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Keryx Biopharmaceuticals Announces Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

Growth in third quarter Auryxia (ferric citrate) product sales driven by increased breadth and depth of prescribers -

Keryx well positioned with strengthened cash position to support Auryxia commercialization and expansion opportunities -

BOSTON, MA

, October 29, 2015 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative therapies to market for people with renal disease, today announced its financial results for the third quarter ended September 30, 2015. The company also reviewed its commercialization progress with Auryxia, corporate mi lestones, cash position and upcoming activities, including:

Auryxia U.S. commercialization:

Auryxia prescription volume increased approximately 45 percent from second quarter to third quarter.

Potential geographic expansion:

Strong label granted for marketing authorization in E.U.; commercial strategy is to identify a partner to access the European market.

Potential label expansion:

Enrollment completed in July in Phase 3 pivotal program in pre-dialysis, iron deficiency anemia; expect to announce top-line safety and efficacy results early in the second quarter of 2016.

Financial:

Pro-forma cash position of $227.2 million at September 30, 2015.

In the third quarter, we achieved unrestricted reimbursement access to the majority of phosphate binder patients and our sales force has begun to leverage that to drive increased breadth and depth of prescribing in their target accounts, said Greg Madison, chief executive officer of Keryx. Moving forward, our top priorities are to execute on the Auryxia launch in the U.S., complete the Phase 3 pivotal study evaluating ferric citrate for the treatment of iron deficiency anemia in pre-dialysis patients, and prepare the U.S. regulatory submission seeking label expansion. All of these efforts underscore our commitment to improving the lives of patients with chronic kidney disease.

BUSINESS HIGHLIGHTS

Auryxia U.S. Commercialization

Net U.S. Auryxia product sales for the third quarter were approximately $3.2 million, based on approximately 5,350 Auryxia prescriptions.

26 percent of previously non-prescribing physicians who received a starter kit since mid-May 2015 have converted to revenue generating Auryxia prescribers.

Keryx is on track to complete its sales force expansion initiative by end of year. The expansion will enable increased reach and frequency of contact with physicians, dieticians and the entire dialysis care team.

The upcoming American Society of Nephrology, being held November 3 8, is expected to include three Auryxia-related poster presentations that provide further understanding of Auryxias safety profile, efficacy controlling serum phosphorus levels, and effect on iron parameters.

Product Expansion Opportunities

In September, Keryx announced that the European Commission approved Fexeric

(ferric citrate coordination complex) for the control of serum phosphorus levels, or hyperphosphatemia, in adults with non-dialysis and dialysis-dependent chronic kidney disease (CKD).

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Keryx announced its commercial strategy for the E.U. is to partner, either through a pan-European partnership or regional partnerships.

Dosing continues in the Phase 3 study evaluating ferric citrate in people with stages 3-5 non-dialysis dependent CKD and iron deficiency anemia, who have previously not responded or were intolerant to oral iron therapy. The company expects to complete the study in January 2016 and release top-line safety and efficacy results early in the second quarter of 2016. If this study is successful, Keryx intends to submit for approval with the FDA in the third quarter of 2016.

Corporate

Keryx added $125 million to its cash position as a result of previously announced private placement of convertible senior notes earlier this month. The company also implemented a cost reduction plan to re-align its operating expense structure.

THIRD QUARTER FINANCIAL RESULTS

We will continue to closely manage our financial profile, which has been designed to ensure we are financially strong as we work to position Auryxia as a market leader, said Scott Holmes, chief financial officer of Keryx. With our increased cash position and re-aligned cost structure, we are well positioned to take the Auryxia franchise to cash flow positive.

At September 30, 2015, the company had pro-forma cash and cash equivalents...


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