FREMONT, Calif., March 14, 2018 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), today reported pipeline highlights and financial
results for the fourth quarter and full-year ended December 31, 2017. In addition, industry-leading
research expert, Jan M. Lundberg,
Ph.D., has been appointed to the company's board of directors,
effective March 23, 2018.
"Jan's extensive research expertise positions him as an
invaluable addition to the Ardelyx team, and we are delighted that
he is joining our board. We look forward to leveraging his
substantial experience, as he has been involved in the discovery,
development and approval of more than 20 products," said
Mike Raab, president and chief
executive officer of Ardelyx. "As we look ahead, our focus is on
addressing the significant need for new treatments for patients
with renal diseases by developing first-in-class, small molecule
medicines, as with tenapanor for hyperphosphatemia and our RDX013
program for hyperkalemia. We believe that the combination of our
proprietary drug discovery platform, renal drug development
capabilities and our plans for a specialized U.S. commercial
approach targeting nephrologists, positions Ardelyx to meaningfully
change the care of many patients, while creating value for
shareholders."
Pipeline Updates
- Second Phase 3 Clinical Trial of Tenapanor for
Hyperphosphatemia Underway: In February 2018, Ardelyx began treating patients in
the Phreedom Trial, the company's second Phase 3 clinical trial of
tenapanor for the treatment of hyperphosphatemia in patients with
end-stage renal disease who are on dialysis. This clinical trial
includes a 26-week open-label treatment period, with a 12-week
placebo-controlled randomized withdrawal period followed by an
additional 14-week safety extension period for a total of up to 52
weeks. An active control group, for safety analysis only and
consistent with other Phase 3 registration studies for
hyperphosphatemia, will receive sevelamer carbonate, open-label,
for the entire 52-week study period. Topline data from this
clinical trial are currently anticipated in 2019.
- Expanding Renal Pipeline with RDX013 Program: Ardelyx is
leveraging its expertise in renal drug development to advance its
early-stage RDX013 program for the potential treatment of
hyperkalemia. RDX013 is a novel, small molecule program
that Ardelyx believes may work by tapping into the
gastrointestinal tract's natural ability to secrete potassium into
the lumen of the gut to reduce serum potassium levels. This
mechanism differs significantly from the potassium binders
currently on or approaching the market, and, like tenapanor for
hyperphosphatemia, has the potential to provide the first
non-binder approach to treat hyperkalemia with the aim of improving
adherence and compliance with potentially better efficacy and
safety.
- Preparing NDA Submission for Tenapanor for IBS-C:
Ardelyx has completed its T3MPO program designed to support the
registration of tenapanor for the treatment of irritable bowel
syndrome with constipation (IBS-C). Both the T3MPO-1 and T3MPO-2
Phase 3 clinical trials achieved their primary endpoints and
demonstrated that tenapanor had a durable effect on reducing
constipation and abdominal pain caused by IBS-C, in many patients
treated. The favorable safety profile of tenapanor was supported by
the completed T3MPO-3 long-term, safety extension study. With the
completion of clinical development for this program, Ardelyx is
preparing a New Drug Application for tenapanor for IBS-C, which the
company currently intends to submit to the U.S. Food and Drug
Administration in the second half of 2018.
"We believe that tenapanor represents a more than $1 billion market opportunity for both
hyperphosphatemia and IBS-C," added Reg
Seeto, MBBS, chief operating officer of Ardelyx. "For our
renal pipeline, our plan is to deploy our internal expertise to
bring tenapanor to the U.S. market on our own, while leveraging
strategic collaborations to bring it to markets outside the U.S.
For IBS-C, we intend to leverage collaborations to bring tenapanor
to patients globally. Our collaborations with KHK in Japan and Fosun Pharma in China are each off to a strong start, and we
look forward to evaluating additional opportunities to expand the
reach of our novel products."
Corporate Updates
- Industry Veteran Jan M. Lundberg, Ph.D. Appointed to
Board of Directors: Dr. Lundberg brings more than 22 years of
experience in biopharma and significant research strength to the
board. He currently serves as executive vice president, science and
technology, and president, Lilly Research Laboratories at Eli Lilly
where he has been instrumental in the submissions and approvals of
10 new products over the last five years. Before Lilly, he was
global head of discovery research at AstraZeneca, where he played a
key role in numerous drug candidate nominations, development
projects and marketed-product support, as well as in-licensing,
partnering and acquisitions. Prior to AstraZeneca, he served as the
head of preclinical research at Astra AB. Dr. Lundberg was also the
co-founder of Aerocrine AB, a biotech diagnostic company with
exhaled nitric oxide as an allergic asthma breath test. He earned a
BSM equivalent in medicine from the University of Gothenburg in Sweden and a Ph.D. in pharmacology from
Karolinska Institute in Stockholm, Sweden.
- Fosun Pharma Agreement Brings Tenapanor to China for Cardiorenal Diseases and IBS-C:
A license agreement with Shanghai Fosun Pharmaceutical Industrial
Development Company Limited (Fosun Pharma), signed in December 2017, provides Fosun Pharma with the
exclusive rights to develop and commercialize tenapanor in
China for the treatment of
patients with hyperphosphatemia related to chronic kidney disease,
as well as patients with IBS-C. Under the terms of the agreement,
Ardelyx received an upfront payment of $12
million and is eligible to receive additional milestones of
up to $113 million, as well as tiered
royalties on net sales ranging from the mid-teens to 20
percent.
- Kyowa Hakko Kirin Agreement Brings Tenapanor to Japan for Cardiorenal Diseases: A license
agreement with Kyowa Hakko Kirin Co., Ltd. (KHK), signed in
November 2017, provides KHK exclusive
rights to develop and commercialize tenapanor for the treatment of
cardiorenal diseases, including hyperphosphatemia, in Japan. Under the terms of the license
agreement, Ardelyx received a $30
million upfront payment and is eligible to receive up to
approximately $130 million in
development and commercialization milestones based upon currency
exchange rates as of the effective date of the license agreement,
as well as high-teen royalties on net sales throughout the term of
the agreement.
Full Year 2017 Financial Results
- Cash Position: As of December 31,
2017, Ardelyx had total capital resources comprising cash,
cash equivalents and short-term investments of $134.0 million compared to total capital
resources comprising cash, cash equivalents and short-term
investments of $200.8 million as of
December 31, 2016.
- Revenue: Licensing revenue for the year ended
December 31, 2017 was $42.0
million, related to the recognition of revenue from upfront
license payments under Ardelyx's agreements with KHK and Fosun
Pharma. The company generated no license revenue for the year
ended December 31, 2016.
- Cost of Revenue: Cost of revenue for the year ended
December 31, 2017 was $8.4
million, representing license payments due to AstraZeneca in
accordance with the company's termination agreement entered into
with AstraZeneca in June 2015. The
company generated no revenue for the year ended
December 31, 2016 and therefore had no cost of revenue.
- R&D Expenses: Research and development expenses were
$75.5 million for the year ended
December 31, 2017, a decrease of
$18.7 million, or 20 percent,
compared to $94.2 million for the
year ended December 31, 2016. The
decrease consisted of a net $23.8
million decrease in external program costs, primarily due to
a decrease in expenses incurred for clinical development activities
related to the completion of some of the company's Phase 3 clinical
trials for tenapanor. This was offset by an increase of
$5.1 million in internal program
costs, primarily due to salaries and related costs, including
stock-based compensation, facilities-related costs, principally
related to supporting the growth of our development team and
severance costs relating to a reduction in the workforce in the
third quarter 2017.
- G&A Expenses: General and administrative expenses
were $23.2 million for the year ended
December 31, 2017, an increase of
$4.5 million, or 24 percent, compared
to $18.7 million for the year ended
December 31, 2016. The increase was
primarily due to increases in salaries and related costs, including
stock-based compensation and facilities costs including
depreciation expense, due to an increase in headcount and expansion
of facilities in late 2016, increased legal fees, and severance
costs due to the refocusing of resources towards late-stage
programs and subsequent reduction in the workforce in the third
quarter of 2017, offset by reductions in certain professional
services.
- Net Loss: Net loss for the year ended December 31, 2017, was $64.3 million compared to a net loss of
$112.4 million for the year ended
December 31, 2016.
About Ardelyx, Inc.
Ardelyx is focused on enhancing
the way people with renal diseases are treated by developing
first-in-class medicines. Ardelyx's renal pipeline includes the
Phase 3 development of tenapanor for the treatment of
hyperphosphatemia in people with end-stage renal disease who are on
dialysis and RDX013, a potassium secretagogue program for the
potential treatment of high potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease. In
addition, Ardelyx has completed Phase 3 development of tenapanor
for the treatment of irritable bowel syndrome with constipation and
anticipates submitting a New Drug Application to the U.S. Food and
Drug Administration for this indication in the second half of 2018.
To efficiently bring its treatments to market, Ardelyx is pursing
strategic collaborations in the U.S. and other countries, with
established agreements with KHK in Japan and Fosun Pharma in China. For more information, please visit
www.ardelyx.com/ and connect with us on Twitter @Ardelyx.
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
Ardelyx's product candidates in treating the diseases and
conditions for which they are being developed; Ardelyx's expected
timing for the filing of its NDA for tenapanor for the treatment of
IBS-C, Ardelyx's expected timing to receive topline data for its
second Phase 3 clinical trial of tenapanor for the treatment of
hyperphosphatemia in patients with end-stage renal disease who are
on dialysis, the potential for Ardelyx to receive milestone and
royalty payments from Shanghai Fosun Pharmaceutical Industrial
Development and Kyowa Hakko Kirin Co., Ltd and Ardelyx's ability to
establish collaborations in the future. Such forward-looking
statements involve substantial risks and uncertainties that could
cause the development of Ardelyx's product candidates 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, including the regulatory approval process. 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 filed with the Securities and
Exchange Commission on March 14,
2018, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Ardelyx,
Inc.
|
Consolidated
Condensed Balance Sheets
|
(In
thousands)
|
|
|
|
December 31,
2017
|
|
December 31,
2016
|
|
|
(Unaudited)
|
|
(1)
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
75,383
|
|
$
74,598
|
Short-term
investments
|
|
58,593
|
|
126,225
|
Accounts
receivable
|
|
10,796
|
|
—
|
Property and
equipment, net
|
|
8,032
|
|
8,991
|
Prepaid and other
assets
|
|
5,099
|
|
3,317
|
Total
Assets
|
|
$
157,903
|
|
$
213,131
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
Accounts payable and
other current liabilities
|
|
$
17,871
|
|
$
19,201
|
Long-term
liabilities
|
|
720
|
|
779
|
Stockholders'
equity
|
|
139,312
|
|
193,151
|
Total liabilities and
stockholders' equity
|
|
$
157,903
|
|
$
213,131
|
|
|
|
|
|
(1)
Derived from the audited financial statements included on Form 10-K
for the year ended December 31, 2016.
|
Ardelyx,
Inc.
|
Consolidated
Statements of Operations
|
(In thousands,
except share and per share amounts)
|
|
|
|
|
Three Months
Ended
December
31,
|
Twelve Months
Ended
December
31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(1)
|
Revenue:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
42,000
|
|
$
—
|
|
$
42,000
|
|
$
—
|
Cost of
revenue
|
8,400
|
|
—
|
|
8,400
|
|
—
|
Gross
profit
|
33,600
|
|
—
|
|
33,600
|
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
17,159
|
|
26,210
|
|
75,484
|
|
94,161
|
General and
administrative
|
5,479
|
|
5,266
|
|
23,231
|
|
18,734
|
Total operating
expenses
|
22,638
|
|
31,476
|
|
98,715
|
|
112,895
|
Income (loss) from
operations
|
10,962
|
|
(31,476)
|
|
(65,115)
|
|
(112,895)
|
Other income,
net
|
331
|
|
200
|
|
1,955
|
|
508
|
Provision for income
taxes
|
(1,179)
|
|
—
|
|
(1,179)
|
|
—
|
Net income
(loss)
|
$
10,114
|
|
$
(31,276)
|
|
$
(64,339)
|
|
$
(112,387)
|
Net income (loss)
per common share, basic
|
$
0.21
|
|
$
(0.66)
|
|
$
(1.36)
|
|
$
(2.80)
|
Shares used in
computing net income (loss) per share - basic
|
47,528,183
|
|
47,303,494
|
|
47,435,331
|
|
40,118,522
|
Net income (loss)
per common share, diluted
|
$
0.21
|
|
$
(0.66)
|
|
$
(1.36)
|
|
$
(2.80)
|
Shares used in
computing net income (loss) per share - diluted
|
48,724,123
|
|
47,303,494
|
|
47,435,331
|
|
40,118,522
|
|
|
|
|
|
|
|
|
|
(1)
Derived from the audited financial statements included on Form 10-K
for the year ended December 31, 2016.
|
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