Net revenue increased to $28.2 million for Q2
2022; Maintains net revenue guidance range of $115-$135 million
from sales of LUPKYNIS® (voclosporin) for 2022
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
$391.7 million of cash and investments as of
June 30, 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 second quarter
ended June 30, 2022. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
Second Quarter 2022 and Recent Highlights & Upcoming
Milestones
- Net product revenues were $28.2 million for the quarter ended
June 30, 2022, compared to $6.6 million for the same period ended
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 since
January 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 at March 31, 2022.
- At 6 months post-treatment-start, an average of approximately
70% of patients remain on treatment; and at 9 months, approximately
60% of patients are still on treatment.
- Received positive CHMP opinion for LUPKYNIS® (voclosporin) for
the treatment of adults with active lupus nephritis in Europe.
Regulatory review of the European Medicines Agency (EMA) marketing
authorization application (MAA) remains on track with a European
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.
- 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 by Sun
Pharmaceuticals, directed at U.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 to July 26, 2023.
Financial Results for the Quarter and Six Months Ended June
30, 2022
Total net revenue was $28.2 million and $6.6 million for the
quarters ended June 30, 2022 and June 30, 2021, respectively. Total
net revenue was $49.8 million and $7.5 million for the six months
ended June 30, 2022 and June 30, 2021, respectively. Our net
revenues primarily consisted of product revenue, net of
adjustments, for LUPKYNIS following FDA approval in late January
2021. Revenue growth is attributed to further progress in the
launch of LUPKYNIS, driven by further penetration in the lupus
nephritis market coupled with improvements in a number of key
revenue driving metrics as noted above. No product sales commenced
and no product marketing was permitted prior to January 22,
2021.
Total cost of sales and operating expenses for the quarters
ended June 30, 2022 and June 30, 2021 were $64.2 million and $53.8
million, respectively. Total cost of sales and operating expenses
were $123.7 million and $105.2 million for the six months ended
June 30, 2022 and June 30, 2021, respectively. Further breakdown of
operating expenses drivers and fluctuations are highlighted in the
following paragraphs.
Cost of sales were $1.6 million and $0.3 million for the
quarters ended June 30, 2022 and June 30, 2021, respectively. Cost
of sales were $1.9 million and $0.4 million for the six months
ended June 30, 2022 and June 30, 2021, respectively. The increase
for both periods was primarily due to an increase in product
revenue coupled with safety stock reserves.
Gross margin for the quarters ended June 30, 2022 and June 30,
2021 was approximately 94% and 95% respectively. Gross margin for
the six months ended June 30, 2022 and June 30, 2021 was
approximately 96% and 95% respectively.
Selling, general and administrative (SG&A) expenses,
inclusive of share-based compensation, were $51.5 million and $44.3
million for the quarters ended June 30, 2022 and June 30, 2021,
respectively. For the six months ended June 30, 2022 and June 30,
2021, SG&A expenses, inclusive of share-based compensation,
were $96.7 million and $84.1 million, respectively. The primary
drivers for the increase for both periods ended June 30, 2022 as
compared to June 30, 2021 were an increase in share-based
compensation expense, corporate legal matters and increased
investment in infrastructure to support the commercialization of
LUPKYNIS.
Non-cash SG&A share-based compensation expense included
above for the quarters ended June 30, 2022 and June 30, 2021 was
$8.9 million and $6.5 million, respectively. Non-cash SG&A
share-based compensation expense included above for the six months
ended June 30, 2022 and June 30, 2021 was $14.9 million and $13.2
million, respectively. The increase in share-based compensation is
primarily due to an increase in annual grants in 2022 coupled with
the full year expense impact from prior year grants.
Research and Development (R&D) expenses, inclusive of
share-based compensation, were $11.5 million and $10.1 million for
the quarters ended June 30, 2022 and June 30, 2021, respectively.
For the six months ended June 30, 2022 and June 30, 2021, R&D
expenses, inclusive of share-based compensation expense, were $24.1
million and $19.9 million, respectively. The primary drivers for
the increase for both periods were due to an increase in CRO and
developmental expenses related to AUR200 and AUR300.
Non-cash R&D share-based compensation expense included above
for the quarters ended June 30, 2022 and June 30, 2021 was $1.1
million for both periods. Non-cash R&D share-based compensation
expense included above for the six months ended June 30, 2022 and
June 30, 2021 was $2.0 million and $2.2 million, respectively.
For the quarter ended June 30, 2022, Aurinia recorded a net loss
of $35.5 million or $0.25 net loss per common share, as compared to
a net loss of $47.0 million or $0.37 net loss per common share for
the quarter ended June 30, 2021. For the six months ended June 30,
2022, Aurinia recorded a net loss of $73.1 million or $0.52 net
loss per common share, as compared to a net loss of $97.4 million
or $0.76 net loss per common share for the six months ended June
30, 2021.
Financial Liquidity at June 30, 2022
As of June 30, 2022, Aurinia had cash, cash equivalents and
restricted cash and investments of $391.7 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, advancement of our pipeline 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 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 June
30, 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 June 30, 2022 financial results today, Thursday,
August 4, 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). 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 manifestation of SLE, a chronic and complex
autoimmune disease. About 200,000-300,000 people live with SLE in
the U.S. and about one-third of these people are diagnosed with
lupus nephritis at the time of their SLE diagnosis. About 50
percent of all people with SLE may develop lupus nephritis. If
poorly controlled, LN can lead to permanent and irreversible tissue
damage within the kidney. Black and Asian individuals with SLE are
four times more likely to develop LN and individuals of 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 introduced LUPKYNIS®
(voclosporin), the first FDA-approved oral therapy for the
treatment of adult patients with active lupus nephritis (LN). The
Company’s head office is in Victoria, British Columbia, its U.S.
commercial hub is in Rockville, Maryland, and 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)
June 30, 2022
December 31, 2021
(unaudited)
ASSETS
Current assets
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
Non-current assets
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
LIABILITIES
Current liabilities
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
Non-current liabilities
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
Common shares - no par value, unlimited
shares authorized, 141,892 and 141,600 shares issued and
outstanding at June 30, 2022 and December 31, 2021,
respectively
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
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per
share data)
Three months ended
Six months ended
June 30,
June 30,
2022
2021
2022
2021
(unaudited)
(unaudited)
Revenue
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
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: DeDe Sheel Vice President,
Investor Relations, Aurinia dsheel@auriniapharma.com
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