Title: NPS Corp Pres
1January 2008
2Safe Harbor Statement
- This presentation contains forward-looking
statements. These statements are based on
managements current expectations and beliefs.
Actual results could differ materially from those
described. Please refer to Company documents
filed with the SEC for a more detailed discussion
of risks. The Company is under no obligation (and
expressly disclaims any such obligation) to
update or alter its forward-looking statements,
whether as a result of new information, future
events, or otherwise. - January 2008
3The New NPS Delivering Value
- High-potential product pipeline
- Two Phase III compounds in multiple areas of
unmet medical need - Three IND-stage programs
- Experienced leadership team
- Strong financial profile
- Over 200 M in value from Cinacalcet royalties
- Over 130 in cash/short-term investments
4The New NPS 2007 Accomplishments
- Completed corporate restructuring
- Expect 08 burn of 35M - 45M
- Raised gt275M
- Retired 2008 convertible debt
- Completed Phase 3 GATTEX SBS study
- Executed GATTEX co-development agreement with
Nycomed - Strengthened leadership team
5The New NPS Experienced Leadership
6NPS Multiple Opportunities to Deliver Value
Product
Pre-IND
Phase 1
Phase 2
Phase 3
Commercial
Partner
cinacalcet
(Sensipar)
Amgen
Secondary HPT
(US/Europe)
Secondary HPT
(REGPARA)
Kirin
(Asia)
GATTEXTM
Nycomed
(ex-N.Am.)
SBS
Crohn's disease
CIGIM
NEC
Nycomed
PREOS
(ex-US)
Osteoporosis
(PREOTACT)
Hypoparathyroidism
calcilytics
GSK
(Worldwide)
Osteoporosis
NPSP156
CNS
7GATTEX Unique and Valuable Asset
- Analog of naturally occurring glucagon-like
peptide 2 (GLP-2) - Promotes GI mucosal regeneration
- Multiple potential indications with significant
unmet needs - Short bowel syndrome (SBS) Orphan Status
- Chemotherapy-induced GI mucositis (CIGIM)
- Necrotizing enterocolitis (NEC)
- Crohns disease
- Co-development with Nycomed
8GATTEX in SBS Study Overview
- 24-week dosing (0.05 or 0.10 mg/kg/d vs. placebo)
- Study enrollment
- 139 pts screened
- 83 pts randomized
- 71 pts completed the trial
- Efficacy measure
- Reduction in PN volume of 20
- Protocol required statistical significance in
high-dose group before evaluating low-dose group
9GATTEX in SBSPromising Efficacy Results
- PN discontinuation
- 2 low-dose subjects at week 16
- 1 high-dose subject at week 24
10GATTEX in SBS Excellent Safety Profile
- Comparable incidence of SAEs
- Placebo 31.3
- Low dose 37.1
- High dose 34.4
- Most common AEs include
- Abdominal distention and pain
- Nausea and vomiting
- Injection site bruising and erythema
- Headache
- Only AE with significant difference versus
placebo.
11GATTEX in SBS Path Forward
- Meeting with FDA Q1 2008
- Complete Phase 3-extension study Q1 2008
- If FDA accepts current data package, submit NDA
in Q3 2008 - If not, start confirmatory study ASAP
- Efficacy endpoint 20 reduction in PN
- Adequate sample size and power
- Total Cost Estimate - 25M to 30M over 3 yrs.
- Simplified study design to be discussed with FDA
12GATTEX Nycomed Partnership Accelerates Global
Development
- Nycomed granted rights to develop and market
GATTEX ex-N.Am. - NPS receives
- 35M upfront (includes 25M post data release)
- Double-digit royalties
- Up to 150M in additional payments for regulatory
approval of new indications and sales milestones - Nycomed pays 50 of joint external development
expenses
13GATTEX Addl Indications
- Necrotizing enterocolitis (NEC)
- Affects 12,000 neonates annually
- Mortality rate gt 50 in premature infants lt 1500
grams - No current treatment
- Pre-IND meeting with FDA in 2H 2008
- Chemotherapy-induced GI mucositis (CIGIM)
- Dose-limiting side effect of chemotherapy
- Affects gt 500,000 patients worldwide annually
- No current treatment
- Meeting with FDA in 2H 2008 to discuss Phase 2
program - Potential combined annual sales gt 500M
- Company estimate
14PREOS Osteoporosis Update
- After careful review, NPS has decided to focus on
hypoparathyroidism (HypoPTH) - Osteoporosis remains a viable opportunity
- PREOTACT performing well in Europe
- Good post-marketing safety record
- Requires US partner to assume cost and risk
15PREOS in HypoPTHA Low-Risk, High-Value
Opportunity
- FDA approved Orphan Drug status in Aug. 2007
- US prevalence 65,000 patients
- Symptoms Paresthesias, muscle spasms, peri-oral
numbness, altered mental status, tetany and
psychoses - Treatment options limited
- Lifelong Vitamin D analogues, high Ca diet, Vit
D2 and Ca supplementation - Some patients require permanent catheter for IV
Ca
16PREOS in HypoPTHA Low-Risk, High-Value
Opportunity
- PREOS could be first true PTH replacement therapy
- Chronic administration of native PTH (1-84)
intuitive - Low mechanism of action risk
- FDA granted Orphan Drug status in August 2007
- Worldwide annual sales could exceed 200M
17PREOS in HypoPTH Path Forward
- Dr. Bilezikian (Columbia U.) IIT ongoing
- NPS initiating pivotal registration study to
demonstrate safety and efficacy - Efficacy endpoints Eucalcemia, reduced
supplemental calcium and vitamin D analogues - 75 -100 patients 2 or 3 doses vs. placebo
- 8 to 10-week screening/stabilization
- 24-week dosing
- Study preparation started Expect data 2H 2010
- Total cost estimate 20 to 25M over 3 years
18Calcilytics (ronacaleret)GSK Partnership Update
- Target indication Osteoporosis
- Currently recruiting for Phase 2 dose-range study
in post-menopausal women - Efficacy endpoint BMD
- Two active comparators with placebo
- 520 patients
- 12-month dosing
- Study initiated May 2007
- 6 additional clinical studies ongoing
19NPS Financial Strength
- Cash/ST investments over 130M
- Adequate resources to fund late-stage studies
- Liquidity to fund over 2 years burn
- Modest debt 50M convert due 2014 (5.44
convert price) - Nycomed partnership expected to reduce GATTEX
development costs significantly - Cinacalcet royalties (US/EU) represent over 200M
additional value
20Cinacalcet Significant Value
- Sensipar
- NPS receives royalties from Amgen on US/EU sales
- Royalties monetized through non-recourse debt
with estimated repayment in 2012 - Royalties projected to accrue to NPS 2013
- NPV of royalties estimated over 200M or approx.
4/share - REGPARA
- NPS receives royalties from Kirin on Far East
sales - Approved in Japan Oct. 2007
- Kirin seeking pricing approval for 2008 launch
21Building Value in 2008 Key Milestones
- GATTEX in SBS
- Complete Phase 3-extension study by Q1 2008
- If FDA accepts current package, submit NDA Q3
2008 - If not, start confirmatory study ASAP
- GATTEX in additional indications
- Complete preclinical studies in NEC and CIGIM
- Initiate at least one FIM study 2H 2008
- PREOS in HypoPTH
- FPFV by 2H 2008
- REGPARA launch in Japan (Kirin)
22The New NPS Delivering Value
- Healthy balance sheet
- Multiple pipeline opportunities focused on unmet
medical needs - Strong partnerships with industry leaders
- Commercialized products
- Experienced leadership
23January 2008