Auryxia
®
(ferric citrate)
Commercial Progress
On January 8, 2017, Keryx reported prescription demand for Auryxia for the fourth quarter of 2016 was
approximately 8,700 prescriptions, which included 4,500 prescriptions for the month of December, the first full month of sales post resupply of Auryxia following the previously announced supply interruption. This compares to approximately 5,000
prescriptions for the month of July 2016, the last full month of sales prior to the interruption.
Keryx also announced that the U.S. Food
and Drug Administration (FDA) has approved Patheons manufacturing facility in France to manufacturer supply of Auryxia for the United States. The approval of this site provides Keryx with a third manufacturing site for finished
Auryxia drug product.
Submission of Supplemental New Drug Application
On January 8, 2017, Keryx also announced that it submitted a supplemental new drug application to the FDA seeking to expand the label of
ferric citrate to include the treatment of iron deficiency anemia in adults with stage
3-5
non-dialysis
dependent chronic kidney disease.
Preliminary Unaudited Financial Data
On
January 8, 2017, Keryx announced the following preliminary unaudited financial data for the quarter and year ended December 31, 2016:
Total
revenues
for the quarter ended December 31, 2016 are expected to be approximately $9.5 million, compared with $5.8 million during the same period in 2015. Total revenue expectations for the fourth quarter of 2016 consist of
approximately $8.2 million in
ex-factory
Auryxia net U.S. product sales, compared to $4.8 million in the fourth quarter of 2015, which were recorded based on actual prescriptions written during the
period. Total expected revenues for the fourth quarter of 2016 also include $1.3 million in license revenues as compared to $1.0 million during the same period in 2015.
For the year ended 2016, total revenues are expected to be approximately $31.9 million as compared to $13.7 million in 2015. Total expected revenues
for 2016 include $27.1 million of Auryxia net U.S. product sales and $4.8 million in license revenues as compared to $10.1 million and $3.5 million, respectively, in 2015.
Cost of goods sold
for the quarter ended December 31, 2016 are expected to be approximately $13.3 million, compared with $1.1 million
during the same period in 2015. Expected cost of goods sold for the fourth quarter of 2016 include an approximately $11.8 million
write-off
of
work-in-process
inventory that was determined to no longer be suitable for commercial manufacture. For the year ended 2016, total cost of goods sold are expected to be approximately $37.7 million, as
compared to $4.5 million in 2015. Total expected 2016 cost of goods sold includes approximately $25.6 million in write-offs of
work-in-process
inventory that
was determined to no longer be suitable for commercial manufacture and approximately $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the companys third-party drug product
manufacturers. Total 2015 cost of goods sold included $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the companys third-party drug product manufacturers.
Cash and cash equivalents
as of December 31, 2016 totaled approximately $112.1 million.
The preliminary unaudited financial data for the quarter and the year ended December 31, 2016 set forth above is derived from preliminary
internal financial reports. Keryx has not yet finalized its complete results of operations for the year ended December 31, 2016. In connection with the finalization of its
year-end
closing and reporting
processes, the completion of its financial statements for the year ended December 31, 2016 and the completion of the audit of its financial statements for the year ended December 31, 2016, Keryx and its auditors may identify items that
would require Keryx to make adjustments, some of which could be material, to the preliminary unaudited financial data set forth above.