Navigation Links
Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financial Results
Date:2/22/2008

Keryx to Host Investor Conference Call on Monday, February 25, 2008 at

8:30am EST

NEW YORK, Feb. 22 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer (the "Company"), today announced its results for the fourth quarter and year ended December 31, 2007.

At December 31, 2007, the Company had cash, cash equivalents, investment securities and interest receivable of $64.7 million, as compared to $125.6 million at December 31, 2006.

The net loss for the fourth quarter ended December 31, 2007 was $29,261,000, or $0.67 per share, compared to a net loss of $18,347,000, or $0.42 per share, for the comparable quarter in 2006, representing an increase in net loss of $10,914,000. The increase in net loss was primarily attributable to a $2,228,000 increase in research and development expenses related to the Company's Sulonex(TM) (sulodexide oral gelcap) pivotal Phase 3 and Phase 4 clinical program, a $4,372,000 increase in expenses related to KRX-0401, a $2,600,000 increase in expenses related to Zerenex, a $446,000 increase in expenses related to the Company's other clinical compounds and a $1,692,000 increase in non-cash compensation expense related to stock option and restricted stock grants.

The net loss for the year ended December 31, 2007 was $90,062,000, or $2.07 per share, compared to a net loss of $73,764,000, or $1.76 per share, for the year ended December 31, 2006, representing an increase in net loss of $16,298,000. The increase in net loss was primarily attributable to a $7,839,000 increase in research and development expenses related to the Company's Sulonex pivotal Phase 3 and Phase 4 clinical program, a $6,702,000 increase in expenses related to KRX-0401 (perifosine), a $3,294,000 increase in expenses related to Zerenex (ferric citrate) and a $1,580,000 increase in expenses related to the Company's other clinical compounds. The increase in net loss was also due to a $1,838,000 decrease in interest and other income. The increase in net loss was partially offset by a $4,252,000 decrease in non- cash compensation expense related to stock option and restricted stock grants.

Commenting on the year and the quarter, Michael S. Weiss, Keryx's Chairman and Chief Executive Officer, said, "This was an important year for the Company as we made substantial progress toward the potential commercialization of Sulonex, including: completion of the active treatment portion of the SUN- MICRO Phase 3 trial with the subsequent completion of the trial in February 2008; enrollment of over 50% of the patients required for completion of the SUN-MACRO Phase 4 trial; completion of four Independent Data Safety Monitoring Committee (DSMC) meetings surrounding the Phase 3 and Phase 4 trials culminating in the fourth quarter DSMC final review of the safety and efficacy data related to the Sulonex Phase 3 trial, at which time the DSMC again found no cogent reason to recommend that we alter or terminate the study; and the completion of our first commercial-scale manufacturing facility with final validation anticipated in 2008." Mr. Weiss, continued, "With the Phase 3 trial now complete, we anxiously await the final results from the study, and continue to target making an announcement of the top line data before the end of next month. In preparation for the potential commercial launch of Sulonex, we continue to build our internal expertise, including key hires in commercial, medical affairs, quality operations, legal and accounting. Financially, we ended the year in line with our expectations and believe that we are well- positioned for an exciting and fruitful 2008."

On Monday, February 25, 2008, at 8:30am EST, the Company will host an investor conference call during which they will provide a brief financial overview of the Company's fourth quarter and year-end 2007 financial results and business outlook for 2008.

In order to participate in the conference call, please call 1-877-874-1565 (U.S.), 1-719-325-4750 (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, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is Sulonex(TM) (sulodexide) oral gelcaps, previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, iron- based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end- stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401 (perifosine), a novel, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. 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. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release and made by our management on the conference call, particularly those anticipating future financial performance, the results of clinical trials, the business prospects for our lead drug candidates Sulonex(TM), Zerenex(TM) and KRX-0401, our growth and operating strategies and similar matters, 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 successfully complete cost-effective clinical trials or meet anticipated development timelines for the drug candidates in our pipeline, including Sulonex(TM), Zerenex(TM) and KRX-0401, due to recruitment, clinical trial results, or manufacturing capabilities; our ability to finalize the new drug application for Sulonex before year-end, even if we receive positive results from the Phase 3 study, for various reasons including the completion of necessary non-clinical studies; 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 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: 212.531.5965E-mail: lfischer@keryx.com

Keryx Biopharmaceuticals, Inc.

Selected Consolidated Financial Data

(Thousands of US Dollars, Except Share and Per Share Data)

Statements of Operations Information:

Three Months Ended Year Ended

December 31, December 31,

2007 2006 2007 2006

(unaudited) (unaudited) (audited)

REVENUE:

License revenue $163 $-- $204 $--

Diagnostic revenue -- 45 66 103

Service revenue 15 56 52 431

Other revenue 727 -- 727 --

TOTAL REVENUE 905 101 1,049 534

OPERATING EXPENSES:

Cost of diagnostics sold -- 71 38 140

Cost of services 34 92 124 390

Research and development:

Non-cash

compensation 666 298 3,574 6,504

Other research and

development 25,791 16,504 74,889 56,139

Total research and

development 26,457 16,802 78,463 62,643

Selling, general and

administrative:

Non-cash

compensation 1,893 569 7,086 8,408

Other selling,

general and

administrative 2,643 2,564 9,919 9,110

Total selling,

general and

administrative 4,536 3,133 17,005 17,518

TOTAL OPERATING EXPENSES 31,027 20,098 95,630 80,691

OPERATING LOSS (30,122) (19,997) (94,581) (80,157)

OTHER INCOME:

Interest and other

income, net 897 1,650 4,555 6,393

NET LOSS BEFORE INCOME

TAXES (29,225) (18,347) (90,026) (73,764)

Income taxes 36 -- 36 --

NET LOSS $(29,261) $(18,347) $(90,062) $(73,764)

NET LOSS PER COMMON SHARE

Basic and diluted $(0.67) $(0.42) $(2.07) $(1.76)

SHARES USED IN COMPUTING

NET LOSS PER COMMON SHARE

Basic and diluted 43,651,587 43,241,090 43,583,950 41,919,741

Balance Sheet Information:

December 31, December 31,

2007 2006*

(unaudited)

Cash, cash equivalents, interest

receivable and investment securities $64,682 $125,610

Total assets 81,061 140,313

Accumulated deficit (278,274) (188,212)

Stockholders' equity 44,422 123,821

* Condensed from audited financial statements.


'/>"/>
SOURCE Keryx Biopharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Fourth Quarter and Year-End 2007 Financial Results on Monday, February 25, at 8:30 A.M. EST
2. Keryx Biopharmaceuticals Announces Additions to Management Team
3. Keryx Biopharmaceuticals Announces Upcoming Corporate Presentations
4. Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2007 Financial Results
5. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Third Quarter 2007 Financial Results on Thursday, October 25, at 8:30 A.M. EDT
6. Keryx Biopharmaceuticals, Inc. Enters into Licensing Agreement with Japan Tobacco and Torii Pharmaceutical for Development and Commercialization of Hyperphosphatemia Drug in Japan
7. Keryx Biopharmaceuticals, Inc. Announces Conference Call to Discuss Strategic Alliance
8. Keryx Biopharmaceuticals, Inc. Announces Appointment of Michael P. Tarnok to Board of Directors
9. Keryx Biopharmaceuticals to Present at Bank of America Investment Conference
10. Webcast Alert: Transgenomic Inc. Announces Fourth Quarter 2007 Earnings Release Conference Call Webcast
11. Genta Announces Senior Management Changes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... BATH, England , February 8, 2016 ... Genetics Ltd ("Atlas Genetics" or the "Company"), the ultra-rapid Point-Of-Care ... approval to CE Mark its Chlamydia trachomatis (CT) test to ... requirements of the IVD Directive (98/79/EC), the CT test is ... --> --> The launch of the ...
(Date:2/5/2016)... DIEGO , Feb. 5, 2016 On ... region,s trusted information source for community, health and disaster ... Diego) will integrate to enhance care coordination and ... to the services they need and to better connect ... improve care.   San Diego ...
(Date:2/4/2016)...  Sangamo BioSciences, Inc. (NASDAQ: SGMO ), the ... Edward Lanphier , Sangamo,s president and chief executive officer, ... ZFP Therapeutic ® development programs and an overview ... on Thursday, February 11, 2016, at the Leerink Partners ... is being held in New York ...
(Date:2/4/2016)... MENLO PARK, Calif. , Feb. 4, 2016 /PRNewswire/ ... "Company"), a biopharmaceutical company focused on the development and commercialization ... at the 18 th Annual BIO CEO & ... a.m. EST in New York, NY . ... will provide an update on the ongoing clinical trial of ...
Breaking Biology Technology:
(Date:2/4/2016)... , Feb. 4, 2016 The field ... one of the most popular hubs of the ... and other huge studies of human microbiota, have ... few years, the microbiome space has literally exploded ... research. This report focuses on biomedical aspects ...
(Date:2/2/2016)... , Feb. 2, 2016  BioMEMS ... are primarily focused on medical screening and ... point-of-care parameters. Wearable devices that facilitate and ... freedom of movement are being bolstered through ... human biomedical signal acquisition coupled with wireless ...
(Date:2/2/2016)... 2, 2016  Based on its recent analysis ... recognizes US-based Intelligent Retinal Imaging Systems (IRIS) with ... for New Product Innovation. IRIS, a prominent cloud-based ... America , is poised to set the ... retinopathy market. The IRIS technology presents superior price-performance ...
Breaking Biology News(10 mins):