FREMONT, Calif., March 4, 2016 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced
financial results for the fourth quarter and full-year ended
December 31, 2015.
![Ardelyx logo Ardelyx logo](http://photos.prnewswire.com/prnvar/20140619/119451)
"2015 was an exceptional year for Ardelyx, highlighted by the
advancement of our clinical programs and other corporate
achievements," said Mike Raab,
President and Chief Executive Officer of Ardelyx. "We regained
worldwide rights to our lead product candidate, tenapanor, from
AstraZeneca, and accelerated its development in multiple
indications. We initiated two Phase 3 clinical trials for tenapanor
in IBS-C and a second Phase 2b clinical trial for tenapanor in
hyperphosphatemia. We also completed a study evaluating the
pharmacodynamic activity of RDX022 in hyperkalemia, the positive
results of which support our plan to initiate a pivotal Phase 3
clinical trial in the second half of 2016. We remain
committed to advancing our late-stage assets and rounding out our
pipeline with the development of promising preclinical assets such
as RDX009, for which we intend to file an IND in the second half of
2016."
Recent Clinical & Corporate Developments
- In December, Ardelyx initiated the second of two planned Phase
3 clinical trials evaluating tenapanor for the treatment of
constipation-predominant irritable bowel syndrome (IBS-C). The
trial's endpoints are similar to those of the first Phase 3
clinical trial, which was initiated in October, including a 12-week
primary endpoint. Additionally, the study will evaluate tenapanor
versus placebo at 13 of 26 weeks along with an open-label
extension.
- In December, the Company also commenced a second Phase 2b
clinical trial evaluating dosing regimens of tenapanor in end-stage
renal disease (ESRD) patients with hyperphosphatemia.
- In October, Ardelyx initiated an open-label clinical study
evaluating the pharmacodynamic (PD) activity of RDX022 in 60
healthy adult volunteers. Positive results from the PD study
(announced in January 2016)
demonstrated RDX022's ability to bind potassium effectively in the
gastrointestinal tract. In this study, RDX022 was generally
well-tolerated at all doses administered up to 27.5 g/day. These
findings support Ardelyx's plans to proceed with a Phase 3 clinical
program. Ardelyx is pursuing regulatory approval for RDX022 using
the 505(b)(2) regulatory pathway.
- Ardelyx further strengthened its senior leadership team with
the appointment in January 2016 of
Paul Korner, MD, MBA, as Executive
Vice President and Chief Medical Officer.
- In January 2016, Ardelyx raised
net proceeds of approximately $80.4
million in an underwritten follow-on public offering of its
common stock.
Upcoming Clinical Milestones
- Results from the second Phase 2b clinical trial evaluating
tenapanor for the treatment of hyperphosphatemia in ESRD patients
are expected in the second half of 2016
- Initiation of a pivotal Phase 3 clinical trial to evaluate
RDX022 for the treatment of hyperkalemia is currently planned in
the second half of 2016
- Planned IND submission in the second half of 2016 for RDX009, a
TGR5 agonist that stimulates local secretion of GLP-1 and GLP-2 in
the gastrointestinal tract
- Results from two Phase 3 clinical trials evaluating tenapanor
for the treatment of IBS-C are expected in 2017
Fourth Quarter and Year Ended December
31, 2015 Financial Results
Net loss for the year ended December 31,
2015 was $29.6 million, or
$1.29 per basic and diluted share,
compared to a net loss of $3.2
million, or $0.31 per basic
and diluted share for the year ended December 31, 2014. Net loss for the fourth
quarter of 2015 was $17.0 million, or
$0.65 per basic and diluted share,
compared to a net loss of $4.0
million, or $0.21 per basic
and diluted share for the fourth quarter of 2014.
Total revenue is comprised of licensing revenue and
collaborative development revenue. Licensing revenue increased to
$21.6 million for the year ended
December 31, 2015 from $18.4 million for the year ended December 31, 2014. The increase primarily
reflects the impact of the recognition of the remaining deferred
revenue balance related to the AstraZeneca license agreement of
$43.1 million during the three months
ended June 30, 2015, which was
recognized as a result of the termination of the license agreement
with AstraZeneca in June 2015. This
amount was primarily offset by an aggregate of $25.0 million in upfront payments made to
AstraZeneca in connection with the termination of the AstraZeneca
agreement. Licensing revenue for the fourth quarter of 2015
decreased to zero from $3.9 million
for the fourth quarter of 2014 because of the termination of the
AstraZeneca agreement in June
2015.
Collaborative development revenue is comprised of development
expenses that were reimbursable to Ardelyx by AstraZeneca.
Collaborative development revenue for the year ended December 31, 2015 decreased to $2.4 million from $13.2
million for the year ended December
31, 2014. Collaborative development revenue for the fourth
quarter of 2015 decreased to zero from $2.5
million for the fourth quarter of 2014. The decrease in both
the full year and fourth quarter was attributable to the
termination of the AstraZeneca agreement in June 2015.
Research and development expense for the year ended December 31, 2015 increased to $39.9 million from $25.9
million for the year ended December
31, 2014. The change was primarily due to the $7.3 million in expenses incurred for the
tenapanor clinical trial material purchased from AstraZeneca as
well as an increase of $6.7 million
in expenses incurred for clinical development activities associated
with tenapanor and RDX022, and manufacturing process development
for RDX022. Research and development expense for the fourth quarter
of 2015 increased to $12.8 million
from $7.4 million for the fourth
quarter of 2014. The increase was driven by an increase of
$5.4 million in expenses incurred
primarily for clinical development activities associated with
tenapanor and RDX022, and manufacturing process development for
RDX022.
General and administrative expense was $13.5 million for the year ended December 31, 2015 compared to $7.3 million for the year ended December 31, 2014. General and administrative
expense was $4.1 million for the
fourth quarter of 2015 as compared to $2.9
million for fourth quarter of 2014. The increase in both the
full year and the fourth quarter was primarily due to an increase
in professional services fees, personnel and public company
costs.
Cash and cash equivalents were $107.0
million as of December 31,
2015 compared with $107.3
million as of December 31,
2014 primarily as a result of the private placement
completed in June 2015 that yielded
approximately $74.3 million in net
proceeds, offset by $3.5 million of
capital equipment purchases and $71.8
million in cash required for operating activities including
the $25.0 million paid to AstraZeneca
in connection with the termination of the license agreement in
June 2015.
On January 13, 2016,
we completed the sale and issuance of an aggregate of
8,625,000 shares of our Common Stock in an underwritten public
offering. We received net proceeds from the offering of
approximately $80.4 million, after
deducting the Underwriters' discounts and commissions and estimated
offering expenses payable by us.
Conference Call & Webcast Information
Ardelyx management will host a live conference call and webcast
today at 8:00 a.m. ET to discuss the financial results for the
fourth quarter and year ended December 31,
2015. The live webcast and a replay may be accessed by
visiting the Investor Relations section of the Ardelyx website at
ir.ardelyx.com.
Please connect to the Company's website at least 15 minutes
prior to the live webcast to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively,
please call 1-855-296-9612 (US) or 920-663-6277 (International) to
listen to the live conference call. The conference ID number for
the live call is 58231765. Please dial in approximately 10 minutes
prior to the call. An archived webcast replay will be available on
the Company's website until March 18,
2016.
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
exclusively in the gastrointestinal tract to treat gastrointestinal
and cardio-renal 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, Ardelyx has discovered and
designed tenapanor, which it is evaluating for the treatment of
constipation-predominant irritable bowel syndrome, or IBS-C, and
management of hyperphosphatemia in patients with end stage renal
disease. In addition to tenapanor, Ardelyx is developing RDX022, a
non-absorbed polymer for the treatment of hyperkalemia, or high
potassium, in kidney and heart disease patients. Ardelyx is also
advancing several research programs focused in gastrointestinal and
cardio-renal 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 the potential for
tenapanor in treating IBS-C and hyperphosphatemia in end stage
renal disease patients, Ardelyx's future development plans for
tenapanor and the timing thereof, the expected timing for the
receipt of the results for the Phase 3 clinical trials in IBS-C,
the expected timing for the receipt of the results for the Phase 2b
hyperphosphatemia clinical trial, the potential for RDX022 in
treating hyperkalemia in kidney and heart disease patients,
Ardelyx's future development plans for RDX022 and the timing
thereof, the expected timing for the initiation of the Phase 3
clinical trial for RDX022, the expected timing for the filing of an
IND for RDX009, and the potential of Ardelyx's drug discovery and
design platform. Such forward-looking statements involve
substantial risks and uncertainties that could cause the
development of tenapanor, RDX022, 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 research and the clinical development process and the
uncertainties in the manufacture of clinical trial material,
including process development, scale up and tech transfer of
manufacturing processes. 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 on Form 10-K to be
filed with the Securities and Exchange Commission on March 4, 2016, and its future current and
periodic reports to be filed with the Securities and Exchange
Commission.
Ardelyx,
Inc.
|
Condensed Balance
Sheets
|
(In
thousands)
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2015
|
|
2014
|
Assets
|
|
(Unaudited)
|
|
(1)
|
Cash and cash
equivalents
|
|
$
107,004
|
|
$
107,286
|
Accounts
receivable
|
|
-
|
|
2,584
|
Property and
equipment, net
|
|
4,711
|
|
2,131
|
Prepaid and other
assets
|
|
5,231
|
|
1,413
|
Total
Assets
|
|
$
116,946
|
|
$
113,414
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
7,723
|
|
$
5,557
|
Deferred license
revenue
|
|
-
|
|
47,053
|
Other
liabilities
|
|
322
|
|
122
|
Stockholders'
equity
|
|
108,901
|
|
60,682
|
Total liabilities and
stockholders' equity
|
|
$
116,946
|
|
$
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 and Comprehensive Loss
|
(In thousands, except
share and per share amounts)
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
December
31,
|
|
December
31,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(1)
|
Revenues:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$ --
|
|
$ 3,884
|
|
$ 21,611
|
|
$ 18,394
|
Collaborative
development revenue
|
--
|
|
2,454
|
|
2,415
|
|
13,229
|
Total
revenue
|
--
|
|
6,338
|
|
24,026
|
|
31,623
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
12,783
|
|
7,386
|
|
39,885
|
|
25,900
|
General and
administrative
|
4,093
|
|
2,884
|
|
13,530
|
|
7,287
|
Total operating expenses
|
16,876
|
|
10,270
|
|
53,415
|
|
33,187
|
Loss from
operations
|
(16,876)
|
|
(3,932)
|
|
(29,389)
|
|
(1,564)
|
Other (expense)
income
|
(123)
|
|
29
|
|
(261)
|
|
(1,583)
|
(Provision for)
benefit from income taxes
|
(1)
|
|
(67)
|
|
29
|
|
(67)
|
Net loss and
comprehensive loss
|
$ (17,000)
|
|
$ (3,970)
|
|
$ (29,621)
|
|
$ (3,214)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.65)
|
|
$ (0.21)
|
|
$ (1.29)
|
|
$ (0.31)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share
|
25,958,716
|
|
18,473,542
|
|
22,892,640
|
|
10,248,337
|
(1)
|
Derived from the
audited financial statements included on Form 10-K for the year
ended December 31, 2014.
|
Logo - http://photos.prnewswire.com/prnh/20140619/119451
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ardelyx-reports-fourth-quarter-and-full-year-2015-financial-results-300230937.html
SOURCE Ardelyx