Keryx Biopharmaceuticals, Inc. Announces First Quarter 2013 Financial Results

Keryx Biopharmaceuticals, Inc. Announces First Quarter 2013 Financial Results

Keryx to Host Investor Conference Call on Wednesday, May 8, 2013 at 8:30am EDT

PR Newswire

NEW YORK, May 7, 2013

NEW YORK, May 7, 2013 /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 first quarter ended March 31, 2013.

At March 31, 2013, the Company had cash and cash equivalents of $87.3 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 first quarter ended March 31, 2013 was $2.1 million, or
$0.03 per share, compared to a net loss of $9.1 million, or $0.13 per share,
for the comparable quarter in 2012, representing a decrease in net loss of
$7.0 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. The net loss for the first quarter
ended March 31, 2013, included $0.6 million of non-cash compensation expense
related to equity incentive grants.

Commenting on the quarter, Ron Bentsur, the Company's Chief Executive Officer,
said, "Following the announcement of top-line data, we are now focusing our
efforts and resources toward the pending NDA and MAA submissions. We are also
progressing with the U.S. Phase 2 CKD study, for which we expect to report
top-line data in the third quarter of 2013."

The Company will host an investor conference call tomorrow, Wednesday, May 8,
2013, at 8:30am EDT, to discuss the Company's first 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, conducted pursuant
to a Special Protocol Assessment (SPA) agreement with the FDA, and the New
Drug Application filing with the FDA and the Marketing Authorization
Application filing with the 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 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 March 31,
                                            2013           2012
REVENUE:
License revenue                             $ 7,000        $ --
OPERATING EXPENSES:
Research and development:
 Non-cash compensation                   191            278
 Other research and development          6,239          7,122
 Total research and development      6,430          7,400
General and administrative:
 Non-cash compensation                   390            368
 Other general and administrative        2,338          1,408
 Total general and administrative    2,728          1,776
TOTAL OPERATING EXPENSES                    9,158          9,176
OPERATING LOSS                              (2,158)        (9,176)
OTHER INCOME:
Interest and other income, net              103            62
NET LOSS                                    $ (2,055)      $ (9,114)
NET LOSS PER COMMON SHARE
Basic and diluted net loss per common share $ (0.03)       $ (0.13)
SHARES USED IN COMPUTING NET LOSS
PER COMMON SHARE
Basic and diluted                           77,990,094     71,225,006



Balance Sheet Information:
                           March 31, 2013
                                               December 31, 2012*
                           (unaudited)
Cash and cash equivalents  $      87,343  $      14,677
Total assets               $      92,549  $      18,569
Accumulated deficit        $    (394,663)   $    (392,608)
Stockholders' equity       $      83,869  $      10,494
* Condensed from audited financial statements.

SOURCE Keryx Biopharmaceuticals, Inc.

Website: http://www.keryx.com
 
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