$21.6 million in net revenue for Q1 2022;
Maintains net revenue guidance range of $115-$135 million from
sales of LUPKYNIS for 2022
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 8:30 a.m.
ET
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today issued its financial results for the first quarter
ended March 31, 2022. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
Net product revenues were $21.6 million for the quarter ended
March 31, 2022, compared to $914 thousand in the prior year period,
reflecting FDA approval of LUPKYNIS in late January 2021.
“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 Peter Greenleaf, President and Chief Executive Officer
of Aurinia. “Heading into the second half of the year, in addition
to expected growth in LUPKYNIS revenues, we look forward to
multiple expected corporate milestones, including potential
European LUPKYNIS approval, the presentation of additional clinical
data sets and continued development progress with our pipeline
products, AUR200 and AUR300.”
For fiscal year 2022, the Company maintains its net revenue
guidance of $115 million 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. Aurinia’s guidance does not include
any potential milestone payments, royalties or contract
manufacturing revenue related to the Company’s licensing agreement
with Otsuka Pharmaceutical or associated with the marketing of
voclosporin in the European Union or Japan.
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
since January 1, 2022.
- PSF conversion rates are now at 80% after 90 days; confirmed
patient access to LUPKYNIS through payors and plans remains steady
representing about 90% of U.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 approximately 70% of patients
remain on treatment.
- Per recent healthcare provider (HCP) surveys, unaided brand
awareness of LUPKYNIS is over 70% while aided brand awareness is
over 90% and intent to use in the next 3 months is over 70%, 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 the European Congress of Rheumatology at the end of
May, 2022 and at the European 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 a
European 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 March 31, 2022
As of March 31, 2022, Aurinia had cash, cash equivalents and
restricted cash and investments of $418.8 million compared to
$466.1 million at December 31, 2021. The decrease in cash, cash
equivalents and restricted cash and investments is primarily
related to the continued investment in commercialization
activities, payments made for our ongoing post approval obligations
and advancement of our pipeline, payments associated with inventory
purchases to ensure adequate supply to meet forecasted demand and a
payment for the achievement of a one-time milestone, partially
offset by an increase in cash receipts from sales of LUPKYNIS.
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 March 31,
2022
Total net revenue was $21.6 million and $914 thousand for the
quarters ended March 31, 2022 and March 31, 2021, respectively. Net
revenues primarily consisted of product revenue, net of adjustments
for LUPKYNIS, following FDA approval in late January 2021. Quarter
over quarter revenue growth is attributed to continued progress in
the launch of LUPKYNIS, driven predominantly by further penetration
into the LN market.
Total cost of sales and operating expenses for the quarter ended
March 31, 2022 were $59.5 million in comparison to $51.5 million
for the quarter ended March 31, 2021.
Cost of sales were $256 thousand and $48 thousand for the
quarters ended March 31, 2022 and March 31, 2021, respectively. The
increase was primarily due to the growth of LUPKYNIS sales, in
comparison to the prior year period.
Gross margin for the quarters ended March 31, 2022 and March 31,
2021 was approximately 99% and 95% respectively. The fluctuation in
gross margin is driven primarily by fixed specialty pharmacy costs
in the first quarter of 2021, as a larger percentage of the overall
cost of sales in the quarter.
Selling, general and administrative (SG&A) expenses were
$45.2 million and $39.8 million for the quarters ended March 31,
2022 and March 31, 2021, respectively, which is consistent with the
prior quarter and represents a fully burdened quarter, as the
Company did not have approval until late January 2021. The increase
was primarily due to an increase in employee related expenses,
professional fees related to various corporate matters,
pharmacovigilance costs and consulting related expenses tied to the
increased investment in back office infrastructure to support the
commercialization of LUPKYNIS.
Non-cash SG&A share-based compensation expense for the
quarters ended March 31, 2022 and March 31, 2021 was $6.0 million
and $6.6 million, respectively.
R&D expenses were $12.6 million and $9.8 million for the
quarters ended March 31, 2022 and March 31, 2021, respectively. The
primary driver for the increase quarter over quarter was due to an
increase in expenses related to AUR200 and AUR300 development,
partially offset by a decrease in expenses related to the AURORA 2
continuation study which was completed during the fourth quarter of
2021 but had wind down activities ongoing in the quarter ended
March 31, 2022.
Non-cash R&D share-based compensation expense for the
quarters ended March 31, 2022 and March 31, 2021 was $1.0 million
compared to $1.1 million, respectively.
For the quarter ended March 31, 2022, Aurinia recorded a net
loss of $37.6 million or $0.27 net loss per common share, as
compared to a net loss of $50.4 million or $0.40 net loss per
common share for the quarter ended March 31, 2021.
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
March 31, 2022 in the Company’s Quarterly Report on Form 10-Q,
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 ended March 31, 2022 financial results today, Tuesday, May
10, 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 (866) 682-6100 / (862)
298-0702 (Toll-free U.S. & Canada). An audio webcast can be
accessed under "News/Events” through the “Investors” section of the
Aurinia corporate website at www.auriniapharma.com. A replay of the
webcast will be available on Aurinia’s website.
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 have developed LN at time of SLE diagnosis; 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
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31, 2022
December 31, 2021
(unaudited)
ASSETS
Current assets
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
Non-current assets
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
506,902
543,367
LIABILITIES
Current liabilities
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
33,838
40,646
Non-current liabilities
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
Common shares - no par value, unlimited
shares authorized, 141,742 and 141,600 shares issued and
outstanding at March 31, 2022 and December 31, 2021,
respectively
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
448,123
479,091
Total liabilities and shareholders’
equity
$
506,902
$
543,367
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per
share data)
Three months ended
March 31,
2022
2021
(unaudited)
Revenue
Product revenue, net
$
21,492
$
884
License and collaboration revenue
133
30
Total revenue, net
21,625
914
Operating expenses
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: Dana Lynch Corporate
Communications, Aurinia dlynch@auriniapharma.com
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