– Growth in third quarter Auryxia™ (ferric
citrate) product sales driven by increased breadth and depth of
prescribers –
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative therapies to market for
people with renal disease, today announced its financial results
for the third quarter ended September 30, 2015. The company also
reviewed its commercialization progress with Auryxia, corporate
milestones, cash position and upcoming activities, including:
- Auryxia U.S. commercialization: Auryxia
prescription volume increased approximately 45 percent from second
quarter to third quarter.
- Potential geographic expansion: Strong
label granted for marketing authorization in E.U.; commercial
strategy is to identify a partner to access the European
market.
- Potential label expansion: Enrollment
completed in July in Phase 3 pivotal program in pre-dialysis, iron
deficiency anemia; expect to announce top-line safety and efficacy
results early in the second quarter of 2016.
- Financial: Pro-forma cash position of $227.2
million at September 30, 2015.
“In the third quarter, we achieved unrestricted reimbursement
access to the majority of phosphate binder patients and our sales
force has begun to leverage that to drive increased breadth and
depth of prescribing in their target accounts,” said Greg Madison,
chief executive officer of Keryx. “Moving forward, our top
priorities are to execute on the Auryxia launch in the U.S.,
complete the Phase 3 pivotal study evaluating ferric citrate for
the treatment of iron deficiency anemia in pre-dialysis patients,
and prepare the U.S. regulatory submission seeking label expansion.
All of these efforts underscore our commitment to improve the lives
of patients with chronic kidney disease.”
BUSINESS HIGHLIGHTS
Auryxia U.S. Commercialization
- Net U.S. Auryxia product sales for the third quarter were
approximately $3.2 million, based on approximately 5,350 Auryxia
prescriptions.
- 26 percent of previously non-prescribing physicians who
received a starter kit since mid-May 2015 have converted to revenue
generating Auryxia prescribers.
- Keryx is on track to complete its sales force expansion
initiative by end of year. The expansion will enable increased
reach and frequency of contact with physicians, dieticians and the
entire dialysis care team.
- The upcoming American Society of Nephrology, being held
November 3 – 8, is expected to include three Auryxia-related poster
presentations that provide further understanding of Auryxia’s
safety profile, efficacy controlling serum phosphorus levels, and
effect on iron parameters.
Product Expansion Opportunities
- In September, Keryx announced that the European Commission
approved Fexeric® (ferric citrate coordination complex) for the
control of serum phosphorus levels, or hyperphosphatemia, in adults
with non-dialysis and dialysis-dependent chronic kidney disease
(CKD).
- Keryx announced its commercial strategy for the E.U. is to
partner, either through a pan-European partnership or regional
partnerships.
- Dosing continues in the Phase 3 study evaluating ferric citrate
in people with stages 3-5 non-dialysis dependent CKD and iron
deficiency anemia, who have previously not responded or were
intolerant to oral iron therapy. The company expects to complete
the study in January 2016 and release top-line safety and efficacy
results early in the second quarter of 2016. If this study is
successful, Keryx intends to submit for approval with the FDA in
the third quarter of 2016.
Corporate
- Keryx added $125 million to its cash position as a result of
previously announced private placement of convertible senior
notes earlier this month. The company also implemented a cost
reduction plan to re-align its operating expense structure.
THIRD QUARTER FINANCIAL RESULTS
“We will continue to closely manage our financial profile, which
has been designed to ensure we are financially strong as we work to
position Auryxia as a market leader,” said Scott Holmes, chief
financial officer of Keryx. “With our increased cash position and
re-aligned cost structure, we are well positioned to take the
Auryxia franchise to cash flow positive.”
At September 30, 2015, the company had pro-forma cash and cash
equivalents of $227.2 million.
Total revenues for the third quarter ended
September 30, 2015 were approximately $4.2 million, compared to
$0.3 million in total revenue in the third quarter of 2014. Total
revenues for the third quarter of 2015 includes the following:
- Net U.S. Auryxia product sales of $3.2 million, and
- License revenue of $1.0 million associated with royalties
received on ferric citrate net sales from Keryx's Japanese partner,
Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd during the
second quarter of 2015.
Cost of goods sold for the third quarter ended
September 30, 2015 was $3.1 million, which includes $2.6 million
related to manufacturing charges incurred as a result of not fully
utilizing planned production at certain of the company’s third
party manufacturers.
Research and development expenses for the third
quarter ended September 30, 2015 were $11.2 million compared to
$19.1 million for the three months ended September 30, 2014. The
decrease was primarily due to a $4.4 million decrease in expenses
related to the manufacturing of Auryxia, which were primarily
expensed in the comparable period in 2014 and have been capitalized
as inventory since the approval of Auryxia in September 2014.
Selling, general and administrative expenses
for the third quarter ended September 30, 2015 were $20.2 million,
as compared to $16.4 million for the three months ended September
30, 2014. The increase was primarily related to a $3.5
million increase in sales expense related to the commercialization
of Auryxia.
Net loss for the third quarter ended September
30, 2015 was $30.7 million, or $0.29 per share, compared to a net
loss of $35.3 million, or $0.38 per share, for the comparable
quarter in 2014.
2016 Financial GuidanceKeryx anticipates that
cash operating expenses in 2016 will be in the range of $87 million
to $92 million. Non-cash operating expenses and cost of goods sold
are not included in guidance. Operating expenses will be primarily
directed towards U.S. commercialization and label expansion
activities for Auryxia.
Keryx plans to provide additional full year 2016 financial
guidance, including guidance for net U.S. Auryxia product sales in
early 2016.
Conference Call Information Keryx will host an
investor conference call today, Thursday, October 29, 2015, at 8:00
a.m. ET to discuss financial results for the third quarter of 2015
and provide a review on the Auryxia launch. In order to participate
in the conference call, please call 1-(844) 253-5359 (U.S.),
1-(815) 680-5932 (outside the U.S.), call-in ID: 64671741. 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. 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/
Keryx Biopharmaceuticals, Inc. |
Selected Consolidated Statement of Operations
Data |
(In thousands, except share and per share
amounts) |
(unaudited) |
|
|
Three Months EndedSeptember
30, |
Nine Months EndedSeptember
30, |
|
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
|
|
Revenues: |
|
|
|
|
|
Net U.S. Auryxia product sales |
$ |
3,191 |
|
$ |
-- |
|
$ |
5,371 |
|
$ |
-- |
|
|
License revenue |
|
1,017 |
|
|
256 |
|
|
2,526 |
|
|
10,256 |
|
|
Total
Revenues |
|
4,208 |
|
|
256 |
|
|
7,897 |
|
|
10,256 |
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
Cost of goods sold |
|
3,065 |
|
|
-- |
|
|
3,445 |
|
|
-- |
|
|
License expenses |
|
611 |
|
|
154 |
|
|
1,516 |
|
|
154 |
|
|
Research and development |
|
11,150 |
|
|
19,053 |
|
|
28,704 |
|
|
45,687 |
|
|
Selling, general and
administrative |
|
20,205 |
|
|
16,447 |
|
|
59,847 |
|
|
36,007 |
|
|
Total Operating
Expenses |
|
35,031 |
|
|
35,654 |
|
|
93,512 |
|
|
81,848 |
|
|
|
|
|
|
|
|
Operating
Loss |
|
(30,823 |
) |
|
(35,398 |
) |
|
(85,615 |
) |
|
(71,592 |
) |
|
Other Income: |
|
|
|
|
|
Interest and other
income, net |
|
100 |
|
|
109 |
|
|
321 |
|
|
359 |
|
|
Loss Before
Income Taxes |
|
(30,723 |
) |
|
(35,289 |
) |
|
(85,294 |
) |
|
(71,233 |
) |
|
|
|
|
|
|
|
Income taxes |
|
22 |
|
|
-- |
|
|
67 |
|
|
-- |
|
|
Net
Loss |
$ |
(30,745 |
) |
$ |
(35,289 |
) |
$ |
(85,361 |
) |
$ |
(71,233 |
) |
|
|
|
|
|
|
|
Net Loss Per
Common ShareBasic and diluted net loss per common
share |
$ |
(0.29 |
) |
$ |
(0.38 |
) |
$ |
(0.83 |
) |
$ |
(0.79 |
) |
|
|
|
|
|
|
|
Shares Used in
Computing Net Loss Per Common Share |
|
|
|
|
|
Basic and diluted |
|
105,205,170 |
|
|
91,846,588 |
|
|
103,458,248 |
|
|
90,639,072 |
|
Selected Consolidated Balance Sheet Data |
(In thousands) |
(unaudited) |
|
|
September 30, 2015 |
|
December 31, 2014* |
Cash, cash equivalents,
interest receivable and investment securities |
$ |
102,208 |
|
|
$ |
85,840 |
|
Inventory |
$ |
36,705 |
|
|
$ |
7,830 |
|
Total assets |
$ |
154,654 |
|
|
$ |
103,628 |
|
|
|
|
|
|
|
|
|
Total liabilities |
$ |
33,584 |
|
|
$ |
30,144 |
|
Stockholders’
equity |
$ |
121,070 |
|
|
$ |
73,484 |
|
*Condensed from audited
financial statements. |
Forward Looking Statements Some of the
statements included in this press release, particularly those
regarding the commercialization and ongoing clinical development of
Auryxia and our expected cash operating expenses, 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 marketed in the
U.S.; whether we can successfully obtain additional reimbursement
coverage for Auryxia; whether we can adjust our operating expenses
to projected levels while maintaining our current clinical 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 Torii Pharmaceutical
Co., Ltd; 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.
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
control of elevated serum phosphorus levels, or hyperphosphatemia,
in patients with chronic kidney disease (CKD) 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. In September
2015, the European Commission granted European market authorization
for Fexeric® (ferric citrate coordination complex) for the control
of hyperphosphatemia in adults with non-dialysis and
dialysis-dependent chronic kidney disease. For more information
about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Corporate Development and Public 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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