Mr. Richard Glickman reports
AURINIA REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
Aurinia Pharmaceuticals Inc. has released its financial results for the fourth quarter and
year ended Dec. 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 (lupus nephritis), initiation of our phase III Aurora trial for LN,
and the announcement of two exciting new clinical programs," said
Richard Glickman, Aurinia's chief executive officer 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 have outlined for 2018. We
intend to submit the first module of a rolling NDA (new drug
application) later this year for
our lead LN program and complete enrolment of our phase III Aurora
trial. In addition, our team is working diligently to initiate phase II
trials for FSGS (focal segmental
glomerulosclerosis) and dry eye syndrome in Q2."
2017 and other recent highlights:
-
Aurinia strengthened the breadth and scope of its board of directors with
the recent additions of Michael Hayden and Joseph Hagan in February,
2018, and George Milne in May, 2017.
- On Oct. 20, 2017, Aurinia announced 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
versus the standard of care for the treatment of dry eye
syndrome will begin in Q2 2018. Calcineurin inhibitors
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, Aurinia initiated its phase III clinical trial (Aurora) to
evaluate voclosporin for the treatment of lupus nephritis. The
Aurora trial is on track to complete enrolment in Q4 2018. Aurinia
currently has 201 clinical trial sites activated and is able to enroll
patients around the globe. Additionally, under voclosporin's
fast-track designation, Aurinia intends to utilize a rolling new drug
application process, with the first module being submitted in
the second half of 2018.
- On March 20, 2017, Aurinia completed a public offering for net proceeds of
$162.3-million, strengthening the company's balance sheet and
extending its cash runway into 2020.
- On March 1, 2017, Aurinia released positive 48-week results from its phase
II Aura clinical trial for the treatment of LN. Additional data were
released on April 20, 2017.
Financial liquidity at Dec. 31, 2017
In 2017, Aurinia 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 Dec. 31, 2017, Aurinia had cash,
cash equivalents and short-term investments of $173.5-million and
working capital of $167.1-million, compared with $39.6-million of cash and
$33.5-million of working capital at Dec. 31, 2016. Net cash used in
operating activities was $41.2-million for the year ended Dec. 31,
2017, compared with $18.7-million for 2016.
Aurinia believes, based on its current plans, that it has sufficient financial
resources to finance its existing LN program, including the Aurora trial
and the NDA submission to the United States Food and Drug Administration, conduct the planned phase II trials
for FSGS and DES, and finance operations into 2020.
Financial results for the fourth quarter ended Dec. 31, 2017
Aurinia reported a consolidated net loss of $3.3-million, or four cents per common
share, for the fourth quarter ended Dec. 31, 2017, as compared with a
consolidated net loss of $8.3-million, or 21 cents per common share, for the
fourth quarter ended Dec. 31, 2016.
The loss for the fourth quarter ended Dec. 31, 2017, reflected a $9.0-million reduction in the estimated fair value of derivative warrant
liabilities compared with a reduction of $658,000 in the estimated fair
value of derivative warrant liabilities for the fourth quarter ended
Dec. 31, 2016.
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 Dec. 31, 2017, compared with $9.0-million for the same period in
2016.
Research and development expenses increased to $8.7-million in
the fourth quarter of 2017, compared with $5.5-million in the fourth
quarter of 2016, primarily due to increased Aurora trial costs related to
patient enrolment and treatment costs.
Corporate, administration and business-development expenses also
increased to $3.1-million for the fourth quarter of 2017, compared with
$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 expenses to $653,000 for the
fourth quarter ended Dec. 31, 2017, compared with $314,000 for the same
period in 2016.
Financial results for the year ended Dec. 31, 2017
For the year ended Dec. 31, 2017, the company recorded a
consolidated net loss of $70.9-million, or 92 cents 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
Dec. 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 with a consolidated net loss of $23.3-million, or 66 cents 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 Dec. 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
primarily driven by the change in Aurinia's share price. Aurinia's share price of
$4.53 was significantly higher at Dec. 31, 2017, compared with Aurinia's
share price of $2.10 at Dec. 31, 2016. This increase in price
resulted in large increases in the estimated fair value of derivative
warrant liabilities. The derivative warrant liabilities will ultimately
be eliminated on the exercise or forfeiture of the warrants and will not
result in any cash outlay by the company.
Aurinia incurred net research and development expenses of $33.9-million for the year ended
Dec. 31, 2017, as compared with $14.5-million for the year ended
Dec. 31, 2016. The increase in these expenses resulted primarily
from the clinical and drug supply expenses associated with the Aurora
trial, which commenced active patient enrollment and treatment in May, 2017. Research and development expenses for 2016 included costs related to the Aurora
planning phase and completion costs for the phase II Aura trial.
Aurinia incurred corporate, administration and business development expenses
of $12.1-million for the year ended Dec. 31, 2017, as compared with
$7.0-million for the same period in fiscal 2016. The increase in these
expenses reflected overall higher activity levels, higher consulting
fees, sponsorships and tradeshows expenses related to greater investor
and public affairs activities and higher personnel compensation costs,
which included non-cash stock compensation expenses of $3.2-million for
the year ended Dec. 31, 2017, compared with $1.0-million for the year
ended Dec. 31, 2016.
The audited financial statements and the management's discussion and
analysis for the year ended Dec. 31, 2017, are accessible on
Aurinia's website,
on SEDAR and on EDGAR.
About Aurinia Pharmaceuticals Inc.
Aurinia is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN), focal segmental glomerulosclerosis (FSGS) and dry eye syndrome (DES). The company is headquartered in Victoria, B.C., and focuses its development efforts globally.
We seek Safe Harbor.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited -- amounts in thousands of U.S. dollars, except per share data)
Three months ended Dec. 31, Year ended Dec. 31,
2017 2016 2017 2016
Licensing revenue $30 $30 $418 $118
Research and development revenue - - - 50
Contract services 1 - 2 5
Total 31 30 420 173
Expenses
Research and development 8,691 5,462 33,930 14,534
Corporate, administration and
business development 3,118 2,227 12,096 6,970
Amortization of acquired intellectual
property and other intangible assets 361 365 1,434 1,457
Amortization of property and
equipment - - 22 22
Contract services - 1 1 4
Other expense (income) 197 966 (195) 2,213
Total 12,367 9,021 47,288 25,200
Net (loss) before change in estimated
fair value of derivative warrant
liabilities (12,336) (8,991) (46,868) (25,027)
Change in estimated fair value of
derivative warrant liabilities 9,004 658 (23,924) 1,732
Net (loss) for the period (3,332) (8,333) (70,792) (23,295)
Other comprehensive income/(loss)
Item that may be reclassified
subsequently to income/(loss)
Net change in fair value of
short-term investments 11 - (78) -
Net comprehensive (loss) for the
period (3,321) (8,333) (70,870) (23,295)
We seek Safe Harbor.
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