Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on the acquisition, development and
commercialization of pharmaceutical products for the treatment of
renal disease (the "Company"), today announced its financial
results for the fourth quarter and year ended December 31, 2013.
At December 31, 2013, the Company had cash and cash equivalents
of $55.7 million, as compared to $14.7 million at December 31,
2012. In January 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. Subsequent to
December 31, 2013, the Company completed another 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, and
also received a $10.0 million milestone payment from Japan Tobacco
Inc. ("JT") and Torii Pharmaceutical Co., Ltd. ("Torii") related to
the manufacturing and marketing approval of ferric citrate in Japan
in January 2014 from the Japanese Ministry of Health, Labour and
Welfare.
The net loss for the fourth quarter ended December 31, 2013 was
$17.7 million, or $0.21 per share, compared to a net loss of $6.6
million, or $0.09 per share, for the comparable quarter in 2012,
representing an increase in net loss of $11.1 million. For the
fourth quarter ended December 31, 2013, other research and
development expenses increased by $4.1 million, as compared to the
fourth quarter of 2012, primarily related to the Company's Zerenex
program, including costs associated with the preparation of our
Marketing Authorization Application ("MAA") submission for
ZerenexTM, and manufacturing of pre-launch inventory and capacity
expansion. Other general and administrative expenses during the
fourth quarter of 2013 increased by $3.5 million, as compared to
the fourth quarter of 2012, primarily related to pre-commercial
activities related to Zerenex. The three months ended December 31,
2013, included $4.0 million of non-cash compensation expense
related to equity incentive grants.
The net loss for the year ended December 31, 2013, was $46.7
million, or $0.58 per share, compared to a net loss of $22.7
million, or $0.32 per share, for the year ended December 31, 2012,
representing an increase in net loss of $24.0 million. In January
2013, the Company recorded license revenue of $7.0 million for a
milestone payment received from its Japanese partner for Zerenex,
JT and Torii, related to JT's January 2013 filing of a New Drug
Application ("NDA") in Japan. For the year ended December 31, 2013,
other research and development expenses increased by $13.0 million,
as compared to the year ended December 31, 2012, primarily related
to costs associated with the filing of our U.S. NDA, preparation of
our MAA, and manufacturing of pre-launch inventory. Other
general and administrative expenses for the year ended December 31,
2013, increased by $10.2 million, as compared to the year ended
December 31, 2012, primarily related to pre-commercial activities
related to Zerenex. The net loss for the year ended December
31, 2012 included a non-cash extraordinary gain of $2.6 million
related to a write-off of a contingent equity rights liability
following the termination of the license agreement for KRX-0401,
and a $1.5 million arbitration award, which was included in
interest and other income, net, resulting from a FINRA arbitration
against a broker-dealer registered with the Securities and Exchange
Commission. The year ended December 31, 2013, included $6.0 million
of non-cash compensation expense related to equity incentive
grants.
Ron Bentsur, the Company's Chief Executive Officer, commented,
"The end of last year and the early part of this year have been
very eventful for the Company. We filed our NDA for Zerenex in
August and were assigned a target PDUFA date of June 7, 2014.
Earlier this month, we marked another important regulatory
milestone with the submission of our Zerenex MAA to the European
Medicines Agency, and we have recently attracted several key hires,
each with a proven track record for the successful launch and
commercialization of renal products." Mr. Bentsur added,
"Following our recent capital raise, and the receipt of the
additional milestone payment from JT and Torii, we believe that our
financial position is strengthened and we are now well-positioned
to continue building our renal commercial organization in
preparation for a potential Zerenex launch."
The Company will host an investor conference call tomorrow,
Thursday, March 13, 2014, at 8:30am ET, to discuss the Company's
fourth quarter and year-end 2013 financial results and provide a
business outlook for 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.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition,
development and commercialization of pharmaceutical products for
the treatment of renal disease. Keryx is developing ZerenexTM
(ferric citrate coordination complex), an oral, ferric iron-based
compound. Zerenex has completed a U.S.-based Phase 3 clinical
program for the treatment of hyperphosphatemia (elevated phosphate
levels) in patients with chronic kidney disease on dialysis,
conducted pursuant to a Special Protocol Assessment agreement with
the FDA. Keryx's New Drug Application, submitted to the FDA in
2013, is currently under review and has an assigned Prescription
Drug User Fee Act (PDUFA) goal date of June 7, 2014. Keryx has
recently submitted a Marketing Authorization Application filing to
the European Medicines Agency. Zerenex has also completed a Phase 2
study in the U.S. for the management of elevated serum phosphorus
levels and iron deficiency anemia in patients with Stage 3 to 5
non-dialysis dependent chronic kidney disease. In addition, Keryx's
Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co.,
Ltd., received marketing approval of ferric citrate in Japan for
the treatment of hyperphosphatemia in patients with chronic kidney
disease on January 17, 2014. 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, regulatory
submissions and 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: the risk that the MAA will not be accepted for review by
the EMA due to deficiencies in the application or for other
reasons; 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,
and/or EMA ultimately deny approval of the U.S. NDA, and/or MAA,
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 Riona® will be successfully
launched and marketed by our Japanese partner, Japan Tobacco, Inc.
and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved
by the FDA and/or EMA, 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: |
|
|
|
|
|
|
Three
Months Ended December 31, |
Year
Ended December 31, |
|
2013 |
2012* |
2013 |
2012* |
|
(unaudited) |
|
(unaudited) |
|
REVENUE: |
|
|
|
|
|
|
|
|
|
License revenue |
$ -- |
$ -- |
$7,000 |
$ -- |
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
Research and development: |
|
|
|
|
Non-cash
compensation |
1,594 |
150 |
2,347 |
662 |
Other research and
development |
8,863 |
4,753 |
32,387 |
19,369 |
Total
research and development |
10,457 |
4,903 |
34,734 |
20,031 |
|
|
|
|
|
General and administrative: |
|
|
|
|
Non-cash
compensation |
2,399 |
388 |
3,606 |
1,505 |
Other general and
administrative |
4,883 |
1,387 |
15,743 |
5,543 |
Total
general and administrative |
7,282 |
1,775 |
19,349 |
7,048 |
|
|
|
|
|
TOTAL OPERATING
EXPENSES |
17,739 |
6,678 |
54,083 |
27,079 |
|
|
|
|
|
OPERATING LOSS |
(17,739) |
(6,678) |
(47,083) |
(27,079) |
|
|
|
|
|
OTHER INCOME: |
|
|
|
|
Interest and other income, net |
71 |
50 |
351 |
1,719 |
|
|
|
|
|
LOSS BEFORE EXTRAORDINARY
GAIN |
(17,668) |
(6,628) |
(46,732) |
(25,360) |
|
|
|
|
|
Extraordinary gain |
-- |
-- |
-- |
2,639 |
|
|
|
|
|
NET LOSS |
$ (17,668) |
$ (6,628) |
$ (46,732) |
$ (22,721) |
|
|
|
|
|
NET LOSS PER COMMON
SHARE |
|
|
|
|
Before
extraordinary gain |
$ (0.21) |
$ (0.09) |
$ (0.58) |
$ (0.36) |
Extraordinary gain |
-- |
-- |
-- |
0.04 |
Basic and diluted net loss per common
share |
$ (0.21) |
$ (0.09) |
$ (0.58) |
$ (0.32) |
|
|
|
|
|
SHARES USED IN COMPUTING
NET LOSS PER COMMON SHARE |
|
|
|
|
Basic and Diluted |
82,427,302 |
71,925,040 |
81,009,561 |
71,633,464 |
|
|
|
|
|
|
|
|
|
|
Balance Sheet
Information: |
|
December 31,
2013 |
December 31,
2012* |
|
(Unaudited) |
|
|
|
|
Cash and cash equivalents |
$55,696 |
$14,677 |
Total assets |
60,766 |
18,569 |
Accumulated deficit |
(439,340) |
(392,608) |
Stockholders' equity |
45,400 |
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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