Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced its recent business progress and
reviewed its corporate strategy to drive continued growth. Greg
Madison, Keryx’s chief executive officer, will review this progress
as part of a live webcast of the company’s corporate presentation
at the 35th Annual J.P. Morgan Healthcare Conference on Wednesday,
January 11 at 2:30 p.m. PST (5:30 p.m. EST).
“As we enter 2017, with the successful return of Auryxia to
dialysis patients in November and the potential approval and launch
of this medicine in iron deficiency anemia, non-dialysis dependent
chronic kidney disease, we believe we are well positioned for
growth,” said Greg Madison, president and chief executive officer
of Keryx Biopharmaceuticals. “The potential expanded indication
would enable us to leverage our commercial infrastructure and
significantly increase the number of people that can potentially be
treated with Auryxia.”
Business ProgressKeryx is making important
progress toward achieving its vision to become a leading renal
company. It has generated momentum since the resupply of Auryxia
for the treatment of hyperphosphatemia in adults with chronic
kidney disease (CKD) on dialysis. In addition, the potential
approval of ferric citrate in late 2017 for the treatment of iron
deficiency anemia (IDA) in adults with non-dialysis dependent (NDD)
CKD may be a significant near-term milestone. The section below
announces the company’s recent progress toward achieving its vision
and selected preliminary unaudited fourth quarter and year-end 2016
financial results.
Auryxia Commercial Progress
- The company reported prescription demand for the fourth quarter
of 2016 was approximately 8,700 prescriptions, which included
approximately 4,500 prescriptions for the month of December, the
first full month of sales post resupply of Auryxia. This compares
to approximately 5,000 prescriptions for the month of July 2016,
the last full month of sales prior to the previously announced
supply interruption.
- Today, Keryx announced that the U.S. Food and Drug
Administration (FDA) has approved Patheon’s manufacturing facility
in France to manufacturer supply of Auryxia for the U.S. The
approval of this site provides Keryx with a third manufacturing
site for finished Auryxia drug product and provides a redundant
source to help ensure continuous supply of this medicine.
Potential Label Expansion Opportunity
- The company announced that the sNDA for Auryxia has been
submitted to the FDA seeking label expansion to include the
treatment of IDA in adults with NDD-CKD. The company will outline
its commercial plan for Auryxia, should it be approved for this
expanded indication, while attending the J.P. Morgan Healthcare
conference.
- Keryx also announced that detailed results from its pivotal
Phase 3 trial that evaluated ferric citrate for the treatment of
IDA in adults with stage 3 - 5 NDD-CKD has been submitted for
publication in a peer-reviewed scientific journal. Publication of
the data is a key component of the company’s strategy to advance
understanding of the potential importance of Auryxia to treat this
difficult disease.
- Abstracts related to clinical trials evaluating IDA, NDD-CKD
have been accepted for presentation at the International Society of
Nephrology (ISN) World Congress of Nephrology (WCN) in April 2017,
a global not-for-profit society dedicated to improving kidney care
and reducing the incidence and impact of kidney disease
worldwide.
Two New Executive Team AppointmentsToday, the company announced
that it has appointed Christine Carberry as chief operating officer
and Melissa Bradford-Klug as chief business officer, both will
report to Greg Madison. Ms. Carberry will start on January 16, 2017
and be responsible for driving a stronger focus on operational
excellence and execution. Ms. Bradford-Klug started on January 3,
2017 and is responsible for business development, corporate
strategy and alliance management for the company.
Ms. Carberry brings to Keryx approximately 30 years of biotech
and pharmaceutical leadership, including most recently as an
executive team member and senior vice president, quality, technical
operations, program and alliance management at Forum
Pharmaceuticals. Prior to Forum, Ms. Carberry spent 25 years at
Biogen and held roles of increasing responsibility, culminating as
vice president, program and alliance management. She brings
operational excellence in technical operations and strategic
development, including research, development and lifecycle
management for commercial medicines.
Ms. Bradford-Klug brings to Keryx more than 17 years of senior
strategic planning and business development experience in the life
sciences industry. Ms. Bradford-Klug joins Keryx most recently from
AMAG Pharmaceuticals where she served as senior vice president of
business development and completed multiple value adding
transactions. Prior to AMAG, she held leadership roles with
Mallinckrodt Pharmaceuticals, Baxter International and Eli Lilly
and Company.
Mr. Madison added, “I am thrilled to have Christine and Melissa
join our management team during this important time in the
evolution of our organization. With their appointments, we believe
we have the depth of expertise and the bandwidth to manage the
business operations while simultaneously seeking to build a leading
renal company. Our entire organization is excited to maximize the
potential we have with Auryxia and execute our strategic plan and
we welcome Christine and Melissa who will be instrumental in
achieving our vision.”
Preliminary Unaudited Financial DataTotal
revenues for the quarter ended December 31, 2016 are
expected to be approximately $9.5 million, compared with $5.8
million during the same period in 2015. Total revenue expectations
for the fourth quarter of 2016 consist of approximately $8.2
million in ex-factory Auryxia net U.S. product sales, compared to
$4.8 million in the fourth quarter of 2015, which were recorded
based on actual prescriptions written during the period. Total
expected revenue for the fourth quarter of 2016 also include $1.3
million in license revenues as compared to $1.0 million during the
same period in 2015.
For the year ended 2016, total revenues are expected to be
approximately $31.9 million as compared to $13.7 million in 2015.
Total expected revenues for 2016 include $27.1 million of Auryxia
net U.S. product sales and $4.8 million in license revenues as
compared to $10.1 million and $3.5 million, respectively in
2015.
Cost of goods sold for the quarter ended
December 31, 2016 are expected to be approximately $13.3 million,
compared with $1.1 million during the same period in 2015. Expected
cost of goods sold for the fourth quarter of 2016 include an
approximately $11.8 million write-off of work-in-process inventory
that was determined to no longer be suitable for commercial
manufacture. For the year ended 2016, total cost of goods sold are
expected to be approximately $37.7 million, as compared to $4.5
million in 2015. Total expected 2016 cost of goods includes
approximately $25.6 million in write-offs of work-in-process
inventory that was determined to no longer be suitable for
commercial manufacture and approximately $2.6 million related to
manufacturing charges incurred as a result of not fully utilizing
planned production at the company’s third-party drug product
manufacturers. Total 2015 cost of goods sold included $2.6 million
related to manufacturing charges incurred as a result of not fully
utilizing planned production at the company’s third-party drug
product manufacturers.
Cash and cash equivalents as of December 31,
2016 totaled approximately $112.1 million.
The preliminary unaudited financial data for the quarter and the
year ended December 31, 2016 set forth above is derived from
preliminary internal financial reports. Keryx has not yet finalized
its complete results of operations for the year ended
December 31, 2016. In connection with the finalization
of its year-end closing and reporting processes, the completion of
its financial statements for the year ended December 31, 2016
and the completion of the audit of its financial statements for the
year ended December 31, 2016, Keryx and its auditors may identify
items that would require Keryx to make adjustments, some of which
could be material, to the preliminary unaudited financial data set
forth above.
WebcastKeryx will webcast its corporate
presentation and breakout session at the 35th Annual J.P. Morgan
Healthcare Conference on Wednesday, January 11, 2017 at 2:30 p.m.
PST (5:30 p.m. EST). A link to the live webcast is available via
Keryx’s website, www.keryx.com, in the Webcasts and Presentations
section. An archived version of the presentation will be available
on Keryx’s website for 15 days following conclusion of the live
presentation.
About Iron Deficiency Anemia, NDD-CKDIron
deficiency anemia is a common complication in patients with
non-dialysis dependent chronic kidney disease (NDD-CKD), and the
prevalence and severity of IDA increases as kidney disease
progresses. It is estimated that there are approximately 1.6
million people living in the U.S. with stage 3-5 non-dialysis
dependent chronic kidney disease and iron deficiency anemia.
Efficacy and tolerability of current oral iron supplements are
mixed. Intravenous (IV) iron administration is associated with
important risks and burdens.
About Auryxia 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 CKD on dialysis. The U.S.
approval of Auryxia was based on data from the company's Phase 3
registration program in dialysis patients. 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.
Auryxia binds with dietary phosphate in the GI tract and
precipitates as ferric phosphate. The unbound portion of Auryxia
has been shown to increase serum iron parameters including ferritin
and transferrin saturation (TSAT). 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 and the U.S. full prescribing
information, visit www.Auryxia.com.
Use of ferric citrate in patients with NDD-CKD and IDA, as
highlighted above, is investigational and has not been determined
to be safe or efficacious.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric
citrate)Contraindication: Patients
with iron overload syndrome, e.g. hemochromatosis, should not take
Auryxia®.
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. Ciprofloxacin should be
taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please
visit http://auryxia.com/important-safety-information/
Forward Looking Statements Some of the
statements included in this press release, particularly those
regarding expected revenues and expenses, the
commercialization and ongoing clinical development of Auryxia and
the expected impact of the new members of management, including
those statements related to Preliminary Unaudited Year-end
Financial Data and the submission of an sNDA to
the FDA to expand the label of ferric citrate to include
the treatment of IDA in adults with stage 3-5 NDD-CKD and the
potential approval in this indication and the impact thereof on
Keryx, 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: the completion of our financial
statements for the year ended December 31, 2016 and the audit
thereof; whether we can increase adoption of Auryxia in patients
with CKD on dialysis; whether we can maintain our operating
expenses to projected levels while continuing our current clinical,
regulatory and commercial activities; whether we will able to
identify and negotiate acceptable terms with a commercialization
partner in the E.U.; whether we or a partner can successfully
launch Fexeric® in the E.U.; whether Riona® will be successfully
marketed in Japan by our Japanese partner, Japan
Tobacco, Inc. and its subsidiary Torii Pharmaceutical
Co., Ltd; the risk that the FDA may not concur with our
interpretation of our Phase 3 study results in NDD- CKD, supportive
data, conduct of the studies, or any other part of our regulatory
submission and could ultimately deny approval of ferric citrate for
the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk
that if approved for use in NDD-CKD that we may not be able to
successfully market Auryxia for use in this indication; our ability
to continue to supply Auryxia following the recent resupply to the
market; 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.
About Keryx Biopharmaceuticals, Inc.Keryx
Biopharmaceuticals, Inc., with headquarters in Boston,
Massachusetts is a commercial stage company focused on bringing
innovative medicines to people with renal disease. Keryx developed
and commercializes Auryxia® (ferric citrate), an iron-based
phosphate binder, in the U.S. Ferric citrate is marketed as
Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and
Torii Pharmaceutical Co. Ltd. In September 2015, the European
Commission granted European market authorization for Fexeric®
(ferric citrate coordination complex). Keryx has programs
underway to leverage its development and commercial infrastructure,
including evaluation of iron deficiency anemia in adults with
non-dialysis depended chronic kidney disease and
in-licensing medicines for renal disease. For more information
about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
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