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 7, 2018
Keryx Biopharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 000-30929 | 13-4087132 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
One Marina Park Drive, 12th Floor
Boston, Massachusetts 02210
(Address of Principal Executive Offices)
(617) 466-3500
(Registrants 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:
☐ | Written communications pursuant to Rule 425 under the Securities Act. | |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. | |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. | |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. | Results of Operations and Financial Condition. |
On February 7, 2018, Keryx Biopharmaceuticals, Inc. (Keryx) issued a press release announcing its results of operations for the fourth quarter and full year ended December 31, 2017. Keryx also announced that on February 7, 2018 at 8:00 a.m. ET, it will host an investor conference call to discuss its fourth quarter and full year 2017 financial results and provide a business update. 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 investor 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 (the Exchange Act), 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. |
(d) | Exhibits. |
The following exhibits are furnished herewith:
99.1 | Press release issued by Keryx Biopharmaceuticals, Inc., dated February 7, 2018. | |
99.2 | Investor presentation to be presented by Keryx Biopharmaceuticals, Inc. on February 7, 2018. |
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.
Keryx Biopharmaceuticals, Inc. | ||||||
(Registrant) | ||||||
Date: February 7, 2018 |
||||||
By: |
/s/ Brian Adams | |||||
Brian Adams | ||||||
General Counsel and Corporate Secretary |
Exhibit 99.1
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 |
BOSTON, MA, February 7, 2018 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 fourth quarter and year ended December 31, 2017. The company also reviewed its commercial progress with Auryxia following approval of the medicines second indication for the treatment of iron deficiency anemia in adults with chronic kidney disease, not on dialysis.
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 Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. With approval of a second indication for Auryxia, we believe we are in a unique position to offer patients and their healthcare providers a medicine that can treat two distinct but related complications of chronic kidney disease. Driving growth in both indications is our focus in 2018 and we look forward to continued progress as we build a leading kidney care company.
2017 Business Highlights
| Full year 2017 net U.S. Auryxia product sales were $55.5 million, as compared to $27.2 million for the full year 2016, a 104 percent increase. |
| Auryxia net U.S. product sales were $17.3 million in the fourth quarter of 2017, as compared to $8.2 million in 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 2017 and was launched in the fourth quarter. |
| Following formulary access expansion in 2017, Auryxia has broad formulary coverage across Medicare Part D and commercial insurance providers with no restrictions. This formulary status applies to both Auryxia indications. |
Fourth Quarter and Year Ended December 31, 2017 Financial Results
The strong prescription demand growth generated in the fourth quarter, coupled with the stabilization of the gross-to-net adjustment, led to $17.3 million of net U.S. Auryxia product sales in the fourth quarter of 2017, said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. As we enter 2018, we believe we will continue to drive Auryxia growth as a chronic kidney disease treatment for both hyperphosphatemia in the dialysis setting, as well as iron deficiency anemia in the non-dialysis setting.
Total revenues for the quarter ended December 31, 2017 were approximately $18.7 million, compared with $9.5 million during the same period in 2016. Total revenues for the fourth quarter of 2017 consist of approximately $17.3 million in net U.S. Auryxia product sales, as compared to $8.2 million in the fourth quarter of 2016. Total revenues for the fourth quarter of 2017 also include $1.4 million in license revenue, as compared to $1.3 million during the same period in 2016.
For the year ended 2017, total revenues were approximately $60.6 million, as compared to $32.0 million in 2016. Total revenues for 2017 include $55.5 million of Auryxia net U.S. product sales and $5.1 million in license revenue, as compared to $27.2 million and $4.8 million, respectively, in 2016.
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Cost of goods sold for the quarter ended December 31, 2017 were $7.4 million, compared with $13.4 million during the same period in 2016. For the year ended 2017, total cost of goods sold were $22.0 million, as compared to $37.8 million in 2016.
Selling, general and administrative expenses for the quarter ended December 31, 2017 were $28.8 million, as compared to $23.0 million during the same period in 2016. For the year ended December 31, 2017, total selling, general and administrative expenses were $99.6 million, as compared to $84.6 million in 2016. Selling, general and administrative expenses for the quarter and full year ended December 31, 2017 included $6.6 million and $15.6 million, respectively, in non-cash stock compensation expense, as compared to $2.8 million and $11.2 million, respectively, during the same periods in 2016.
Research and development expenses for the quarter ended December 31, 2017 were $12.6 million, as compared to $6.2 million during the same period in 2016. For the year ended December 31, 2017, total research and development expenses were $37.7 million, as compared to $29.5 million in 2016. Research and development expenses for the quarter and full year ended December 31, 2017 included $1.0 million and $2.6 million, respectively, in non-cash stock compensation expense, as compared to $0.6 million and $2.8 million, respectively, during the same periods in 2016.
Net loss for the quarter ended December 31, 2017 was $30.4 million, or $0.26 per share, as compared to a net loss of $33.8 million, or $0.32 per share, for the comparable period in 2016. For the full year 2017, net loss was $163.4 million, or $1.43 per share, as compared to $161.1 million, or $1.52 per share, in 2016.
Cash and cash equivalents as of December 31, 2017 totaled approximately $93.5 million.
Conference Call Information
Keryx Biopharmaceuticals will host an investor conference call today, February 7, 2018, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year of 2017. 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: 3697815. The call will also be webcast with slides, which will be accessible through the Investors section of the companys website at www.keryx.com. The audio replay will be available at http://www.keryx.com for approximately 15 days after the call.
About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in patients 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. |
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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.
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 Keryxs first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com.
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Keryx Biopharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(unaudited)
Three Months Ended December 31, |
Year Ended December 31, |
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2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenues: |
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Net U.S. Auryxia product sales |
$ | 17,296 | $ | 8,228 | $ | 55,514 | $ | 27,173 | ||||||||
License revenue |
1,386 | 1,305 | 5,127 | 4,810 | ||||||||||||
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Total Revenues |
18,682 | 9,533 | 60,641 | 31,983 | ||||||||||||
Costs and Expenses: |
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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 | ||||||||||||
License expense |
832 | 783 | 3,076 | 2,886 | ||||||||||||
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Total Costs and Expenses |
49,694 | 43,440 | 162,332 | 154,746 | ||||||||||||
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Operating Loss |
(31,012 | ) | (33,907 | ) | (101,691 | ) | (122,763 | ) | ||||||||
Other Income (expense): |
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Other income (expense), net |
288 | 143 | (61,984 | ) | (38,252 | ) | ||||||||||
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Loss Before Income Taxes |
(30,724 | ) | (33,764 | ) | (163,675 | ) | (161,015 | ) | ||||||||
Income tax (benefit) expense |
(295 | ) | 20 | (235 | ) | 80 | ||||||||||
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Net Loss |
$ | (30,429 | ) | $ | (33,784 | ) | $ | (163,440 | ) | $ | (161,095 | ) | ||||
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Net Loss Per Common Share |
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Basic and diluted net loss per common share |
$ | (0.26 | ) | $ | (0.32 | ) | $ | (1.43 | ) | $ | (1.52 | ) | ||||
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Shares Used in Computing Net Loss Per Common Share |
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Basic and diluted |
119,193,548 | 105,962,622 | 114,507,668 | 105,845,121 | ||||||||||||
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Keryx Biopharmaceuticals, Inc.
Selected Consolidated Balance Sheet Data
(In thousands)
(unaudited)
December 31, 2017 | December 31, 2016 | |||||||
Assets |
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Cash and cash equivalents |
$ | 93,526 | $ | 111,810 | ||||
Accounts receivable |
$ | 8,146 | $ | 5,236 | ||||
Inventory |
$ | 28,695 | $ | 12,681 | ||||
Other current assets |
$ | 11,199 | $ | 3,170 | ||||
Total assets |
$ | 158,872 | $ | 141,427 | ||||
Liabilities and Stockholders Equity (Deficit) |
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Accounts payable and accrued expenses |
$ | 45,031 | $ | 21,190 | ||||
Convertible senior notes |
$ | 125,000 | $ | 125,000 | ||||
Total liabilities |
$ | 172,967 | $ | 149,723 | ||||
Stockholders equity (deficit) |
$ | (14,095 | ) | $ | (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, 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 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.
KERYX BIOPHARMACEUTICALS CONTACTS
Amy Sullivan
Senior Vice President, Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Page 5 of 5
Keryx biopharmaceuticals 4Q and Full Year 2017 Financial Results Call February 7, 2018 Exhibit 99.2
Agenda Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Topic Speakers Welcome Amy Sullivan, SVP, Corporate Affairs Opening Remarks Greg Madison, President & CEO 4Q 2017 Results Scott Holmes, CFO Commercial Progress Doug Jermasek, VP, Marketing & Strategy Question & Answer All
Forward-Looking Statements Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Some of the statements included in this presentation, 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 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. The fourth quarter 2017 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.
Opening remarks Greg Madison, CEO
Fourth Quarter – A Strong Finish to 2017 Received FDA approval for a second indication for Auryxia® for the treatment of iron deficiency anemia in patients with CKD, not on dialysis Delivered strong Auryxia demand growth for the treatment of hyperphosphatemia Launched Auryxia for our second indication Strengthened our supply chain Copyright © 2018 by Keryx Biopharmaceuticals, Inc.
Second Indication for Auryxia® Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Second Indication: treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD), not on dialysis Label supports use of Auryxia as a first-line treatment option Auryxia’s expanded indication now gives us the opportunity to help millions of people living with iron deficiency anemia and CKD Only oral iron medicine designed, studied and approved specifically for the treatment of iron deficiency anemia in CKD patients
4Q17 REsults Scott Holmes, CFO
4Q 2017 Prescription and Revenue Growth Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Highlights 22% growth in prescriptions from 3Q 4Q17 net product revenue of $17.3 million Gross-to-net adjustment stabilized in 4Q (54%) IMS/Specialty mix: 56%/44% Absolute inventory levels were flat compared to 3Q
Commercial Performance Metrics Copyright © 2018 by Keryx Biopharmaceuticals, Inc. 2017 Quarterly Auryxia Market Share Calcium Acetate Auryxia Sevelamer* Lanthanum** Velphoro % TRx Change 4Q17 vs 3Q17 Highlights Auryxia market share: >4% Fastest growing phosphate binder * Includes generics and branded Renvela and Renagel ** Includes generics and branded Fosrenol
Selected Financial Results Copyright © 2018 by Keryx Biopharmaceuticals, Inc. ($ in millions, except per share amounts) Three Months Ended Dec. 31, 2017 (unaudited) Three Months Ended Dec. 31, 2016 (unaudited) Year Ended Dec. 31, 2017 (unaudited) Year Ended Dec. 31, 2016 (audited) Net U.S. Auryxia Product Sales $ 17.3 $ 8.2 $ 55.5 $ 27.2 License Revenue $ 1.4 $ 1.3 $ 5.1 $ 4.8 Total Revenue $ 18.7 $ 9.5 $ 60.6 $ 32.0 Cost of Goods Sold $ 7.4 $ 13.4 $ 22.0 $ 37.8 Operating Expenses* $ 41.4 $ 29.2 $ 137.3 $ 114.1 Net loss** $ (30.4) $ (33.8) $ (163.4) $ (161.1) Net loss per share $ (0.26) $ (0.32) $ (1.43) $ (1.52) (In millions) December 31, 2017 (unaudited) December 31, 2016 (audited) Cash and Cash Equivalents $ 93.5 $111.8 Convertible Debt (at face value) $125.0 $125.0 Common Shares Outstanding 119.2 105.8 * Reflects SG&A expenses ($28.8M in 4Q 2017 and $23.0M in 4Q 2016), plus R&D expenses ($12.6M in 4Q 2017 and $6.2M in 4Q 2016). **The year to date periods in 2017 and 2016, include $63M and $34.2M, respectively, in non-cash debt discount amortization related to our outstanding convertible debt. Not expected to recur. Note: numbers may not foot due to rounding.
Dynamics Related to Iron Deficiency Anemia Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Expect the IMS Rx capture rate to increase over time Demand tablets vs. Rxs will better correlate to brand performance Starting doses are different between the two indications Gross to net adjustment stabilized at 54% in fourth quarter Mix of business in 4Q17 consistent with 3Q17 Mix for IDA expected to have greater commercial activity, which could benefit the gross to net adjustment over time
Commercial Progress Doug Jermasek, VP of Marketing and Strategy
Auryxia Offers Continuity of Care Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Progressing patients typically referred to nephrologist Prepare for renal replacement therapy Patients initiate dialysis GFR (mL/min) Often not diagnosed Patients typically under care of PCP Patients typically under care of PCP Moderate to severe loss of kidney function Severe loss of kidney function Kidney failure Below normal to mild loss of kidney function Mild to moderate loss of kidney function Stage 3 Stage 4 Stage 5/5D Stage 1 Stage 2 Hemoglobin levels progressively fall Advanced disease with multiple complications requiring more intensive management Phosphorus levels progressively rise Iron deficiency presents Auryxia can treat patients at every stage of CKD* *Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease, not on dialysis
Copyright © 2018 by Keryx Biopharmaceuticals, Inc. 650,000 Non-dialysis CKD, Iron Deficiency Anemia (treated) 700,000 Non-dialysis CKD (untreated) 400,000 Non-dialysis CKD, Iron Deficiency Anemia (untreated) 70,000 - Dialysis not on Binder 380,000 Dialysis (treated with binder) 2.2 million under care of nephrologist Source: Keryx Data on File 30 million people in U.S. with CKD Today’s Focus: Nephrology Nephrologist care for >1.4 million people who could potentially benefit from treatment with Auryxia
Today’s Focus: Nephrology Our Market Approach to Hyperphosphatemia Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Clinical Challenge: 30-40% of people have uncontrolled phosphorus levels; associated with higher rates of morbidity and mortality Greatest challenge: Patient adherence (pill burden & tolerability) Auryxia Solution: Auryxia is the non-calcium, non-chewable choice for clinically proven control of hyperphosphatemia Data showed patients switched to Auryxia achieved phosphorus control with fewer pills Differentiated tolerability profile Hyperphosphatemia, on Dialysis Sources: DOPPS, Keryx data on file, Cosmos study data, Case-study data at ASN 2016 2017 Quarterly Auryxia Market Share
Today’s Focus: Nephrology Our Market Approach to Iron Deficiency Anemia Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Clinical Challenge: Prevalent, significant and highly symptomatic Associated w/cardiovascular disease & reduced quality of life Guidelines recommend oral iron first Greatest challenge: Efficacy and tolerability of traditional oral iron Auryxia Solution: The only oral iron medicine approved specifically for CKD patients Proven efficacy & tolerability in patients who had previously failed traditional oral iron Iron Deficiency Anemia, not on Dialysis Sources: DOPPS, Keryx data on file, Cosmos study data, Case-study data at ASN 2016 Patients randomized to ferric citrate were significantly more likely to achieve an increase in Hgb of ≥1.0 g/dL at any time point between baseline and the end of the 16-week Randomized Period Primary Endpoint
Key Iron Deficiency Launch Objectives Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Drive rapid awareness of new indication in iron deficiency anemia Differentiate Auryxia from existing treatment options Communicate favorable reimbursement access to Auryxia
Iron Deficiency Anemia Promotion Market Research Highlights* Awareness of Auryxia’s new indication is strong 80% of nephrologists are aware of Auryxia’s indication for iron deficiency anemia in patients with CKD not on dialysis. Auryxia representative call rates are high Share of voice has increased Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Sources: Spherix 4Q17 Anemia in CKD Syndicated Research; aided brand awareness data.
Future Opportunity Auryxia’s Expanded Label Supports Reach Beyond Nephrology Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Growth Opportunity ~14 million people with CKD not under care of nephrologist are iron deficient Potential to extend reach to non-nephrology targets Source: Keryx Data on File
Closing remarks Greg Madison
2018 Keryx Objectives Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Increase number of patients treated with Auryxia Drive rapid awareness of IDA indication and differentiate from existing treatment options Continued growth in dialysis Assess opportunity for Auryxia outside of nephrology Explore portfolio expansion opportunities
Strong Foundation to Build a Leading Kidney Care Company Copyright © 2018 by Keryx Biopharmaceuticals, Inc. Phosphate Management Anemia Management THANK YOU!
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