Full Press Release Details
Reports Fourth Quarter and Full Year 2014 Financial Results and
Highlights Initiation of Its Open Label Clinical Study to Investigate
the Impact of Voclosporin on Lupus Nephritis Biomarkers
VICTORIA, British Columbia--(BUSINESS WIRE)--March 30, 2015--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, 2014. Amounts, unless specified otherwise, are expressed in
In support of their on-going large randomized Phase 2b lupus nephritis
clinical trial ("AURA-LV"), the Company announced on February 9, 2015
the initiation of an open label, exploratory study called AURION to
assess short term predictors of response using voclosporin in
combination with mycophenolate mofetil (MMF) in patients with active
lupus nephritis (LN). AURION will examine biomarkers of disease activity
at 8 weeks and their ability to predict response at 24 and 48 weeks.
On February 14, 2014, the Company completed a $52 million private
placement (the "Offering") pursuant to which the Company issued 18.9
million Units (the "Units"). The Offering was led by venBio, New
Enterprise Associates, Redmile Group, RA Capital Management, Great Point
Partners, and Apple Tree Partners, with participation from various other
institutional investors, including existing shareholders Lumira Capital,
ILJIN Life Science Co. Ltd (ILJIN) and Difference Capital.
On June 26, 2014 the Company announced enrollment of the first patient
in AURA-LV to evaluate the efficacy of voclosporin as a treatment for
LN. LN is an inflammation of the kidneys, that if inadequately treated
can lead to end-stage renal disease, making LN a serious and potentially
life-threatening condition.
On September 2, 2014 the Company commenced trading on the NASDAQ Global
Market under the trading symbol "AUPH". The Company continues to trade
on the Toronto Stock Exchange in Canada.
Financial Results for 2014
The Company had cash, cash equivalents and short term investments of
$32.7 million at December 31, 2014. Aurinia believes its cash position
will be sufficient to finance its operational needs until at least
December 31, 2016. However, future cash requirements could vary
materially from current estimates due to a number of factors including
the costs associated with its clinical trial and potential strategic
The Company's activities were focused on patient recruitment, enrollment
and treatment activities for AURA-LV.
For the year ended December 31, 2014, the Company recorded a net
consolidated loss of $16.7 million or $0.57 per common share, as
compared to a consolidated net loss of $2.7 million or $0.42 per common
share in 2013. The higher consolidated net loss reflected a significant
increase in operational activities in 2014 as the Company was able to
move forward with its strategic plan upon completion of the February 14,
The Company incurred net research and development expenditures of $9.1
million for the year ended December 31, 2014, as compared to $2.0
million for the same period in 2014. Research and development
expenditures in 2014 reflected Phase 2b LN trial costs including patient
recruitment, enrollment and treatment activity expenditures. The Phase
2b LN study was at the planning stage in the fourth quarter of 2013 and
therefore costs were much less in 2013.
The Company incurred corporate, administration and business development
expenditures of $6.9 million for the year ended December 31, 2014, as
compared with $2.3 million for the same period in fiscal 2013.
Corporate, administration and business development expenditures for 2014
were higher than the comparable period in 2013 as a result of increased
business activity levels as the Company implemented its strategic plan
and supported the Phase 2b LN trial activities. Corporate,
administration and business development expense in 2014 also included
$1.9 million of non-cash stock option compensation expense related to
the issuance of stock options in 2014 to certain officers and directors
of the Company whereas stock option compensation expense in 2013 was
$135,000 as no stock options were granted throughout 2013.
Other expense (income) reflected income of $1.7 million for the year
ended December 31, 2014 compared to other expense of $906,000 for 2013.
The Company recorded non-cash gains of $2.8 million on extinguishment
and re-measurement of warrant liability initially recorded upon the
completion of the private placement on February 14, 2014. The Company
also recorded as other expense, a revaluation adjustment on contingent
consideration to ILJIN in the amount of $848,000 in 2014. Other expense
in 2013 reflected fair value adjustments arising from the Plan of
Arrangement completed on September 20, 2013 whereby the Company realized
a gain on Aurinia Pharma Corp. of $3.5 million and a loss on contract
settlement with ILJIN of $4.3 million.
Financial results for the fourth quarter ended December 31, 2014
The Company reported a consolidated net loss of $4.9 million or $0.15
per common share for the three months ended December 31, 2014, as
compared to an adjusted consolidated net loss of $1.7 million or $0.14
per common share for the three months ended December 31, 2013.
Research and development expenditures increased to $3.1 million in the
fourth quarter of 2014, compared to $691,000 in the fourth quarter of
Corporate and administration expenses were $1.4 million for the fourth
quarter of 2014, compared to $899,000 for the fourth quarter of 2013.
The audited financial statements and the Management's Discussion and
Analysis for the year ended December 31, 2014, are accessible on
Aurinia's website at www.auriniapharma.com or on SEDAR at www.sedar.com
or on EDGAR at www.sec.gov/edgar.
Aurinia is a clinical stage pharmaceutical company focused on the global
nephrology market. It is currently enrolling patients in its Phase 2b
clinical trial to evaluate the efficacy of its drug, voclosporin, as a
treatment for LN. LN is an inflammation of the kidneys, that if
inadequately treated can lead to end-stage renal disease, making LN a
serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best in class calcineurin
inhibitor ("CNI") with extensive clinical data in over 2,600 patients in
other indications. Voclosporin is made by a modification of a single
amino acid of the cyclosporine molecule (a CNI approved for use in
transplant patients since 1983). This modification results in a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency vs. cyclosporine, an altered metabolic profile, and