FREMONT, Calif., Feb. 25, 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 fourth quarter and twelve
months ended December 31, 2014.
"2014 has been a highly productive year at Ardelyx, with
advancements in the clinical program for tenapanor, including the
completion of two Phase 2b clinical trials in patients with
constipation-predominant irritable bowel syndrome and in chronic
kidney disease patients on dialysis with hyperphosphatemia," said
Mike Raab, President and Chief
Executive Officer. "We continue to work diligently with AstraZeneca
to support the clinical development for tenapanor, and plan to
report the results of the Phase 2a clinical trial in CKD patients
in the second quarter of 2015. We are also accelerating the
development of our own proprietary pipeline and expect to provide
updates about our pipeline development activities mid-year."
Recent Clinical & Corporate Developments
- Ardelyx announced results from AstraZeneca's 161-patient Phase
2b clinical study evaluating tenapanor in hyperphosphatemic chronic
kidney disease patients on dialysis (CKD-5D, also known as
end-stage renal disease, or ESRD). The study met its primary
endpoint by demonstrating a statistically significant dose-related
decrease in serum phosphate levels for tenapanor-treated patients
compared to patients receiving placebo (p=0.012). The most
frequently observed adverse event was diarrhea, with the rate of
diarrhea and the discontinuation rate due to diarrhea higher than
observed in previous tenapanor trials. Higher discontinuations
rates due to diarrhea were observed primarily in the 30mg once
daily and 30mg twice daily dose groups.
- Ardelyx announced results from AstraZeneca's 371-patient Phase
2b clinical trial evaluating tenapanor in patients with
constipation-predominant irritable bowel syndrome (IBS-C). At
the 50 mg twice daily dose, the study met its primary efficacy
endpoint of an increase in the complete spontaneous bowel movement
(CSBM) responder rate, and produced a statistically significant
effect in abdominal pain responder and overall responder
rates. Most secondary endpoints, including abdominal pain and
other abdominal and IBS-C symptoms, demonstrated statistically
significant and clinically meaningful improvements also at 50mg
twice daily.
- Ardelyx announced the appointment of Jeremy S. Caldwell, Ph.D. as Executive Vice
President and Chief Scientific Officer.
- A $25 million milestone payment
was received from AstraZeneca under its collaboration agreement for
the initiation of a Phase 2b clinical trial evaluating tenapanor
for the treatment of hyperphosphatemia, or elevated serum
phosphorus, in patients with CKD-5D.
- Ardelyx raised net proceeds of approximately $61.2 million in an initial public offering of
its common stock.
- Ardelyx licensed its novel NaP2b phosphate transport inhibitor
program for the treatment of hyperphosphatemia in CKD-5D patients
to Sanofi in exchange for an upfront payment and potential
milestones that could total $198
million.
- For additional information regarding the clinical trial results
of tenapanor in the Phase 2b trials in CKD-5D and IBS-C, please
refer to our Form 8-K filed with the Securities and Exchange
Commission on February 9, 2015.
Upcoming Clinical Milestones
- AstraZeneca and Ardelyx are also evaluating tenapanor in a
Phase 2a trial in 154 patients with chronic kidney disease, type 2
diabetes mellitus and albuminuria (NCT01847092). The study consists
of a 4-week run-in period, 12 weeks of blinded treatment with
tenapanor, and a 2-week follow-up period. Data from this
clinical trial are expected in the second quarter 2015. Ardelyx
currently expects AstraZeneca to determine its future clinical
development plans for tenapanor after it has received all of the
Phase 2 data.
Fourth Quarter and Year Ended December
31, 2014 Financial Results
Net loss for the year ended December 31,
2014 was $3.2 million, or
$0.31 per basic and diluted share,
compared to a net loss of $6.6
million, or $5.82 per basic
and diluted share for the year ended December 31, 2013. Net loss for the fourth
quarter of 2014 was $4.0 million, or
$0.21 per basic and diluted share,
compared to a net loss of $4.3
million, or $3.53 per basic
and diluted share for the fourth quarter of 2013.
Total revenue is comprised of licensing revenue and
collaborative development revenue. Licensing revenue for the year
ended December 31, 2014 increased to
$18.4 million from $8.1 million for the year ended December 31, 2013. Licensing revenue for the
fourth quarter of 2014 increased to $3.9
million from $2.1 million for
the fourth quarter of 2013. The increase in both the full year and
the fourth quarter was primarily due to the amortization of
deferred revenue from a $15.0 million
development milestone payment that the Company received in
December 2013 and a milestone payment
of $25.0 million that the Company
received in May 2014.
Collaborative development revenue is comprised of development
expenses that are reimbursable to Ardelyx by AstraZeneca.
Collaborative development revenue for the year ended December 31, 2014 decreased to $13.2 million from $20.9
million for the year ended December
31, 2013. Collaborative development revenue for the fourth
quarter of 2014 decreased to $2.5
million from $6.4 million for
the fourth quarter of 2013.The decrease in both the full year and
fourth quarter was primarily attributable to a decrease in the
development activities performed by Ardelyx under the collaboration
agreement with AstraZeneca.
Total research and development expense is comprised of discovery
research and AstraZeneca collaboration development expense.
Discovery research expense for the year ended December 31, 2014 increased to $12.7 million from $7.7
million for the year ended December
31, 2013. Discovery research expense for the fourth quarter
of 2014 increased to $5.0 million
from $2.0 million for the fourth
quarter of 2013. The increase in both the full year and fourth
quarter was driven by an increase in personnel costs resulting from
increased headcount, consultant service fees and lab supply
expenses resulting from increased research activities for
non-partnered programs.
AstraZeneca collaboration development expense for the year ended
December 31, 2014 decreased to
$13.2 million from $20.3 million for the year ended December 31, 2013. AstraZeneca collaboration
development expense for the fourth quarter of 2014 decreased to
$2.4 million from $6.4 million for the fourth quarter of 2013. The
decrease in both the full year and fourth quarter 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 $7.3 million for the year ended December 31, 2014 as compared to $3.7 million for the year ended December 31, 2013. General and administrative
expense was $2.9 million for the
fourth quarter of 2014 as compared to $0.9
million for fourth quarter of 2013. The increase in both the
full year and the fourth quarter 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 $107.3
million as of December 31,
2014 as compared to $34.4
million as of December 31,
2013.The increase in cash and cash equivalents compared to
December 31, 2013 was primarily due
to receipt of milestone payments from AstraZeneca and completion of
the Company's initial public offering in June 2014.
Conference Call & Webcast Information
Ardelyx management will host a live conference call and webcast
today at 4:30 pm Eastern Time to discuss the financial results
for the fourth quarter and year ended December 31, 2014. The live webcast and a replay
may be accessed by visiting Ardelyx's website on the investor page
of the Company's website at http://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 89320171. Please dial in approximately 10 minutes
prior to the call. An archived webcast replay will be available on
the Company's website for two weeks.
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 cardio-renal,
gastrointestinal and metabolic diseases. The Company 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. Ardelyx formed a collaborative partnership with
AstraZeneca in October 2012 to
develop and commercialize tenapanor. In addition to
tenapanor, the Company has discovered small molecule NaP2b
inhibitors for the treatment of hyperphosphatemia in CKD-5D, 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 our intentions to provide updates regarding progress on
our proprietary pipeline and the timing thereof, the availability
and timing of data from the ongoing Phase 2a clinical trial
evaluating tenapanor in chronic kidney disease patients, the timing
of AstraZeneca's decisions regarding future development plans for
tenapanor, the potential for tenapanor in treating IBS-C patients,
the potential for tenapanor in treating hyperphosphatemia in
patients with end stage renal disease on dialysis, and the
potential of our drug discovery and design platform. 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 third quarter report filed on Form 10-Q with the
Securities and Exchange Commission on November 7, 2014, and its future periodic reports
to be filed with the Securities and Exchange
Commission.
Ardelyx
Inc.
Condensed Balance
Sheets
(In
thousands)
|
|
December 31,
2014
|
|
|
December 31,
2013
|
|
|
(Unaudited)
|
|
|
(1)
|
|
Assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
107,286
|
|
|
$
|
34,435
|
|
Accounts
receivable
|
|
2,584
|
|
|
|
6,436
|
|
Property and
equipment, net
|
|
2,131
|
|
|
|
530
|
|
Prepaid and other
assets
|
|
1,413
|
|
|
|
1,503
|
|
Total
assets
|
$
|
113,414
|
|
|
$
|
42,904
|
|
|
|
|
|
|
|
|
|
Liabilities,
convertible preferred stock, and stockholders' equity
(deficit)
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
5,557
|
|
|
$
|
3,311
|
|
Deferred license
revenue
|
|
47,053
|
|
|
|
40,298
|
|
Convertible preferred
stock warrant liability
|
|
—
|
|
|
|
6,456
|
|
Other
liabilities
|
|
122
|
|
|
|
163
|
|
Convertible preferred
stock
|
|
—
|
|
|
|
56,155
|
|
Shareholders' equity
(deficit)
|
|
60,682
|
|
|
|
(63,479)
|
|
Total liabilities,
convertible preferred stock, and stockholders' equity
|
$
|
113,414
|
|
|
$
|
42,904
|
|
(1)
|
Information
derived from audited financial statements included on form S1 for
the year ended December 31, 2013.
|
Ardelyx,
Inc.
Condensed
Statements of Operations and Comprehensive Income
(Loss)
(In thousands, except
share and per share amounts)
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(1)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
|
3,884
|
|
$
|
2,096
|
|
$
|
18,394
|
|
$
|
8,063
|
|
Collaborative
development revenue
|
|
2,454
|
|
|
6,392
|
|
|
13,229
|
|
|
20,865
|
|
Total
revenue
|
|
6,338
|
|
|
8,488
|
|
|
31,623
|
|
|
28,928
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
|
|
|
|
|
|
|
|
|
Discovery research
expense
|
|
4,964
|
|
|
1,958
|
|
|
12,734
|
|
|
7,746
|
|
AZ collaboration
development expense
|
|
2,422
|
|
|
6,378
|
|
|
13,166
|
|
|
20,347
|
|
Total research and
development expense
|
|
7,386
|
|
|
8,336
|
|
|
25,900
|
|
|
28,093
|
|
General and
administrative
|
|
2,884
|
|
|
870
|
|
|
7,287
|
|
|
3,700
|
|
Total operating
expenses
|
|
10,270
|
|
|
9,206
|
|
|
33,187
|
|
|
31,793
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss)
from operations
|
|
(3,932)
|
|
|
(718)
|
|
|
(1,564)
|
|
|
(2,865)
|
|
Other income
(expense)
|
|
29
|
|
|
(3,516)
|
|
|
(1,583)
|
|
|
(3,558)
|
|
Benefit from
(provision for) income taxes
|
|
(67)
|
|
|
(35)
|
|
|
(67)
|
|
|
(141)
|
|
Net income (loss) and
comprehensive income (loss)
|
$
|
(3,970)
|
|
$
|
(4,269)
|
|
$
|
(3,214)
|
|
$
|
(6,564)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
income (loss) per share
|
$
|
(0.21)
|
|
$
|
(3.53)
|
|
$
|
(0.31)
|
|
$
|
(5.82)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share...
|
|
18,473,542
|
|
|
1,208,229
|
|
|
10,248,337
|
|
|
1,127,948
|
|
(1)
|
Information
derived from audited financial statements included on form S1 for
the year ended December 31, 2013.
|
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SOURCE Ardelyx, Inc.