Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
kidney disease, today announced its financial results for the
quarter ended September 30, 2017. The company also reviewed its
progress with Auryxia, upcoming milestones, and withdrew its 2017
financial guidance.
“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 Greg Madison, president and chief
executive officer of Keryx Biopharmaceuticals. “Our confidence in
Auryxia remains strong with brand awareness and clinical experience
expanding. With the approval of Auryxia for the treatment of
iron deficiency anemia in patients with chronic kidney disease, not
on dialysis, we are thrilled to have the opportunity to now make
Auryxia available to millions of people in the United States living
with this condition. With a medicine that can treat two
complications of chronic kidney disease, we believe we have a
strong foundation from which to build a leading kidney care
company.”
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 D insurance.
- 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
- The FDA approved 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 Society
of Nephrology’s (ASN) 2017 Kidney Week. The accepted
abstracts are available online on the ASN conference website.
Third Quarter September 30, 2017
Financial Results“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 Scott Holmes, senior vice president and chief financial
officer of Keryx Biopharmaceuticals. “The growth in Medicare Part D
prescriptions, aided by the two large payer contracts added in
March and June of this year, outpaced growth in the remainder of
the business, leading to a faster acceleration in our gross-to-net
adjustment than anticipated. The broad payer coverage across
Medicare Part D and commercial plans we have today is critical to
continued adoption of Auryxia for the treatment of
hyperphosphatemia and positions us well in terms of access for
those patients with iron deficiency anemia and chronic kidney
disease, not on dialysis.”
Total revenues for the quarter
ended September 30, 2017 were $15.0 million, compared with $6.3
million during the same period in 2016. Total revenues for the
third quarter of 2017 include $13.6 million in net U.S. Auryxia
product sales, compared to $5.1 million in the third quarter of
2016. Total revenues also include $1.4 million in license revenue
during the third quarter of 2017 and $1.3 million in the third
quarter of 2016.
Cost of goods sold for the
quarter ended September 30, 2017 were $5.9 million, compared with
$18.2 million during the same period in 2016.
Selling, general and administrative
expenses for the quarter ended September 30, 2017 were
$22.7 million, as compared to $20.5 million during the same period
in 2016. The increase was related to the continued
commercialization of Auryxia, and preparations for Auryxia’s launch
in iron deficiency anemia.
Research and development
expenses for the quarter ended September 30, 2017 were
$9.3 million, as compared to $8.7 million during the same period in
2016. The increase was primarily related to manufacturing and
clinical activities to support the long-term growth of Auryxia.
Net loss for the quarter ended
September 30, 2017 was $23.5 million, or $0.20 per share, compared
to a net loss of $41.7 million, or $0.39 per share, for the
comparable period in 2016.
Cash and cash equivalents as of
September 30, 2017 totaled $114.0 million compared to $111.8
million as of December 31, 2016.
Conference Call
InformationKeryx Biopharmaceuticals will host an investor
conference call today at 8:00 a.m. ET to discuss financial
results for the third quarter of 2017 and the FDA approval of
Auryxia for the treatment of iron deficiency anemia in patients
with chronic kidney disease, not on dialysis. To participate in the
conference call, please call 1-(888) 396-2320 (U.S.), 1-(774)
264-7560 (outside the U.S.), call-in ID: 2193619. The call will
also be webcast with slides, which will be accessible through the
Investors section of the company's website at www.keryx.com. The
audio replay will be available at http://www.keryx.com for
approximately 15 days after the call.
About Iron Deficiency Anemia in Adults
with Chronic Kidney Disease, not on DialysisOne 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)
tabletsAuryxia (ferric citrate) was approved by the U.S.
Food and Drug Administration on September 5, 2014 for the control
of serum phosphorus levels in adults with chronic kidney
disease on dialysis and approved on November 6, 2017 for the
treatment of iron deficiency anemia in adults with chronic
kidney disease not on dialysis. Auryxia tablets were designed to
contain 210 mg of ferric iron, equivalent to 1 gram of ferric
citrate, and offers convenient mealtime dosing. The starting dose
of Auryxia for the treatment of hyperphosphatemia for patients on
dialysis is six tablets per day (two per meal) and for the
treatment of iron deficiency anemia in patients not on dialysis is
three tablets per day (one per meal). For more information about
Auryxia and the U.S. full prescribing information, please visit
www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR
AURYXIA® (ferric citrate)
CONTRAINDICATION
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.
ADVERSE REACTIONS
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%)
SPECIFIC POPULATIONS
- 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
Keryx Biopharmaceuticals at 1-844-445-3799.
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) |
(unaudited) |
|
|
|
Three Months
EndedSeptember 30, |
|
Nine Months Ended September
30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
Net U.S.
Auryxia product sales |
|
$ |
13,597 |
|
$ |
5,050 |
|
$ |
38,218 |
|
$ |
18,945 |
|
License
revenue |
|
|
1,399 |
|
|
1,287 |
|
|
3,741 |
|
|
3,505 |
|
Total
Revenues |
|
|
14,996 |
|
|
6,337 |
|
|
41,959 |
|
|
22,450 |
|
|
|
|
|
|
|
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 |
|
License
expense |
|
|
838 |
|
|
772 |
|
|
2,244 |
|
|
2,103 |
|
Total Costs and
Expenses |
|
|
38,715 |
|
|
48,163 |
|
|
112,638 |
|
|
111,306 |
|
|
|
|
|
|
|
Operating Loss |
|
|
(23,719 |
) |
|
(41,826 |
) |
|
(70,679 |
) |
|
(88,856 |
) |
Other Income
(expense): |
|
|
|
|
|
Other income (expense),
net |
|
|
241 |
|
|
150 |
|
|
(62,272 |
) |
|
(38,395 |
) |
Loss Before
Income Taxes |
|
|
(23,478 |
) |
|
(41,676 |
) |
|
(132,951 |
) |
|
(127,251 |
) |
|
|
|
|
|
|
Income taxes |
|
|
20 |
|
|
20 |
|
|
60 |
|
|
60 |
|
Net
Loss |
|
$ |
(23,498 |
) |
$ |
(41,696 |
) |
$ |
(133,011 |
) |
$ |
(127,311 |
) |
|
|
|
|
|
|
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 |
(In thousands) |
(unaudited) |
|
|
|
September 30, 2017
|
|
December 31, 2016
|
Assets |
|
|
|
|
Cash and cash
equivalents |
|
$ |
113,999 |
|
$ |
111,810 |
|
Accounts
receivable |
|
$ |
9,198 |
|
$ |
5,236 |
|
Inventory |
|
$ |
26,010 |
|
$ |
12,681 |
|
Other current
assets |
|
$ |
15,571 |
|
$ |
3,170 |
|
Total assets |
|
$ |
173,822 |
|
$ |
141,427 |
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity (Deficit) |
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
36,538 |
|
$ |
21,190 |
|
Convertible senior
notes |
|
$ |
125,000 |
|
$ |
125,000 |
|
Total liabilities |
|
$ |
164,860 |
|
$ |
149,723 |
|
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 Medicare Part D
subscribers will increase our gross-to-net adjustment greater than
we anticipate; 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.
About Keryx Biopharmaceuticals,
Inc.
Keryx Biopharmaceuticals, Inc., with
headquarters in Boston, Massachusetts, is focused on the
development and commercialization of innovative medicines that
provide unique and meaningful advantages to people with kidney
disease. The Keryx team consists of approximately 200 committed
people working with passion to advance the care of people with this
complex disease. This dedication has resulted in two FDA-approved
indications for Keryx’s first medicine, Auryxia® (ferric citrate)
tablets. For more information about Keryx, please visit
www.keryx.com.
INVESTORS:KERYX BIOPHARMACEUTICALS
CONTACTSAmy SullivanSenior Vice President, Corporate
AffairsT: 617.466.3519amy.sullivan@keryx.com
Lora PikeSenior Director, Investor Relations & Corporate
CommunicationsT: 617.466.3511lora.pike@keryx.com
MEDIA:SALUTEMLindsay CangemiT:
312-240-3379Lindsay.cangemi@salutemcomms.com
Keryx Biopharmaceuticals, Inc. (delisted) (NASDAQ:KERX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Keryx Biopharmaceuticals, Inc. (delisted) (NASDAQ:KERX)
Historical Stock Chart
From Sep 2023 to Sep 2024