FREMONT, Calif., Aug. 12, 2015 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on gastrointestinal and cardio-renal diseases, today announced
financial results for the second quarter ended June 30, 2015.
"We have made significant progress towards our goal of becoming
a fully-integrated bio-pharmaceutical company,'" said Mike Raab, President and Chief Executive
Officer. "Under our leadership, tenapanor's clinical development is
accelerating, with a Phase 3 clinical program in IBS-C and a Phase
2b dosing trial in hyperphosphatemia patients on dialysis planned
to begin in the fourth quarter of 2015. Our recent financing gives
us the financial strength to initiate these late stage clinical
programs and continue to pursue our goal to bring several compounds
from the clinic to commercialization."
Recent Highlights and Anticipated Near-Term Milestones for
Key Development Programs
- IBS-C Phase 2b data at Digestive Disease Week: In May 2015, the Company presented clinical data
from its Phase 2b program evaluating tenapanor in IBS-C at the
annual Digestive Disease Week conference in an oral presentation
entitled, "Efficacy and Safety of Tenapanor Patients with
Constipation Predominant Irritable Bowel Syndrome: A 12-Week,
Double-Blind, Placebo-Controlled, Randomized Phase 2b Trial."
Subsequently, the Company presented additional results from the
Phase 2b trial, all of which achieved statistical significance with
a clinically meaningful response versus placebo, including
sustained overall responder rates, sustained overall complete
spontaneous bowel movement (CSBM) responder rates, and sustained
overall abdominal pain responder rates.
- Re-acquisition of rights to tenapanor: In June 2015, the Company entered into a termination
agreement with AstraZeneca, under which all the rights to Ardelyx's
portfolio of NHE3 inhibitors, including Ardelyx's lead product
candidate, tenapanor, were returned to Ardelyx. Under the terms of
the agreement, the Company agreed to pay AstraZeneca certain
amounts for the return of the program, including (a) an upfront fee
of $15.0 million, (b) future
royalties at a royalty rate of 10% of net sales of tenapanor or
other NHE3 products by the Company or its licensees, and (c) 20% of
non-royalty revenue received from a new collaboration partner,
should it elect to license, or otherwise provide rights to develop
and commercialize tenapanor or any other NHE3 product. The
amounts payable to AstraZeneca in upfront payments, royalties and
non-royalty revenue sharing are capped at the aggregate amount of
$90.0 million. In addition, the Company also paid AstraZeneca $10.0
million as reimbursement for certain research and development
expenses incurred by AstraZeneca under the collaboration agreement
during 2015. Under the agreement, for an additional payment of up
to $10.0 million, AstraZeneca is obligated to supply the Company
with clinical trial materials and all drug substance and drug
product produced under the original agreement.
- Announced clinical development plans for RDX022: The Company
recently announced its plans for the development of RDX022,
Ardelyx's next generation potassium binder for the treatment of
hyperkalemia. RDX022 is currently undergoing early-stage human
trials, and Ardelyx expects to initiate a pharmacodynamic (PD)
study of RDX022 in the fourth quarter of 2015. This new study will
evaluate safety and PD effects of RDX022 with results expected in
the first half of 2016. The Company has met with the FDA and, based
on those discussions, intends to pursue an accelerated 505(b)2
development pathway for RDX022. Additionally, the Company
expects to initiate a Phase 3 clinical trial to evaluate RDX022 for
the treatment of hyperkalemia in the second half of 2016.
- Hosted Inaugural R&D Day: The Company provided a
comprehensive update of its research and development programs at
its first inaugural R&D Day in New
York City on July 14, 2015.
The Company emphasized its goal of creating a new standard in
gastrointestinal and cardio-renal care and provided additional
details regarding its robust clinical program. Specific highlights
included:
- Additional Phase 2b data for tenapanor in IBS-C demonstrating a
sustained or durable responder rate of 14.6 percent greater than
the placebo group
- Proof of concept study in an animal model of
chemotherapy-induced diarrhea for RDX009, a TGR5 agonist that
stimulates local secretion of GLP-1 and GLP-2 in the gut
- Proof of concept data demonstrating that RXD013, an oral
potassium secretagogue, causes the secretion of potassium into the
intestines in a preclinical model
Summary of Upcoming Clinical Milestones
- Initiation of a 12-week Phase 3 study of tenapanor in IBS-C
patients in 4Q2015
- Initiation of a Phase 2b study of tenapanor in
hyperphosphatemia patients on dialysis in 4Q2015 with results
expected in 2H2016
- Initiation of pharmacodynamic study of RDX022 in 4Q2015 with
results expected in 1H2016
- Initiation of a six-month Phase 3 study of tenapanor in IBS-C
patients in 1H2016
- Initiation of a Phase 3 clinical trial to evaluate RDX022 for
the treatment of hyperkalemia in 2H2016
- Planned submission of an IND for RDX009 in 2H2016
Second Quarter 2015 Financial Results
Net income in the second quarter of 2015 was $9.0 million, or $0.43 per basic and $0.42 per diluted share, compared to a net income
of $3.8 million, or $0.20 per basic and $0.18 per diluted share in the second quarter of
2014.
Total revenue is comprised of licensing revenue and
collaborative development revenue. Licensing revenue in the second
quarter of 2015 increased to $17.7
million from $6.5 million in
the second quarter of 2014. The increase was primarily due to
recognition of the remaining deferred revenue balance of
$43.1 million during the three months
ended June 30, 2015 as a result of
the Company's termination agreement with AstraZeneca. This was
partially offset by a $15.0 million
upfront payment for the return of the license granted to
AstraZeneca as well as the $10.0
million reimbursement for research and development expenses
and for the acceleration of the transfer of information and
materials.
Collaborative development revenue in the second quarter of 2015
decreased to $0.4 million from
$2.6 million in the second quarter of
2014. The decrease was due to the termination of the Company's
agreement with AstraZeneca.
Research and development expense in the second quarter of 2015
increased to $6.2 million from
$5.2 million in the second quarter of
2014. The change resulted from a $3.2
million increase in discovery research expenses primarily
due to an increase in personnel costs, consultant service fees,
process development costs and lab supply expenses from increased
research activities for unpartnered programs. The increase was
partially offset by a $2.2 million
decrease in AstraZeneca collaboration development expense due to
the decrease in development activities related to tenapanor
conducted by Ardelyx under the license agreement with
AstraZeneca.
General and administrative expense was $2.9 million in the second quarter of 2015 as
compared to $1.2 million in the
second 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 $141.5
million as of June 30, 2015 as
compared to $107.3 million as of
December 31, 2014. The increase in
cash and cash equivalents compared to December 31, 2014 was primarily due to
$74.4 million in net proceeds, after
all costs, from issuance of common stock and warrants to purchase
common stock offset by changes in working capital, cash paid for
purchases of property and equipment, the $15
million up-front payment to AstraZeneca in connection with
the termination agreement, and the $10
million payment to AstraZeneca for reimbursement of certain
research and development expenses incurred by AstraZeneca under the
collaboration agreement during 2015.
About Ardelyx
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, the Company has discovered and
designed tenapanor, which it is evaluating for the treatment of
IBS-C and hyperphosphatemia in chronic kidney disease patients on
dialysis. 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, and has discovered
small molecule NaP2b inhibitors for the treatment of
hyperphosphatemia in CKD patients on dialysis, a program licensed
to Sanofi. Ardelyx is also independently 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 patients, the potential for tenapanor
in treating hyperphosphatemia in chronic kidney disease patients on
dialysis, Ardelyx's future development plans for tenapanor and the
timing thereof, the potential for RDX022 in treating hyperkalemia,
Ardelyx's future development plans for RDX022 and the timing
thereof, the potential of RDX009 in treating chemotherapy induced
diarrhea and the potential timing for filing 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, 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, Ardelyx's reliance upon AstraZeneca
for the timely delivery of clinical trial material required for the
initiation of the Phase 3 clinical program in IBS-C and the Phase
2b clinical trial in hyperphosphatemia, and Ardelyx's reliance upon
AstraZeneca to facilitate a complete and timely transition of the
tenapanor program from AstraZeneca 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 current report filed on Form 8-K with the Securities and
Exchange Commission on July 14, 2015,
and its future periodic reports to be filed with the Securities and
Exchange Commission.
ARDELYX,
INC.
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
|
|
|
|
June
30,
2015
|
|
December
31,
2014
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$ 141,534
|
|
$
107,286
|
Accounts
receivable
|
|
27
|
|
2,584
|
Property and
equipment, net
|
|
4,061
|
|
2,131
|
Prepaid and other
assets
|
|
2,566
|
|
1,413
|
Total
Assets
|
|
$ 148,188
|
|
$
113,414
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
5,546
|
|
$
5,557
|
Deferred
license revenue
|
|
—
|
|
47,053
|
Other
liabilities
|
|
382
|
|
122
|
Stockholders'
equity
|
|
142,260
|
|
60,682
|
Total liabilities and
stockholders' equity
|
|
$ 148,188
|
|
$
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
June 30,
|
|
Six Months Ended
June 30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
17,727
|
|
$
6,507
|
|
$
21,611
|
|
$
9,743
|
Collaborative
development revenue
|
416
|
|
2,630
|
|
2,415
|
|
7,944
|
Total
revenues
|
18,143
|
|
9,137
|
|
24,026
|
|
17,687
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expense
|
6,198
|
|
5,183
|
|
12,396
|
|
12,820
|
General and
administrative expense
|
2,889
|
|
1,203
|
|
6,064
|
|
2,580
|
Total operating
expenses
|
9,087
|
|
6,386
|
|
18,460
|
|
15,400
|
Income from
operations
|
9,056
|
|
2,751
|
|
5,566
|
|
2,287
|
Other
expense
|
(49)
|
|
(8)
|
|
(61)
|
|
(12)
|
Change in fair value
of preferred stock warrant liability
|
-
|
|
1,010
|
|
-
|
|
(1,593)
|
Provision for income
taxes
|
-
|
|
-
|
|
-
|
|
-
|
Net income and
comprehensive income
|
$
9,007
|
|
$
3,753
|
|
$
5,505
|
|
$
682
|
|
|
|
|
|
|
|
|
Basic net income per
share
|
$
0.43
|
|
$
0.20
|
|
$
0.28
|
|
$
-
|
Diluted net income
per share
|
$
0.42
|
|
$
0.18
|
|
$
0.27
|
|
$
-
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income per share
|
20,880,235
|
|
2,611,259
|
|
19,749,778
|
|
1,937,509
|
Shares used in
computing diluted net income per share
|
21,636,487
|
|
3,904,136
|
|
20,506,916
|
|
1,937,509
|
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SOURCE Ardelyx