Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2009 Financial Results
* Reuters is not responsible for the content in this press release.
Keryx to Host Investor Conference Call on Tuesday, November 10, 2009 at 8:30am
EST
NEW YORK, Nov. 9 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(Nasdaq: KERX), a biopharmaceutical company focused on the acquisition,
development and commercialization of medically important pharmaceutical
products for the treatment of life-threatening diseases, including cancer and
renal disease (the "Company"), today announced its results for the third
quarter ended September 30, 2009.
At September 30, 2009, the Company had cash, cash equivalents, interest
receivable and investment securities of $41.0 million, as compared to $22.7
million at December 31, 2008. On September 30, 2009, the Company completed a
$20.0 million registered direct offering of common stock and warrants, which
provided proceeds to the Company of approximately $18.4 million, net of
offering costs of approximately $1.6 million which were paid subsequent to
September 30, 2009.
The net income for the third quarter ended September 30, 2009, was $0.6
million, or $0.01 per diluted share, compared to a net loss of $6.8 million,
or $0.15 per diluted share, for the third quarter in 2008. The change in net
income (loss) was primarily attributable to the recognition of $3.5 million in
other revenue, related to the settlement of a dispute with the former licensor
of Sulonex (sulodexide), in July 2009, over issues arising from the terminated
license agreement, a $1.4 million decrease in other selling, general and
administrative expenses, and a $1.4 million decrease in non-cash compensation
expense related to equity grants.
The net income for the nine months ended September 30, 2009, was $15.1
million, or $0.31 per diluted share, compared to a net loss of $49.1 million,
or $1.11 per diluted share, for the comparable period in 2008. The change in
net income (loss) was primarily attributable to a $26.9 million decrease in
research and development expenses related to the cessation of the development
of Sulonex in March 2008, a $5.4 million decrease in research and development
expenses related to KRX-0401 (perifosine), a $20.8 million increase in license
revenue related to an amendment to the September 2007 sublicense agreement
with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. (JT/Torii) which
eliminated the Company's significant ongoing obligations included in the
original agreement ($18.0 million) and a $3.0 million milestone payment from
JT/Torii earned in the first quarter of 2009, and a $3.6 million increase in
other revenue primarily related to the settlement of a dispute for $3.5
million (as discussed above).
Commenting on the quarter, Ron Bentsur, the Company's Chief Executive Officer,
remarked, "Keryx has made substantial progress in the third quarter.
Following our announcements of an SPA for the Phase 3 trial of perifosine in
multiple myeloma, and exciting long-term safety and efficacy data for Zerenex,
we solidified our balance sheet with a $20 million registered direct
offering." Mr. Bentsur added, "We believe we now have sufficient capital to
complete the Phase 3 programs for Perifosine and Zerenex, both of which are
nearing commencement."
On Tuesday, November 10, 2009, at 8:30am EST, the Company will host an
investor conference call during which they will provide a brief overview of
the Company's third quarter financial results and a business outlook for the
remainder of 2009.
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 life-threatening diseases, including cancer and renal disease.
Keryx is developing KRX-0401 (perifosine), a novel, potentially
first-in-class, oral anti-cancer agent that inhibits the phosphoinositide
3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to
induce cell growth and cell transformation. KRX-0401 has demonstrated both
safety and clinical efficacy in several tumor types, both as a single agent
and in combination with novel therapies. KRX-0401 also modulates a number of
other key signal transduction pathways, including the JNK and MAPK pathways,
which are pathways associated with programmed cell death, cell growth, cell
differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical
development for multiple tumor types, with a Phase 3 in multiple myeloma,
under Special Protocol Assessment (SPA), pending commencement by year-end.
Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based
compound that has the capacity to bind to phosphate and form non-absorbable
complexes. Zerenex has recently completed a Phase 2 clinical program as a
treatment for hyperphosphatemia (elevated phosphate levels) in patients with
end-stage renal disease, and Keryx is in the process of finalizing the U.S.
Phase 3 program for Zerenex in consultation with the FDA. 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.
Among the factors that could cause our actual results to differ materially are
the following: our ability to complete cost-effective clinical trials or meet
the projected development timelines for the drug candidates in our pipeline,
including KRX-0401 and Zerenex; or the effect on our stock value of the 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 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:
Three Months Ended Nine Months Ended
September 30, September 30,
(unaudited) (unaudited)
2009 2008 2009 2008
---- ---- ---- ----
REVENUE:
License revenue $ -- $ 327 $21,616 $ 853
Service revenue -- 41 3 103
Other revenue 3,500 -- 3,575 --
--------------------------------------------
TOTAL REVENUE 3,500 368 25,194 956
OPERATING EXPENSES:
Cost of services -- 13 -- 27
Research and development:
Non-cash compensation 388 334 950 (395)
Other research and
development 1,527 2,208 4,357 37,277
--------------------------------------------
Total research and
development 1,915 2,542 5,307 3,882
--------------------------------------------
Selling, general and
administrative:
Non-cash compensation 250 1,662 1,648 5,146
Other selling, general and
administrative 904 2,284 3,473 6,249
--------------------------------------------
Total selling, general and
administrative 1,154 3,946 5,121 11,395
--------------------------------------------
TOTAL OPERATING EXPENSES 3,069 6,501 10,428 48,304
--------------------------------------------
OPERATING INCOME (LOSS) 431 (6,133) 14,766 (47,348)
OTHER INCOME (EXPENSE):
Interest and other income
(expense), net 129 (622) 377 (1,551)
--------------------------------------------
INCOME (LOSS) FROM CONTINUING
OPERATIONS 560 (6,755) 15,143 (48,899)
Loss from discontinued operations -- (86) -- (175)
--------------------------------------------
NET INCOME (LOSS) $ 560 $(6,841) $15,143 $(49,074)
============================================
NET INCOME (LOSS) PER COMMON
SHARE
Basic $ 0.01 $ (0.15) $ 0.32 $ (1.11)
============================================
Diluted $ 0.01 $ (0.15) $ 0.31 $ (1.11)
============================================
SHARES USED IN COMPUTING NET
INCOME (LOSS) PER COMMON
SHARE
Basic 47,932,029 45,222,053 47,880,737 44,348,537
============================================
Diluted 49,028,254 45,222,053 48,326,718 44,348,537
============================================
Balance Sheet Information:
September 30, 2009 December 31, 2008*
------------------ ------------------
(unaudited)
Cash, cash equivalents, interest
Receivable and short-term
investment securities $33,687 $15,467
Long-term investment securities 7,333 7,185
Total assets 45,458 26,634
Accumulated deficit (316,775) (331,918)
Stockholders' equity (deficiency) 34,959 (1,489)
* Condensed from audited financial statements.
SOURCE Keryx Biopharmaceuticals, Inc.
Lauren Fischer, Director - Investor Relations, Keryx Biopharmaceuticals, Inc.,
+1-212-531-5965, lfischer@keryx.com
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