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 first quarter ended March
31, 2015.
"With the first full quarter of launch behind us, we have made
great progress in securing formulary wins for Auryxia™ (ferric
citrate), which is a critical catalyst for future success," said
Greg Madison, Chief Executive Officer of Keryx. "Today, I am
pleased to report that over the past two months, we have achieved
two additional Medicare Part D formulary wins, with approvals now
at 8 of the top 15 Part D plans, we have made significant progress
since launch and are advancing towards our goal of 80% unrestricted
access."
First Quarter 2015 Business Highlights
- For the quarter ended March 31, 2015, Keryx reported total
revenue of approximately $1.2 million, including net U.S. Auryxia
product revenue and license revenue associated with royalties
received on sales of Riona® (ferric citrate) in Japan. The Company
recognized U.S. product sales based on 1,218 prescriptions filled
for Auryxia during the quarter, based on data received from IMS
Health and specialty pharmacies that don't report data to IMS,
including Davita Rx and Fresenius Rx.
- 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. Keryx ended the first quarter with $168.8
million in cash and cash equivalents. Additionally, the Company
ended the first quarter with approximately $27.2 million of
inventory on its consolidated balance sheet, primarily consisting
of Auryxia active pharmaceutical ingredient.
- The Company is seeking to expand the indication for Auryxia to
include the treatment of iron deficiency anemia in patients with
stages 3 – 5 non-dialysis dependent chronic kidney disease (CKD),
who have previously not responded to oral iron therapy. Keryx
initiated a phase 3 study for this target indication in September
2014 and this study is now more than 70% enrolled. 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.
- The European review of the marketing authorization application
(MAA), seeking regulatory approval of Auryxia as a treatment for
hyperphosphatemia in patients with CKD, including dialysis- and
non-dialysis-dependent CKD, is ongoing. In January, the Company
responded to the European Medicine Agency's (EMA) 120-day
questions. In April, Keryx requested a 2-month extension to provide
adequate time to respond to the final questions from the EMA and
expects a mid-2015 opinion from the Committee for Medicinal
Products for Human Use (CHMP) and subsequent regulatory approval
from the EMA.
First Quarter Ended March 31, 2015 Financial
Results
At March 31, 2015, the Company had cash and cash equivalents of
$168.8 million. In January 2015, 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 first quarter ended March 31, 2015 was
$27.7 million, or $0.28 per share, compared to a net loss of $13.5
million, or $0.15 per share, for the comparable quarter in 2014,
representing an increase in net loss of $14.2 million. In the
first quarter ended March 31, 2015, the Company recognized total
revenue of approximately $1.2 million, which included net U.S.
Auryxia product revenue of $422,000 and license revenue of $753,000
associated with royalties received on ferric citrate sales in
Japan. The first quarter ended March 31, 2014 included $10.0
million of license revenue related to a non-refundable milestone
payment for the achievement of marketing approval in Japan by our
partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd (JT
and Torii). The net loss for the first quarter ended March 31,
2015 included $4.3 million of stock-based compensation related to
the recording of the fair value of equity awards granted.
For the first quarter ended March 31, 2015, research and
development expenses decreased by $6.8 million to $9.6 million, as
compared to $16.4 million for the three months ended March 31,
2014. The change was due to a $2.9 million decrease in
regulatory and clinical study expenses related to Auryxia and a
$3.8 million decrease in expenses related to the manufacturing of
Auryxia, which were expensed in the comparable period in 2014 and
primarily capitalized as inventory following the approval of
Auryxia in September 2014. The three months ended March 31, 2015
included $2.0 million of expenses for medical affairs activities,
as the medical affairs group will increasingly be supporting
additional research and development of Auryxia in the post-approval
setting and, therefore, the associated costs are included in
research and development expenses as of January 2015. The three
months ended March 31, 2014, included a $2.0 million one-time
milestone payment to the licensor of Auryxia for JT and Torii's
achievement of the Japanese marketing approval milestone in January
2014.
For the first quarter ended March 31, 2015, selling, general and
administrative expenses increased by $11.6 million to $18.9
million, as compared to $7.3 million for the three months ended
March 31, 2014. The increase was primarily related to a $10.2
million increase in commercial activities and associated personnel
costs related to the commercialization of Auryxia, which included a
$1.7 million increase in associated stock-based compensation
expense related to the recording of the fair value of equity awards
granted.
Conference Call Information
Keryx will host an investor conference call today, Monday, May
4, 2015, at 8:00 a.m. ET to discuss financial results for the first
quarter 2015 and provide an update on the Auryxia launch. 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. The
call will also be webcast with slides, which will be accessible
through the Investors section of the Company's website at
www.keryx.com. The audio replay will be available 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.
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), 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.
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 we can successfully obtain reimbursement coverage for
Auryxia; whether Riona® will be successfully marketed in Japan 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.
Keryx
Biopharmaceuticals, Inc. Selected Consolidated
Financial Data (In Thousands, Except Share and Per
Share Amounts) |
Statements of Operations Information
(Unaudited): |
|
|
|
Three Months
Ended March 31, |
|
2015 |
2014 |
REVENUES: |
|
|
Product revenue, net |
$ 422 |
$ -- |
License revenue |
753 |
10,000 |
TOTAL REVENUES |
1,175 |
10,000 |
|
|
|
OPERATING EXPENSES: |
|
|
Cost of goods sold |
76 |
-- |
License expenses |
452 |
-- |
Research and development |
9,591 |
16,359 |
Selling, general and
administrative |
18,880 |
7,292 |
TOTAL OPERATING
EXPENSES |
28,999 |
23,651 |
|
|
|
OPERATING LOSS |
(27,824) |
(13,651) |
|
|
|
OTHER INCOME: |
|
|
Interest and other income, net |
107 |
121 |
LOSS BEFORE INCOME
TAXES |
(27,717) |
(13,530) |
|
|
|
Income taxes |
22 |
-- |
NET LOSS |
$ (27,739) |
$ (13,530) |
|
|
|
NET LOSS PER COMMON
SHARE |
|
|
Basic and diluted net loss per common
share |
$ (0.28) |
$ (0.15) |
|
|
|
SHARES USED IN COMPUTING NET
LOSS PER COMMON SHARE |
|
|
Basic and diluted |
100,553,490 |
88,517,437 |
|
|
|
Balance Sheet
Information: |
|
|
|
March 31, 2015
(unaudited) |
December 31, 2014* |
Cash, cash equivalents,
interest receivable and investment securities |
$ 168,836 |
$ 85,840 |
Inventory |
27,242 |
7,830 |
Total assets |
205,719 |
103,628 |
Deferred revenue |
714 |
414 |
Accumulated deficit |
(578,597) |
(550,858) |
Stockholders' equity |
168,542 |
73,484 |
* Condensed from audited financial statements.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices in New York and Boston,
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.
CONTACT: Amy Sullivan
Vice President, Corporate Development and Public Affairs
Tel: 617.466.3447
e-mail: amy.sullivan@keryx.com
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