Keryx Biopharmaceuticals Announces First Quarter 2018 Financial Results
- First quarter 2018 total revenues of
$21.7 million, including net U.S. Auryxia® (ferric citrate) product sales of $20.6 million; a 96 percent increase compared to the first quarter of 2017
- Company exchanges its convertible senior notes due 2020 in debt restructuring and financing
- Conference call today at
“I am excited to be serving as the interim CEO of Keryx – we are in the midst of the launch of Auryxia for the treatment of iron deficiency anemia in people living with CKD and are seeing early indicators of traction,” said
- Net U.S. Auryxia product sales were
$20.6 millionin the first quarter of 2018, as compared to $10.5 millionin the same quarter in 2017, representing growth of 96 percent.
- Approximately 34,600 Auryxia prescriptions were reported in the first quarter of 2018, representing 6.9 million Auryxia tablets. This compares to approximately 15,800 prescriptions and 3.4 million Auryxia tablets in the first quarter of 2017.
- The company launched Auryxia for the treatment of iron deficiency anemia in adults living with chronic kidney disease, not on dialysis, late in the fourth quarter of 2017 and is pleased with the progress in this market to date.
- The company exchanged its
$125 millionconvertible senior notes due 2020 issued in 2015 and raised an additional $10 millionin a private transaction with funds managed by The Baupost Group L.L.C. As part of the exchange, the company issued new $164.746 millionconvertible senior notes due 2021, which are convertible into shares of the company’s common stock based on a conversion price of $4.63per share, the closing price of the company’s common stock on Monday May 7, 2018, the day before we entered into the definitive agreement for the exchange. The new notes allow the company to pursue an asset-based revolving line of credit facility, for up to $40 million, as a non-dilutive financing source that could leverage the company’s growing asset base.
First Quarter Ended
“Revenue growth in the first quarter of 2018, as compared to the first quarter of 2017, was driven by an increase in Auryxia prescription and tablet demand, partially offset, by a reduction in the net price realized per tablet due to an increase in our gross-to-net adjustment,” 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 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||20,622||10,505|
|Costs and Expenses:|
|Cost of goods sold||9,601||4,273|
|Research and development||8,388||6,764|
|Selling, general and administrative||25,837||23,103|
|Total Costs and Expenses||44,503||34,929|
|Loss Before Income Taxes||(22,530||)||(22,996||)|
|Income tax (benefit) expense||(634||)||20|
|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||119,844,320||107,071,634|
Selected Consolidated Balance Sheet Data
|March 31, 2018||December 31, 2017|
|Cash and cash equivalents||60,087||93,526|
|Other current assets||11,130||11,199|
|Liabilities and Stockholders’ Deficit|
|Accounts payable and accrued expenses||44,522||45,031|
|Convertible senior notes||125,000||125,000|
Some of the statements included in this press release, particularly those regarding the commercialization of and demand for Auryxia and the potential asset-based revolving credit facility, including the expectation to close such facility and the impact it may have on us, 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 transition the chief executive role to Ms. Morrison and to a permanent chief executive; our ability to successfully negotiate and enter into definitive agreements with respect to the asset-based revolving credit facility; the risk that the borrowing base we may utilize at any one time under the asset-based revolving credit facility, if successfully entered into, may be significantly lower than the total commitment; 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 CONTACT:
Amy SullivanSenior Vice President, Corporate Affairs T: 617.466.3519; email@example.com
Source: Keryx Biopharmaceuticals, Inc.