keryx biopharmaceuticals march 2015
DESCRIPTION
Keryx BiopharmaceuticalsCorporate PresentationTRANSCRIPT
NEW YORK Keryx Biopharmaceuticals, Inc. 750 Lexington Ave., 20th Floor New York, NY 10022
1.212.531.5965 tel 1.212.531.5961 fax
www.keryx.com
BOSTON Keryx Biopharmaceuticals, Inc. One Marina Drive, Tenth Floor Boston, MA 02210
1. 617.466.3500 tel 1. 617.466.3501 fax
At Keryx, the patient comes first. Our goal is to bring innovative therapies to market that provide unique and meaningful advantages to patients with renal disease and their healthcare providers – because we know that
when patient care improves, everybody succeeds.
Copyright © 2015 by Keryx Biopharmaceuticals, Inc.
NASDAQ: KERX | March 2015
Keryx Biopharmaceuticals Corporate Presentation
Safe Harbor Statement
1
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 launched and marketed in the U.S.; whether Riona® will be successfully marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the risk that the EMA may not concur with our interpretation of our Phase 3 study results, supportive data, conduct of the studies, or any other part of our MAA submission and could ultimately deny approval of the MAA; the risk that we may not be successful in the development of ferric citrate 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.
Keryx’s Evolution
2
2014 + 2011- 2013 1998 - 2011
Fully integrated,
commercial, specialty
pharmaceutical company
Data-driven organization;
regulatory focused
Early-stage development
company
• Keryx strengthened its leadership team early in 2014 to ensure a successful transition to a commercial organization
• Keryx has undergone a well-executed transition from development-stage to a fully integrated commercial entity in a very short period of time.
• 2015 is a logical transition point for the leadership of Keryx • Announced earlier this year that we are transitioning CEO position to Greg Madison
by the end of May
The First and Only Absorbable-Iron-Based Phosphate Binder
• Approved on September 5, 2014, by the U.S. Food and Drug Administration (FDA) – INDICATION: For the control of serum phosphorus levels in patients with chronic kidney
disease (CKD) on dialysis
• Auryxia Launched in US late December 2014 – Ferric Citrate is currently being marketed in Japan, under the trade name Riona®, by the
Company’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
• Additional potential growth areas for Ferric Citrate – Label expansion: Iron deficiency anemia in non-dialysis dependent chronic kidney disease – Geographical expansion: EU and emerging markets
3
3 2 1
Binds to dietary
phosphate
This compound is insoluble,
and is excreted in the stool
Increases serum iron parameters though systemic
absorption
The First and Only Absorbable-Iron-Based Phosphate Binder
4
Chronic Kidney Disease in the U.S.
5 Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 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; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year.
We believe that the CKD patient community is underserved and are committed to bringing new therapies to market for patients with renal disease.
• 70%-80% on phosphate binders
• Majority on PB and IDA treatment 450,000
on Dialysis
16 million with Stage 3 – 5 NDD-CKD
26 million U.S. Adults with CKD
The Dialysis Patient
• Dialyzed 3 times per week; ~3 hours per session
• Take multiple medications – Prescribed 8 - 15 different medications – Receive multiple IV drugs during dialysis session (including IV iron, ESAs, vitamin D,
antibiotics, etc.)
• All parameters monitored regularly (including iron parameters)
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• MINERAL BONE DISEASE
• ANEMIA
• CARDIOVASCULAR DISEASE
• DIABETES
Dialysis Providers Operate Under a Bundled Payment System
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Bundled Payment
Dialysis Centers CMS
• Dialysis providers receive ~$240 per patient, per dialysis session • Injectable drugs (IV iron, ESAs and Vitamin D) are included in the bundled
payment
• Providers reimbursed based on achievement of quality care metrics
• Economic pressures to become more efficient in care • Oral phosphate binders excluded from the bundle until 2025
-
500,000
1,000,000
1,500,000
2,000,000
2,500,000
3,000,000
Tota
l Pre
scrip
tions
(TR
x)
Phosphate Binder Annual Prescription Volume*
U.S. Phosphate Binder Market is >2.5M Scripts Per Year
8
Notes: * IMS NPA excludes non-retail suppliers that do not report to IMS. **Company estimates total market including prescriptions filled through channels not captured by IMS. Source: IMS New Product Spectra; IMS NPA (Rolling 12 Months through November 2014)
Current U.S. market estimated at 2.6 million prescriptions/year**
IMS Data
NEW YORK | BOSTON | WWW.KERYX.COM
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Commercial Launch
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Auryxia Launch Update
10
APPROVAL TO LAUNCH
LAUNCH
• Priced: $4.21/tablet • Hired and trained field force
• 60 territories • Formulary reviews begin • Promotional campaign finalized • Trade name approved: November 17
• Reps in Field: December 8 • Drug in channel: December 22 • Base of payer coverage
established • Formulary reviews continue • Keryx Patient Plus launched
Commercial Team Focused on All Stakeholders
11
THE PAYER THE PHYSICIAN
and DIALYSIS CARE TEAM
THE PROVIDER
INFLUENCER INFLUENCER
Auryxia Sales Process
Confidential 12
Nephrologist – Practice
Renal Care Team – Dialysis Unit
Nephrologist – Dialysis Unit
• Drive awareness and clinical understanding of Auryxia • Gain “permission” to educate dialysis unit staff • Identify patient types to discuss with dietician
• Drive awareness and clinical understanding of Auryxia • Perform individual and in-service presentations • Identify specific patients • Initiate patient access process
• Prescription written
Reimbursement Driven by Part D and Commercial Plans
Medicare Part D • Medicare Part D plans cover ~60%
of dialysis patients ~2/3rds of these patients are LIS
eligible • Top 15 Part D plans cover 95%
of patients • All formulary reviews scheduled
to take place by end of April • 6 Part D formulary wins to date
Commercial Insurers • Commercial carriers cover ~30%
of dialysis patients • Top 15 payers/PBMs cover majority
of commercial patients • Non-preferred brand placement on
majority of formularies • Co-pay assistance in place to
ensure patient access to Auryxia
13
2011 Point Prevalent Dialysis Population (433,000 patients)
2012 – Estimated Drop-out Population (Transplant, Death, Lost to Follow-up)
(95,000 patients)
2012 Incident Dialysis Population (112,000 patients)
Dialysis Prevalence and Turnover
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2012 Point Prevalent Dialysis Population (450,000 patients)
GAIN 25% of patients
LOSS 21% of patients
TURNOVER
Source: U.S. Renal Data System, USRDS 2014 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2014.
Sources of Business
15
NEW PATIENTS New to Dialysis
• Patients are likely not yet on a competitive phosphate binder
• 25% of dialysis patients start PBs each year • First target for representative
PROACTIVE SWITCH Patients Being Switched From Current Binder due to AURYXIATM Benefits
• Patients may be well controlled on a phosphate binder • Nephrologists generally only switch for negative reasons • Due to the pharmacodynamic properties of Auryxia,
Nephrologists may decide to proactively switch from the currently prescribed phosphate binder
REACTIVE SWITCH Patients Being Switched From Current Binder due to Concerns
• Approximately 20% of prevalent patients are switched from one phosphate binder to another
• Reasons for switches: lack of efficacy, concern about calcium levels, GI side-effects
• Logical for Auryxia utilization
Patient Assistance Program in Place
16
Anemia Manager
Nurse/ PA Dietician Social
Worker
Key Areas of Focus for Launch – Year 1
• Drive brand awareness • Establish unique positioning and differentiation • Data generation to support brand strategy • Create broad access through payers • Ensure patient ‘affordability’ through access programs • Establish Keryx as a renal focused specialty company
21
NEW YORK | BOSTON | WWW.KERYX.COM
Photo Here
Growth Opportunities
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Chronic Kidney Disease in the U.S.
19
450,000 on Dialysis
• >10% with iron deficiency anemia
• Majority untreated
16 million with Stage 3 – 5 NDD-CKD
26 million U.S. Adults with CKD
We believe that the CKD patient community is underserved and are committed to bringing new therapies to market for patients with renal disease.
Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 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; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year.
Potential Indication Expansion: Treatment of Iron Deficiency Anemia in pre-dialysis CKD Patients
• Phase 2 study evaluated Ferric Citrate as a phosphate binder and as an oral iron treatment for iron deficiency anemia in NDD-CKD patients (Stage 3 to 5, pre-dialysis)
– Multicenter, randomized, double-blind, placebo-controlled study – 149 patients enrolled, 12-week treatment period – No IV iron or ESAs permitted during the study, with a washout from both agents preceding
the study
• Successfully completed – met primary and key secondary endpoints with high statistical significance
20
Placebo (n=69) Ferric Citrate (n=72) P-value Baseline EOT Baseline EOT
Phosphorus (mg/dL) 4.7 4.4 4.5 3.9 <0.001 TSAT (%) 21 20 22 32 <0.001 Ferritin (ng/mL) 110 106 116 189 <0.001 Hemoglobin (g/dL) 10.6 10.4 10.5 11.0 <0.001 Intact FGF-23 (pg/mL) 263 293 319 200 0.017
Clinicaltrials.gov identifier: NCT02128074
Iron Deficiency Anemia Phase 3 Trial
Study Initiated in September 2014 • ~230 stage 3 – 5 CKD patients with iron deficiency anemia
– 50% enrolled as of February 21st
• Primary endpoint: % of patient that achieve a 1 g/dL or greater increase in hemoglobin at any point during the 16-week randomization period
• 2-month safety follow up period, for a total of 24 weeks • IND filed with Hematology/Oncology Division of FDA for this trial
21 Clinicaltrials.gov identifier: NCT02268994
Potential Role of Auryxia in Treatment of CKD patients
• If successfully developed and approved, administration earlier in the CKD patient journey for the treatment of iron deficiency anemia could significantly enhance the value proposition of Auryxia for all stakeholders
22 *Stages are illustrative of progression of BMD in CKD patients.
Stages 3 & 4*: Iron deficiency presents as CKD progresses
Stage 5*: Phosphorus increases as patients get
closer to dialysis
Dialysis: Average patient is dialyzed 3 days a week for the rest
of their lives.
TODAY: Majority of pre-dialysis patients are under the care of a nephrologist, but IDA is typically untreated.
Patients typically enter dialysis and need to endure several invasive procedures and medications.
If approved for pre-dialysis patients, Auryxia has the potential to address iron deficiency anemia.
As patients phosphorus levels begin to rise, Auryxia dosing would be adjusted to control serum phosphorus levels.
Our goal would be to have patients treated earlier so they come into dialysis with their iron levels replete and the phosphorus levels in control. Auryxia dosing would potentially continue throughout dialysis.
2015 Company Milestones
• Successfully launch Auryxia in the US
• Create broad unrestricted access for Auryxia through rolling formulary wins
• Complete Phase III pre-dialysis IDA trial
• EU marketing authorization decision expected mid-2015
23
NEW YORK Keryx Biopharmaceuticals, Inc. 750 Lexington Ave., 20th Floor New York, NY 10022
1.212.531.5965 tel 1.212.531.5961 fax
www.keryx.com
BOSTON Keryx Biopharmaceuticals, Inc. One Marina Drive, Tenth Floor Boston, MA 02210
1. 617.466.3500 tel 1. 617.466.3501 fax
At Keryx, the patient comes first. Our goal is to bring innovative therapies to market that provide unique and meaningful advantages to patients with renal disease and their healthcare providers – because we know that
when patient care improves, everybody succeeds.
Copyright © 2015 by Keryx Biopharmaceuticals, Inc.
NASDAQ: KERX | March 2015
Keryx Biopharmaceuticals Corporate Presentation