$23.4 million in net revenue for the fourth
quarter 2021 (60% increase from third quarter) and $45.6 million in
net revenue for full year 2021
2021 readout of strong results from AURORA 2
continuation study fuels momentum for year two of launch
Cash and cash equivalents, and investments of
$466.1 million as of December 31, 2021
Company projects a net revenue guidance range
of $115-$135 million from sales of LUPKYNIS™ (voclosporin) for
2022
Conference call to be hosted today at 8:30 a.m.
ET
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today issued its financial results for the fourth quarter
and year ended December 31, 2021. Amounts, unless specified
otherwise, are expressed in U.S. dollars.
Aurinia achieved $23.4 million and $45.6 million for the quarter
and full year ended December 31, 2021, respectively. These results
align with the previously stated annual revenue estimate in the
range of $40 to $50 million for 2021.
“In the fourth quarter 2021, we performed well against our
commercial launch objectives, doubling our total revenue from the
previous three quarters with increases in LUPKYNIS patient start
forms and improved conversion rates and payor coverage,” said Peter
Greenleaf, President and Chief Executive Officer of Aurinia.
“Despite unpredictable COVID realities, varying by geographic
region, as well as the typical challenges we would expect to manage
in the first year of a product launch, we are very pleased with the
progress we have made to ensure awareness, adoption, and access to
LUPKYNIS.”
For fiscal year 2022, the Company is providing net revenue
guidance of $115 to $135 million from sales of LUPKYNIS. This range
is based on assumptions regarding the impact of COVID-19 on the
current business environment and represents an increase of more
than 150 to 200% in net revenue from sales of LUPKYNIS compared to
fiscal year 2021.
“The positive results from the AURORA 2 two-year continuation
study, announced in December 2021, will fuel our momentum and
differentiate LUPKYNIS going forward as we have the first and only
FDA-approved medicine for LN with three years of pivotal trial
results, including long-term safety data. Outside of the U.S., we
continue to work closely with our partner Otsuka Pharmaceutical
Co., Ltd. (Otsuka) to secure regulatory approval of voclosporin in
the EU and expand global access to this important treatment,” added
Mr. Greenleaf. “With a healthy balance sheet, including
approximately $466.1 million of cash, cash equivalents and
investments on hand as of year end, strong commercial, research and
development programs, and talented, passionate employees, we are
poised for continued growth and success as we work to change the
course of lupus nephritis and other autoimmune diseases.”
Fourth Quarter 2021 Highlights & Upcoming
Milestones:
- Aurinia added 477 patient start forms (PSFs) in Q4 2021, a 17%
increase from Q3 2021, with a total of 1,572 PSFs received during
2021.
- PSF conversion rates continue to increase with more than 70% of
PSFs converted to patients on therapy. Time to convert continues to
decrease since launch: 30- and 60-day conversion rates have
improved each month.
- Since January 2021 (launch of LUPKYNIS), the Company has
secured a total of 1,773 PSFs to date.
- Aurinia now has confirmed payor coverage in plans covering more
than 90% of total lives in the United States.
- In December 2021, the Company presented top-line data from the
AURORA 2 two-year continuation study demonstrating a favorable
risk/benefit profile for voclosporin over a three-year period, with
safety comparable to AURORA 1, and sustained efficacy. Additional
data from this study is expected to be published and presented in
peer-reviewed journals and/or medical meetings throughout
2022.
- Regulatory review of the European Medicines Agency (EMA)
marketing authorization application (MAA) remains on track with a
Committee for Medicinal Products for Human Use (CHMP) opinion
expected in the second half of 2022 followed by a European
Commission (EC) approval decision expected in the second half of
2022.
- Further stabilized balance sheet through the utilization of an
at the market offering (ATM), raising net proceeds of $196.7
million through December 31, 2021, at an average price of $19.91
and at an average discount of 2.63%. The Company has terminated the
ATM sales agreement with no further sales to occur under the
ATM.
Financial Liquidity at December 31, 2021
As of December 31, 2021, Aurinia had cash and cash equivalents
and investments of $466.1 million compared to $422.7 million at
December 31, 2020. The increase was primarily due to the receipt of
net proceeds from the Company’s ATM offering, cash proceeds from
the exercise of stock options and warrants and cash receipts from
the sale of LUPKYNIS, offset by the commercial infrastructure spend
to support the launch of LUPKYNIS. The offset also includes
payments for inventory, an upfront payment made as part of a
collaborative agreement with Lonza to build a dedicated
manufacturing capability (or monoplant) and an upfront license
payment related to its recently acquired developmental programs
(AUR200 and AUR300).
Net cash used in operating activities was $157.7 million for the
year ended December 31, 2021 compared to $69.9 million for the year
ended December 31, 2020. The increase was primarily due to the
commercial infrastructure spend to support the launch of LUPKYNIS,
payments for inventory, an upfront payment made as part of a
collaborative agreement with Lonza to build the monoplant, payments
to advance clinical programs and one-time payments to a related
party upon achievement of specific milestones partially offset by
cash receipts from sales of LUPKYNIS.
The Company believes that it has sufficient financial resources
to fund its current plans, 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,
executing on its business development strategy and funding its
operating activities for at least the next few years.
Financial Results for the Quarter and Year Ended December 31,
2021
Total net revenue was $23.4 million and $50.0 million for the
quarters ended December 31, 2021 and December 31, 2020,
respectively. Total net revenue was $45.6 million and $50.1 million
for the years ended December 31, 2021 and December 31, 2020,
respectively. The net revenue for the quarter ended and year ended
December 31, 2021, primarily consisted of commercial sales of
LUPKYNIS, following FDA approval in January of 2021. Total revenue
for the quarter and year ended December 31, 2020, was primarily due
to an upfront payment from Otsuka of $50.0 million resulting from
entering into its collaboration agreement with Otsuka.
Cost of sales were $0.5 million and nil for the quarters ended
December 31, 2021 and December 31, 2020, respectively. Cost of
sales were $1.1 million and nil for the years ended December 31,
2021 and December 31, 2020, respectively. In 2020, the Company did
not have any drugs approved for commercial sale and the upfront
payment from Otsuka did not have cost of sales associated with it.
Gross margin for the three and twelve months ended December 31,
2021 was approximately 98%.
Selling, general and administrative (SG&A) expenses were
$44.2 million and $38.8 million for the quarters ended December 31,
2021 and December 31, 2020, respectively. For the years ended
December 31, 2021 and December 31, 2020, SG&A expenses were
$171.4 million and $96.0 million, respectively. The increase for
both periods was due to the increase in salaries, incentive pay and
employee benefits related to the expansion of the commercial and
administrative functions to support the launch and
commercialization of LUPKYNIS which ramped up during the third
quarter of 2020. Also contributing was an increase in travel, trade
shows and sponsorships connected with the sales activity occurring
in 2021.
Non-cash SG&A share-based compensation expense were $7.2
million and $4.5 million for the quarters ended December 31, 2021
and December 31, 2020, respectively. For the years ended December
31, 2021 and December 31, 2020, non-cash share-based compensation
expense were $26.4 million and $13.6 million, respectively.
For the quarters ended December 31, 2021 and December 31, 2020,
research and development (R&D) expenses were $11.1 million and
$13.2 million, respectively. The primary driver for the decrease
was due to the decrease in salaries, incentive pay and employee
benefits due to the allocation of costs related to post approval
support of LUPKYNIS to SG&A.
For the years ended December 31, 2021 and December 31, 2020,
R&D expenses were $51.1 million and $50.3 million,
respectively. The primary drivers for the increase were due to the
upfront license and accrued milestone expenses related to its
recently acquired developmental programs, AUR200 and AUR300, and
higher clinical research organization expenses related to its new
clinical programs offset by a decrease in voclosporin development
costs following the approval of LUPKYNIS.
Non-cash R&D share-based compensation expense were $1.2
million and $0.6 million for quarters ended December 31, 2021 and
December 31, 2020, respectively. For the years ended December 31,
2021 and December 31, 2020, non-cash share-based compensation
expense were $4.4 million and $3.7 million, respectively.
For the quarter ended December 31, 2021, Aurinia recorded a net
loss of $33.3 million or $0.25 net loss per common share, as
compared to a net loss of $8.1 million or $0.06 net loss per common
share for the quarter ended December 31, 2020. For the year ended
December 31, 2021, Aurinia recorded a net loss of $181.0 million or
$1.40 net loss per common share as compared to a net loss of $102.7
million or $0.87 net loss per common share for the previous
period.
This press release is intended to be read in conjunction with
the Company’s consolidated financial statements and Management's
Discussion and Analysis for the year ended December 31, 2021 in the
Company’s Annual Report on Form 10-K, which will be accessible on
Aurinia's website at www.auriniapharma.com, on SEDAR at
www.sedar.com or on EDGAR at www.sec.gov/edgar.
Conference Call Details
Aurinia will host a conference call and webcast to discuss the
quarter and year ended December 31, 2021 financial results today,
Monday, February 28, 2022 at 8:30 a.m. ET. The audio webcast can be
accessed under "News/Events” through the “Investors” section of the
Aurinia corporate website at www.auriniapharma.com. In order to
participate in the conference call, please dial +1-877-407-9170
(Toll-free U.S. & Canada).
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 U.S. and approximately
one out of three of these individuals have already developed LN at
the time of SLE diagnosis. If poorly controlled, LN can lead to
permanent and irreversible tissue damage within the kidney,
resulting in kidney failure. Black and Asian individuals with SLE
are four times more likely to develop LN and individuals with
Hispanic ancestry are approximately twice as likely to develop the
disease when compared with Caucasian individuals. Black and
Hispanic individuals with SLE also tend to develop LN earlier and
have poorer outcomes when compared to Caucasian individuals.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to treat targeted patient
populations that are impacted by serious diseases with a high unmet
medical need. In January 2021, the Company has introduced LUPKYNIS
(voclosporin), the first FDA-approved oral therapy dedicated for
the treatment of adult patients with active LN. The Company’s head
office is in Victoria, British Columbia, its U.S. commercial office
is in Rockville, Maryland. The Company focuses its development
efforts globally.
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 United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: Aurinia’s
estimates as to annual net revenue from sales of LUPKYNIS in the
range of $115-$135 million in 2022; Aurinia’s estimates as to the
number of patients with SLE in the U.S. and the proportion of those
persons who will develop LN; Aurinia being confident that it is
poised for growth and success; Aurinia’s belief that it has
sufficient financial resources to fund its current plans for at
least the next few years; and the expected timing for the EMA CHMP
opinion and EC decision relating to the EMA MAA. It is possible
that such results or conclusions may change. Words such as
“anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”,
“target”, “plan”, “goals”, “objectives”, “may” and other similar
words and expressions, identify forward-looking statements. We have
made numerous assumptions about the forward-looking statements and
information contained herein, including among other things,
assumptions about: the accuracy of reported data from third party
studies and reports; the number, and timing of receipt, of PSFs and
their rate of conversion into patients on therapy; that Aurinia’s
intellectual property rights are valid and do not infringe the
intellectual property rights of third parties; Aurinia’s
assumptions relating to the capital required to fund operations;
the assumption that Aurinia’s current good relationships with its
suppliers, service providers and other third parties will be
maintained; assumptions relating to the burn rate of Aurinia’s cash
for operations; the relationship between COVID vaccinations and
patient treatment; assumptions related to timing of interactions
with regulatory bodies; and that Aurinia’s third party service
providers will comply with their contractual obligations. Even
though the management of Aurinia believes that the assumptions
made, and the expectations represented by such statements or
information are reasonable, there can be no assurance that the
forward-looking information will prove to be accurate.
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 U.S. Securities and Exchange Commission’s
Electronic Document Gathering and Retrieval System (EDGAR) website
at www.sec.gov/edgar, and on Aurinia’s website at
www.auriniapharma.com.
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31, 2021
December 31, 2020
Assets
Current assets:
Cash, cash equivalents and restricted
cash
$
231,900
$
272,350
Short-term investments
234,178
125,979
Accounts receivable, net
15,414
—
Inventories, net
19,326
13,927
Prepaid expenses and other current
assets
12,506
7,171
Total current assets
513,324
419,427
Non-current assets:
Long-term investments
—
24,380
Other non-current assets
11,838
247
Property and equipment, net
4,418
4,786
Acquired intellectual property and other
intangible assets, net
8,404
9,332
Right-of-use assets
5,383
5,489
Total assets
$
543,367
$
463,661
Liabilities
Current liabilities:
Accounts payable and accrued
liabilities
34,947
24,797
Other current liabilities (of which $6,000
due to related party in 2020)
4,640
6,412
Operating lease liabilities
1,059
788
Total current liabilities
40,646
31,997
Non-current liabilities:
Deferred compensation and other
non-current liabilities
15,950
16,295
Operating lease liabilities
7,680
7,619
Total liabilities
64,276
55,911
Shareholders’ Equity:
Common shares - no par value, unlimited
shares authorized, 141,600 and 126,725 shares issued and
outstanding at December 31, 2021 and 2020, respectively
1,177,051
944,328
Additional paid-in capital
59,014
39,383
Accumulated other comprehensive loss
(852
)
(805
)
Accumulated deficit
(756,122
)
(575,156
)
Total shareholders' equity
479,091
407,750
Total liabilities and shareholders’
equity
$
543,367
$
463,661
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per
share data)
Three months ended
Years ended
December 31, 2021
December 31, 2020
December 31, 2021
December 31, 2020
(unaudited)
Revenue:
Product revenue, net
$
23,375
$
—
$
45,488
$
—
License and contract revenue
29
50,030
117
50,118
Total revenue, net
23,404
50,030
45,605
50,118
Operating expenses:
Cost of sales
481
—
1,091
—
Selling, general and administrative
44,242
38,779
171,438
95,983
Research and development
11,149
13,173
51,139
50,327
Amortization of intangible assets
522
387
2,098
1,289
Other (income) expense, net
(285
)
5,743
574
6,809
Total cost of sales and operating
expenses
56,109
58,082
226,340
154,408
Loss from operations
(32,705
)
(8,052
)
(180,735
)
(104,290
)
Interest income
109
135
529
1,516
Net loss before income taxes
(32,596
)
(7,917
)
(180,206
)
(102,774
)
Income tax expense (benefit)
726
157
760
(94
)
Net loss
$
(33,322
)
$
(8,074
)
$
(180,966
)
$
(102,680
)
Basic and diluted loss per common
share
$
(0.25
)
$
(0.06
)
$
(1.40
)
$
(0.87
)
Weighted-average common shares outstanding
used in computation of basic and diluted loss per share
132,054
126,618
129,369
118,473
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220228005164/en/
Investors/Media: Dana Lynch Corporate Communications,
Aurinia dlynch@auriniapharma.com
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