Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2013 Financial Results

Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2013 Financial Results

Keryx to Host Investor Conference Call on Thursday, August 1, 2013 at 8:30am
EDT

NEW YORK, July 31, 2013 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2013.

At June 30, 2013, the Company had cash, cash equivalents, interest receivable,
and investment securities of $80.4 million, as compared to $14.7 million at
December 31, 2012. On January 30, 2013, the Company completed an underwritten
public offering of common stock, which provided proceeds to the Company of
approximately $74.8 million, net of underwriting discounts and offering
expenses of approximately $5.6 million. Also in January 2013, the Company
received a $7.0 million milestone payment from its Japanese partner for
Zerenex (ferric citrate), Japan Tobacco Inc. ("JT") and Torii Pharmaceutical
Co., Ltd. ("Torii"), related to JT's January 2013 filing of a New Drug
Application ("NDA") with the Japanese Ministry of Health, Labour and Welfare
for marketing approval of ferric citrate in Japan for the treatment of
hyperphosphatemia in patients with chronic kidney disease ("CKD").

The net loss for the second quarter ended June 30, 2013 was $11.4 million, or
$0.14 per share, compared to a net loss of $1.5 million, or $0.02 per share,
for the comparable quarter in 2012, representing an increase in net loss of
$9.9 million. For the second quarter ended June 30, 2013, other research and
development expenses increased by $3.2 million, as compared to the second
quarter of 2012, primarily related to our Zerenex program, including the
preparation of the NDA and Marketing Authorization Application ("MAA")
filings, and other general and administrative expenses increased by $2.3
million, as compared to the second quarter of 2012, primarily related to
pre-commercial activities related to Zerenex. The three months ended June 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 (perifosine), and a $1.5 million
arbitration award, included in interest and other income, net, resulting from
a FINRA arbitration against a broker-dealer registered with the Securities and
Exchange Commission. The three months ended June 30, 2013, included $0.6
million of non-cash compensation expense related to equity incentive grants.

The net loss for the six months ended June 30, 2013 was $13.4 million, or
$0.17 per share, compared to a net loss of $10.6 million, or $0.15 per share,
for the comparable period in 2012, representing an increase in net loss of
$2.8 million. In January 2013, the Company recorded license revenue of $7.0
million for the milestone payment received from its Japanese partner for
Zerenex, JT & Torii, as discussed above. For the six months ended June 30,
2013, other research and development expenses increased by $2.3 million and
other general and administrative expenses increased by $3.3 million, as
compared to the six months ended June 30, 2012, primarily related to the
regulatory filings and pre-commercial activities discussed above. The six
months ended June 30, 2012 included the non-cash extraordinary gain of $2.6
million and $1.5 million arbitration award, also discussed above. The six
months ended June 30, 2013, included $1.2 million of non-cash compensation
expense related to equity incentive grants.

Ron Bentsur, the Company's Chief Executive Officer, said, "Over the past few
months, we have focused much of our efforts toward the pending NDA filing,
expected shortly, which will represent a significant milestone for Keryx. In
addition, with the upcoming completion of the U.S. Phase 2 CKD study and the
MAA filing in Europe, we look forward to an eventful second half of the year."

The Company will host an investor conference call tomorrow, Thursday, August
1, 2013, at 8:30am EDT, to discuss the Company's second quarter financial
results and provide a business outlook for the remainder of 2013.

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. Keryx has completed a U.S.-based Phase 3
clinical program for Zerenex for the treatment of hyperphosphatemia (elevated
phosphate levels) in patients with end-stage renal disease on dialysis,
conducted pursuant to a Special Protocol Assessment (SPA) agreement with the
Food and Drug Administration (FDA), and the New Drug Application filing with
the FDA and the Marketing Authorization Application filing with the European
Medicines Agency (EMA) are pending submission. Zerenex is also in Phase 2
development in the U.S. for the management of phosphorus and iron deficiency
in anemic patients with Stages 3 to 5 non-dialysis dependent chronic kidney
disease. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and Torii
Pharmaceutical Co., Ltd. has filed its New Drug Application for marketing
approval of ferric citrate in Japan for the treatment of hyperphosphatemia in
patients with chronic kidney disease. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release 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.
The factors that could cause our actual results to differ materially are
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 intend 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 in our website
is not incorporated by reference into this press release and is included as an
inactive textual reference only.

Keryx Biopharmaceuticals, Inc.
Selected Consolidated Financial Data
(In Thousands, Except Share and Per Share Amounts)
                                                             
Statements of Operations Information (Unaudited):
                                                             
                        Three Months Ended June 30, Six Months Ended June 30,
                        2013         2012           2013        2012
                                                             
REVENUE:                                                      
                                                             
License revenue          $----       $----         $7,000      $----
                                                             
OPERATING EXPENSES:                                           
                                                             
Research and                                                  
development:
Non-cash compensation   243          73             434         351
Other research and      6,934        3,726          13,173      10,848
development
Total research and      7,177        3,799          13,607      11,199
development
                                                             
General and                                                   
administrative:
Non-cash compensation   395          365            785         733
Other general and       3,882        1,535          6,220       2,943
administrative
Total general and       4,277        1,900          7,005       3,676
administrative
                                                             
TOTAL OPERATING EXPENSES 11,454       5,699          20,612      14,875
                                                             
OPERATING LOSS           (11,454)     (5,699)        (13,612)    (14,875)
                                                             
OTHER INCOME:                                                 
Interest and other      96           1,556          199         1,618
income, net
                                                             
LOSS BEFORE              ($11,358)    ($4,143)       ($13,413)   ($13,257)
EXTRAORDINARY GAIN
                                                             
EXTRAORDINARY GAIN       ----         2,639          ----        2,639
                                                             
NET LOSS                 ($11,358)    ($1,504)       ($13,413)   ($10,618)
                                                             
BASIC AND DILUTED NET                              
LOSS PER COMMON SHARE
 Before extraordinary   ($0.14)      ($0.06)        ($0.17)     ($0.19)
gain
 Extraordinary gain     ----         0.04           ----        0.04
Basic and diluted net    ($0.14)      ($0.02)        ($0.17)     ($0.15)
loss per common share
                                                             
SHARES USED IN COMPUTING
NET LOSS PER COMMON                  
SHARE
 Basic and diluted      81,739,731   71,466,740     79,875,273  71,345,873
                                                             
Balance Sheet                                                 
Information:
                                    June 30, 2013             December 31,
                                                                 2012*
                                    (unaudited)               
Cash, cash equivalents,              $80,399                   $14,677
interest receivable,
and short-term                                                
investment securities
Total assets                         $85,103                   $18,569
Accumulated deficit                  ($406,021)                ($392,608)
Stockholders' equity                 $73,271                   $10,494
                                                             
* Condensed from audited financial                             
statements.

CONTACT: KERYX CONTACT:
         Lauren Fischer
         Director - Investor Relations
         Keryx Biopharmaceuticals, Inc.
         Tel: 212.531.5965
         E-mail: lfischer@keryx.com

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