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Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2012 Financial Results



Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2012 Financial Results

Keryx to Host Investor Conference Call on Thursday, November 8, 2012 at 8:30am
EST

PR Newswire

NEW YORK, Nov. 7, 2012

NEW YORK, Nov. 7, 2012 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (NASDAQ:
KERX), a biopharmaceutical company focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of renal disease (the "Company"), today announced its results for
the third quarter ended September 30, 2012.

At September 30, 2012, the Company had cash, cash equivalents, interest
receivable, and investment securities of $20.2 million, as compared to $39.5
million at December 31, 2011. 

The net loss for the quarter ended September 30, 2012 was $5.5 million, or
$0.08 per share, compared to a net loss of $10.2 million, or $0.15 per share,
for the comparable quarter in 2011, representing a decrease in net loss of
$4.7 million.  Other research and development expenses for the third quarter
ended September 30, 2012 decreased by $4.9 million, as compared to the third
quarter of 2011, principally related to the termination of the KRX-0401
(perifosine) Phase 3 clinical development program in May 2012.  The net loss
for the third quarter ended September 30, 2012 included $0.5 million of
non-cash compensation expense related to equity incentive grants.

The net loss for the nine months ended September 30, 2012 was $16.1 million,
or $0.22 per share, compared to a net loss of $19.7 million, or $0.30 per
share, for the comparable period in 2011, representing a decrease in net loss
of $3.6 million.  Other research and development expenses for the nine months
ended September 30, 2012, decreased by $4.9 million, as compared to the
comparable period in 2011, principally related to the termination of the
KRX-0401 (perifosine) Phase 3 clinical development program in May 2012.  The
net loss for the nine months ended September 30, 2012, included a non-cash
extraordinary gain of $2.6 million related to a write-off of the contingent
equity rights liability following the termination of the license agreement for
KRX-0401 in May 2012 and $1.6 million of non-cash compensation expense related
to equity incentive grants.  The net loss for the nine months ended September
30, 2011, included license revenue of $5.0 million related to a milestone
payment from the Company's Japanese partner for Zerenex (ferric citrate),
Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd., for their commencement,
in April 2011, of a Phase 3 clinical program in Japan.

Ron Bentsur, the Company's Chief Executive Officer, said, "With the pending
completion of our long-term Phase 3 study of Zerenex as a treatment for
hyperphosphatemia in ESRD patients on dialysis, we look forward to reporting
top-line data by year-end and anticipate the NDA filing for this indication in
the first quarter of 2013.  We are also excited to have recently initiated our
Phase 2 study exploring Zerenex in the non-dialysis dependent chronic kidney
disease setting, which we believe represents a substantial potential
additional opportunity for Zerenex."  Mr. Bentsur added, "Importantly, we
believe that we have sufficient cash to take us beyond our key anticipated
clinical and regulatory milestones."

The Company will host an investor conference call tomorrow, Thursday, November
8, 2012, at 8:30am EST, to discuss the Company's third quarter financial
results and provide a business outlook for the remainder of 2012.   

In order to participate in the conference call, please call 1-877-869-3847
(U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The audio
recording of the conference call will be available for replay at
http://www.keryx.com, for a period of 15 days after the call.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an
oral, ferric iron-based compound that has the capacity to bind to phosphate
and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for
the treatment of hyperphosphatemia (elevated phosphate levels) in patients
with end-stage renal disease is being conducted pursuant to a Special Protocol
Assessment (SPA) agreement with the FDA. Zerenex is also in Phase 2
development for the management of phosphorus and iron deficiency in anemic
patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease. 
Keryx is headquartered in New York City. 

Cautionary Statement

Some of the statements included in this press release, particularly those
anticipating any clinical trials and business prospects for Zerenex (ferric
citrate) 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: our ability, and our Japanese
partner's ability, to successfully and cost-effectively complete clinical
trials for Zerenex (ferric citrate); the risk that the data (both safety and
efficacy) from the ongoing Phase 3 trials for Zerenex (ferric citrate) will
not coincide with the data analyses from previous clinical trials reported by
the Company; the risk that the data (both safety and efficacy) from the
ongoing Phase 2 study in non-dialysis dependent chronic kidney disease will be
negative or inconclusive; our ability to meet anticipated development
timelines for Zerenex due to clinical trial results, manufacturing
capabilities or other factors; 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 CONTACT:
Lauren Fischer
Director – Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com

 

 

Keryx Biopharmaceuticals, Inc.

Selected Consolidated Financial Data

(In Thousands, Except Share and Per Share Amounts)

 
Statements of Operations Information (Unaudited):
                         Three Months Ended         Nine Months Ended

                         September 30,              September 30,
                         2012          2011         2012        2011
REVENUE:
License revenue          $          -- $        --  $        -- $        5,000
OPERATING EXPENSES:
Research and
development:
     Non-cash            161           152          512         616
compensation
     Other research and  3,768         8,620        14,616      19,533
development
       Total research    3,929         8,772        15,128      20,149
and development
General and
administrative:
     Non-cash            384           320          1,117       948
compensation
     Other general and   1,213         1,263        4,156       3,951
administrative
      Total general and  1,597         1,583        5,273       4,899
administrative
TOTAL OPERATING EXPENSES 5,526         10,355       20,401      25,048
OPERATING LOSS           (5,526)       (10,355)     (20,401)    (20,048)
OTHER INCOME:
     Interest and other  51            108          1,669       300
income, net
LOSS BEFORE              (5,475)       (10,247)     (18,732)    (19,748)
EXTRAORDINARY GAIN
EXTRAORDINARY GAIN       --            --           2,639       --
NET LOSS                 $    (5,475)  $   (10,247) $  (16,093) $   (19,748)
BASIC AND DILUTED NET
LOSS PER COMMON SHARE
    Before extraordinary $    (0.08)   $    (0.15)  $    (0.26) $    (0.30)
gain
    Extraordinary gain   --            --           0.04        --
Basic and diluted net    $    (0.08)   $    (0.15)  $    (0.22) $    (0.30)
loss per common share
SHARES USED IN COMPUTING
NET LOSS PER COMMON
SHARE
     Basic and diluted   71,910,817    70,483,909   71,535,561  66,139,443

 

 

Balance Sheet Information:
                                      September 30, 2012   December 31, 2011*
                                      (unaudited)
Cash, cash equivalents, interest
receivable, and short-term investment $        20,248      $       39,470
securities
Total assets                          24,271               43,488
Accumulated deficit                   (385,980)            (369,887)
Stockholders' equity                  16,584               31,047
* Condensed from audited financial statements.

 

SOURCE Keryx Biopharmaceuticals, Inc.

Website: http://www.keryx.com
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