Keryx Biopharmaceuticals Announces Third Quarter 2017 Financial Results
- Company reported
$15.0 millionin third quarter 2017 total revenues, including net U.S. Auryxia® product sales of $13.6 million U.S. Food and Drug Administration( FDA) approves Auryxia® (ferric citrate) tablets as a treatment for adults with iron deficiency anemia and chronic kidney disease, not on dialysis Keryx Biopharmaceuticalsto hold a conference call for investors at 8:00 a.m. ET today to discuss its third quarter 2017 financial results and the FDAapproval
“Auryxia prescriptions grew 18 percent in the third quarter compared to the second quarter of 2017, reflecting continued adoption of Auryxia; however, this growth was offset by a change in our payer mix,” said
Third Quarter 2017 Financial Results
- Approximately 24,900 Auryxia prescriptions were written in the third quarter of 2017, representing 18 percent growth over the second quarter of 2017.
- Keryx reported third quarter 2017 net U.S. Auryxia product sales of
$13.6 million; sequential quarter prescription growth was offset by an increase in the gross-to-net adjustment due to a change in the mix of business, with greater prescription volume coming from patients with Medicare Part Dinsurance.
- Given the potential of the additional Auryxia indication on future prescription demand and the dynamics surrounding Auryxia’s payer mix, prescription demand growth and the resulting net U.S. Auryxia product sales in the third quarter, Keryx is withdrawing its 2017 financial guidance.
Recent Business Highlights
FDAapproved Auryxia for an additional indication for the treatment of iron deficiency anemia in adults with chronic kidney disease, not on dialysis. Additional information on the approval is available in a separate press release issued today by Keryx Biopharmaceuticals.
- Three abstracts related to Auryxia – one oral presentation and two poster presentations – were presented at the
American Societyof Nephrology’s (ASN) 2017 Kidney Week. The accepted abstracts are available online on the ASN conference website.
“Third quarter net U.S. product sales were lower than anticipated due to a change in the payer mix for Auryxia as well as lower-than-expected growth in prescriptions,” said
Total revenues for the quarter ended
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 Iron Deficiency Anemia in Adults with Chronic Kidney Disease, not on Dialysis
One out of every seven adults in the U.S. has chronic kidney disease. This disease carries a significant burden with complex issues requiring many different medications. A common complication of CKD is iron deficiency anemia. Iron is an essential mineral for the human body and is typically obtained from the diet. It is a critical component of human blood as it is necessary to make healthy red blood cells. People with chronic kidney disease often have anemia as a result of insufficient iron (called iron deficiency anemia) and do not produce enough hemoglobin, the component of the red blood cell that carries oxygen throughout the body. Iron deficiency anemia can negatively impact a patient’s quality of life and is associated with cardiovascular complications and increased mortality risk. Based on market research, Keryx estimates that nephrologists currently treat 650,000 people for iron deficiency anemia who have chronic kidney disease and are not on dialysis. There are estimated to be an additional 250,000 – 400,000 people under the care of a nephrologist who have chronic kidney disease and iron deficiency anemia but are not treated today. The prevalence and severity of iron deficiency anemia increases as kidney disease progresses.
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.
|Keryx Biopharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
|Nine Months Ended
|Net U.S. Auryxia product sales||$||13,597||$||5,050||$||38,218||$||18,945|
|Costs and Expenses:|
|Cost of goods sold||5,856||18,196||14,508||24,365|
|Research and development||9,275||8,674||25,051||23,320|
|Selling, general and administrative||22,746||20,521||70,835||61,518|
|Total Costs and Expenses||38,715||48,163||112,638||111,306|
Other Income (expense):
|Other income (expense), net||241||150||
|Loss Before Income Taxes||(23,478||)||(41,676||)||
|Net Loss Per Common Share|
|Basic and diluted net loss per common share||$||(0.20||)||$||(0.39||)||$||(1.18||)||$||(1.20||)|
|Shares Used in Computing Net Loss Per Common Share|
|Basic and diluted||118,992,825||105,924,106||112,928,551||105,805,669|
|Keryx Biopharmaceuticals, Inc.|
|Selected Consolidated Balance Sheet Data|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||113,999||$||111,810|
|Other current assets||$||15,571||$||3,170|
|Liabilities and Stockholders’ Equity (Deficit)|
|Accounts payable and accrued expenses||$||36,538||$||21,190|
|Convertible senior notes||$||125,000||$||125,000|
|Stockholders’ equity (deficit)||$||8,962||$||(8,296||)|
Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia 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
Senior Director, Investor Relations & Corporate Communications
Source: Keryx Biopharmaceuticals, Inc.