Preliminary unaudited net revenue for the
fourth quarter and full year 2022 of approximately $28.4 million
and $134.0 million
Preliminary unaudited net product revenue for
the fourth quarter and full year 2022 of approximately $28.3
million and $103.5 million
Reiterates net product revenue guidance for
2023 in the range of $120-$140 million
Approximately $388.7 million of cash, cash
equivalents, restricted cash and investments as of December 31,
2022 (unaudited)
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company) today provided an update on its business performance.
Preliminary unaudited net revenue for the three months and full
year ended December 31, 2022 was approximately $28.4 million and
$134.0 million. For the three months ended December 31, 2022,
preliminary unaudited net revenues included net product revenues of
approximately $28.3 million and license and collaboration revenue
of approximately $0.1 million. For the full year ended December 31,
2022, preliminary unaudited net revenues included net product
revenues of approximately $103.5 million and license and
collaboration revenue of approximately $30.5 million. As of
December 31, 2022, Aurinia had unaudited cash, cash equivalents and
restricted cash and investments of approximately $388.7
million.
Peter Greenleaf, President and Chief Executive Officer of
Aurinia, will discuss these updates as part of a webcast
presentation at the 41st Annual J.P. Morgan Healthcare Conference
on Wednesday, January 11 at 4:30 p.m. Pacific Time / 7:30 p.m.
Eastern Time in San Francisco, CA.
Preliminary Fourth Quarter 2022 LUPKYNIS Product
Metrics
- There were approximately 1,525 patients on LUPKYNIS therapy at
December 31, 2022, compared with 1,354 at September 30, 2022.
- Aurinia added approximately 406 patient start forms (PSFs)
during the fourth quarter 2022, as compared to 374 in the third
quarter 2022.
“Given strong commercial execution in the fourth quarter, we
demonstrated substantial growth in our key metrics for LUPKYNIS,
including an increased total number of patients on therapy and an
uptick in patient start forms in the back half of the fourth
quarter, compared to the monthly average in the third quarter of
2022,” said Peter Greenleaf, President and Chief Executive Officer
of Aurinia. “Given this progress, we believe we have achieved our
2022 full year net product revenue guidance and are positioned to
achieve our net revenue guidance from product sales for 2023 in the
range of $120-$140 million.”
About LUPKYNIS
LUPKYNIS is the first FDA-approved oral therapy for lupus
nephritis (LN). LN causes irreversible kidney damage and
significantly increases the risk of kidney failure, cardiac events,
and death. It is one of the most serious and common complications
of the autoimmune disease systemic lupus erythematosus (SLE).
LUPKYNIS is approved in the United States (U.S.), the United
Kingdom and across the European Union (E.U).
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 preliminary unaudited net revenue of approximately
$134 million for the full year 2022 and approximately $28.4 million
for the fourth quarter of 2022; Aurinia’s estimates as to
preliminary unaudited fourth quarter and full year net product
revenues of approximately $28.3 million and $103.5 million,
respectively; Aurinia’s estimates as to holding approximately
$388.7 million in cash, cash equivalents and investments as of
December 31, 2022; Aurinia’s estimates as to net product revenue
for 2023 in the range of $120-$140 million; Aurinia’s estimates as
to the number of patients on LUPKYNIS therapy at December 31, 2022
and the number of patient start forms added in the fourth quarter
of 2022; Aurinia’s belief that it has achieved its 2022 full year
net product revenue guidance; Aurinia’s believe it is positioned to
achieve its net revenue guidance from product sales for 2023;
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; and Aurinia believing it is well positioned
to achieve its 2023 net revenue guidance from product sales of
LUPKYNIS in 2023. 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 on the product; 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 and its
other public available filings 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230106005081/en/
Investor/Media: Aurinia@westwicke.com
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