Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative therapies to market for
patients with renal disease (the "Company" or "Keryx"), today
announced its financial results for the fourth quarter and year
ended December 31, 2014. The Company ended 2014 with $85.8 million
in cash, cash equivalents, interest receivable and investment
securities. In January 2015, Keryx completed an underwritten public
offering of common stock, which provided proceeds to the Company of
approximately $118.3 million, net of underwriting discounts and
offering expenses.
Ron Bentsur, the Company's Chief Executive Officer, commented,
"I am very proud of the entire Keryx team and all that we have
accomplished. Over the course of 2014, Keryx completed the
transition from a development-stage company to a fully integrated
commercial organization, culminating with the FDA approval and
commercial launch of Auryxia™ (ferric citrate) in the United
States."
2014 Business Highlights
- Auryxia (ferric citrate) was approved by the U.S. Food and Drug
Administration (FDA) on September 5, 2014 for the control of serum
phosphorus levels in chronic kidney disease (CKD) patients on
dialysis. Keryx launched Auryxia tablets in the United States at
the end of 2014. The Company continues to work through the cycle of
formulary reviews with Medicare Part D insurance providers, and has
gained unrestricted formulary access at 6 of the top 15 Part D
health plans.
- The European review of the marketing authorization application,
seeking regulatory approval of Auryxia as a treatment for
hyperphosphatemia in patients with CKD, including dialysis- and
non-dialysis-dependent CKD, is ongoing. The Company has responded
to the European Medicine Agency's (EMA) 120-day questions and
remains on track for a mid-2015 regulatory decision from the
EMA.
- In September 2014, the Company initiated a phase 3 clinical
study of Auryxia for the treatment of iron deficiency anemia in
patients with stages 3 – 5 non-dialysis dependent CKD, who have
previously not responded to oral iron therapy. This placebo
controlled study is expected to enroll 230 patients and will
evaluate changes in hemoglobin as the primary endpoint. The
Company is on track to complete the study by the end of 2015. If
this study is successful, Keryx intends to file a supplemental new
drug application with the FDA seeking label expansion of
Auryxia.
- In May 2014, Keryx's partner in Japan, Japan Tobacco &
Torii Pharmaceutical (JT/Torii), launched ferric citrate under the
trade name Riona®. In the fourth quarter of 2014, Riona sales
in Japan grew by 46%, to 915M Yen, when compared to the third
quarter of 2014, according to Torii's reported financial
results.
- Throughout 2014 the Company experienced major growth and
transformation, building out its infrastructure and business from a
25-person development-stage biotechnology company into a 150+
person fully integrated commercial-stage specialty pharmaceutical
organization. Throughout the process, the Company strengthened
its leadership team and on January 11, 2015, it was announced that
the CEO position will be transitioned from Ron Bentsur to Greg
Madison, the Company's President and Chief Operating Officer by the
end of May 2015.
"I am very pleased to report that the U.S. launch of Auryxia is
progressing as planned, with a good reception to date from both
payers and providers," said Greg Madison, President and Chief
Operating Officer. "We are well on our way to achieving the goal of
broad unrestricted access for Part D and commercial payers within
several months."
Mr. Madison added, "We believe that we are poised for a
successful 2015 with the launch of Auryxia, the EMA regulatory
decision on our MAA expected mid-year, and the results of the phase
3 trial evaluating Auryxia as a treatment of iron deficiency anemia
in patients with pre-dialysis CKD."
Fourth Quarter and Year Ended December 31, 2014
Financial Results
At December 31, 2014, the Company had cash, cash equivalents,
interest receivable and investment securities of $85.8 million, as
compared to $55.7 million at December 31, 2013. Subsequent to
December 31, 2014, the Company completed an underwritten public
offering of common stock, which provided proceeds to the Company of
approximately $118.3 million, net of underwriting discounts and
offering expenses of approximately $8.2 million.
The net loss for the fourth quarter ended December 31, 2014 was
$40.3 million, or $0.44 per share, compared to a net loss of $17.7
million, or $0.21 per share, for the comparable quarter in 2013,
representing an increase in net loss of $22.6 million. For the
fourth quarter ended December 31, 2014, research and development
expenses decreased by $4.7 million to $5.8 million, as compared to
$10.5 million for the three months ended December 31, 2013, due
primarily to the capitalization of inventory during the fourth
quarter of 2014, as opposed to expensing the inventory-build in the
prior quarter in 2013. For the fourth quarter ended December
31, 2014, selling, general and administrative expenses increased by
$26.8 million to $34.1 million, as compared to $7.3 million for the
three months ended December 31, 2013, primarily related to a $12.6
million increase in pre-commercial/commercial activities and
associated personnel costs in preparation for the commercialization
of Auryxia and a $10.9 million increase in non-cash stock-based
compensation expense primarily related to the vesting of
milestone-based stock options and restricted shares upon the first
commercial sale of Auryxia, as well as to increased selling,
general and administrative personnel and the recording of the fair
value of equity awards granted, which are expensed over the vesting
periods of the individual awards.
The net loss for the year ended December 31, 2014 was $111.5
million, or $1.23 per share, compared to a net loss of $46.7
million, or $0.58 per share, for the comparable period in 2013,
representing an increase in net loss of $64.8 million. In
February 2014, the Company received a $10.0 million milestone
payment from its Japanese partner for ferric citrate, JT &
Torii, related to the manufacturing and marketing approval of
ferric citrate in Japan in January 2014. For the year ended
December 31, 2014, research and development expenses increased by
$16.8 million to $51.5 million, as compared to $34.7 million for
the year ended December 31, 2013, primarily due to a $12.7 million
increase in expenses associated with the manufacturing of
pre-approval inventory and the submission of our Marketing
Authorization Application (MAA) filing, a $4.0 million increase in
non-cash stock-based compensation expense primarily related to the
vesting of milestone-based equity grants upon the FDA approval of
Auryxia, as well as $5.0 million of milestone payments due to the
licensor of Auryxia related to the regulatory approvals of Auryxia
in the U.S. and Japan. Selling, general and administrative
expenses increased by $50.7 million to $70.1 million for the year
ended December 31, 2014, as compared to $19.3 million for the year
ended December 31, 2013, primarily related to a $24.3 million
increase in pre-commercial/commercial activities, including
associated personnel costs, in preparation for the
commercialization of Auryxia, and a $17.0 million increase in
non-cash stock-based compensation expense primarily related to the
vesting of milestone-based stock options and restricted shares upon
FDA approval and the first commercial sale of Auryxia, as well as
to increased selling, general and administrative personnel and the
recording of the fair value of equity awards granted, which are
expensed over the vesting periods of the individual awards.
Conference Call Information
Keryx will host an investor conference call today, February 27,
2015 at 8:00 a.m. ET to discuss financial results for the fourth
quarter and year-ended 2014, and a business outlook for 2015.
In order to participate in the conference call, please call
1-(888) 396-2320 (U.S.), 1-(774) 264-7560 (outside the U.S.),
call-in ID: KERYX.
A telephone replay will be available from approximately 11:00
a.m. ET on February 27, 2015 through midnight March 14, 2015. To
access a replay of the conference call, dial (855)
859-2056 from the United States or (404) 537-3406 for
international access. The pass code for the replay is 85542669. The
audio recording of the conference call will also be available for
replay at http://www.keryx.com, for a period of 15 days after the
call.
About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was approved by the U.S. Food and Drug
Administration on September 5, 2014 and is indicated in the U.S.
for the control of serum phosphorus levels in patients with chronic
kidney disease (CKD) on dialysis. The U.S. approval of Auryxia was
based on data from the Company's Phase 3 registration program. In
the Phase 3 clinical trials, Auryxia effectively reduced serum
phosphorus levels to within the KDOQI guidelines range of 3.5 to
5.5 mg/dL.
The ferric iron component of Auryxia binds with dietary
phosphate in the GI tract, and precipitates as ferric phosphate.
The unbound ferric iron in Auryxia has been shown to increase serum
iron parameters including ferritin and transferrin saturation
(TSAT), whereas these parameters remained relatively constant in
patients treated with active control (Renvela® and/or Phoslo®).
Iron absorption from Auryxia may lead to excessive elevations in
iron stores. Accordingly, physicians should assess and monitor iron
parameters before starting and while on Auryxia, and may need to
decrease or discontinue IV iron for these patients. The most common
adverse events for Auryxia treated patients were
gastrointestinal-related, including diarrhea, nausea, vomiting and
constipation. For more information about Auryxia, visit
www.Auryxia.com.
Auryxia™ (ferric citrate) Important Safety
Information
Contraindication: Patients with iron
overload syndrome, e.g. hemochromatosis, should not take Auryxia™
(ferric citrate).
Iron Overload: Iron absorption from
Auryxia may lead to increased iron in storage sites. Iron
parameters should be monitored prior to and while on Auryxia.
Patients receiving IV iron may require a reduction in dose or
discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental
overdose of iron containing products is a leading cause of fatal
poisoning in children under 6 years of age. Keep Auryxia away
from children as it contains iron. Call a poison control
center or your physician in case of an accidental overdose in a
child.
Patients with Gastrointestinal Bleeding or
Inflammation: Safety has not been established for
these patients.
Adverse Events: The most common adverse
events with Auryxia were diarrhea (21%), nausea (11%), constipation
(8%), vomiting (7%) and cough (6%). Gastrointestinal adverse
reactions were the most common reason for discontinuing Auryxia
(14%). Auryxia contains iron and may cause dark stools, which is
considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be
taken at least 1 hour before Auryxia.
For Full Prescribing Information for Auryxia, please
visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Keryx
Biopharmaceuticals, Inc. |
Selected Consolidated
Financial Data |
(In Thousands, Except
Share and Per Share Amounts) |
|
|
Statements of Operations
Information (Unaudited): |
|
|
Three Months
Ended December 31, |
Year
Ended December 31, |
|
2014 |
2013 |
2014 |
2013 |
REVENUE: |
|
|
|
|
License revenue |
$ 569 |
$ -- |
$ 10,825 |
$ 7,000 |
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
License expenses |
341 |
-- |
495 |
-- |
Research and development |
5,815 |
10,457 |
51,502 |
34,734 |
General and administrative |
34,050 |
7,282 |
70,057 |
19,349 |
TOTAL OPERATING
EXPENSES |
40,206 |
17,739 |
122,054 |
54,083 |
|
|
|
|
|
OPERATING LOSS |
(39,637) |
(17,739) |
(111,229) |
(47,083) |
|
|
|
|
|
OTHER INCOME: |
|
|
|
|
Interest and other income, net |
52 |
71 |
411 |
351 |
LOSS BEFORE INCOME
TAXES |
(39,585) |
(17,668) |
(110,818) |
(47,083) |
|
|
|
|
|
Income taxes |
700 |
-- |
700 |
-- |
NET LOSS |
$ (40,285) |
$ (17,668) |
$ (111,518) |
$ (46,732) |
|
|
|
|
|
NET LOSS PER COMMON
SHARE |
|
|
|
|
Basic and diluted net loss per common
share |
$ (0.44) |
$ (0.21) |
$ (1.23) |
$ (0.58) |
|
|
|
|
|
SHARES USED IN COMPUTING NET
LOSS PER COMMON SHARE |
|
|
|
|
Basic and diluted |
92,074,596 |
82,427,302 |
91,000,902 |
81,009,561 |
|
|
|
Balance Sheet
Information: |
|
|
|
December 31,
2014 |
December 31,
2013* |
|
(unaudited) |
|
Cash, cash equivalents, interest
receivable and investment securities |
$ 85,840 |
$ 55,696 |
Total assets |
$ 103,628 |
$ 60,766 |
Accumulated deficit |
$ (550,858) |
$ (439,340) |
Stockholders' equity |
$ 73,484 |
$ 45,400 |
|
|
|
* Condensed from audited financial
statements. |
|
|
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused
on bringing innovative therapies to market for patients with renal
disease. In December 2014, the Company launched its first
FDA-approved product, Auryxia (ferric citrate) for the treatment of
elevated serum phosphorus levels in patients with chronic kidney
disease on dialysis, in the United States. . In January 2014,
ferric citrate was approved for the treatment of patients with all
stages of CKD in Japan, where it is being marketed as Riona® by
Keryx's Japanese partner, Japan Tobacco Inc. and Torii
Pharmaceutical Co. Ltd. For more information about Keryx, please
visit www.keryx.com.
Cautionary Statement
Some of the statements included in this press release,
particularly those regarding the commercialization and subsequent
clinical development of Auryxia, may be forward-looking statements
that involve a number of risks and uncertainties. For those
statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. Among the factors that could cause
our actual results to differ materially are the following: whether
Auryxia will be successfully launched and marketed in the U.S.;
whether Riona® will be successfully marketed by our Japanese
partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the
risk that the EMA may not concur with our interpretation of our
Phase 3 study results, supportive data, conduct of the studies, or
any other part of our MAA submission and could ultimately deny
approval of the MAA; the risk that we may not be successful in the
development of Auryxia for the treatment of iron deficiency anemia
in non-dialysis dependent chronic kidney disease patients; and
other risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at http://www.keryx.com. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
CONTACT: KERYX CONTACT:
Amy Sullivan
Vice President, Corporate Development and Public Affairs
Tel: 617.466.3447
e-mail: amy.sullivan@keryx.com
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