Full Press Release Details
Reports First Quarter 2019 Financial Results and Recent Operational
Conference call and webcast to be hosted today at 4:30pm EDT -
VICTORIA, British Columbia--(BUSINESS WIRE)--May 14, 2019--Aurinia
Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) ("Aurinia" or the
"Company") today reported financial results for the first quarter ended
March 31, 2019 and provided an update on recent operational highlights.
Amounts, unless specified otherwise, are expressed in U.S. dollars.
First Quarter 2019 Highlights
Fully-enrolled AURORA Phase 3 trial in lupus nephritis ("LN")
continues on track with results anticipated in late 2019.
Reported results from a Phase 2a Dry Eye study with voclosporin
ophthalmic solution ("VOS") that achieved statistically superior
efficacy in secondary objective endpoints compared to cyclosporin
ophthalmic emulsion 0.05% (Restasis ), the current DES market leader.
VOS did not meet the primary endpoint as both drugs were well
tolerated and demonstrated less than anticipated drop discomfort.
Received a Notice of Allowance from the United States Patent and
Trademark Office ("USPTO") for claims which have the potential to
cover voclosporin's method of use and dosing protocol for lupus
nephritis ("LN') until December 2037.
Appointed Mr. Peter Greenleaf as Chief Executive Officer and Dr.
George Milne to Chairman of the Board of Directors.
Cash, cash equivalents, and short-term investments of $144.3
million as of March 31, 2019.
Recent Director and Officer Appointments
On April 29, 2019, Aurinia appointed Peter Greenleaf as Chief Executive
Officer and a Director on the Aurinia Board.
Concurrently, Dr. Richard M. Glickman, who previously announced his
plans to retire on November 6, 2018, stepped down from his role as
Chairman and CEO. Dr. Glickman remains an advisor to the Company for a
period of 12 months.
"It is an honor to join Aurinia at this time and lead the organization
through its next phase of growth to advance voclosporin toward
commercialization based upon the Phase 3 AURORA results in lupus
nephritis anticipated by the end of this year," commented Mr. Peter
Greenleaf, Chief Executive Officer of Aurinia. "After following the
Aurinia story and after conducting further due diligence, I am truly
impressed with the Aurinia team, their ability to execute and advance
voclosporin in a cost-efficient manner, with the ongoing goal of
bringing voclosporin to help patients suffering with LN."
In conjunction with Dr. Glickman's retirement as the Chairman, the Board
elevated George M. Milne, Jr., PhD, to the position of Chairman of the
Board effective April 29, 2019. In addition, the Board appointed Dr.
Daniel Billen to the Board also effective April 29, 2019.
Dr. Milne stated, "With the appointment of Peter and Daniel to the
board, combined with our experienced and committed employees and
management team, Aurinia is strongly positioned to achieve our
milestones and maximize the value of voclosporin for all of our
VOS for Dry Eye Syndrome ("DES")
Based upon the exploratory Phase 2a results generated with VOS in a
head-to-head comparison vs. the current market leader for the treatment
of DES, Aurinia plans to initiate a Phase 2/3 study by late 2019. This
study will encompass certain critical regulatory requirements that the
FDA has traditionally required for DES product approval, these
requirements include both dose-optimization requirements along with a
comparison versus vehicle.
"I'm confident that the internal Aurinia team along with our key
ophthalmology clinical advisors have crafted a framework of a plan that
minimizes the clinical and regulatory risk for VOS and maximizes our
probability of launching VOS into the multi-billion dollar DES market in
due course," said Michael R. Martin, Chief Operating Officer of Aurinia.
Financial Liquidity at March 31, 2019
As at March 31, 2019, Aurinia had cash, cash equivalents and short-term
investments of $144.3 million compared to $125.9 million of cash, cash
equivalents and short-term investments as at December 31, 2018. Net cash
used in operating activities was $13.1 million for the first quarter
ended March 31, 2019 compared to $14.4 million for the first quarter
ended March 31, 2018.
The Company believes, that based on its current plans that Aurinia has
sufficient financial resources to fund the existing LN program,
including the AURORA trial and the AURORA 2 extension trial, complete
the NDA submission to the FDA, conduct the ongoing Phase 2 study for
FSGS, commence additional DES studies and fund operations into mid-2020.
The increase in our cash position at March 31, 2019 was primarily the
result of the following:
At-The-Market ("ATM") Facility
On November 30, 2018, Aurinia had entered into an open market sale
agreement with Jefferies LLC pursuant to which the Company could from
time to time sell, through ATM offerings, common shares that would have
an aggregate offering amount of up to $30 million. The ATM was fully
utilized in the first quarter. Aurinia received gross proceeds of $30
million and issued 4.6 million common shares. The Company incurred share
issue costs of $1.2 million including a 3% commission and professional
and filing fees related to the ATM offerings.
February 14, 2014 Warrant Exercises
The remaining derivative warrants outstanding from the February 14, 2014
private placement were exercised in the first quarter ended March 31,
2019. Certain holders of these warrants elected the cashless exercise
option and the Company issued 687,000 common shares on the cashless
exercise of 1.3 million warrants. Three holders of 464,000 warrants
exercised these warrants for cash, at a price of $3.2204 per common
share. The Company received cash proceeds of $1.5 million and issued
464,000 common shares.
Financial Results for the First Quarter Ended March 31, 2019
The Company reported a consolidated net loss of $12.4 million or $0.14
per common share for the first quarter ended March 31, 2019, as compared
to a consolidated net loss of $15.5 million or $0.18 per common share
for the first quarter ended March 31, 2018.
The loss for the first quarter ended March 31, 2019 reflected a
reduction of $1.7 million in the estimated fair value of derivative