Navigation Links
Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2009 Financial Results
Date:11/9/2009

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.


'/>"/>
SOURCE Keryx Biopharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Third Quarter 2009 Financial Results on Tuesday, November 10, 2009 at 8:30 a.m. EST
2. Keryx Biopharmaceuticals, Inc. Announces Upcoming Poster Presentation of Zerenex (ferric citrate) for the Treatment of Hyperphosphatemia at the Upcoming American Society of Nephrology Renal Week Meeting in San Diego
3. Keryx Reports Results of Open Label Extension Study Examining Long-Term Use of Zerenex, an Iron-Based Phosphate Binder, for the Treatment of Hyperphosphatemia
4. Keryx Biopharmaceuticals Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Cancer Selected for Oral Presentation at the Eighth International Kidney Cancer Symposium
5. Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center
6. Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
7. Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
8. Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401s Activity in the Treatment of Advanced Metastatic Renal Cell Cancer
9. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
10. Keryx Biopharmaceuticals, Inc. Reports Phase 1/2 Data on KRX-0401 (Perifosine) at 50th Annual Meeting of American Society of Hematology
11. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- One of Australia,s successful biotechnology scientists, ... new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). ... list on the ASX. Noxopharm is a clinic-ready company ... Phase 1 clinical study later this year. ... biggest problems facing cancer patients - the ability of cancers to ...
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
Breaking Medicine News(10 mins):