“We are off to a very good start in 2017 with Auryxia in the dialysis patient population,” said
Mr. Madison continued, “we look forward to important milestones over the year that would mark continued progress toward our goal of maximizing Auryxia’s potential. These include continued growth in the U.S. dialysis market, acceptance and assignment of a target review date for the supplemental new drug application submitted in January to the U.S.
FOURTH QUARTER, FULL YEAR 2016 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
Auryxia Recent Commercial Progress
Potential Label Expansion Opportunity
Fourth Quarter and Year Ended
Total revenues for the quarter ended
For the year ended 2016, total revenues were approximately
Cost of goods sold for the quarter ended
For the year ended 2016, total cost of goods sold were approximately
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Net loss for the quarter ended
Cash and cash equivalents as of
Conference Call Information
Keryx will host an investor conference call today,
About Iron Deficiency Anemia, NDD-CKD
Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. Efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens.
Auryxia (ferric citrate) was approved by the
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.
Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/
|Keryx Biopharmaceuticals, Inc.|
|Condensed Consolidated Statement of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
|Net U.S. Auryxia product sales||$||8,228||$||4,770||$||27,173||$||10,141|
|Costs and Expenses:|
|Cost of goods sold||13,437||1,075||37,803||4,520|
|Research and development||6,185||7,990||29,504||36,694|
|Selling, general and administrative||23,035||21,563||84,553||81,410|
|Total Costs and Expenses||43,440||31,236||154,746||124,748|
|Other income (expense), net||143||(12,308||)||(38,252||)||(11,987||)|
|Loss Before Income Taxes||(33,764||)||(37,761||)||(161,015||)||(123,055||)|
|Net Loss Per Common Share
Basic and diluted net loss per common share
|Shares Used in Computing Net Loss Per Common Share|
|Basic and diluted||105,962,622||105,204,495||105,845,121||103,898,399|
|Selected Consolidated Balance Sheet Data|
|December 31, 2016||December 31, 2015|
|Cash and cash equivalents||$||111,810||$||200,290|
|Liabilities and Stockholders’ (Deficit) Equity|
|Accounts payable and accrued expenses||$||21,190||$||26,795|
|Convertible senior notes, net of discount||$||125,000||$||90,773|
|Stockholders’ (deficit) equity||$||(8,296||)||$||86,934|
Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, 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: whether we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; and 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 undertake 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 found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy SullivanSenior Vice President, Corporate Affairs T: 617.466.3519 firstname.lastname@example.org Lora PikeSenior Director, Investor Relations T: 617.466.3511 email@example.com