The Company will host an investor conference call tomorrow, Tuesday, March 12, 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. 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 Keryx expects to submit an NDA with the FDA in the second quarter of 2013 and a MAA with the EMA in mid-2013. 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 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 Biopharmaceuticals, Inc.
Selected Consolidated Financial Data
(In Thousands, Except Share and Per Share Amounts)
Statements of Operations Information (Unaudited):
Three Months Ended December 31, Year Ended December 31, 2012
2011
2012
2011
REVENUE:
License revenue $ Â Â Â Â Â Â Â — $ Â Â Â Â Â Â — $ Â Â Â Â Â — $ Â Â Â Â Â Â 5,000 OPERATING EXPENSES:
Research and development: Â Â Â Â Non-cash compensation
150
187
662
803 Â Â Â Â Other research and development
4,753
6,676
19,369
26,209 Â Â Â Â Â Â Total research and development
4,903
6,863
20,031
27,012
General and administrative: Â Â Â Â Non-cash compensation
388
341
1,505
1,289 Â Â Â Â Other general and administrative
1,387
1,497
5,543
5,448 Â Â Â Â Â Total general and administrative
1,775
1,838
7,048
6,737
TOTAL OPERATING EXPENSES
6,678
8,701
27,079
33,749
OPERATING LOSS
(6,678)
(8,701)
(27,079)
(28,749) OTHER INCOME: Interest and other income, net
50
80
1,719
380
LOSS FROM CONTINUINGÂ Â Â Â Â OPERATIONS (6,628)
(8,621)
(25,360)
(28,369)
Gain from discontinued operations
—
246
—
246
Extraordinary gain
— — 2,639 — NET LOSS $ Â Â Â (6,628) $ Â Â (8,375) $ (22,721) $ Â Â Â Â (28,123) NET LOSS PER COMMON SHARE Â Â Â Â Â Continuing operations $ Â Â Â Â (0.09) $ Â Â Â (0.12) $ Â Â (0.36) $ Â Â Â Â Â Â (0.42) Â Â Â Â Â Discontinued operations — Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â –* — Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â –* Â Â Â Â Â Extraordinary gain — — 0.04 — Basic and diluted net loss per common share $ Â Â Â Â (0.09) $ Â Â Â (0.12) $ Â Â (0.32) $ Â Â Â Â Â Â (0.42) Â SHARES USED IN COMPUTING NETÂ Â Â Â Â Â Â Â Â Â Â LOSS PER COMMON SHARE Â Â Â Â Â Basic and Diluted 71,925,040
71,022,951
71,633,464
67,370,354 Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â –* Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â –* SHARES USED IN COMPUTING NETÂ Â Â Â Â Â Â Â Â Â Â LOSS PER COMMON SHARE