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):
May 5, 2006
PDL BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-19756 | 94-3023969 | ||
| (State or other jurisdiction of incorporation) |
(Commission File No.) | (I.R.S. Employer Identification No.) |
34801 Campus Drive
Fremont, California 94555
(Address of principal executive offices)
Registrant’s telephone number, including area code:
(510) 574-1400
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 (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On May 5, 2006, PDL BioPharma, Inc. (“we” or the “Company”) will conduct a live webcast of our First Annual Business Update in New York City. The slides we will present in this webcast are attached as Exhibit 99.1 to this current report on Form 8-K and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 99.1 | PDL BioPharma, Inc. Business Update Presentation dated May 5, 2006 |
SIGNATURES
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.
Date: May 5, 2006
| PDL BIOPHARMA, INC. | ||
| By: | /s/ Andrew Guggenhime | |
| Andrew Guggenhime | ||
| Senior Vice President and Chief Financial Officer | ||
Exhibit 99.1
Business Update
May 5, 2006
PDL BioPharma, Inc.
Safe Harbor Statement
This presentation contains certain forward-looking statements, including those regarding product development, corporate and financial goals. While these represent our current judgment on the matters presented, they are subject to certain risks and uncertainties that could cause the actual results to differ materially from those presented. In addition to any factors that are discussed in this presentation, important factors relating to our revenues, product development, business and operations are described in our SEC filings which are available from the Company. The forward-looking statements made in this presentation should be considered accurate only as of the date of this presentation. Although we may elect to update forward-looking statements from time to time in the future, we specifically disclaim any duty or obligation to do so, even as new information becomes available or other events occur in the future.
All information, data and images provided in this presentation were prepared by PDL BioPharma, Inc. and remain the copyright of PDL BioPharma, Inc. No part of this presentation may be reproduced in any manner without the prior written permission of PDL BioPharma, Inc.
For more detailed prescribing information about PDL BioPharma, Inc.’s commercial products, please refer to the Company’s website at www.pdl.com.
© Copyright 2006, PDL BioPharma, Inc. All Rights Reserved.
2
PDL’s first business update
| 8:05 |
|
am Introduction and Overview |
Mark McDade, Chief Executive Officer
| 8:15 |
|
am Cardene® I.V. |
John Gill, Senior Director, North American Marketing
Kiwon Lee, MD, Thomas Jefferson University, Philadelphia
| 8:40 |
|
am Retavase® |
David Iwanicki, Vice President, Sales and Sales Operations
William Boden, MD, Hartford Hospital, Connecticut
| 9:05 |
|
am IV Busulfex® |
David Iwanicki, Vice President, Sales and Sales Operations
Claudio Anasetti, MD, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida
| 9:30 |
|
am Q&A |
| 9:50 |
|
am Financial Perspectives Andrew Guggenhime, Senior Vice President, Chief Financial Officer |
| 10:00 |
|
am Future Commercial Opportunities |
Jaisim Shah, Senior Vice President, Marketing and Business Affairs
| 10:15 |
|
am Q&A |
| 10:25 |
|
am Summary and Wrap-up |
Mark McDade, Chief Executive Officer
agenda
3
PDL BioPharma: poised for growth
Q2’05—Q1’06: our first commercial 12 months
Commercial focus on acute-care, hospital market
| 3 |
|
novel products marketed in US |
Deep, later-stage pipeline with six programs
New Phase 1 mAb for myeloma expected by Q4’06
Validated antibody platform; increasing royalties
Fully-integrated with over 1,000 employees
Global partners for 3 mid-stage products
Financially strong with diversified revenue streams
Positive non-GAAP earnings expected for full-year 2006
overview
4
Our aims for today
Review first year of commercial efforts, by product
Provide insight into our marketed product strategies
Provide an overview of key opportunities for our most advanced three pipeline products
Give you first-hand access to independent thought leaders involved in key product categories
Provide improved clarity on current product sales
aims for today
5
PDL’s revenue growth
25% CAGR aim for royalties/products from ‘05 to ‘08
Cardene I.V., Retavase, IV Busulfex, Net Sales Revenues
License and Other Revenues
Royalty Revenues
$279.7
$111.4
$130.1
$46.4
$40.4
$66.7
$52.7
$96.0
$83.8
$430-
$400
$185-
$175
$180-
$170
revenue growth
02
03
04
05
06E
6
Vision 2010: aiming higher
Reach #1
or #2 dollar market
share for marketed drugs
Expand commercial operations to Europe
Develop/launch
3 products
Terlipressin®
Nuvion®
Ularitide
In-licensed
Reach $1 billion
in total operating revenues by 2010
Deliver top and bottom line growth of > 25% annually
Multiple global partnerships
Deeper, stronger pipeline by 2010
7
How did we get commercial?
Built royalty stream from humanization technology licensed broadly
Developed robust pipeline of novel products
Focused PDL strategy on hospital-based approach
Purchased ESP Pharma, Inc. and Retavase to create a solid foundation for future pipeline success
Partnered non-hospital products to speed development, save commercial resources
getting commercial
8
PDL’s unique business strategy
A highly diversified revenue stream…
Product-based:
Create a strong foundation for future pipeline launches
Build acute-care, hospital audience competence
Focus promotional efforts on Cardene I.V., Retavase
Partner molecules in pipeline if outside hospital
Create strong hospital-based practices of excellence
Build Nuvion and ularitide in EU into acute-care, hospital setting
In-license to support key hospital franchises
Humanization platform:
Third party licensed royalty generation
Continue to seek partners for humanization licenses
Utilize platform and internal capabilities to attract product candidates
business strategy
9
A word about partnering
A core component of PDL growth strategy
Seek expertise, resources for products to be developed and marketed outside hospital
In addition:
For ularitide, add cardiovascular and new formulation competency
For Nuvion, consider new IBD approaches
For antibody partnering, seek ability to manufacture and sell into hospital
partnering
10
PDL’s new commercial team
Sales management and operations, based in NJ
105 talented hospital-based sales professionals
In-line marketing function based in NJ, focused on support of 3 marketed drugs:
Cardene I.V.
Retavase
IV Busulfex
New product planning, market research and marketing communications based in CA, focused on:
Terlipressin
Nuvion
Ularitide
new commercial team
11
PDL’s product overview
Cardene I.V.
Continuing rapid growth due to new penetration, uses
Use well-supported by guidelines, especially in neuro
Growth sensitive to promotion; awareness still on rise
Single largest sales driver from ’06-’08
Retavase
Regaining market share from TNKase
Emergency department, smaller hospital call
Supports sales force expansion for Cardene
IV Busulfex
Working to expand label and overseas potential
product overview
12
Products pave way for growth*
ED Physicians
Cardiologists
Neuro Critical Care
Critical Care
BMT Specialists
Hepatologists/ Gastroenterologists (Liver Specialists)
Nephrologists
Liver Transplant Specialists
Gastroenterologists
| * |
|
Future product launches and sales force estimates are based on company expectations as of May 02, 2006. |
products
13
Cardene® I.V.: Commercial Overview
John Gill, Senior Director North American Marketing
Cardene I.V.: key growth driver
Novel IV antihypertensive
Only rapid-onset IV antihypertensive agent that provides tight, targeted blood pressure control that is easily achieved and maintained
Broad opportunity across patients
AHA / Emergency Cardiac Care and ASA guidelines recommend as a first-line treatment
Opportunity for #1 position in hypertension related to stroke
Market Opportunity
3.1 million patients treated with IV HTN agents in US in 2005
Unit growth from additional hospital penetration and awareness
Cardene I.V.
15
Cardene I.V.: outpacing market growth
The total IV antihypertensive market continues to grow
The target market continues to grow
Cardene I.V. is leading the growth
% Growth 2004 vs. 2005
Total Market 5%
Target Market
(Cardene, sodium nitroprusside and labetalol) 12%
Cardene I.V. Units 46%
Cardene I.V. Gross Sales 62%
Source: 2004 and 2005 NDC data
Cardene I.V.
16
Campaign reinforces key advantages
In the treatment of acute hypertension choose IV therapy that is….
STEADY UNDER PRESSURE
Key messages
Consistent and reliable blood pressure control
Predictable titration for precise control
Targeted BP reduction
Well-documented tolerability and safety profile
Cardene I.V.
17
Cardene I.V. versus the competition
Safety
Fewer Dose Adjustments
Cardene I.V.
18
National guidelines support Cardene
Current AHA/ASA Treatment Guidelines for Ischemic Stroke
Cardene I.V.
Source: AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and American Stroke Association Guidelines for hypertension management of acute ischemic stroke
AHA / ASA Updates for Ischemic Stroke (2005) recommend Cardene I.V. (nicardipine) as first line therapy
Updated guidelines for ICH and SAH in development; last published in 1999 and 1994
BP Level (mm Hg)
Systolic blood pressure (SBP) <220 or DBP <120
SBP >220
or DBP >121-140
DBP >140
Recommended Treatment
No treatment unless end organ involvement
Nicardipine or labetalol to 10% - 15% in BP
Nitroprusside to 10% -15 in BP
19
Cardene I.V. unit sales
Continued Cardene I.V. growth based on three-month rolling average
450,000 400,000 350,000 300,000 250,000 200,000 150,000 100,000 50,000 0
total market
labetalol
sodium nitroprusside
Cardene I.V.
Mar 2004
Mar Mar 2005 2006
Source: 2004-2006 NDC data
20
Cardene I.V.’s segment growth
Cardene I.V.
Source: 2004 & 2005 Premier Rx Advisor DB
Cardene IV amps
2004
2005
neuro
cardiovascular
0
50,000
100,000
150,000
200,000
250,000
300,000
261,155
252,993
Parallel pathways to drive long-term growth…
21
Cardene I.V. quarterly sales trends
Sustained unit growth for Cardene I.V.
Strong hospital and patient demand based on NDC gross sales
Highly profitable brand based on net sales
Cardene I.V.
$20.1
Q205
$21.8
Q305
$25.5
Q405
$26.9
Q106
Source: Gross sales based on 2005-2006 Wolters Kluwer (NDC) data
$24.8
NDC gross sales ($MM)
net sales ($MM)
22
Retavase®: Commercial Overview
David Iwanicki, Vice President Sales and Sales Operations
Retavase: rebuilding an AMI franchise
Strategic fit for acute-care portfolio
Only fibrinolytic with unit-dose regimen
Meets ‘04 AHA/ACC AMI treatment guidelines
Addresses delay to PCI when hospital transfers don’t meet recommended “door-to-balloon” times
Emergency department target audience; entry for Cardene I.V. and in future, ularitide
FINESSE study currently underway in fPCI
Market Opportunity
1.5 million AMIs in US annually
Retavase
24
Campaign focuses on key attributes
Key Messages
Rapid reperfusion with convenient fixed dosing
No need to weigh patients
No estimating or rounding to a dosing tier
No dosing calculations, which may eliminate potential for errors
For the Way You Treat AMI Today…
Retavase Flows With You
Retavase
25
Retavase / TNKase promotion activity
Retavase
PDL now has a competitive share of detailing effort
Note: Promotion is hospital + office reported detailing
Source: IMS Health-integrated promotion services report
$0
$100,000
$200,000
$300,000
Q2 2005
Q3 2005
Q4 2005
Q1 2006
Retavase
TNKase
44%
19%
16%
81%
84%
2%
98%
56%
Audited details X estimated cost
26
Retavase taking share from TNKase
Three-month rolling average shows continued Retavase growth
60% 50% 40% 30% 20% 10% 0%
TNKase
Retavase
Feb 2005 Mar 2006
Retavase now positioned to impact key drivers Retavase taking share away from TNKase Positive trends in highly competitive marketplace
Source: Feb 2006 NDC Sales Data, unit market share, 3 months rolling
27
STEMI patient flow shows lytic need
Onset of Symptoms
34%
Non–PCI Capable Hospital
Only 60% received lytic
66%
PCI Capable Hospital
Go to Hospital
A portion transferred to PCI Hospital
30-33% of AMI patients didn’t get treated with a lytic or PCI
Source: SBR Quantitative Market Research, Jan 2006, N=300; GRACE & NRMI Registries
Retavase
28
Retavase quarterly sales trends
Market was flat Q1’06 versus 10% decline in ’05
Share of voice positions Retavase to compete aggressively
Full financial impact of product contracting being seen in Q4’05 and Q1’06
Retavase
Source: Gross sales based on 2005-2006 Wolters Kluwer (NDC) data
$14.0
Q205
$13.2
Q305
$12.7
Q405
$12.8
Q106
$5.8
NDC gross sales ($MM)
net sales ($MM)
29
IV Busulfex®: Commercial Overview
David Iwanicki, Vice President Sales and Sales Operations
IV Busulfex: a growing opportunity
Novel IV conditioning agent for stem cell transplantation for CML
Convenience over oral therapy due to reliability, control, dosing
Goal to be preferred agent in CML, with or without other therapies
Close collaborations with Pierre Fabre in EU and Kirin in Japan
Lifecycle management opportunities being considered
Market Opportunity
80% market share compared to 20% oral busulfan
Significant opportunity in US and non-US markets
IV Busulfex
31
IV Busulfex campaign in CML
For optimal HSCT conditioning for CML…
Control lies in the balance
Key messages
Provides dose assurance due to the 100% bioavailability and predictable PK profile
Dosimetry – allows for targeting of precise dose and exposure
Delivers controlled myeloablation
Low incidence of toxicity
IV Busulfex
32
Exploring broader transplant market opportunities
annual transplants
4,500
0
500
1,000
1,500
2,000
2,500
3,000
4,000
3,500
Breast Cancer
NHL
Multiple Myeloma
AML
ALL
CML
MDS/ Other Leukemia
CLL
Other Cancer
Neuro- blastoma
Hodgkin Disease
Non- Malignant Disease
Busulfex Indication (US)
Source: IBMTR, 2004
allogeneic (total N = 7,200)
autologous (total N = 10,500)
IV Busulfex
33
IV Busulfex quarterly sales trends
IV Busulfex continues to demonstrate strong sales
IV Busulfex
US gross sales ($MM)
Worldwide net sales ($MM)
$4.3
Q205
$4.6
Q305
$4.7
Q405
$4.5
Q106
$5.2
Source: Gross sales based on 2005-2006 Wolters Kluwer (NDC) data
34
IV Busulfex: our first global product
IV Busulfex
transplants (Asia): 2,700
transplants (Japan): 2,500
transplants: 25,000
Pierre Fabre
transplants: 18,000
North America
Europe
Asia, Japan
35
Financial Perpectives
Andrew Guggenhime, Senior Vice President and Chief Financial Officer
Q1’06 net product sales ($MM)
Total product sales of $36.8 million
products
Note: Gross sales data obtained from Wolters Kluwer are included in this presentation for illustration and comparison purposes. The gross sales data reported by Wolters Kluwer for a given product over a given period may differ signficantly from the net product sales. PDL may recognize for the same product during the same period.
NDC
net sales
NDC
net sales
NDC
net sales
Other (3%)
IV Busulfex (14%)
Retavase (16%)
Cardene I.V. (67%)
$26.9
$24.8
$12.8
$5.8
$4.5
$5.2
$1.1
37
Gross margin analysis
Product sales, gross
Cash discounts
Charge-backs
Government rebate programs
Returns
Wholesaler service fees
= Product sales, net
Cost of goods sold
Other
Royalty expenses
= Gross margin
cost of product sales
38
Future Commercial Opportunities
Jaisim Shah, Senior Vice President Marketing and Business Affairs
Large US markets, focused customer base
Liver Disease Market
Acute CV
Market
IBD Market
Pharmaceutical Market (US)
$1.8B1
$3.3B2
$1.75B2
Specialty Physicians
GEs/Heps
(2-5K)4
Heart failure experts
Intensivists3 (6K)
GEs/IBD Experts (5K)4
Targeted Indications and Patient Population5
HRS (14K)
ADHF (1M)
AMI (1M)
Hypertensive
Crisis (3M)
IBD (1M)
Source: 1 IMS, Datamonitor 2004, AGA (HBV/HCV/Liver Cirrhosis), 2 NDC 2005, 3 COMPACCS study; JAMA 2000, 4 AMA and Company Market Research, 5 Hospital Discharge Data
pipeline
40
PDL’s proprietary pipeline
| Terlipressin(1) |
|
Type 1 HRS |
| Nuvion® |
|
IV steroid-refractory UC |
Crohn’s disease (CD)
| Ularitide |
|
Acute decompensated heart failure (ADHF) |
| Daclizumab(2) |
|
Chronic, persistent asthma |
Multiple sclerosis (MS)
Transplant maintenance(3)
| M200(4) |
|
Solid tumors |
| HuZAF™(4) |
|
Rheumatoid arthritis (RA) |
1) Developed with Orphan Therapeutics; designated as an Orphan Drug program and granted Fast Track status
2) Partnered with Roche for asthma and other respiratory diseases; partnered with Biogen Idec for MS and other indications
3) Study anticipated to begin H2 ’06
4) Partnered with Biogen Idec for all indications
pipeline
P1
Disease Setting
P2
P2/3
P3
41
Terlipressin: opportunity in HRS
terlipressin
First potential treatment for type 1 hepatorenal syndrome (HRS)
FDA Fast Track and Orphan status
Enrollment completed in Phase 3 pivotal study; double-blind, placebo-controlled single trial
Primary endpoint: reversal of HRS
Secondary endpoint: creatinine levels, others
Top-line data anticipated Q3 ‘06
Possible presentation at AASLD in late October
PDL’s partner, Orphan Therapeutics, targets NDA filing Q1 ‘07
42
Type 1 HRS: US market estimates
terlipressin
Cirrhosis (hospitalized)
350 – 380 K
Chronic Renal Failure
(1%)
Acute Renal Failure
33 – 47 K
Pre-Renal Failure
30 – 41 K
Intrinsic/ Organic Renal Failure
(Acute Tubular Necrosis)
| 4 |
|
– 7 K |
Post-Renal Failure
(Obstructive)
(<1%)
Hypovolemia or Precipitating Event
(hemorrhage,
GI fluid loss,
diuretics, sepsis, shock)
17 – 23 K
Source: Literature Review, Premier Hospital Discharge Data 2003-2005, PDL market research
HRS Type 1
(12 – 34%)
10 – 13 K
HRS Type 2
(7 – 11%)
| 3—5 |
|
K |
| 43 |
|
HRS potential for terlipressin
Annual US hospital discharges for HRS*
A majority of in-patients with HRS are type 1
High mortality with current treatment**
No approved therapeutic options available for HRS in US
Source: *Solucient, **Gines, NEJM, 2004, *** Medicare Claims Analysis 1999 to 2000
terlipressin
2002
2003
2004
Inpatient discharges
11,379
13,361
14,237
44
| * |
|
Others include transplant (7), hemodialysis (6), misoprostol (3), etc. |
No treatments approved for HRS in US
Source: PDL Market research (n=150), Nov. 2005
For what percentage of your HRS patients are you using the following medications/treatments?
62%
45%
34%
27%
23%
18%
29%
Albumin
Octreotide + Midodrine
Dopamine
Octreotide alone
TIPS
Vasopressin
Others*
Q
Physician usage of available treatments in combination in HRS patients
terlipressin
45
Cost of HRS pharmacologic therapy
Source : Redbook 2004 and Gines 2004 (NEJM) Albumin Recommendations (Table 4)
Physicians use albumin in a majority of HRS patients, but albumin alone could cost up to $4,700 per course of therapy
terlipressin
* Assumptions: Dose: 1 g/kg on day 1, followed by 20-40g daily; Duration: 10-14 days; Weight: 70 kg (average); ~ $200 per 100 mL bottle of 25% albumin, which delivers 25g albumin
Therapeutic Regimen
Sandostatin (octreotide)
Midodrine
Albumin 25%*
$1,200
$1,800
$2,100
$4,700
46
Terlipressin: getting to US launch
Terlipressin for type 1 HRS reinforces acute-care, hospital focus
Commercial infrastructure ready for implementation by Q1’07
If approved, terlipressin will be the first and only drug for HRS in the US
Potential launch planned in mid-2007
Consider post-marketing development in other potential indications, including esophageal variceal hemorrhage (EVH)
terlipressin
47
Nuvion: promising activity in IVSR-UC
Potential first indication is treatment of IV steroid-refractory ulcerative colitis (IVSR-UC)
Majority of patients are between ages 25-45
High need for safe and effective agents to prevent relapse and disease progression in severe UC
Positive efficacy and safety results from Phase 1/2 programs of Nuvion in IVSR-UC
Pivotal program underway in UC; potential in Crohn’s disease
Ongoing Phase 2/3 trial called RESTORE 1 in patients with IVSR-UC
Oral presentation at DDW 2006 in May for preliminary data of Nuvion in CD
Nuvion
48
Nuvion: registration plan for IVSR-UC
| * |
|
Timelines reflect company estimates only |
2009
2008
2007
2006
2005
Mid ‘08 BLA
UC: Phase 3
Crohn’s disease pilots
Retreatment feeder
UC: Phase 2 / 3
Retreatment
Oral steroid-dependent UC
Pediatric UC
Nuvion
>50,000 IVSR-UC patients in the US and Europe
49
Nuvion in IBD: global opportunity
Nuvion
*Based on # of patients
NOTE: Estimates of EUROPE based upon France, Germany, Italy, Spain, and the UK
Source: CCFA 2005; EFCCA 2005; Decision Resources, Inc. 2003-2005; Data Monitor 2004
United States*
Total Severe
UC 500,000 100,000
CD 500,000 110,000
Europe*
Total Severe
UC 610,000 120,000
CD 500,000 110,000
Japan*
Total Severe
UC 34,000 7,000
CD 15,000 3,000
50
Cost of acute treatment for severe UC
Therapeutic
Regimen
IV Cyclosporine1
Remicade2
Cost per Course
of Therapy
~$750
$15,900 – $37,100
Therapeutic
Regimen
IV Steroids3
Total Cost of
Treatment
~$9,000
Average US single-stay colectomy costs $30,000 with 23-day length of stay
Nuvion
Sources: Redbook 2005; Lichtiger, S., et.al., NEJM, 1994; Swenson, B. et.al., Dis Colon Rectum, 2003
| 1 |
|
Assumptions: Dose: 4 mg/kg/day for 14 day course of therapy; Weight: 70 kg (average) |
2 Assumptions: Dose: 5 mg/kg or 10 mg/kg induction at 0, 2, and 6 weeks followed by maintenance every 8 weeks; range of 3 – 5 maintenance doses per course of therapy; Weight: 70 kg (average)
| 3 |
|
Daily dose of 300mg hydrocortisone IV per day; average length of stay 7 days |
| 51 |
|
Ularitide: a potential new treatment for acute decompensated heart failure
ularitide
Significant unmet need
European clinical data support safety and tolerability; show activity at multiple doses
Positive outcome from EMEA Scientific Advice received in late April ‘06 paves way for pivotal program H2 ‘06
US study to initiate H2 ‘06
PDL holds exclusive development and commercialization rights worldwide
52
Ularitide in ADHF: large global opportunity
NOTE: Estimates of EUROPE based upon France, Germany, Italy, Spain, and the UK
Source: Decision Resources, Inc.
United States (millions)
2012 2002
ADHF Incidence 1.0 1.3
Europe (millions)
2002 2012
ADHF Incidence 0.9 1.2
+3.0%
+2.7%
Japan (millions)
2002 2012
ADHF Incidence 0.25 0.30
ularitide
+2.3%
53
Current treatment of ADHF in the US
ADHF treatment paradigm
Cost of current course of therapy for nesiritide: $1,000—$1,600 in 2005
Source: AWP, WAC and Medicare; Average of 2.6 vials per patient, administered intravenously over an average of 2-3 days.
Diuretics
Inotropes
Vasodilators
Natriuretic Peptides (e.g., nesiritide)
+
54
Ularitide: Pivotal opportunity in EU
ADHF is the most common cause of hospitalizations for people over the age of 65
Around 75% of heart failure expenditure relates to in-patient care
Combined rate of mortality or readmission within 60 days post-hospitalization is around 35%
Natriuretic peptide (BNP) not available in major EU markets
Pivotal trials to commence in H2 ‘06
Two Phase 3 trials to enroll a total of 3,300 patients
Received written input from the EMEA Scientific Advice late April ‘06
Source: DR report 2005; ESC guideline for Acute Heart Failure 2005; EU Product Concept Testing in 2005
ularitide
55
New commercial opportunities
Strong pipeline opportunity to accelerate sales
Indication
Potential Patients
Potential
Launch
Terlipressin Type 1 HRS
> 10,000 –
13,000
Mid-2007
Nuvion
IVSR-UC
> 50,000
(US/Europe)
H2 2009
(US)
Ularitide
ADHF
2.5 million
(US/Europe)
H2 2010
(Europe)
new commercial opportunities
Wrap-up and Q&A
Q&A