2014

Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2011 Financial Results Keryx to Host Investor Conference Call on Thursday, March 1, 2012 at 8:30am EST

NEW YORK, Feb. 29, 2012 /PRNewswire/ -- 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 fourth quarter and year ended December 31, 2011.

At December 31, 2011, the Company had cash, cash equivalents, interest receivable, and investment securities of $39.5 million, as compared to $28.5 million at December 31, 2010.  

The net loss for the fourth quarter ended December 31, 2011 was $8.4 million, or $0.12 per share, compared to a net loss of $5.3 million, or $0.09 per share, for the comparable quarter in 2010, representing an increase in net loss of $3.1 million.  The change in net loss in the fourth quarter of 2011, as compared to the fourth quarter of 2010, was primarily attributable to a $2.5 million increase in other research and development expenses, principally related to the KRX-0401 (perifosine) and Zerenex Phase 3 clinical programs.  The net loss for the fourth quarter ended December 31, 2011, included $0.5 million of non-cash compensation expense related to equity incentive grants.

The net loss for the year ended December 31, 2011, was $28.1 million, or $0.42 per share, compared to a net loss of $20.3 million, or $0.34 per share, for the year ended December 31, 2010, representing an increase in net loss of $7.8 million.  The change in net loss in the year ended December 31, 2011, as compared to 2010, was primarily attributable to a $12.5 million increase in other research and development expenses, principally related to the KRX-0401 (perifosine) and Zerenex Phase 3 clinical programs, partially offset by $5.0 million of license revenue in the year ended December 31, 2011, related to a milestone payment from the Company's Japanese partner for Zerenex (ferric citrate), Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd., for their commencement, in April 2011, of a Phase 3 clinical program in Japan.  The net loss for the year ended December 31, 2011, included $2.1 million of non-cash compensation expense related to equity incentive grants.

Ron Bentsur, the Company's Chief Executive Officer, commented, "During the fourth quarter of 2011, we remained focused on our three ongoing Phase 3 studies.  With the completion of our Perifosine Phase 3 study in metastatic colorectal cancer expected in March, we look forward to the top-line data release within several weeks thereafter.  With respect to Zerenex, we remain on track to complete our long-term Phase 3 study in the fourth quarter of 2012."  Mr. Bentsur added, "As we approach these important clinical data events, our financial position remains strong and we believe that we have sufficient capital to reach our key milestones."

The Company will host an investor conference call tomorrow, Thursday, March 1, 2012, at 8:30am EST, to discuss the Company's fourth quarter and year-end 2011 financial results and provide a business outlook for 2012.

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 cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement 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. 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 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 (Unaudited):



Three Months Ended December 31,

Year Ended December 31,


2011

2010

2011

2010

REVENUE:





License revenue

$               --

$            --

$     5,000

$            --






OPERATING EXPENSES:





Research and development:





    Non-cash compensation

187

238

803

1,236

    Other research and development

6,676

4,144

26,209

13,728

      Total research and development

6,863

4,382

27,012

14,964






General and administrative:





    Non-cash compensation

341

278

1,289

1,237

    Other general and administrative

1,497

1,341

5,448

5,014

     Total general and administrative

1,838

1,619

6,737

6,251






TOTAL OPERATING EXPENSES

8,701

6,001

33,749

21,215






OPERATING LOSS

(8,701)

(6,001)

(28,749)

(21,215)






OTHER INCOME:





Interest and other income, net

80

567

380

764






LOSS FROM CONTINUING  OPERATIONS

(8,621)

(5,434)

(28,369)

(20,451)






Gain from discontinued operations

246

120

246

120






NET LOSS

$    (8,375)

$  (5,314)

$ (28,123)

$ (20,331)






NET LOSS PER COMMON SHARE





    Continuing operations

$    (0.12)

$      (0.09)

$     (0.42)

$      (0.34)

    Discontinued operations

                --*  

                --*  

                --*

                --*

Basic and diluted net loss per common share

$    (0.12)

$      (0.09)

$     (0.42)

$      (0.34)


SHARES USED IN COMPUTING NET  LOSS PER COMMON SHARE





    Basic

71,022,951

61,266,886

67,370,354

58,987,854






    Diluted

71,022,951

61,266,886

67,370,354

58,987,854









Balance Sheet Information:






December 31, 2011

(Unaudited)


December 31, 2010**

Cash, cash equivalents, interest receivable




   and short-term investment securities

$           39,470


$           28,512

Total assets

43,488


32,114

Accumulated deficit

(369,887)


(341,764)

Stockholders' equity

31,047


23,248





*   Amount less than one cent.

**  Condensed from audited financial statements



SOURCE Keryx Biopharmaceuticals, Inc.



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