KERX - Keryx Biopharmaceuticals Inc.

KERX - Keryx Biopharmaceuticals Inc.

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Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, engages in the acquisition, development, and commercialization of pharmaceutical products for the treatment of diabetes and cancer. The company's endocrine/renal products include Sulonex, a Phase III and Phase IV clinical stage product for the treatment of diabetic nephropathy; and Zerenex, a Phase II clinical stage product for the treatment of Hyperphosphatemia in patients with end-stage renal disease. Its oncology products include KRX-0401, a Phase II clinical stage product for the treatment of multiple forms of cancer; KRX-0402, a Phase II clinical stage product for the treatment of brain cancer; KRX-0601, a Phase II clinical stage product for the treatment of multiple forms of cancer; and KRX-0404, a pre-clinical stage product for the treatment of multiple forms of cancer. The company also develops neurology products, including KRX-0501, a pre-clinical stage product for the treatment of neurological disorders. In addition, it offers AccuminTM, a patent protected, diagnostic for the direct measurement of total and intact urinary albumin. It has strategic alliances with Alfa Wassermann S.p.A.; Collaborative Study Group; AEterna Zentaris, Inc.; Panion & BF Biotech, Inc.; Kyowa Hakko Kogyo Co., Ltd.; and AusAm Biotechnologies, Inc. for the manufacture and commercialization of its products. Keryx Biopharmaceuticals was founded in 1998. It was formerly known as Paramount Pharmaceuticals, Inc. and changed its name to Lakaro Biopharmaceuticals, Inc. in 1999. Later, the company changed its name to Keryx Biopharmaceuticals, Inc. in 2000. Keryx Biopharmaceuticals is based in New York, New York.

nice jump today. gonna keep an eye on it. financials looked kind of bad last year:

Feb 22, 2008 5:06:00 PM

NEW YORK, Feb 22, 2008 /PRNewswire-FirstCall via COMTEX News Network/ --

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.

I'm not worrried too much about the reported earnings only because they knew they were going to be spending an incredible amount of money in the R & D for Sulonex which is almost at the end of Phase 3 (hence the $21.69 target). Once it enters commercialization I think this may have some great potentional.

8-K just filed, here's the gist:

Form 8-K for KERYX BIOPHARMACEUTICALS INC

14-Mar-2008

Change in Directors or Principal Officers


Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(b) As a result of cost-cutting initiatives resulting from the recent clinical failure of Sulonex (sulodexide), Keryx Biopharmaceuticals, Inc. (the "Company") and its Chief Accounting Officer, Mark Stier, have mutually agreed that Mr. Stier will resign from the Company effective June 30, 2008.

Keryx Biopharmaceuticals Receives Nasdaq Notification
PR Newswire - April 25, 2008 5:00 PM ET

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has received notice from The NASDAQ Stock Market ("Nasdaq") stating that the Company is not in compliance with the $1.00 minimum bid price requirement for continued inclusion on the Nasdaq Global Market pursuant to Marketplace Rule 4450 (a)(5). This notification, which was received in a letter dated April 22, 2008, is a standard communication when the bid price of a Nasdaq-listed company closes below the minimum $1.00 per share requirement for 30 consecutive business days. The letter states that, in accordance with Marketplace Rule 4450(e)(2), the Company will be provided 180 calendar days to regain compliance by having the bid price of its common stock close at $1.00 per share or more for a minimum of 10 consecutive business days. The letter has no immediate effect on the listing of the Company's common stock at this time.

The Company plans to apply to transfer its listing to the Nasdaq Capital Market. If the Company's application to transfer its listing to the Nasdaq Capital Market is approved and the listing is transferred, the Company will be subject to the continued listing requirements of the Nasdaq Capital Market after such transfer, and no longer subject to the continued listing requirements of the Nasdaq Global Market. The Company's common stock will continue to trade on the Nasdaq Global Market until the transfer application has been reviewed and approved.

The Company currently meets the requirements for listing on the Nasdaq Capital Market, with the exception of the $1.00 minimum closing bid price requirement, although the Company cannot provide assurance that in the future it will continue to meet these requirements. Under the rules of the Nasdaq Capital Market, the Company would have an additional 180-calendar day compliance period through April 17, 2009 to comply with the $1.00 minimum closing bid price requirement on the Nasdaq Capital Market, provided the Company otherwise meets the continued listing requirements for the Nasdaq Capital Market.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, or ESRD. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, 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. The Company also has an 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 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: There can be no assurance that the Company will apply for inclusion on the Nasdaq Capital Market, or if so, that the Company's application for inclusion on the Nasdaq Capital Market will be approved,, or that if approved and the listing is transferred, that the Company will continue to meet the Nasdaq Capital Market listing requirements, and/or if the Company's application is denied, that the Company will satisfy Nasdaq's conditions for continued listing on the Nasdaq Global Market, that any potential appeal or hearing for a stay of delisting from the Nasdaq Global Market will be successful, or that the Company's common stock will remain listed on the Nasdaq Global Market; that the Company will complete cost- effective clinical trials or meet as anticipated the development timelines for the drug candidates in its pipeline, including Zerenex and KRX-0401, to help generate greater interest in the market for its common stock; or that the Company's stock will not be affected by 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
SOURCE Keryx Biopharmaceuticals, Inc.

http://www.keryx.com