Full Press Release Details
Reports Fourth Quarter and Full Year 2017 Financial Results and
Operational Highlights
Phase III Trial in lupus nephritis on track
FSGS and Dry Eye to begin in Q2 2018
$173.5 million as of December 31, 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--March 15, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the fourth quarter and
year ended December 31, 2017. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
"Aurinia gained remarkable momentum in 2017, as demonstrated by the
achievement of all of our important milestones-strong Phase II results
for voclosporin in LN, initiation of our Phase III AURORA trial for LN,
and the announcement of two exciting new clinical programs," said
Richard Glickman, Aurinia CEO and Chairman of the Board. "We are
well-capitalized into 2020 and positioned for a prolific 2018 as the
team continues to execute on the plans we've outlined for 2018. We
intend to submit the first module of a rolling NDA later this year for
our lead LN program and complete enrollment of our Phase III AURORA
trial. In addition, our team is working diligently to initiate Phase II
trials for FSGS and dry eye syndrome in Q2."
2017 and other recent highlights
We strengthened the breadth and scope of our Board of Directors with
the recent additions of Michael Hayden and Joseph Hagan in February of
2018 and George Milne in May of 2017.
On October 20, 2017, we announced our plans to pursue additional
indications for voclosporin, representing an expansion of the Company's
strategy, pipeline and commercial opportunities.
A Phase II proof-of-concept trial in focal segmental
glomerulosclerosis ("FSGS") will begin in Q2 2018. A pre-IND meeting
was completed in February 2018.
A Phase IIa tolerability study of voclosporin ophthalmic solution
("VOS") versus the standard of care for the treatment of dry eye
syndrome ("DES") will begin in Q2 2018. Calcineurin inhibitors
("CNIs") are a mainstay in the treatment for DES, and the goal of this
program is to develop a best-in-class treatment option.
In May 2017, we initiated our Phase III clinical trial ("AURORA") to
evaluate voclosporin for the treatment of lupus nephritis ("LN"). The
AURORA trial is on track to complete enrollment in Q4 2018. We
currently have 201 clinical trial sites activated and able to enroll
patients around the globe. Additionally, under voclosporin's
fast-track designation, we intend to utilize a rolling New Drug
Application ("NDA") process, with the first module being submitted in
the second half of 2018.
On March 20, 2017, we completed a public offering for net proceeds of
$162.3 million, strengthening the Company's balance sheet and
extending our cash runway into 2020.
On March 1, 2017, we released positive 48-week results from our Phase
II AURA clinical trial for the treatment of LN. Additional data were
released on April 20, 2017.
Financial Liquidity at December 31, 2017
In 2017, we raised net proceeds of $162.3 million from the March 20,
2017 public offering and received $12.8 million from the exercise of
warrants and options. As a result, at December 31, 2017, we had cash,
cash equivalents and short term investments of $173.5 million and
working capital of $167.1 million compared to $39.6 million of cash and
$33.5 million of working capital at December 31, 2016. Net cash used in
operating activities was $41.2 million for the year ended December 31,
2017, compared to $18.7 million for the year ended 2016.
We believe, based on our current plans that we have sufficient financial
resources to fund our existing LN program, including the AURORA trial
and the NDA submission to the FDA, conduct the planned Phase II trials
for FSGS and DES and fund operations into 2020.
Financial results for the fourth quarter ended December 31, 2017
We reported a consolidated net loss of $3.3 million or $0.04 per common
share for the fourth quarter ended December 31, 2017, as compared to a
consolidated net loss of $8.3 million or $0.21 per common share for the
fourth quarter ended December 31, 2016.
The loss for the fourth quarter ended December 31, 2017 reflected a $9.0
million reduction in the estimated fair value of derivative warrant
liabilities compared to a reduction of $658,000 in the estimated fair
value of derivative warrant liabilities for the fourth quarter ended
The net loss before this non-cash change in estimated fair value of
derivative warrant liabilities was $12.4 million for the fourth quarter
ended December 31, 2017 compared to $9.0 million for the same period in
Research and development ("R&D") expenses increased to $8.7 million in
the fourth quarter of 2017, compared to $5.5 million in the fourth
quarter of 2016 primarily due to increased AURORA trial costs related to
patient enrollment and treatment costs.
Corporate, administration and business development expense also
increased to $3.1 million for the fourth quarter of 2017, compared to
$2.2 million for the fourth quarter of 2016, reflecting increased
personnel and level of activities. In addition, these expenses reflected
an increase in non-cash stock compensation expense to $653,000 for the
fourth quarter ended December 31,2017 compared to $314,000 for the same
Financial Results for the year ended December 31, 2017
For the year ended December 31, 2017, the Company recorded a
consolidated net loss of $70.9 million or $0.92 per common share, which
included a non-cash increase of $23.9 million related to the estimated
fair value annual adjustment of derivative warrant liabilities at
December 31, 2017. After adjusting for this non-cash impact, the net
loss before this change in estimated fair value of derivative warrant
liabilities was $47.0 million.
This compared to a consolidated net loss of $23.3 million or $0.66 per
common share in 2016 which included a non-cash reduction of $1.7 million
in the estimated fair value of derivative warrant liabilities for the
year ended December 31, 2016. After adjusting for the non-cash impact
for 2016, the net loss before this change in estimated fair value of
derivative warrant liabilities was $25.0 million.
The change in the revaluation of the derivative warrant liabilities is