Slides to be shown during investor and securities analyst presentations

EX-99.1 2 dex991.htm SLIDES TO BE SHOWN DURING INVESTOR AND SECURITIES ANALYST PRESENTATIONS Slides to be shown during investor and securities analyst presentations

Confidential ©

Pharsight

Corporation

Pharsight Corporation

Investor Presentation

February 2006

Shawn O’Connor

President & CEO

Exhibit 99.1

Forward-Looking Statements

This press release includes forward- looking statements, including statements regarding our financial

model, growth opportunities and strategic investments, our market position, the demand and market

opportunity for our products and services, financial and product

developments or performance, expected

benefits to customers from the use of our products, our customer

base and our expectations for revenue,

net cash flow, gross margin and net income for the fiscal year ending March 31, 2006. These forward-

looking statements involve risks and uncertainties, and factors that could cause actual results to differ

materially include the following: uncertainties involved in pharmaceutical drug development, changes in

government regulation of the pharmaceutical industry, changes in

the demand for our products and

services, changes in our research and development focus or operating strategies, the failure to develop

new products and services or to keep pace with technological changes, the failure of the market for our

products and services to develop as expected, or for new customers beyond large pharmaceutical

customers, who form a large component of our client base, to adopt our solutions, and the failure of our

products and services to meet customer’s expectations. Actual releases of future versions of our

software, including any new features and/or functionality that may be included therein, will be on a

when-and- if available basis only, and whether any new version will actually be made available remains at

the sole discretion of Pharsight.

Pharsight is under no obligation whatsoever to release any new versions of its software at any time.

Further information on potential factors that could affect actual results is included in Pharsight’s

Quarterly

Report

Form

10-Q,

filed

with

the

Securities

and

Exchange

Commission

November

14,

2005.

All

forward-looking

statements

are

based

information

available

Pharsight

the

date

hereof, and Pharsight assumes no obligation to update such statements, whether as a result of new

developments or otherwise.

Profile

•

Background

–

Founded 1995; IPO August 2000

–

Headquarters -

Mountain View, CA

•

Satellite office -

Cary, North Carolina

–

Headcount -

approx 90

•

US, Europe, Australia

–

OTCBB: PHST

•

Key Considerations

–

Large Pharma drug development marketplace

–

Modeling & simulation moving beyond first adopter environment

–

Leverageable software and professional service business models

Pharsight Enables Strategic Decision

Making in

Clinical Drug Development

•

Market-leading software

improves the value and availability

of clinical pharmacology data for PK/PD modeling, analysis and

reporting, PK data repositories, and clinical trial simulation

–

Decisions are faster, more reliable and more robust

•

Strategic consulting

based on quantitative, predictive

models improves the quality, visibility, and therefore the value

of critical drug development decisions

–

Decisions explicitly account for the interaction of treatment, patient

population, endpoint, risk, cost and benefit

–

Decisions can create better trials, better portfolios and ultimately

higher market value

Executive Team

Shawn O’Connor

President & Chief Executive Officer

QRS, Diasonics Ultrasound, Peat Marwick

TBH

Chief Financial Officer

James Hayden

SVP Global Sales

Accelrys, Bio-Rad Laboratories, Raytheon

Mark Hovde

SVP Marketing

Hovde Associates, Fast Track Systems, DataEdge

Mona Sowiski

SVP Drug Development Consulting Services

Mitchell Madison Consulting, CSC/APM Healthcare, Stanford, Pitt

Daniel Weiner, PhD

SVP Software Products

IVAX, Merrell Dow, Syntex, Quintiles

William Gillespie, PhD

VP & Lead Scientist, Consulting Services, East Coast

GloboMax, FDA (CDER), Univ. of Texas at Austin-College of Pharmacy

Greg Lee, PhD

VP Research & Development

Sunrise Test Systems, Weitek, Schlumberger

Nancy Risch

VP Global Sales

BBN Corporation, Interleaf, GE, Wang

Russ Wada, PhD

VP Consulting Services, West Coast and Japan

Stanford, MiniMed Infusion Systems, Hughes Aircraft, TRW

Rene Bruno, PhD

Managing Director, Consulting Services, Europe

Genentech, Rhone-Poulenc Rorer, Syntex

Our Market Opportunity:

Drug Development Cost and Timeline

2002 Estimated Global Pharma and Biotech R&D Spending by Category: BioPharm International, March 2003

PhRMA 2003 Industry Profile, March 2003

Bain & Co, December 2003

Research

$25 Billion

Significant Productivity

Increase and Investment

Clinical Development

$48 Billion

Productivity Continues

To Decline

•

High throughput screening

•

Combinatorial chemistry

•

Genomics

•

Rational drug design

•

Long, risky and complex

process

•

Of 5,000 screened

compounds, 250 enter

preclinical testing, 5

enter clinical testing,

1 is approved by FDA²

•

Avg

cost to develop new

drug $802M² –

$1.7B³

•

Only 3 out of 10 drugs

produce revenues that match

or exceed R&D costs²

Our Market Opportunity:

Development Expenditure Estimates

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

$70,000

$80,000

2003

2004

2005

2006

2007

2008

Branded Pharma

Generics

Biotech

2003 –

2008 CAGR

Branded Pharma 8.6%

Generics

22.6%

Biotech

2.7%

Total Pharma 11.0%

Development Expenditure by Segment & Product Development Phase:

Jefferies & Company -

Jefferies Pharmaceutical Services Quarterly

Preview –

January 19, 2005

Our Market Opportunity:

Increasing Drug Failure Rates

•

Decreasing FDA Approval Rates

–

Chance of drug successfully reaching FDA approval from Phase I has

rapidly decreased

•

Today = 8% approval rate¹

•

25 Years Ago = 14% approval rate¹

•

Impact of Shifting Failure Rates to Earlier Phases

–

Shifting 5%

of failures from Phase III to Phase I = $20M

reduction in

drug development costs¹

–

Improving ability to predict failure by 10%

before beginning clinical trials

= $100M

reduction in drug development costs¹

Pacific Research Institute –

Peter J. Pitts, Challenges and Opportunities in Health Care, Financial Times

Global

Pharmaceutical Conference, October 18-19, 2004

Return on Investment Example

Aventis turned to a computer model from …

Pharsight. Using its own

animal and human test data, Aventis was able to simulate later-stage

clinical trials. Based on that simulation, “we stopped funding development

of the compound. The ratio between the therapeutic benefit and side effect

demonstrated that this compound was not as beneficial as Evista.”

Douglas estimates that the Pharsight computer model saved Aventis $50M

to $100M, the cost of later-stage clinical trials. “We were able to switch to

another project with a greater chance of success.”

Frank Douglas, former Aventis Chief Scientific Officer and Executive VP of Drug Innovation &

Approval

Forbes ASAP, 10/7/02

Faster failure

Higher productivity

sanofi-aventis

Return on Investment Example

“Within 2 years of (implementing Pharsight’s WinNonlin automation and other

measures) the two people conducting the routine pharmacokinetic studies

had completed 45 studies in 1 year.”

(previous staff of 19 for the same work)

“The cycle time to issue final reports decreased from 16 months on average

to less than 3 months.”

Richard Lalonde, PharmD, Executive Director, Department of Clinical Pharmacokinetics and

Pharmacodynamics, Pfizer Global Research and Development, Ann Arbor, Mich. et al,, from

the

International Journal of Pharmaceutical Medicine 18 (1): 13-17

Higher productivity

Faster cycle times

Pfizer

Confidential ©

Pharsight, Inc.

Software Products

•

Desktop Software Products

–

WinNonlin

(“WNL™”)

•

Industry Standard for Pharmacokinetic (“PK”), Pharmacodynamic (“PD” ) Modeling and

Non Compartmental Analysis

–

Trial Simulator™

(“TS2™”)

•

Computer Assisted Clinical Trial Design & Simulation

–

WinNonMix

(“WNM™”)

•

Population Pharmacokinetic Modeling & Simulation

•

Pharsight

Knowledgebase Server™

(“PKS™”)

–

Enterprise Data Management Systems for Secure Storage and Management of PK/PD

Data

•

Drug Model Explorer™

(“DMX™”)

–

Software-Based Communication Technology,

Designed to Facilitate Quantitative

Decision-Making in Drug Development

Overview of Key Software Offerings

Key Software Offerings

WinNonlin

(“WNL™”)

Industry Standard for Pharmacokinetic (“PK”), Pharmacodynamic (“PD ”)

Modeling and Non Compartmental Analysis

•

Key Benefits

–

Used to simulate effects of different dosing regimens and changes in

pharmacokinetic parameters required in regulatory submissions

–

Increases productivity in modeling, analysis and reporting activities

•

Potential Growth Drivers

–

Maintain market share under current subscription model via renewals

–

Provide upgrade path to support incremental new revenue opportunity

•

Sales Model

–

Subscription license model

–

Low-cost inside sales force

–

Distributor in Asia

•

ASP = $5,000

State-of-the-Art Clinical Trial Design & Simulation Software

•

Market Opportunity

–

Total opportunity estimated by Pharsight at approx $29 million

25% market share = $7 million

50% market share = $15 million

75% market share = $22 million

•

Key Benefits

–

Minimize risk of trial design

–

Formalize assumptions

–

Quantify uncertainty

–

Reduce cost of clinical trials and drug development time-to-market

•

Growth Drivers

–

Increase potential interoperability with other Pharsight tools

•

Sales Model

–

Subscription license model

–

Low-cost inside sales force

–

Distributor in Asia

•

ASP = $16,000

Key Software Offerings

Trial Simulator™

2.0

(“TS2™”)

Key Software Offerings

WinNonMix

(“WNM™”)

Nonlinear Mixed Effects (Population) Analysis Software Application

•

Key Benefits

–

Extensive built-in library of PK, PD and PK-PD models

–

NONMEM data import wizard

–

Built-in report-ready graphics capability

–

Estimation algorithms for sparse and for rich data sets

–

Maximum likelihood or restricted maximum likelihood

•

Growth Drivers

–

Increase interoperability with other Pharsight tools

–

Provide upgrade path, expanded utility

•

Sales Model

–

Subscription license model

–

Low-cost inside sales force

–

Distributor in Asia

•

ASP = $7,000

Key Software Offerings

Pharsight

Knowledgebase Server™

(“PKS™”)

Enterprise Data Management Systems for Secure Storage and Management of PK/PD

Data

•

Market Opportunity

–

Total opportunity estimated by Pharsight at approx $187 million

25% market share = $47 million

50% market share = $94 million

75% market share = $140 million

•

Key Benefits

–

Dramatically improves data management and data access

–

Increases productivity in analysis and reporting tasks

–

Supports compliance with FDA requirements for electronic records

and signature,

CFR 21 part 11

•

Potential Growth Drivers

–

Installed base of current large pharma clients –

expand seat count within current

clients

–

Optimize adoption pattern of industry

–

Provide upgrade path, expanded utility

•

Sales Model

–

Subscription and perpetual license model

–

Software license plus services

–

Direct sales force

•

ASP = $10,000 per seat

Key Software Offerings

Drug Model Explorer™

(“DMX™”)

Software-Based Communication Technology, Designed to Facilitate

Quantitative Decision-Making in Drug Development

•

Market Opportunity

–

Total opportunity estimated by Pharsight at approx $33 million

25% market share = $8 million

50% market share = $17 million

75% market share = $25 million

•

Key Benefits

–

Facilitates more efficient collaboration within project teams to

explore key

drug attributes, and their respective uncertainties

–

Enables more flexible scenarios & generates views of program data from

underlying model outputs & simulated responses over defined problem-

space

•

Potential Growth Drivers

–

Expand client base of early adopters

–

Expand utility and footprint of application

–

Increase interoperability with other

Pharsight tools

–

Bundling with strategic consulting services

•

Sales Model

–

Subscription and perpetual license model

•

Over 1,000 customers as of December 31, 2005

•

All Top 50 Pharma²

license at least one of our software products

•

Our software applications are licensed for use on more than 3,500

desktops in industry, more than 3,300 desktops in academia

•

4 of the Top 50 Pharma²

are DMX

customers

•

9 of the Top 50 Pharma²

are PKS

customers

–

14 active PKS™

customers

–

Over 500 active seats

Software Products

Market Acceptance¹

As of December 31, 2005

Pharma Exec 50: Pharmaceutical Executive, May 2005

Confidential ©

Pharsight,

Corporation

Strategic Consulting Services

Strategic Consulting Services

Formal, quantitative,

model-based decision-making

method

Increases drug development productivity

Decreases late stage attrition

Decreases time-to-market

Reduces financial investment

Improves clinical quality and commercial

performance of final product

Quantitative Modeling Supports Both Trial-

and Program-Level Decisions

Animal

PK Data

Human

PK Data

Treatment,

Exposure

Patient

Endpoints

Trial

Outcomes

Market

Acceptance

Drug and Patient Models

Trial Models

Market Models

•

Optimize treatment

regimens and

patient populations

for the market and

for a trial

•

Compare probable

safety and efficacy

of new drug to

competitors

•

Match trial design to

the purpose of the

trial

•

Optimize design via

clinical trial

simulations

•

Choose the decision

path with greatest

economic return

–

Treatment regimen(s)

–

Trial design

–

Development

program

Strategic Consulting Services

Potential Growth Drivers

•

Industry Factors

–

Increased acceptance of modeling and simulation as

alternative to clinical trial results in Pharma’s development

cycle

–

FDA Critical Path Initiative

•

Internal Factors

–

Expanding scope and increasing efficiency of consulting

engagements

–

Expanded service offering

–

Continuing recruitment of best & brightest in the scientific

community

Strategic Consulting Services

Market Penetration –

Current Clients

Market Opportunity

Current Clients

Market Opportunity

Top 10 Pharma²

60% Market Penetration

Top 50 Pharma²

34% Market Penetration

December 31, 2005

Pharma Exec 50: Pharmaceutical Executive, May 2004

•

Over

30 active clients during Fiscal Year 2006 to date

–

17 of the Top 50 Pharma are active consulting clients

•

Over 119 projects engaged during Fiscal Year 2005

•

Over 85 projects engaged during Fiscal Year 2006 to date

•

Typical workplans

range from several hours of consulting time to

annual engagements, and vary in size from $3,500 to over $3M²

Strategic Consulting Services

Market Acceptance

Pharma

Exec 50: Pharmaceutical Executive, May 2004

As of Fiscal Year 2006 to date

Confidential ©

Pharsight, Inc.

Financial Overview

FY05 Accomplishments

FY06 Objectives

Fiscal Year 2005 Results

•

Continued revenue growth

•

Y-Y revenue growth of 27%

•

2nd

consecutive year of 25%+ growth

•

Profitability

•

Net income of $2.7 million, or 12% of

revenues

•

Profitability in both business units

•

Achieved positive annual net cash

flow

•

Additional new product

development

•

DMX Web Server

•

Trial Simulator upgrade

Fiscal Year 2006 Objectives

•

Continued revenue growth

•

YTD FY06 Y/Y revenue growth of 5%

•

Profitability

•

Q3 FY06 net income of $0.1 million, or

1% of revenues.

•

Eight consecutive quarters of net income

•

Expansion of market footprint

•

Continued expansion of software and

strategic consulting customer base in Q3

FY06

•

Additional new product

development

•

PKS 3.0 released

•

WNL 5.0.1 released

•

WNL & PKS Validation Suites

Summary Statement of Operations -

Y/Y

Q3 FY06 and YTD FY06

('000s except per share data)

YTD

FY06

FY05

FY06

FY05

Revenues

5,757

6,462

17,371

16,568

Cost of revenues

1,829

1,948

5,770

5,606

Gross profit

3,928

4,514

11,601

10,962

Operating expenses

3,636

3,024

10,741

8,851

Income from operations

292

1,490

860

2,111

Net income

274

1,411

791

1,926

Net income attributable to common

stockholders

1,266

242

1,461

EPS (common), basic

0.07

0.01

0.08

EPS (common), diluted

0.05

0.01

0.07

WASO - basic

19,445

19,117

19,393

19,088

WASO - diluted

21,967

28,195

22,120

22,282

Summary Operating Results –

Software Products

Q3 FY06 and YTD FY 06

('000s)

OPERATING RESULTS

Revenues

Initial license

1,672

41%

2,391

58%

3,793

35%

4,425

48%

Renewal license

1,258

31%

1,127

27%

3,639

34%

3,387

44%

Maintenance

272

768

139

Services

868

21%

582

14%

2,365

22%

1,358

15%

Total

4,070

100%

4,153

100%

10,565

100%

9,309

100%

Gross profit

3,593

88%

3,597

87%

9,029

85%

7,907

85%

Income (loss) from

operations

894

22%

1,397

34%

1,619

15%

1,899

20%

PRODUCT LINE REVENUE

Desktop products

1,993

49%

1,565

38%

5,056

48%

4,548

49%

PKS

527

13%

1,838

44%

1,523

14%

2,885

31%

DMX

682

17%

168

1,621

15%

518

Services

868

21%

582

15%

2,365

22%

1,358

16%

Total

4,070

100%

4,153

100%

10,565

100%

9,309

100%

YTD

FY06

FY05

FY06

FY05

Summary Operating Results –

Strategic Consulting

Q3 FY06 and YTD FY 06

('000s)

OPERATING RESULTS

Revenues

1,687

100%

2,309

100%

6,806

100%

7,259

100%

Gross profit

335

20%

917

40%

2,572

38%

3,055

42%

Income (loss) from operations

(599)

-36%

187

(755)

-11%

306

FY06

FY05

YTD

FY06

FY05

Quarterly Revenues

(‘000s)

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

$7,000

Q1 FY05

Q2 FY05

Q3 FY05

Q4 FY05

Q1 FY06

Q2 FY06

Q3 FY06

Strategic Consulting

Software Products

Quarterly Gross Profit

(Percentage of Segment Revenues)

10%

20%

30%

40%

50%

60%

70%

80%

90%

Q1 FY05

Q2 FY05

Q3 FY05

Q4 FY05

Q1 FY06

Q2 FY06

Q3 FY06

Strategic Consulting

Software Products

Continued Profitability

(‘000s)

FY04

FY05

FY06

$3,500

$4,000

$4,500

$5,000

$5,500

$6,000

$6,500

Revenues

Costs & Expenses

Profitability achieved Q4

FY04

Quarterly Operating Income

(000s)

$500

$1,000

$1,500

Q1 FY05

Q2 FY05

Q3 FY05

Q4 FY05

Q1 FY06

Q2 FY06

Q3 FY06

Quarterly Operating Cash Flow

(‘000s)

-$500

$500

$1,000

$1,500

$2,000

$2,500

Q1 FY05

Q2 FY05

Q3 FY05

Q4 FY05

Q1 FY06

Q2 FY06

Q3 FY06

Summary Balance Sheet

December 31, 2005

('000s)

December 31,

2005

March 31,

2005

Cash & Cash Equivalents

9,974

10,579

Accounts Receivable, Net

5,130

4,809

Total Current Assets

15,492

15,982

Total Assets

17,649

16,822

LIABILITIES & STOCKHOLDERS' DEFICIT

A/P & Accrued Expenses

3,585

3,497

Deferred Revenue - Short Term

7,301

7,178

Notes Payable & Capital Leases

1,737

1,975

Total Current Liabilities

12,623

12,650

Deferred Revenue - Long Term

126

Notes Payable - Long Term

467

410

Redeemable Conv Pref Stock

6,525

6,266

Stockholders Deficit

(2,310)

(2,630)

Total Liabilities & S/H Deficit

17,649

16,822

ASSETS

Equity Structure

(All share data as of December 31, 2005)

•

Common Shares O/S: 19.5 million

•

Preferred Shares O/S: 1.9 million

–

Series A 1.8 million / Series B 0.1 million

•

Common Equivalent Shares (as converted): 29.7 million

•

PIPE Financing 6/02 and 9/02 = $7.5M

–

1.8 million Units = 1 share Series A redeemable convertible stock + 1 warrant

–

Preferred conversion ratio 1:4

–

Warrants exercisable for 1 share common @ $1.15

–

Dividend rights: 8%/annum cash or Series B shares

–

Conversion:

•

Automatically upon consent of 75% of preferred holders, or

•

Upon close of public offering of at least $3.006 per share and proceeds of $40M

–

Redemption:

•

At election of at least 75% of preferred holders (or at Pharsight’s option) after 5 th

anniversary of initial issuance at $4.008 per share (June 2007)

Summary

•

Current Pharma Market Trends Look Favorable…

•

Increasing Mindshare for Quantitative-Based Modeling & Simulation…

•

Continuing Pharsight Investment in Sales, Marketing & Product

Development…

•

Financially Stable & Healthy Business Model…

All Support Our Drive Towards Expansion of Pharsight’s

Market Footprint & Sustainable Growth and Profitability

Proprietary Notice

The copyright for this document is owned by Pharsight Corporation.

No part of this document may be reproduced or transmitted in any

form or

by any means, electronic or mechanical, including photocopying, for any

purpose, without the express written permission of Pharsight Corporation.

WinNonlin

®,

WinNonMix

and Pharsight

are registered trademarks of

Pharsight Corporation. Pharsight Knowledgebase Server

TM,

PKS

, PKS

Reporter

, Drug Model Explorer

, DMX

, Trial Simulator

and TS2

are

trademarks of Pharsight Corporation.

All other brand and product names are trademarks or registered trademarks

of their respective holders.

Notices