Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2013 Financial Results

Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2013 Financial Results

NEW YORK, Nov. 4, 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 third quarter ended September 30, 2013.

At September 30, 2013, the Company had cash, cash equivalents and interest
receivable of $67.9 million, as compared to $14.7 million at December 31,
2012. In July 2013, the Company paid a $2.0 million New Drug Application
("NDA") user fee related to the submission of its NDA filing to the Food and
Drug Administration ("FDA"). In October 2013, the Company received a full
refund of the $2.0 million NDA user fee following its receipt of a waiver
granted under the small business waiver provision of the Federal Food, Drug,
and Cosmetic Act.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 coordination complex), Japan Tobacco Inc. ("JT") and
Torii Pharmaceutical Co., Ltd. ("Torii"), related to JT's January 2013 filing
of a 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 quarter ended September 30, 2013 was $15.7 million, or
$0.19 per share, compared to a net loss of $5.5 million, or $0.08 per share,
for the comparable quarter in 2012, representing an increase in net loss of
$10.2 million. For the third quarter ended September 30, 2013, other research
and development expenses increased by $6.6 million, as compared to the third
quarter of 2012, primarily related to the Company's Zerenex program, including
costs associated with the filing of the NDA, preparation of the Marketing
Authorization Application ("MAA") submission, and manufacturing of pre-launch
inventory and capacity expansion.The three months ended September 30, 2013,
includes a one-time $1.0 million milestone payment to the licensor of Zerenex,
related to the Company's submission of the NDA in August 2013. Other general
and administrative expenses during the third quarter of 2013 increased by $3.4
million, as compared to the third quarter of 2012, primarily related to
pre-commercial activities related to Zerenex.The three months ended September
30, 2013, included $0.7 million of non-cash compensation expense related to
equity incentive grants.

The net loss for the nine months ended September 30, 2013 was $29.1 million,
or $0.36 per share, compared to a net loss of $16.1 million, or $0.22 per
share, for the comparable period in 2012, representing an increase in net loss
of $13.0 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 nine months ended September
30, 2013, other research and development expenses increased by $8.9 million
and other general and administrative expenses increased by $6.7 million, as
compared to the nine months ended September 30, 2012, primarily related to the
regulatory filings, manufacturing of inventory, one-time milestone payment,
and pre-commercial activities discussed above. 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 (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 nine months ended September 30, 2013, included $2.0
million of non-cash compensation expense related to equity incentive grants.

Ron Bentsur, the Company's Chief Executive Officer, said, "The last few months
have been very exciting for the Company. We submitted the Zerenex NDA, which
filing has now been accepted by the FDA for review, and has been assigned a
PDUFA goal date of June 7, 2014. Additionally, we have been actively building
our commercial infrastructure with seasoned professionals in the dialysis and
chronic kidney disease therapeutic areas to support the anticipated launch in
mid-2014."

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
coordination complex), 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 chronic
kidney disease on dialysis, conducted pursuant to a Special Protocol
Assessment (SPA) agreement with the Food and Drug Administration (FDA).The
Company's New Drug Application (NDA) is currently under review by the FDA with
an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7,
2014.The Marketing Authorization Application filing with the European
Medicines Agency (EMA) is pending submission. Zerenex is also in Phase 2
development in the U.S. for the management of elevated 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, particularly those
relating to the results of clinical trials, the clinical benefits to be
derived from Zerenex (ferric citrate coordination complex), regulatory
submissions and the timing of any such review, approvals, the commercial
opportunity and competitive positioning, and any business prospects for
Zerenex, 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: acceptance of the NDA filing
represents only a preliminary evaluation of the application and is not
indicative of deficiencies that may be identified during the FDA's review; a
PDUFA goal date is subject to change and does not guarantee that the review of
the NDA will be completed on a timely basis; the risk that the FDA, EMA,
and/or the Japanese Ministry of Health, Labour and Welfare ultimately deny
approval of the U.S. NDA, MAA and/or Japanese NDA, respectively; the risk that
SPAs are not a guarantee that the FDA will ultimately approve a product
candidate following filing acceptance; whether the FDA and EMA will concur
with our interpretation of our Phase 3 study results, supportive data, or the
conduct of the studies; whether, Zerenex, if approved, will be successfully
launched and marketed; 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       Nine Months Ended
                            September 30,            September 30,
                            2013         2012        2013        2012
REVENUE:                                                       
License revenue              $--       $ --     $7,000    $--
                                                              
OPERATING EXPENSES:                                            
Research and development:                                      
Non-cash compensation       319          161         753         512
Other research and          10,351       3,768       23,524      14,616
development
Total research and          10,670       3,929       24,277      15,128
development
                                                              
General and administrative:                                    
Non-cash compensation       422          384         1,207       1,117
Other general and           4,640        1,213       10,860      4,156
administrative
Total general and           5,062        1,597       12,067      5,273
administrative
                                                              
TOTAL OPERATING EXPENSES     15,732       5,526       36,344      20,401
                                                              
OPERATING LOSS               (15,732)     (5,526)     (29,344)    (20,401)
                                                              
OTHER INCOME:                                                  
Interest and other income,  81           51          280         1,669
net
                                                              
LOSS BEFORE EXTRAORDINARY    (15,651)    (5,475)    (29,064) (18,732)
GAIN
                                                              
EXTRAORDINARY GAIN           --           --          --          2,639
                                                              
NET LOSS                     $(15,651) $ (5,475) $(29,064)  $ (16,093)
                                                              
BASIC AND DILUTED NET LOSS                                     
PER COMMON SHARE
Before extraordinary gain   $ (0.19)   $ (0.08)  $(0.36)   $(0.26)
Extraordinary gain          --           --          --          0.04
Basic and diluted net loss   $ (0.19)   $(0.08)   $(0.36)   $(0.22)
per common share
                                                              
SHARES USED IN COMPUTING NET                                   
LOSS PER COMMON SHARE
Basic and diluted           81,823,415   71,910,817  80,531,785  71,535,561


Balance Sheet Information:
                                                          
                                        September 30, 2013 December 31, 2012*
                                        (unaudited)        
Cash, cash equivalents, and interest     $67,894           $14,677
receivable
Total assets                             $75,065           $18,569
Accumulated deficit                      $(421,672)        $ (392,608)
Stockholders' equity                     $58,570           $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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