Jefferies Healthcare Conference June 6, 2018
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1 Jefferies Healthcare Conference June 6, 2018
2 Forward-Looking Statements 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 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 forwardlooking 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 The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Copyright 2018 by Keryx Biopharmaceuticals, Inc. 2
3 Building a Leading Kidney Care Company Future MULTI-PRODUCT COMPANY Present ONE MEDICINE, TWO INDICATIONS Past ONE MEDICINE, ONE INDICATION Copyright 2018 by Keryx Biopharmaceuticals, Inc. 3
4 Leveraging Auryxia s MOA to Treat Two Common Complications Associated with CKD The ferric iron component binds to dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and excreted in the stool Phosphate Management Cit Fe Fe Fe Cit Fe Fe Cit Cit Cit Fe Cit Cit Cit The ferric iron/citrate component remains soluble in the GI tract enabling absorption and transport of the iron and eventual incorporation into hemoglobin Anemia Management Copyright 2018 by Keryx Biopharmaceuticals, Inc. 4
5 Auryxia (ferric citrate) Label INDICATIONS AND USAGE > Auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease, not on dialysis > Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis Copyright 2018 by Keryx Biopharmaceuticals, Inc. 5
6 GFR (ml/min) Auryxia Offers Continuity of Care Stage 1 Stage 2 Often not diagnosed Patients typically under care of PCP Iron deficiency presents Patients typically under care of PCP Hemoglobin levels progressively fall Stage 3 Stage 4 Stage 5/5D Progressing patients typically referred to nephrologist Advanced disease with multiple complications requiring more intensive management Prepare for renal replacement therapy Patients initiate dialysis Auryxia can treat patients at every stage of CKD* Phosphorus levels progressively rise 10 0 Below normal to mild loss of kidney function Mild to moderate loss of kidney function Moderate to severe loss of kidney function Severe loss of kidney function Kidney failure *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. 6
7 Today s Focus: Nephrology Nephrologist care for >1.4 million people who could potentially benefit from treatment with Auryxia 2.2 million under care of nephrologist 70,000 - Dialysis not on Binder 30 million people in U.S. with CKD 700,000 Non-dialysis CKD (untreated) 27.8 million not under care of 0.8 million 1.4 million 400,000 Non-dialysis CKD, Iron Deficiency Anemia (untreated) nephrologist 650, 000 Non-dialysis CKD, Iron Deficiency Anemia (treated) 380,000 Dialysis (treated with binder) Source: Keryx Data on File Copyright 2018 by Keryx Biopharmaceuticals, Inc. 7
8 Today s Focus: Nephrology Our Market Approach to Hyperphosphatemia Hyperphosphatemia, on Dialysis 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) 2017 Quarterly Auryxia Market Share 4.5% 4.0% 3.5% 3.0% 2.5% 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 2.0% 1.5% 1.0% 0.5% 0.0% 1Q17 2Q17 3Q17 4Q17 Sources: DOPPS, Keryx data on file, Cosmos study data, Case-study data at ASN 2016 Copyright 2018 by Keryx Biopharmaceuticals, Inc. 8
9 Today s Focus: Nephrology Our Market Approach to Iron Deficiency Anemia Iron Deficiency Anemia, not on Dialysis Primary Endpoint 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 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 Sources: DOPPS, Keryx data on file, Cosmos study data, Case-study data at ASN 2016 Copyright 2018 by Keryx Biopharmaceuticals, Inc. 9
10 First Quarter Business Highlights
11 First Quarter 2018 Business Highlights > Commercial progress Auryxia prescription demand increased 118% compared to 1Q17; revenue increased 96% Invested heavily in iron deficiency anemia launch in first quarter of 2018 Promotionally sensitive market - Frequency of contact and samples are drivers of prescribing > Restructured Baupost convertible senior notes due 2020 $10 million of additional capital; extends maturity date to 2021 Now allows for up to $40 million asset-based revolving line of credit facility Copyright 2018 by Keryx Biopharmaceuticals, Inc. 11
12 Prescriptions $ in Millions First Quarter 2018 Prescription and Revenue Growth > 118% growth in prescriptions compared to 1Q17 Binder market flat to Q4 > 96% growth in net product revenue compared to 1Q17 1Q18 gross-to-net adjustment: 50% > IMS/Specialty Mix for 1Q18: 59/41 > Tablets per prescription in 1Q18: ,000 30,000 25,000 20,000 15,000 10,000 5,000 Quarterly Prescription Demand Quarterly Net Product Revenue 0 1Q17 2Q17 3Q17 4Q17 1Q18 0 1Q17 2Q17 3Q17 4Q17 1Q18 Copyright 2018 by Keryx Biopharmaceuticals, Inc. 12
13 Prescriptions Tablets (in millions) End of 1Q Momentum Continued in April 15, ,500 Trx Pill Count , , , , Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr Sources: IMS Weekly data; Davita Rx and Fresenius Rx Copyright 2018 by Keryx Biopharmaceuticals, Inc. 13
14 Commercial Progress for the Auryxia Brand (compared to 1Q17) More Physicians Prescribing Auryxia Greater Depth of Prescribing Significant Increase in Auryxia Prescriptions >2000 New Auryxia prescribers 34% Increase in prescriptions per prescriber 118% Increase in prescriptions Copyright 2018 by Keryx Biopharmaceuticals, Inc. 14
15 % of HCPs Success Moving Physicians Along Adoption Curve Sales Dynamics > Significantly increased the number of high-prescribing physicians > Expect to move more physicians along this adoption curve > Clinical familiarity, broad formulary coverage and availability of samples should accelerate this curve in iron deficiency anemia Physicians Representing 50% of Auryxia Volume 100% 90% 80% Market Share 70% 0%-5% 60% 5%-10% 10%-15% 50% 15%-20% 40% 20%+ 30% 20% 10% 0% 1Q15 1Q16 1Q17 1Q18 Copyright 2018 by Keryx Biopharmaceuticals, Inc. 15
16 Auryxia Market Share Promotionally Sensitive Market Frequency of Contact and Samples Drive Prescribing Drivers of Prescribing > Continuous brand presence correlates to increased prescribing > Samples are a leading indicator of prescribing behavior >75% of physician sampled in 4Q17 wrote an Auryxia prescription in 1Q18 Significant increase in market share with prescribers who received samples vs. those who did not > 30% increase in physicians sampled in 1Q18 vs. 4Q Q18 Auryxia Market Share 0 Not Sampled Sampled Copyright 2018 by Keryx Biopharmaceuticals, Inc. 16
17 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 Sources: Spherix 4Q17 Anemia in CKD Syndicated Research; aided brand awareness data. Copyright 2018 by Keryx Biopharmaceuticals, Inc. 17
18 Commercial Summary > During 1Q18, we laid the foundation for trial and adoption in iron deficiency anemia, executing against our launch objectives Drive rapid awareness of the iron deficiency anemia indication - Syndicated market research indicates that ~90% of nephrologists are aware of Aurxyia s indication for iron deficiency anemia Differentiate Auryxia from existing treatment options - Since 4Q17, the number of nephrologists who are extremely satisfied with Auryxia as a treatment for iron deficiency anemia in CKD has increased by 70% - The majority of physicians surveyed believe Auryxia is a clinical advance over traditional oral iron > Important that we continue to grow hyperphosphatemia business while gaining traction in iron deficiency anemia Sources: Spherix Global Anemia 1Q Pulse; aided awareness data Copyright 2018 by Keryx Biopharmaceuticals, Inc. 18
19 Future Opportunity Auryxia s Expanded Label Supports Reach Beyond Nephrology Growth Opportunity ~14 million people with CKD not under care of nephrologist are iron deficient Potential to extend reach to nonnephrology targets Source: Keryx Data on File Copyright 2018 by Keryx Biopharmaceuticals, Inc. 19
20 2018 Keryx Objectives > Increase number of patients treated with Auryxia in both hyperphosphatemia and iron deficiency anemia indications > Assess opportunity for Auryxia outside of nephrology > Explore portfolio expansion opportunities Copyright 2018 by Keryx Biopharmaceuticals, Inc. 20
21 Strong Foundation to Build a Leading Kidney Care Company Anemia Management Phosphate Management 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. 21
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