FREMONT, Calif., May 12, 2015 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on cardio-renal, gastrointestinal and metabolic diseases, today
announced financial results for the first quarter ended
March 31, 2015.
Recent Clinical & Corporate Developments
- Following the completion of two Phase 2b clinical trials in
constipation-predominant irritable bowel syndrome (IBS-C) and
hyperphosphatemia, as well as a recent Phase 2a clinical trial in
chronic kidney disease (CKD) patients, AstraZeneca is now assessing
the results from all of the tenapanor trials. Under the terms of
the Company's agreement with AstraZeneca, AstraZeneca is obligated
to communicate to Ardelyx, on or before June
29, 2015, whether it will continue the development of
tenapanor.
- Ardelyx announced the appointment of Dr. Annalisa Jenkins to the Company's Board of
Directors.
"Our recently announced Phase 2a CKD trial, though it missed the
primary endpoint, showed that tenapanor can have an effect on stool
form and reduce phosphate absorption, which further support the
potential for tenapanor in the treatment of IBS-C and for the
management of hyperphosphatemia in dialysis patients," said
Mike Raab, President and Chief
Executive Officer. "We continue to work with AstraZeneca as they
evaluate the data in totality from the tenapanor development
program, and we are prepared to move forward in IBS-C and
hyperphosphatemia either independently or with AstraZeneca."
Upcoming Clinical & Corporate Milestones
- In June, Ardelyx is scheduled to have an End of Phase 2 meeting
with the Food and Drug Administration (FDA) in order to obtain
agreement on pivotal study designs, and safety and efficacy
endpoints for Phase 3 studies for tenapanor to treat IBS-C.
- Ardelyx is preparing for the continuation of the development of
tenapanor under a variety of scenarios, and intends to be in a
position to initiate a Phase 3 clinical program for tenapanor in
IBS-C in the fourth quarter of 2015 and to continue the development
of tenapanor for the treatment of hyperphosphatemia in CKD patients
on dialysis should it regain the worldwide rights to the
program.
- Data from the IBS-C study will be presented at Digestive
Disease Week from May 16-19, 2015 in
Washington D.C. An oral
presentation entitled, "Efficacy and Safety of Tenapanor in
Patients with Constipation Predominant Irritable Bowel Syndrome: A
12-Week, Double-Blind, Placebo-Controlled, Randomized Phase 2b
Trial" will be presented on Tuesday, May
19, at 2:45 pm ET to provide
additional information about the study.
First Quarter Ended March 31,
2015 Financial Results
Net loss for the first quarter of 2015 was $3.5 million, or $0.19 per basic and diluted share, compared to a
net loss of $3.1 million, or
$2.44 per basic and diluted share for
the first quarter of 2014.
Total revenue is comprised of licensing revenue and
collaborative development revenue. Licensing revenue for the first
quarter of 2015 increased to $3.9
million from $3.2 million for
the first quarter of 2014. The increase was primarily due to the
amortization of deferred revenue from a milestone payment of
$25.0 million that the Company
received in May 2014.
Collaborative development revenue is comprised of revenue
received from AstraZeneca as reimbursement for development expenses
for tenapanor incurred by Ardelyx. Collaborative development
revenue for the first quarter of 2015 decreased to $2.0 million from $5.3
million for the first quarter of 2014. The decrease was
primarily attributable to a decrease in the development activities
performed by Ardelyx under the collaboration agreement with
AstraZeneca.
Discovery research expense for the first quarter of 2015
increased to $4.2 million from
$2.4 million for the first quarter of
2014. The increase was driven by an increase in personnel costs
resulting from increased headcount, consultant service fees, lab
supply expenses and process development expenses resulting from
increased research activities for unpartnered programs.
AstraZeneca collaboration development expense for the first
quarter of 2015 decreased to $2.0
million from $5.3 million for
the first quarter of 2014. The decrease was driven by a decrease in
expenses primarily related to the completion of certain clinical
trial activities that are a part of the AstraZeneca agreement.
General and administrative expense was $3.2 million for the first quarter of 2015 as
compared to $1.4 million for first
quarter of 2014. The increase was primarily due to higher personnel
related costs, public company expenses and additional costs to
support the Company's infrastructure.
Cash and cash equivalents were $98.3
million as of March 31, 2015
as compared to $107.3 million as of
December 31, 2014. The decrease in
cash and cash equivalents compared to December 31, 2014 was primarily due to
operational expenses as well as changes in working capital and
purchases of property and equipment.
About Ardelyx, Inc.
Ardelyx is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of innovative,
minimally-systemic, small molecule therapeutics that work in the
gastrointestinal tract to treat cardio-renal, gastrointestinal and
metabolic diseases. Ardelyx has developed a proprietary drug
discovery and design platform enabling it, in a rapid and
cost-efficient manner, to discover and design novel drug
candidates. Utilizing this platform, the Company has discovered and
designed tenapanor. Ardelyx formed a partnership with
AstraZeneca in October 2012 to
develop and commercialize tenapanor. In addition to
tenapanor, Ardelyx has discovered small molecule NaP2b inhibitors
for the treatment of hyperphosphatemia in patients on dialysis, a
program licensed to Sanofi, and independently is advancing several
additional research programs focused in cardio-renal,
gastrointestinal and metabolic diseases. Ardelyx is located in
Fremont, California. For more
information, please visit Ardelyx's website at www.ardelyx.com.
Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Ardelyx, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor of the
Private Securities Reform Act of 1995, including statements
regarding the potential for tenapanor in treating IBS-C patients,
the potential of tenapanor in treating hyperphosphatemia in CKD
patients on dialysis, the timing of AstraZeneca's decisions
regarding its future plans for tenapanor, the potential receipt and
timing of milestone payments from AstraZeneca in connection with
any decision by it to continue the development of tenapanor and our
future development plans and the timing thereof, if the rights to
tenapanor are returned to us. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
development of tenapanor, or Ardelyx's future results, performance
or achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical development process, Ardelyx's reliance upon
AstraZeneca for the development of tenapanor, AstraZeneca's right
under the license agreement to choose which indication or
indications for which tenapanor will be developed, and
AstraZeneca's right under the license agreement to terminate the
agreement upon written notice to Ardelyx. Ardelyx undertakes no
obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to Ardelyx's business in general, please refer to
Ardelyx's annual report filed on Form 10-Q filed with the
Securities and Exchange Commission on May
12, 2015.
ARDELYX,
INC.
|
|
CONDENSED BALANCE
SHEETS
|
|
(in
thousands)
|
|
|
|
|
|
March 31,
2015
|
|
December 31,
2014
|
|
|
|
(Unaudited)
|
|
(1)
|
|
Assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$ 98,318
|
|
$
107,286
|
|
Accounts
receivable
|
|
2,043
|
|
2,584
|
|
Property and
equipment, net
|
|
3,289
|
|
2,131
|
|
Prepaid and other
assets
|
|
1,749
|
|
1,413
|
|
Total
Assets
|
|
$ 105,399
|
|
$
113,414
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
3,959
|
|
$
5,557
|
|
Deferred license revenue
|
|
43,143
|
|
47,053
|
|
Other
liabilities
|
|
297
|
|
122
|
|
Shareholders'
equity
|
|
58,000
|
|
60,682
|
|
Total liabilities and
stockholders' equity
|
|
$ 105,399
|
|
$
113,414
|
|
|
|
|
|
|
|
|
(1) Derived from the audited
financial statements included on Form 10-K for the year ended
December 31, 2014.
|
|
|
|
|
|
ARDELYX,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share amounts)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2015
|
|
2014
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
Licensing
revenue
|
|
$
3,884
|
|
$ 3,236
|
Collaborative
development revenue
|
|
1,999
|
|
5,314
|
Total
revenues
|
|
5,883
|
|
8,550
|
Operating
expenses:
|
|
|
|
|
Research and
development expense:
|
|
|
|
|
Discovery
research expense
|
|
4,179
|
|
2,360
|
AstraZeneca collaboration development expense
|
|
2,019
|
|
5,277
|
Total
research and development expense
|
|
6,198
|
|
7,637
|
General and
administrative expense
|
|
3,175
|
|
1,377
|
Total operating
expenses
|
|
9,373
|
|
9,014
|
Loss from
operations
|
|
(3,490)
|
|
(464)
|
Other expense,
net
|
|
(12)
|
|
(4)
|
Change in fair value
of preferred stock warrant liability
|
|
-
|
|
(2,603)
|
Provision for income
taxes
|
|
-
|
|
-
|
Net loss
|
|
$
(3,502)
|
|
$ (3,071)
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.19)
|
|
$ (2.44)
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
|
18,606,760
|
|
1,256,245
|
|
|
|
|
|
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SOURCE Ardelyx, Inc.