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2014-05-08

Keryx Biopharmaceuticals, Inc.: Keryx Biopharmaceuticals, Inc. Announces First Quarter 2014 Financial Results

Keryx to Host Conference Call Today at 8:00 am ETNEW YORK, May 8, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc.
(Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative
therapies to market for patients suffering from renal disease (the
"Company"), today announced its financial results for the first quarter ended
March 31, 2014. In the first quarter, Keryx raised approximately $107.6
million, net of underwriting discounts and offering expenses, through an
underwritten public offering of common stock, ending the quarter with $155.1
million of cash, cash equivalents, short-term investments and interest
receivable, and no debt.

"Over the past few months we have made significant strides in expanding our
leadership team and building our commercial organization to support the
launch of Zerenex(TM), pending potential approval," said Ron Bentsur, Chief
Executive Officer of Keryx. "This work, along with the progress made on
regulatory filings and clinical development, bring us closer to potentially
providing Zerenex to patients in the U.S. and Europe."

Business Highlights

* Keryx has made significant progress preparing for the potential launch of
Zerenex(TM) (ferric citrate coordination complex) in the U.S. With key
strategic staff in place, the Company has opened an office in Boston, which
will serve as the home base for its expanding commercial infrastructure.
Among a host of activities, the Company is developing a brand plan,
conducting market research, and determining sales force sizing and
territory alignment to support the launch of Zerenex late in the third
quarter, pending FDA approval.
* Important data related to Zerenex were presented in several posters and a
late-breaking oral presentation at the National Kidney Foundation's Spring
Clinical Meeting in Las Vegas in late April. The data included several
analyses of the potential pharmacoeconomic benefits of Zerenex use in
dialysis-dependent chronic kidney disease (CKD), if approved by the FDA, as
well as efficacy and safety data from a phase 2 trial of Zerenex in
non-dialysis dependent CKD patients.
* Outside of the U.S., progress was made on two important fronts: * The
European Medicines Agency (EMA) validated the Company's marketing
authorization application (MAA), which seeks the approval of Zerenex as a
treatment for hyperphosphatemia in patients with CKD, including both
dialysis and non-dialysis dependent CKD. The review is ongoing and, if
reviewed on a standard timeline, the Company would anticipate a
determination by the EMA in mid-2015. * The Company's Japanese partner,
Japan Tobacco Inc. and Torii Pharmaceutical (JT/Torii), received
manufacturing and marketing approval of ferric citrate in Japan for the
improvement of hyperphosphatemia in patients with CKD, including both
dialysis and non-dialysis dependent CKD. The Japanese launch is planned for
May 12, 2014, where it will be marketed as Riona®. Keryx will receive
royalties on net sales of Riona in Japan.
* During the quarter, Keryx also made progress on the further clinical
development of Zerenex. The Company has substantially finalized the trial
design for a phase 3 study to evaluate Zerenex for the treatment of iron
deficiency anemia in non-dialysis dependent CKD patients. Keryx plans to
initiate the phase 3 trial in the third quarter of 2014.

First Quarter Ended March 31, 2014 Financial Results

At March 31, 2014, the Company had cash, cash equivalents, short-term
investments and interest receivable of $155.1 million, as compared to $55.7
million at December 31, 2013. In January 2014, the Company completed an
underwritten public offering of common stock, which provided proceeds to the
Company of approximately $107.6 million, net of underwriting discounts and
offering expenses of approximately $7.5 million. In February 2014, the
Company received a $10.0 million milestone payment from its Japanese partner
for Zerenex, JT/Torii, related to the manufacturing and marketing approval of
ferric citrate in Japan in January 2014.

The net loss for the first quarter ended March 31, 2014 was $13.5 million, or
$0.15 per share, compared to a net loss of $2.1 million, or $0.03 per share,
for the comparable quarter in 2013, representing an increase in net loss of
$11.4 million. In January 2014, the Company recorded license revenue of $10.0
million for the milestone payment received from its Japanese partner for
Zerenex, JT&Torii, as discussed above. For the first quarter ended March 31,
2014, other research and development expenses increased by $9.3 million, as
compared to the first quarter of 2013, related to the Company's Zerenex
program, including costs associated with the manufacturing of pre-launch
inventory and capacity expansion and preparation and submission of its MAA to
the EMA. The three months ended March 31, 2014, also includes a $2.0 million
one-time milestone payment to the licensor of Zerenex, related to JT/Torii's
achievement of the Japanese marketing approval milestone in January 2014.
Other general and administrative expenses during the first quarter of 2014
increased by $3.2 million, as compared to the first quarter of 2013,
primarily related to pre-commercial activities related to Zerenex. The net
loss for the first quarter ended March 31, 2014, included $2.6 million of
non-cash compensation expense related to equity incentive grants.

Conference Call Information

Keryx will host an investor conference call today, Thursday, May 8, 2014, at
8:00am ET to discuss the Company's first quarter 2014 financial results and
provide a business outlook for the remainder of 2014.

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.

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|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, |
| 2014 2013 |
| |
|REVENUE: |
|License revenue $10,000 $7,000 |
| |
|OPERATING EXPENSES: |
|Research and development: |
|Non-cash compensation 804 191 |
|Other research and development 15,555 6,239 |
|Total research and development 16,359 6,430 |
| |
|General and administrative: |
|Non-cash compensation 1,748 390 |
|Other general and administrative 5,544 2,338 |
|Total general and administrative 7,292 2,728 |
| |
|TOTAL OPERATING EXPENSES 23,651 9,158 |
| |
|OPERATING LOSS (13,651) (2,158) |
| |
|OTHER INCOME: |
|Interest and other income, net 121 103 |
| |
|NET LOSS $ (13,530) $ (2,055) |
| |
|NET LOSS PER COMMON SHARE |
|Basic and diluted net loss per common share $(0.15) $(0.03) |
| |
|SHARES USED IN COMPUTING NET LOSS |
|PER COMMON SHARE |
|Basic and diluted 88,517,437 77,990,094 |
| |
|Balance Sheet Information: |
| March 31, 2014 December 31, 2013* |
| (unaudited) |
|Cash, cash equivalents, interest receivable, and short-term investment $155,117 $55,696 |
|securities |
|Total assets $160,325 $60,766 |
|Accumulated deficit $ (452,870) $ (439,340) |
|Stockholders' equity $143,91...

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