Preliminary unaudited total net revenue for the
fourth quarter and full year 2023 of approximately $45 million and
$176 million
Preliminary unaudited net product revenue for
the fourth quarter and full year 2023 of approximately $42 million
and $159 million
Approximately $351 million of cash, cash
equivalents, restricted cash and investments as of December 31,
2023 (unaudited)
Net product revenue guidance for 2024 in the
range of $200 -$220 million; targeting to be cash flow positive in
the second half of 2024
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today provided an update on its 2023 fourth quarter and
full year business performance. Preliminary unaudited net product
revenue was approximately $42 million for the three months ended
December 31, 2023, and $28.3 million for the same period in 2022,
representing growth of approximately 49%. Preliminary unaudited net
product revenue was approximately $159 million for the full year,
and $103.5 million for the same period in 2022, representing growth
of approximately 53%.
Preliminary unaudited total net revenue was approximately $45
million for the three months ended December 31, 2023 and $28.4
million for the same period 2022, representing growth of
approximately 59%. Preliminary unaudited total net revenue was
approximately $176 million for the year and $134.0 million for the
same period 2022, representing growth of approximately 31%.
The Company had unaudited cash, cash equivalents, restricted
cash and investments of approximately $351 million as of December
31, 2023. The Company is expecting to become cash flow positive on
a go forward basis in the second half of 2024.
As previously announced, the Company initiated a robust
strategic review at the end of June 2023 and is continuing to
review all strategic options for the Company, which include a
variety of possibilities including, but not limited to, a potential
sale, merger, or other strategic transaction. At this time, there
are no further updates on the matter, other than that the process
is continuing. The Board of Directors and the Executive Leadership
team remain committed to running a fulsome process that reflects
the best interests of the Company, our shareholders, and other key
stakeholders, including our patients, healthcare providers, and our
employees.
“We are extremely proud of the strong performance and growth for
LUPKYNIS throughout 2023, including publication and presentation of
the AURORA 2 extension study and the renal biopsy sub-study, both
of which further differentiate and support LUPKYNIS as foundation
therapy in treating patients with active lupus nephritis. Our
collaboration partner, Otsuka Pharmaceuticals Co., Ltd. filed for
approval of LUPKYNIS to treat lupus nephritis (LN) with Japanese
authorities, received pricing and reimbursement approvals in the
UK, Italy, and Spain, and are continuing their commercialization
efforts across Europe. At the end of the year, we also advanced our
pipeline with the submission of an Investigational New Drug
application to the FDA for AUR200, a potential next generation
therapy for B-cell mediated autoimmune diseases. We are looking
forward to continuing our momentum throughout 2024,” said Peter
Greenleaf, President, and CEO of Aurinia.
Preliminary Fourth Quarter 2023 LUPKYNIS Product
Metrics
- There were approximately 2,066 patients on LUPKYNIS therapy at
December 31, 2023, compared with 1,525 at prior year end and 1,939
at September 30, 2023.
- Aurinia added approximately 438 patient start forms (PSFs) in
the fourth quarter of 2023. In addition, the Company added
approximately 101 new patients, as restarts (patients coming back
onto therapy), as well as an estimate of new patients beginning
therapy in the hospital channel. The fourth quarter PSFs of 438
compare to 406 PSFs in the fourth quarter of 2022 and 436 in the
third quarter of 2023. The addition of patient restarts and
estimated patients coming through the hospital channel are newly
reported in the fourth quarter since they have achieved numerical
significance for the first time.
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 is a fully integrated biopharmaceutical company focused
on delivering therapies to treat targeted patient populations with
a high unmet medical need that are impacted by autoimmune, kidney
and rare diseases. 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 Edmonton, Alberta and 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 preliminary unaudited net revenue of approximately
$176 million for the full year 2023 and approximately $45 million
for the fourth quarter of 2023; Aurinia’s estimates as to
preliminary unaudited fourth quarter and full year net product
revenues of approximately $42 million and $159 million,
respectively; Aurinia’s estimates as to holding approximately $351
million in cash, cash equivalents, restricted cash and investments
as of December 31, 2023; Aurinia's target to be cash flow positive
in the second half of 2024; Aurinia’s estimates as to net product
revenue for 2024 in the range of $200 - $220 million; Aurinia’s
estimates as to the number of patients on LUPKYNIS therapy at
December 31, 2023 and the number of patient start forms added in
the fourth quarter of 2023; Aurinia’s belief that it has achieved
its 2023 full year net product revenue guidance; and 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. 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; assumptions relating to pricing for LUPKYNIS
and patient persistency and adherence to on the product;
assumptions related to the number of patients on LUPKYNIS 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; 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
widespread health concerns 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.sedarplus.ca 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240105424869/en/
Media Inquiries: Andrea Christopher Corporate
Communications Director, Aurinia achristopher@auriniapharma.com
Investor/Media Contact: ir@auriniapharma.com
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