$14.7 million in net revenue for the third
quarter 2021 (122% increase from second quarter 2021)
Steady increases in LUPKYNIS Patient Start
Forms, Conversion Rates and Payer Coverage
Addition of two preclinical assets with
potential in rare autoimmune conditions to grow and diversify the
pipeline
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 third quarter
ended September 30, 2021. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
Aurinia achieved third quarter revenue of $14.7 million, with
nine months ended September 30, 2021 revenue of $22.2 million and
maintains its previously stated annual revenue estimate in the
range of $40 to $50 million for 2021.
“We are very pleased with Q3 results as we continue to execute
on our LUPKYNIS commercialization strategies,” said Peter
Greenleaf, President and Chief Executive Officer of Aurinia.
“Despite the challenge of the COVID-19 Delta variant and a slight
seasonal slowdown, we saw steady increases in patient start forms
and patients on treatment toward the end of the quarter and
continue to see this upward momentum through October.”
“Data presentations at key medical meetings this week, including
additional interim results from the AURORA 2 continuation study,
will help bolster awareness of and confidence in the efficacy and
safety of LUPKYNIS and we expect final results of the continuation
study to be announced by the end of 2021,” Greenleaf added.
“Finally, while our commercial team focused on increasing
adoption of LUPKYNIS, Aurinia recently added two exciting
preclinical assets – AUR200 and AUR300,” said Greenleaf. “We are
eager to leverage our expertise and capabilities to advance these
compounds for the treatment of rare autoimmune diseases with high
unmet needs.”
Third Quarter 2021 Highlights & Upcoming
Milestones:
- Aurinia has secured 412 patient start forms (PSFs) in the third
quarter and as of November 3, 2021, Aurinia has secured a total of
more than 1,265 PSFs.
- PSF conversion rates continue to increase with more than 68% of
PSFs converted to patients on therapy. Q2 conversion rates were
50%. Time to convert continues to decrease since launch: 30- and
60-day conversion rates have improved each month.
- As of early October, Aurinia has confirmed coverage for
LUPKYNIS through published payer policies for 65% of total lives in
the market. Through patients gaining access to LUPKYNIS, the
company now has confirmed coverage in plans covering 87% of total
lives.
- On August 17, 2021, Aurinia announced the addition of two novel
pipeline assets: AUR200, an Fc protein targeting BAFF/APRIL (B-cell
Activating Factor, known as BAFF, and A Proliferation-Inducing
Ligand known as APRIL) and AUR300, a novel peptide therapeutic that
modulates M2 macrophages via the macrophage mannose receptor CD206.
For the acquisitions, an Investigational New Drug Application (IND)
filing for AUR200 is expected by the end of 2022 and an AUR300 IND
filing is expected during the first half of 2023.
- On October 1, 2021, Aurinia’s licensing partner, Otsuka
Pharmaceutical Co., Ltd., filed an initial marketing authorization
application (MAA) with the Swiss Agency for Therapeutic Products
(Swissmedic) seeking approval for the use of voclosporin for the
treatment of adult patients with active LN. The Swiss filing was
based on the June 24, 2021 MAA submission to the European Medicines
Agency (EMA).
- Regulatory review of the EMA MAA remains on track with a
Committee for Medicinal Products for Human Use (CHMP) opinion
expected around mid-2022 followed by an EMA decision expected
sometime in the third quarter of 2022. Additionally, Otsuka
continues to work to finalize the timeline for the Japanese New
Drug Application (JNDA) regulatory filing with Pharmaceutical and
Medical Device Agency (PMDA) to seek approval of voclosporin for
the treatment of LN in Japan.
- This week, Aurinia will present efficacy, safety and
tolerability data for LUPKYNIS at two key medical meetings. The
American College of Rheumatology (ACR) Convergence 2021 meeting
(November 3-6) will feature an updated analysis of the AURORA 2
continuation study and two poster presentations on the efficacy of
LUPKYNIS (from AURORA 1 data) across biopsy classes as well as in
recent onset LN. The AURORA 2 updated interim analysis showed
patients treated with LUPKYNIS maintained meaningful reductions in
proteinuria with no change in mean eGFR at 30 months of treatment.
At the American Society of Nephrology (ASN) Kidney Week 2021
(November 2-7) two Aurinia abstracts were accepted including an
oral presentation on the efficacy of LUPKYNIS in achieving complete
renal response in severe lupus nephritis.
- Data from the full AURORA 2 two-year continuation study is
expected to be announced late in the fourth quarter of 2021.
Financial Liquidity at September 30, 2021
As of September 30, 2021, Aurinia had cash and cash equivalents
and investments of $286.4 million compared to $422.7 million at
December 31, 2020. The decrease was primarily related 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 a dedicated
manufacturing capability (or monoplant) and an upfront license
payment related to our recently acquired developmental program.
Net cash used in operating activities was $131.8 million for the
nine months ended September 30, 2021 compared to $73.1 million for
the nine months ended September 30, 2020. The increase was
primarily due to the commercial infrastructure spend to support the
launch of LUPKYNIS, payments for inventory and a one-time payment
to a related party upon achievement of specific milestones
partially offset by an increase in cash receipts. In the prior
year, the Company was still in the development phase 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 our
supporting commercial infrastructure, conducting planned research
and development (R&D) programs, investing in our pipeline and
operating activities into at least 2023.
Financial Results for the Quarter and Year Ended September
30, 2021
For the quarter ended September 30, 2021, Aurinia recorded a net
loss of $50.3 million or $0.39 net loss per common share, as
compared to a net loss of $42.1 million or $0.34 net loss per
common share for the quarter ended September 30, 2020. For the nine
months ended September 30, 2021, Aurinia recorded a net loss of
$147.6 million or $1.15 net loss per common share as compared to a
net loss of $94.6 million or $0.82 net loss per common share for
the previous period.
Total revenue was $14.7 million and $29 thousand for the
quarters ended September 30, 2021 and September 30, 2020,
respectively. Total revenue was $22.2 million and $88 thousand for
the nine months ended September 30, 2021 and September 30, 2020,
respectively. Our revenues primarily consisted of product revenue,
net of adjustments for LUPKYNIS, following FDA approval in January
of 2021.
Cost of sales were $254 thousand and nil for the quarters ended
September 30, 2021 and September 30, 2020, respectively. Cost of
sales were $610 thousand and nil for the nine months ended
September 30, 2021 and September 30, 2020, respectively. The
increase for both periods was primarily the result of commercial
sales of LUPKYNIS. Gross margin for the three and nine months ended
September 30, 2021 was approximately 98% and 97% respectively.
Selling, general and administrative (SG&A) expenses were
$44.1 million and $30.7 million for the quarters ended September
30, 2021 and September 30, 2020, respectively. For the nine months
ended September 30, 2021 and September 30, 2020, SG&A expenses
were $127.2 million and $57.2 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 of LUPKYNIS
which ramped up during the third quarter of 2020. Also contributing
was an increase in professional fees for activities such as patient
assistance programs, consulting, recruiting, legal, market research
and marketing.
Non-cash SG&A share-based compensation expense for the three
and nine months ended September 30, 2021 was $6.0 million and $19.2
million as compared to $3.8 million and $9.2 million for the same
periods of 2020.
Research and Development (R&D) expenses were $20.1 million
and $12.2 million for the quarters ended September 30, 2021 and
September 30, 2020, respectively. For the nine months ended
September 30, 2021 and September 30, 2020, R&D expenses were
$40.0 million and $37.2 million, respectively. The primary driver
for the increase for the three months ended September 30, 2021 as
compared to the same period of 2020 was the upfront license and
accrued milestone expense related to our recently acquired
developmental programs, AUR200 and AUR300. In accordance with U.S.
GAAP, these transactions did not meet the definition of a business
combination and therefore, were recorded as asset acquisitions. We
expensed the cost of the assets as R&D expense at the
acquisition dates. The increase was partially offset by a decrease
in clinical supply and distribution costs due to our new drug
application and voclosporin related clinical trial expenditures in
2020 not recurring in 2021. Also contributing was a decrease in
salaries, incentive pay and employee benefits due to the allocation
of costs related to post approval support of LUPKYNIS to
SG&A.
The primary drivers for the increase for the nine months ended
September 30, 2021 as compared to the same period of 2020 were due
to the upfront license and accrued milestone expense related to our
recently acquired developmental programs, AUR200 and AUR300, and
higher CRO expenses related to our new clinical programs offset by
a decrease in clinical supply and distribution costs following the
approval of LUPKYNIS, including a reduction in new drug application
preparation costs and termination of the dry eye trial during the
fourth quarter of 2020.
Non-cash R&D share-based compensation expense for the three
and nine months ended September 30, 2021 was $1.0 million and $3.2
million as compared to $0.8 million and $3.1 million for the same
periods of 2020.
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
September 30, 2021 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 and year ended September 30, 2021 financial results today,
Wednesday, November 3, 2021 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 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. 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 in the range of $40-$50 million
in 2021; 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 well-poised for growth;
Aurinia’s belief that it has sufficient financial resources to fund
its current plans until 2023; the expected timing for the EMA CHMP
opinion and EMA decision relating to the EMA MAA; and the planned
timing for reporting top-line results from the ongoing AURORA-2
continuation study. 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 into 2023; 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, or on Aurinia’s website at
www.auriniapharma.com.
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2021
December 31, 2020
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
57,587
$
272,350
Short-term investments
228,813
125,979
Accounts receivable, net
9,814
—
Inventories, net
19,293
13,927
Prepaid expenses and other current
assets
13,712
7,171
Total current assets
329,219
419,427
Non-current assets
Long-term investments
—
24,380
Other non-current assets
11,838
247
Property and equipment, net
4,551
4,786
Acquired intellectual property and other
intangible assets, net
8,926
9,332
Right-of-use assets
5,532
5,489
Total assets
360,066
463,661
LIABILITIES
Current liabilities
Accounts payable and accrued
liabilities
29,970
24,797
Other current liabilities (of which $2,000
and $6,000, due to related party in 2021 and 2020,
respectively)
6,456
6,412
Operating lease liabilities
1,111
788
Total current liabilities
37,537
31,997
Non-current liabilities
Other non-current liabilities
16,562
16,295
Operating lease liabilities
7,795
7,619
Total liabilities
61,894
55,911
SHAREHOLDER’S EQUITY
Common shares - no par value, unlimited
shares authorized, 129,570 and 126,725 shares issued and
outstanding as at September 30, 2021 and December 31, 2020,
respectively
967,159
944,328
Additional paid-in capital
54,607
39,383
Accumulated other comprehensive loss
(794
)
(805
)
Accumulated deficit
(722,800
)
(575,156
)
Total shareholder’s equity
298,172
407,750
Total liabilities and shareholders’
equity
$
360,066
$
463,661
AURINIA PHARMACEUTICALS INC.
AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per
share data)
Three months ended
Nine months ended
September 30,
September 30,
2021
2020
2021
2020
(unaudited)
(unaudited)
Revenue
Product revenue, net
$
14,638
$
—
$
22,113
$
—
License revenue
29
29
88
88
Total revenue
14,667
29
22,201
88
Operating expenses:
Cost of sales
254
—
610
—
Selling, general and administrative
44,128
30,702
127,196
57,204
Research and development
20,066
12,243
39,990
37,154
Amortization of intangible assets
517
316
1,576
902
Other (income) expense, net
55
(917
)
859
1,066
Total cost of sales and operating
expenses
65,020
42,344
170,231
96,326
Loss from operations
(50,353
)
(42,315
)
(148,030
)
(96,238
)
Interest income
106
170
420
1,381
Net loss before income taxes
(50,247
)
(42,145
)
(147,610
)
(94,857
)
Income tax expense (benefit)
8
(15
)
34
(251
)
Net loss
$
(50,255
)
$
(42,130
)
$
(147,644
)
$
(94,606
)
Basic and diluted loss per share
$
(0.39
)
$
(0.34
)
$
(1.15
)
$
(0.82
)
Weighted-average common shares outstanding
used in computation of basic and diluted loss per share
128,443
122,357
128,084
115,738
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211103005234/en/
Investor/Media Contact: Dana Lynch Corporate
Communications, Aurinia dlynch@auriniapharma.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Historical Stock Chart
From Sep 2023 to Sep 2024