|
39,990 |
|
Other (income) expense, net |
|
|
(311 |
) |
|
|
55 |
|
|
|
647 |
|
|
|
859 |
|
Total cost of sales and operating expenses |
|
|
65,278 |
|
|
|
65,020 |
|
|
|
188,965 |
|
|
|
170,231 |
|
Loss from operations |
|
|
(9,499 |
) |
|
|
(50,353 |
) |
|
|
(83,370 |
) |
|
|
(148,030 |
) |
Interest income |
|
|
1,464 |
|
|
|
106 |
|
|
|
2,209 |
|
|
|
420 |
|
Net loss before income taxes |
|
|
(8,035 |
) |
|
|
(50,247 |
) |
|
|
(81,161 |
) |
|
|
(147,610 |
) |
Income tax expense |
|
|
954 |
|
|
|
8 |
|
|
|
973 |
|
|
|
34 |
|
Net loss |
|
|
(8,989 |
) |
|
|
(50,255 |
) |
|
$ |
(82,134 |
) |
|
$ |
(147,644 |
) |
Basic and diluted loss per share |
|
$ |
(0.06 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.15 |
) |
Weighted-average common shares outstanding used in computation of basic and diluted loss per share |
|
|
141,856 |
|
|
|
128,443 |
|
|
|
141,831 |
|
|
|
128,084 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005471/en/
Investor/Media Contact:
Aurinia@westwicke.com
Source:
FAQ
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