UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 25, 2016
Keryx Biopharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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| Delaware |
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000-30929 |
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13-4087132 |
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of Incorporation) |
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(Commission
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(IRS Employer
Identification No.) |
One Marina Park Drive, 12th Floor
Boston, Massachusetts 02210
(Address of Principal Executive Offices)
(617) 466-3500
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act. |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Item 2.02. Results of Operations and Financial Condition.
On February 25, 2016, Keryx Biopharmaceuticals, Inc. (“Keryx”) issued a press release announcing its
results of operations for the fourth quarter and year ended December 31, 2015. Keryx also announced that on February 25, 2016 at 8:00 a.m. ET, it will host an investor conference call to discuss the Company’s fourth quarter and
year-end 2015 financial results and provide a business outlook for 2016. A copy of such press release is being furnished as Exhibit 99.1 to this report and is incorporated herein by reference. A copy of the PowerPoint presentation to be used on the
investor conference call is being furnished as Exhibit 99.2 to this report and is incorporated herein by reference.
The
information set forth in Exhibits 99.1 and 99.2 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be
incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements And Exhibits.
The following exhibits are furnished herewith:
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| 99.1 |
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Press release issued by Keryx Biopharmaceuticals, Inc., dated February 25, 2016. |
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| 99.2 |
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PowerPoint presentation to be presented by Keryx Biopharmaceuticals, Inc. on February 25, 2016. |
SIGNATURE
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Keryx Biopharmaceuticals, Inc. |
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(Registrant) |
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| Date: February 25, 2016 |
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By: |
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/s/ Brian Adams |
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Brian Adams |
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General Counsel and Corporate Secretary |
INDEX TO EXHIBITS
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Description |
| 99.1 |
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Press release issued by Keryx Biopharmaceuticals, Inc., dated February 25, 2016. |
| 99.2 |
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PowerPoint presentation to be presented by Keryx Biopharmaceuticals, Inc. on February 25, 2016. |
Exhibit 99.1
Keryx Biopharmaceuticals Announces Fourth Quarter and Year-End 2015 Financial Results
- Fourth quarter Auryxia net U.S. product sales of $4.8 million –
- Keryx provides 2016 Auryxia net U.S. product sales guidance of $31 - $34 million –
- Company on track to provide pivotal phase 3 data for iron deficiency anemia (IDA) in adults with
pre-dialysis chronic kidney disease in early second quarter –
BOSTON, MA, February 25, 2016 – Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to
market for people with renal disease, today announced its financial results for the fourth quarter and year ended December 31, 2015. The company also reviewed its commercialization progress with Auryxia™ (ferric citrate), upcoming
milestones and selected 2016 financial guidance.
“As we enter 2016, the fundamentals of Auryxia are solid, and we plan to build on that foundation to advance
our launch in the U.S.,” said Greg Madison, chief executive officer of Keryx. “Importantly, the data readout expected in early second quarter from the ferric citrate phase 3 label expansion trial will be an important marker of our efforts
to help people with pre-dialysis chronic kidney disease. Specifically, we believe that ferric citrate – which, through its novel mechanism of action, delivers iron orally through the body’s natural absorption process – could be the
first FDA-approved oral medicine to treat iron deficiency anemia (IDA) in this patient population.”
FOURTH QUARTER 2015 AND RECENT BUSINESS HIGHLIGHTS
Auryxia (ferric citrate) Commercialization
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Auryxia net U.S. product sales for the fourth quarter of 2015 were $4.8 million, based on approximately 7,850 prescriptions, an increase of 46 percent from the third quarter. For the full year 2015, Auryxia net U.S.
product sales were $10.1 million, representing greater than 18,000 prescriptions. |
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Cumulative target physicians who have written a prescription for Auryxia increased more than 25 percent from the third quarter of 2015. |
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Keryx completed its sales force expansion and now will have 95 sales representatives calling on target prescribers. The expansion enables increased reach and frequency of contact with physicians, dieticians and the
entire dialysis care team. |
Product Expansion Opportunities
Pivotal Phase 3 Trial Aimed at Increasing the Number of Adults Eligible for Treatment with Ferric Citrate
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The 24-week pivotal phase 3 trial evaluating ferric citrate for the treatment of IDA in patients with stages 3-5 CKD completed in January, as planned. Early in the second quarter of 2016, Keryx expects to announce
topline safety and efficacy results. If the results are successful, Keryx intends to submit a regulatory application for approval to the U.S. FDA in the third quarter of 2016, and submit the data for presentation at a fourth quarter 2016 medical
conference. |
Potential Geographic Expansion
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Keryx is seeking potential partners to make Fexeric® (ferric citrate) available to patients in Europe. |
Page 1 of 6
Fourth Quarter and Year Ended December 31, 2015 Financial Results
“In the fourth quarter of 2015, we strengthened our financial position through a re-alignment of our cost structure and an infusion of capital, which we expect will
take the Auryxia franchise to cash flow positive,” said Scott Holmes, chief financial officer of Keryx. “For 2016, we expect prescription volume to increase between 20 percent and 35 percent on a sequential quarter basis, ramping as we
realize the full impact of our expanded sales force. As we progress through 2016, we are committed to maintaining fiscal discipline, while advancing our business and supporting the continued growth of Auryxia.”
At December 31, 2015, the company had cash and cash equivalents of $200.3 million.
Total revenues for the quarter ended December 31, 2015 were approximately $5.8 million, compared to $0.6 million during the same period in 2014. Total
revenues for the quarter consisted of Auryxia net U.S. product sales of $4.8 million, and license revenue of $1.0 million associated with royalties received on ferric citrate net sales from Keryx’s Japanese partner. For the year ended 2015,
total revenues were $13.7 million, including $10.1 million of Auryxia net U.S. product sales.
Cost of goods sold for the quarter ended December 31,
2015 was $1.1 million. Cost of goods sold for the full year 2015 was $4.5 million, which included $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at certain of the company’s third
party manufacturers as reported in the third quarter.
Research and development expenses for the quarter ended December 31, 2015 were $8.0 million
compared to $5.8 million during the same period in 2014. The increase was primarily due to an increase in costs associated with our medical affairs efforts in support of Auryxia. For the full year 2015, total research and development expenses were
$36.7 million compared to $51.5 million in 2014.
Selling, general and administrative expenses for the quarter ended December 31, 2015 were $21.6
million, as compared to $34.1 million during the same period in 2014. The decrease was related to a $10.5 million decrease in non-cash stock-based compensation expense compared to the prior period, primarily related to expense recognized in
connection with the first commercial sale of Auryxia in 2014. For the full year 2015, total selling, general and administrative expenses were $81.4 million compared to $70.1 million in 2014.
Net loss for the fourth quarter ended December 31, 2015 was $37.8 million, or $0.36 per share, compared to a net loss of $40.3 million, or $0.44 per share,
for the comparable quarter in 2014. For the full year 2015, net loss was $123.1 million or $1.19 per share compared to a net loss of $111.5 million, or $1.23 per share in 2014.
2016 Financial Guidance
This section contains forward-looking guidance
about the financial outlook for Keryx Biopharmaceuticals
Auryxia net U.S. product sales: Keryx expects full year 2016 Auryxia net U.S. product sales to
be in the range of $31 to $34 million. The company expects sales to ramp throughout the year, as it realizes the full impact of its expanded sales force.
Cash
operating expenses: Keryx reiterated its cash operating expenses in 2016 will be in the range of $87 million to $92 million. Cash operating expense guidance excludes cost of goods sold, license expenses, and other non-cash expenses.*
Page 2 of 6
* Please refer to the section below titled “Use of Non-GAAP Financial Measures” for information about
Keryx’s use of non-GAAP financial measures.
Conference Call Information
Keryx will host an investor conference call today, Thursday, February 25, 2016, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year of
2015 and provide a review on the Auryxia launch. In order 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: 43760032. 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 a period of 15 days after the call.
About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was
approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The U.S. approval of Auryxia was based on
data from the Company’s Phase 3 registration program. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.
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), whereas these parameters remained relatively constant in patients treated with active control (Renvela® and/or Phoslo®). 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, visit
www.Auryxia.com.
About Iron Deficiency Anemia in Chronic Kidney Disease
Iron deficiency anemia is the most common type of anemia and among the most common complication of chronic kidney disease. IDA is a condition where the body does not
make enough healthy red blood cells and causes a considerable amount of weakness and fatigue, leading people to live a poor quality of life. IDA begins to develop in the early stages of CKD and tends to worsen as CKD progresses. Current oral
medicines to treat IDA are not well tolerated. As a result, anemia in many patients remains untreated until hemoglobin levels severely decline. It is estimated that approximately 1.5 million people in the U.S. with stages 3-5 chronic kidney
disease suffer from IDA, with the majority of these patients untreated.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA™ (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia™ (ferric citrate).
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.
Page 3 of 6
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)
(unaudited)
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Three Months Ended
December 31, |
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Year Ended
December 31, |
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2015 |
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2014 |
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2015 |
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2014 |
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| Revenues: |
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| Net U.S. Auryxia product sales |
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$ 4,770 |
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$ -- |
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$ 10,141 |
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$ -- |
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| License revenue |
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1,013 |
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569 |
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3,539 |
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10,825 |
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| Total Revenues |
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5,783 |
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569 |
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13,680 |
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10,825 |
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| Operating Expenses: |
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| Cost of goods sold |
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1,075 |
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-- |
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4,520 |
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-- |
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| License expenses |
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608 |
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341 |
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2,124 |
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495 |
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| Research and development |
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7,990 |
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5,815 |
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36,694 |
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51,502 |
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| Selling, general and administrative |
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21,563 |
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34,050 |
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81,410 |
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70,057 |
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| Total Operating Expenses |
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31,236 |
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40,206 |
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124,748 |
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122,054 |
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| Operating Loss |
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(25,453) |
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(39,637) |
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(111,068) |
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(111,229) |
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| Other Income: |
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| Other income (expense), net |
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(12,308) |
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52 |
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(11,987) |
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411 |
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| Loss Before Income Taxes |
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(37,761) |
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(39,585) |
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(123,055) |
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(110,818) |
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| Income taxes |
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23 |
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700 |
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90 |
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700 |
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| Net Loss |
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$ (37,784) |
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$ (40,285) |
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$ (123,145) |
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$ (111,518) |
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| Net Loss Per Common Share
Basic and diluted net loss per common share |
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$ (0.36) |
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$ (0.44) |
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$ (1.19) |
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$ (1.23) |
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| Shares Used in Computing Net Loss Per Common Share |
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| Basic and diluted |
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105,204,495 |
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92,074,596 |
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103,898,399 |
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91,000,902 |
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Page 4 of 6
Selected Consolidated Balance Sheet Data
(In thousands)
(unaudited)
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December 31, 2015
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December 31, 2014*
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| Assets |
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| Cash and cash equivalents |
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$ |
200,290 |
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$ |
85,840 |
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| Inventory |
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$ |
41,881 |
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$ |
7,830 |
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| Total assets |
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$ |
258,685 |
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$ |
103,628 |
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| Liabilities and Stockholders’ Equity |
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| Accounts payable and accrued expenses |
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$ |
26,795 |
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$ |
28,897 |
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| Deferred revenue |
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$ |
3,526 |
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$ |
414 |
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| Derivative liability |
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$ |
46,686 |
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$ |
-- |
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| Convertible senior notes, net of discount |
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$ |
90,773 |
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$ |
-- |
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| Total liabilities |
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$ |
171,751 |
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$ |
30,144 |
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| Stockholders’ equity |
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$ |
86,934 |
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$ |
73,484 |
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Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia and our expected
cash operating expenses, 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 Auryxia will be successfully marketed in the U.S.; whether we can successfully obtain additional reimbursement
coverage for Auryxia; whether we can adjust our operating expenses to projected levels while maintaining our current clinical and commercial activities; whether we will able to identify and negotiate acceptable terms with a commercialization partner
in the E.U.; whether we or a partner can successfully launch Fexeric in the E.U.; whether Riona® will be successfully marketed in Japan by our Japanese partner, Japan Tobacco, Inc. and Torii
Pharmaceutical Co., Ltd; the risk that we may not be successful in the development of Auryxia for the treatment of iron deficiency anemia in non-dialysis dependent chronic kidney disease patients; 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.
Use of Non-GAAP Financial Measures
To supplement the financial measures presented in Keryx’ press release and related conference call or webcast in accordance with accounting principles generally
accepted in the United States (“GAAP”), Keryx also presents expected cash operating expenses in the 2016 financial guidance discussion above, which is a non-GAAP financial measure. This non-GAAP financial measure’s most comparable
GAAP financial measure is total operating expenses. Keryx believes that the non-GAAP financial measure cash operating expenses provides investors with useful information regarding the company’s financial condition and prospects because this
measure helps an investor better understand the company’s expected liquidity needs. Also, this non-GAAP measure is used by Keryx management for internal review of the company’s operating performance.
Page 5 of 6
A “non-GAAP financial measure” refers to a numerical measure of the company’s historical or future
financial performance, financial position, or cash flows that excludes (or includes) amounts that are included in (or excluded from) the most directly comparable measure calculated and presented in accordance with GAAP in the company’s
financial statements. Keryx provides the non-GAAP measure listed above as additional information relating to Keryx’ expected operating results as a complement to results provided in accordance with GAAP. The non-GAAP financial information
presented here should be considered in conjunction with, and not as a substitute for or superior to, the financial information presented in accordance with GAAP. There are significant limitations associated with the use of non-GAAP financial
measures. Further, these measures may differ from the non-GAAP information, even where similarly titled, used by other companies and therefore should not be used to compare Keryx’ performance to that of other companies.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices
in New York and Boston, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the company launched its first FDA-approved product, Auryxia™ (ferric citrate) for the control of elevated serum
phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis, in the United States. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is
being marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization
for Fexeric® (ferric citrate coordination complex) for the control of hyperphosphatemia in adults with non-dialysis-dependent and dialysis-dependent chronic kidney disease. For more
information about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Corporate Development and Public Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
Page 6 of 6
Fourth Quarter and Year End 2015
Financial Results February 25, 2016 Keryx Biopharmaceuticals, Inc. Exhibit 99.2
Safe Harbor Statement Various remarks
that we make about our future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Important factors may cause our actual
results to differ materially, including: whether Auryxia™ (ferric citrate), will be successfully marketed in the U.S.; whether we can successfully obtain reimbursement coverage for Auryxia; whether we can adjust our operating expense to
projected levels while maintaining our current clinical and commercial activities; whether we will be able to identify and negotiate acceptable terms with a commercialization partner in the E.U.; whether a partner can successfully launch
Fexeric® in the E.U.; whether Riona® will be successfully marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the risk that we may not be successful in the development of Auryxia for the treatment of
iron deficiency anemia in non-dialysis chronic kidney disease patients; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. These and other important factors that may affect our
results are discussed under the heading “Risk Factors” in public filings including our 2014 Annual Report on Form 10-K, Form 10-Qs, as well as other filings we periodically make with the SEC. In addition, any forward-looking statements
made during this presentation speak only as of the date of this presentation. While we may update these forward-looking statements to reflect events or circumstances that occur after this date, we specifically disclaim any obligation to do so, even
if our estimates and expectations change.
Fourth Quarter and Full Year 2015
Financial Results – Agenda Topic Speaker Introduction Amy Sullivan, VP, Corporate Development Business Highlights Greg Madison, Chief Executive Officer 4Q 2015 Results & 2016 Guidance Scott Holmes, Chief Financial Officer Auryxia
Commercial Overview Abe Ceesay, VP, Sales, Marketing and Operations IDA pre-dialysis CKD John Neylan, M.D., Chief Medical Officer
Building a Leading Renal Company Today
Near Term Future One medicine, multiple indications Multi-product company focused on improving the lives of people with renal disease One medicine, one indication * Auryxia is currently indicated for the control of serum phosphorus levels in CKD
patients on dialysis; **Keryx is currently conducting a phase 3 trial evaluating ferric citrate for use in pre-dialysis CKD patients as a treatment for iron deficiency anemia.
Business Highlights Ended 2015 with
solid fundamentals Expanded sales force to drive depth and breadth of prescribing Secured reimbursement coverage for majority of phosphate binder patients Received EU approval of ferric citrate for the control of hyperphosphatemia in patients with
all stages of CKD Completed, in January, pivotal phase 3 trial for the treatment of iron deficiency anemia in pre-dialysis CKD patients Realigned cost structure and infused capital to support Auryxia opportunities and take the franchise to cash flow
positive Auryxia U.S. net product sales of $4.8MM in 4Q; $10.1MM for 2015 Introduced Auryxia in ESRD Expanded Geographic Opportunity Advanced Label Expansion Efforts Strengthened Financial Position
Current Auryxia™ (Ferric Citrate)
Indication Phosphate Management Non-calcium, non-chewable, absorbable, iron-based phosphate binder Pharmacodynamic properties have shown to increase serum iron parameters, including TSAT and ferritin Established safety profile Most common AEs
GI-related Recommended starting dose: 6 tablets per day **Keryx is currently conducting a phase 3 trial evaluating ferric citrate for use in pre-dialysis CKD patients as a treatment for iron deficiency anemia. Indicated for the control of serum
phosphorus levels in CKD patients on dialysis
A Potential New Treatment for Iron
Deficiency Anemia Anemia Management In January, completed pivotal phase 3 trial evaluating ferric citrate for treatment of IDA in pre-dialysis stages 3-5 CKD Plan to provide top-line safety and efficacy results in early 2Q 2016 If successful, plan
to: submit regulatory application in 3Q 2016 present data at medical conference in 4Q 2016 * Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis; **Keryx is currently conducting a phase 3 trial
evaluating ferric citrate for use in pre-dialysis CKD patients as a treatment for iron deficiency anemia.
A Potential New Treatment Category for
CKD Phosphate Management Anemia Management * Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis; **Keryx is currently conducting a phase 3 trial evaluating ferric citrate for use in pre-dialysis CKD
patients as a treatment for iron deficiency anemia.
Building a Foundation for Long-Term
Growth SOLID FUNDAMENTALS ESTABLISHED 2015 2017 POTENTIAL IDA APPROVAL 2016 DRIVE DIALYSIS ADOPTION AURYXIA: A NEW TREATMENT CATEGORY Leverage sales force expansion Increase utilization Increase breadth & depth of prescribing Generate further
data to support differentiation Drive awareness of IDA in pre-dialysis Educate physicians on treatment guidelines 2017 POTENTIAL IDA APPROVAL * Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis;
**Keryx is currently conducting a phase 3 trial evaluating ferric citrate for use in pre-dialysis CKD patients as a treatment for iron deficiency anemia Built brand awareness Refined sales messaging Introduced samples Established reimbursement
Expanded sales force
Financial Highlights Scott Holmes
Chief Financial Officer
Fourth Quarter and Full Year 2015
Financial Highlights ($ in thousands) Three Months Ended December 31, 2015 (unaudited) Full Year December 31, 2015 (unaudited) Auryxia Net U.S. Product Sales $4,770 $10,141 License Revenue $1,013 $3,539 Total Revenue $5,783 $13,680 COGS $1,075
$4,520 SG&A Expense $21,563 $81,410 R&D Expense $7,990 $36,694 Total Operating Expenses* $29,553 $118,104 ($ in thousands) At December 31, 2015 (unaudited) At December 31, 2014 (audited) Cash and Cash Equivalents $200,290 $85,840 Convertible
Debt (at face value) $125,000 $0 Deferred Revenue $3,526 $414 * Excludes cost of goods sold and license expenses.
Selected 2015 Financial Results and
2016 Guidance $ in millions FY 2015 Actuals FY 2016 Guidance Auryxia Net U.S. Product Sales* $10.1MM $31MM - $34MM Cash Operating Expenses $99.7MM* $87MM - $92MM** Notes: * 2015 Cash Operating Expense amount excludes a total of $18.4M in non-cash
expenses, comprised of non-cash stock compensation expenses, non-cash commercial expenses and non-cash depreciation/amortization. ** 2016 Cash Operating Expenses excludes; non-cash stock compensation expenses, non-cash commercial expenses and
non-cash depreciation/amortization
Commercial Progress Abe Ceesay VP,
Sales, Marketing and Operations
Source: IMS NPA, DaVita and
Fresenius Prescription Volume Increased ~46% from 3Q to 4Q 2015 ~7,850 Auryxia prescriptions in 4Q 2015 43% of Auryxia prescriptions in 4Q 2015 not captured by IMS Non-IMS reporting channel prescription volume increased ~60% from 3Q to 4Q Volume
growth driven by increased breadth and depth of prescribing
Key Factors That Drove
Auryxia™ Adoption and Growth in 4Q’15 Refined commercial message: New dialysis patients 30% - 40% of ESRD patients with serum phosphorus levels above 5.5 mg/dL Increased new writers: Cumulative targets who have written an Rx grew >25%
from 3Q to 4Q Focused sales effort: Directed representatives to spend requisite amount of time with dialysis care team Increased breadth and depth of prescribing: Driven by adoption efforts and positive clinical experience with Auryxia Persistency:
~70% of patients remain on therapy Prescription Growth Adoption
Represents ~85% of Rxs Sales Force
Expansion Supports Continued Auryxia Adoption in Dialysis ~5,000 Prescribers Sales Force Expansion Complete and New Reps Trained Dialysis Care Team 95 Sales Representatives Total Market Coverage 11 Regional Managers
Solid Fundamentals to Support Future
Dialysis Growth Physician Payer Patient Increased breadth and depth of adoption Increased field base team to 95, with 11 district managers Majority of phosphate binder patients have unrestricted access >70% of claims paid at the pharmacy ~74% of
co-pays <$10 Patient persistency consistent at ~70% Auryxia source of business: 70% switch / 30% new patients Sources: Spherix, December 2015, Keryx reported data
Label Expansion Efforts John Neylan,
M.D. Chief Medical Officer
The Potential to Treat Iron
Deficiency Anemia in Pre-Dialysis Represents a Practice-Changing Opportunity Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2015 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the
United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013; NHANES 2012, Spherix Global Insights. 26 MILLION U.S. ADULTS WITH CKD 16 million with stage 3 – 5 CKD ~650K
treated for iron deficiency anemia Current oral iron preparations viewed as ineffective by nephrologists: Poorly tolerated Lack of efficacy Poor absorption Poor patient adherence Access and use of IV iron is limited due to logistical constraints and
risk of hypersensitivity reactions Anemia not adequately treated in most CKD patients Market development opportunity ~1.7 million under nephrologists care Ferric Citrate has the potential to be the first and only FDA-approved oral iron for treatment
of IDA in CKD patients
Phase 3 Iron Deficiency Anemia Label
Expansion Study Primary endpoint: % of patients achieve a 1 g/dL or greater increase in hemoglobin during 16-week randomization period Two-month safety follow up period, for total of 24 weeks Screening Randomization 1:1 2 Week 16 Week Randomized,
Double-Blind Placebo controlled 8 Week Safety Extension Period Ferric Citrate Placebo Ferric Citrate Status: Completed trial in January 2016 Expect top-line safety/efficacy results early 2Q 2016 FDA submission planned for 3Q 2016 Design: Stage 3
– 5 CKD patients with iron deficiency anemia (n=234), intolerant to or had an inadequate therapeutic response to oral iron supplements
Auryxia Well Positioned for Future
Market Leadership CKD** ESRD* Stage 3 Stage 4 Iron Deficient Value A Two-Staged Growth Strategy for Auryxia Uncontrolled Phosphorus * Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis; **Keryx is
currently conducting a phase 3 trial evaluating ferric citrate for use in pre-dialysis CKD patients as a treatment for iron deficiency anemia. Auryxia Market Leadership Illustrative of the market Stages 5 5D Incident Prevalent
Priorities for the Future Drive
Auryxia’s path to success in dialysis: Increase awareness Drive breadth and depth of prescribing Address the unmet need in pre-dialysis CKD patients with iron deficiency anemia** Expand global reach of ferric citrate * Auryxia is currently
indicated for the control of serum phosphorus levels in CKD patients on dialysis; **If approved for the treatment of iron deficiency anemia in pre-dialysis CKD patients. Keryx is currently conducting a phase 3 trial evaluating ferric citrate for use
in pre-dialysis CKD patients as a treatment for iron deficiency anemia. Establish Auryxia as a new treatment category Understand if we can better manage kidney patient care during the transition to dialysis with Auryxia treatment in the pre-dialysis
setting 2017 and Beyond 2016
Fourth Quarter and Year End 2015
Financial Results February 25, 2016 Keryx Biopharmaceuticals, Inc.
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