Keryx Biopharmaceuticals Announces Fourth Quarter and Full Year 2017 Financial Results
- Fourth quarter 2017 total revenues of
$18.7 million, including net U.S. Auryxia® (ferric citrate) product sales of $17.3 million
- Full year 2017 total revenues of
$60.6 million; net U.S. Auryxia product sales more than doubled in 2017 to $55.5 million, as compared to 2016
“In 2017, we brought Auryxia to an increasing number of people with hyperphosphatemia, and with the recent approval of a second indication, we are confident we can bring Auryxia to even more patients living with chronic kidney disease in the coming years,” said
2017 Business Highlights
- Full year 2017 net U.S. Auryxia product sales were
$55.5 million, as compared to $27.2 millionfor the full year 2016, a 104 percent increase.
- Auryxia net U.S. product sales were
$17.3 millionin the fourth quarter of 2017, as compared to $8.2 millionin the same quarter in 2016.
- Approximately 30,400 Auryxia prescriptions were reported in the fourth quarter of 2017, these prescriptions represent 6.5 million Auryxia tablets. This compares to approximately 8,700 prescriptions and 1.8 million Auryxia tablets in the fourth quarter of 2016.
- Auryxia received U.S. approval for the treatment of iron deficiency anemia in adults with chronic kidney disease, not on dialysis in
November 2017and was launched in the fourth quarter.
- Following formulary access expansion in 2017, Auryxia has broad formulary coverage across
Medicare Part Dand commercial insurance providers with no restrictions. This formulary status applies to both Auryxia indications.
Fourth Quarter and Year Ended
“The strong prescription demand growth generated in the fourth quarter, coupled with the stabilization of the gross-to-net adjustment, led to
Total revenues for the quarter ended
For the year ended 2017, total revenues were approximately
Cost of goods sold for the quarter ended
Selling, general and administrative expenses for the quarter ended
Research and development expenses for the quarter ended
Net loss for the quarter ended
Cash and cash equivalents as of
Conference Call Information
About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
- Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact
Please click here to view the Full Prescribing Information for Auryxia.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|Three Months Ended
|Net U.S. Auryxia product sales||$||17,296||$||8,228||$||55,514||$||27,173|
|Costs and Expenses:|
|Cost of goods sold||7,447||13,437||21,955||37,803|
|Research and development||12,628||6,185||37,679||29,504|
|Selling, general and administrative||28,787||23,035||99,622||84,553|
|Total Costs and Expenses||49,694||43,440||162,332||154,746|
Other Income (expense):
|Other income (expense), net||288||143||
|Loss Before Income Taxes||(30,724||)||(33,764||)||
|Income tax (benefit) expense||(295||)||20||(235||
|Net Loss Per Common Share
Basic and diluted net loss per common
|Shares Used in Computing Net Loss
Per Common Share
|Basic and diluted||119,193,548||105,962,622||114,507,668||105,845,121|
Selected Consolidated Balance Sheet Data
|December 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||93,526||$||111,810|
|Other current assets||$||11,199||$||3,170|
|Liabilities and Stockholders’ Equity (Deficit)|
|Accounts payable and accrued expenses||$||45,031||$||21,190|
|Convertible senior notes||$||125,000||$||125,000|
|Stockholders’ equity (deficit)||$||(14,095||)||$||(8,296||)|
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, including statements with respect to the demand and growth of Auryxia patients, prescriptions and sales, 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 successfully market Auryxia and whether we can increase adoption of Auryxia in patients with CKD on dialysis and successfully launch Auryxia for the treatment of iron deficiency anemia in patients with chronic kidney disease, not on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; our ability to continue to supply Auryxia to the market; the risk that increased utilization by
KERYX BIOPHARMACEUTICALS CONTACTS
Senior Vice President, Corporate Affairs
Source: Keryx Biopharmaceuticals, Inc.