QUESTCOR PHARMACEUTICALS INC - FORM 8-K - EX-99.2 - PRESENTATION MADE BY QUESTCOR PHARMACEUTICALS, INC.

Attached files

file	filename
8-K - FORM 8-K - QUESTCOR PHARMACEUTICALS INC	d8k.htm
EX-99.1 - QUESTCOR PHARMACEUTICALS, INC. PRESS RELEASE DATED JANUARY 10, 2011 - QUESTCOR PHARMACEUTICALS INC	dex991.htm

Exhibit 99.2

JANUARY 2011

JP Morgan Healthcare

NASDAQ:

QCOR

NASDAQ:

QCOR

C O N F E R E N C E

Safe Harbor Statement

Note: Except for the historical information contained herein, this presentation contains forward-looking statements that are based on management's

current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially

from those described. All such statements have been made pursuant to the Private Securities Litigation Reform Act of 1995, as amended. These

statements relate to future events or our future financial performance, customer and prescriber patterns or practices, reimbursement activities and

outcomes and other such estimates and results. In some cases, you can identify forward-looking statements by terminology such as “opportunity,”

“potential,”

“believes,”

“continue,”

“could,”

“preliminary,”

“estimates,”

“run rate,”

“expects,”

“may,”

“plans,”

“will,”

“consistent,”

or “should”

or the

negative of such terms and other comparable terminology. These statements are only predictions. Actual events or results may differ materially.

Factors

that

could

cause

contribute

such

differences

include,

but

are

not

limited

to,

the

following:

Questcor’s

ability

continue

successfully

implement its Acthar-centric business strategy, including its expansion in the MS marketplace and other therapeutic areas; FDA approval of and the

market introduction of competitive products; Questcor’s

ability to operate within an industry that is highly regulated at both the Federal and state level;

Regulatory changes or other policy actions by governmental authorities and other third parties as recently adopted U.S. healthcare reform legislation

implemented;

The

complex

nature

Questcor’s

manufacturing

process

and

the

potential

for

supply

disruptions

other

business

disruptions;

Questcor’s

ability

receive

high

reimbursement

levels

from

third

party

payers;

Questcor’s

ability

estimate

reserves

required

for

Acthar

used

government

entities

and

Medicaid-eligible

patients;

The

inventories

carried

Questcor’s

distributor

–

Curascript

Specialty

Distributor,

well

inventories

carried

specialty

pharmacies

and

hospitals;

Research

and

development

risks,

including

risks

associated

with

Questcor’s

preliminary

work

the

area

nephrotic

syndrome;

The

lack

patent

protection

for

Acthar;

Volatility

Questcor’s

monthly

and

quarterly

Acthar

shipments

and

end-user

demand;

Questcor’s

ability

attract

and

retain

key

management

personnel

and

sales

representatives;

The

impact

Questcor’s

business

caused

economic

conditions;

and

Other

risks

discussed

Questcor’s

annual

report

Form

10-K

for

the

year

ended

December

31,

2009,

its

quarterly report on Form 10-Q for the quarter ended September 30, 2010 and other documents filed with the Securities and Exchange Commission.

The

risk

factors

and

other

information

contained

these

documents

should

considered

evaluating

Questcor’s

prospects

and

future

financial

performance.

Note: Except for the historical information contained herein, this presentation contains forward-looking statements that are based on management's

current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially

from those described. All such statements have been made pursuant to the Private Securities Litigation Reform Act of 1995, as amended. These

statements relate to future events or our future financial performance, customer and prescriber patterns or practices, reimbursement activities and

outcomes and other such estimates and results. In some cases, you can identify forward-looking statements by terminology such as “opportunity,”

“potential,”

“believes,”

“continue,”

“could,”

“preliminary,”

“estimates,”

“run rate,”

“expects,”

“may,”

“plans,”

“will,”

“consistent,”

or “should”

or the

negative of such terms and other comparable terminology. These statements are only predictions. Actual events or results may differ materially.

Factors

that

could

cause

contribute

such

differences

include,

but

are

not

limited

to,

the

following:

Questcor’s

ability

continue

successfully

implement its Acthar-centric business strategy, including its expansion in the MS marketplace and other therapeutic areas; FDA approval of and the

market introduction of competitive products; Questcor’s

ability to operate within an industry that is highly regulated at both the Federal and state level;

Regulatory changes or other policy actions by governmental authorities and other third parties as recently adopted U.S. healthcare reform legislation

implemented;

The

complex

nature

Questcor’s

manufacturing

process

and

the

potential

for

supply

disruptions

other

business

disruptions;

Questcor’s

ability

receive

high

reimbursement

levels

from

third

party

payers;

Questcor’s

ability

estimate

reserves

required

for

Acthar

used

government

entities

and

Medicaid-eligible

patients;

The

inventories

carried

Questcor’s

distributor

–

Curascript

Specialty

Distributor,

well

inventories

carried

specialty

pharmacies

and

hospitals;

Research

and

development

risks,

including

risks

associated

with

Questcor’s

preliminary

work

the

area

nephrotic

syndrome;

The

lack

patent

protection

for

Acthar;

Volatility

Questcor’s

monthly

and

quarterly

Acthar

shipments

and

end-user

demand;

Questcor’s

ability

attract

and

retain

key

management

personnel

and

sales

representatives;

The

impact

Questcor’s

business

caused

economic

conditions;

and

Other

risks

discussed

Questcor’s

annual

report

Form

10-K

for

the

year

ended

December

31,

2009,

its

quarterly report on Form 10-Q for the quarter ended September 30, 2010 and other documents filed with the Securities and Exchange Commission.

The

risk

factors

and

other

information

contained

these

documents

should

considered

evaluating

Questcor’s

prospects

and

future

financial

performance.

Questcor

Overview

A biopharmaceutical company

whose product helps patients with serious,

difficult-to-treat medical conditions

A biopharmaceutical company

whose product helps patients with serious,

difficult-to-treat medical conditions

Questcor

Overview

Flagship Product:

•

Profitable, cash flow positive, $115M in cash, debt-free

•

Profitable, cash flow positive, $115M in cash, debt-free

•

19 approved indications

•

19 approved indications

Key Markets:

•

Multiple Sclerosis, Infantile Spasms, Nephrotic

Syndrome

•

Combined markets opportunity exceeds $1.5 billion

•

Multiple Sclerosis, Infantile Spasms, Nephrotic

Syndrome

•

Combined markets opportunity exceeds $1.5 billion

Strategy:

•

Grow Acthar

sales in each key market

•

Grow Acthar

sales in each key market

Financials:

History of Acthar

1952

First Approved

1968-1973

DESI Review

Label Expands

1950

1978

MS Indication Added

2000

2001

Questcor Acquires

Acthar

2010

Label Modernized

19 Indications

2007

Questcor Changes

Strategy

2010

Significant Barriers to Entry

Questcor Growth Engine

Multiple Sclerosis

Infantile Spasms

Nephrotic Syndrome

Large Market Opportunity

*Represents estimated net sales market opportunity based on internal company estimates

** Represents approximate current net sales annualized run rate based on internal company estimates

Multiple Sclerosis

$500M to $2B+

Potential Market

$500M to $2B+

Potential Market

*Data on this slide is based on US only. Based on internal company estimates.

Acthar and MS

•

Acute treatment

•

Treatment for 1-2 weeks

(based on prescription

data)

•

$40K-$50K/Rx

Acthar

when

“Steroids

are not

suitable”

•

Q4-2010 results

–

Q4-10 new paid Rxs

up 66% vs. Q409

–

MS sales over 50% of QCOR sales

–

Over $65M annualized run rate

–

Approximately one in six Rxs

is a repeat patient

•

Growing number of Acthar

prescribers

–

But only <400 out of 8,000 neurologists

•

Speakers bureau growing

•

Q4-2010 results

–

Q4-10 new paid Rxs

up 66% vs. Q409

–

MS sales over 50% of QCOR sales

–

Over $65M annualized run rate

–

Approximately one in six Rxs

is a repeat patient

•

Growing number of Acthar

prescribers

–

But only <400 out of 8,000 neurologists

•

Speakers bureau growing

MS Trends

MS Sales -

Record of Consistent Growth

New Paid Rxs

Notes: Historical trend information is not necessarily indicative of future results. Chart includes "Related Conditions" - diagnoses that are either alternative descriptions of the condition or are

closely related to the medical condition which is the focus of the table.

MS Sales Calls vs. New Paid Rxs

*MS call data approximate

•

Doubled sales force: hiring/training Aug-Oct 2010 (38 to 77 sales reps)

•

Newly expanded sales force began call activity Nov 1

–

Significant increase in MS-treating neurologists targeted for sales calls

–

Now also targeting child neurologists for sales calls

•

Doubled sales force: hiring/training Aug-Oct 2010 (38 to 77 sales reps)

•

Newly expanded sales force began call activity Nov 1

–

Significant increase in MS-treating neurologists targeted for sales calls

–

Now also targeting child neurologists for sales calls

Sales Force Expansion

•

Devastating, refractory form of childhood epilepsy

–

Very poor developmental outcome if inadequately treated

•

Not responsive to standard anti-epileptic drugs

•

Ultra-rare orphan disorder

–

1,500 to 2,000 patients annually

•

Typically occurs in children less than 2 years old

•

Characterized by

–

“spasms”

a specific type of seizure

–

“hypsarrhythmia”

abnormal EEG pattern

•

Devastating, refractory form of childhood epilepsy

–

Very poor developmental outcome if inadequately treated

•

Not responsive to standard anti-epileptic drugs

•

Ultra-rare orphan disorder

–

1,500 to 2,000 patients annually

•

Typically occurs in children less than 2 years old

•

Characterized by

–

“spasms”

a specific type of seizure

–

“hypsarrhythmia”

abnormal EEG pattern

Infantile Spasms

•

Used by over half of child neurologists

•

FDA approval 10/15/10

–

7 year orphan exclusivity for IS indication

•

Crisis therapy

•

Treatment for 2-4 weeks (based on prescription data)

–

In a randomized, single-blinded, controlled study, 87% of patients achieved

overall response (no spasms and no hypsarrhythmia) at two weeks versus

29% on prednisone

•

$100K-$125K/Rx

–

About half of patients receive drug for free

•

Used by over half of child neurologists

•

FDA approval 10/15/10

–

7 year orphan exclusivity for IS indication

•

Crisis therapy

•

Treatment for 2-4 weeks (based on prescription data)

–

In a randomized, single-blinded, controlled study, 87% of patients achieved

overall response (no spasms and no hypsarrhythmia) at two weeks versus

29% on prednisone

•

$100K-$125K/Rx

–

About half of patients receive drug for free

Acthar and IS

•

Significant quarterly variability

•

Q4-2010 sales within historic range

•

Promotion effort began 11/1/10

•

Potential to increase IS revenue

–

Acthar

currently used to treat 30-50% of IS patients

•

Significant quarterly variability

•

Q4-2010 sales within historic range

•

Promotion effort began 11/1/10

•

Potential to increase IS revenue

–

Acthar

currently used to treat 30-50% of IS patients

IS Sales Plan

•

Characterized by excessive spilling of protein from the kidney into the

urine (proteinuria)

•

Can result in end-stage renal disease (ESRD), dialysis, transplant

•

Significant unmet need

–

Few treatment options

•

Characterized by excessive spilling of protein from the kidney into the

urine (proteinuria)

•

Can result in end-stage renal disease (ESRD), dialysis, transplant

•

Significant unmet need

–

Few treatment options

Nephrotic Syndrome

•

Single application treatment for reduction of proteinuria in:

–

Membranous nephropathy (on-label)

–

Lupus nephritis (on-label)

–

Focal segmental glomerular sclerosis (FSGS) (on-label)

–

Diabetic nephropathy (not on-label)

•

Treatment for 4-6 months (based on prescription data)

•

$150K-250K/Rx

•

Single application treatment for reduction of proteinuria in:

–

Membranous nephropathy (on-label)

–

Lupus nephritis (on-label)

–

Focal segmental glomerular sclerosis (FSGS) (on-label)

–

Diabetic nephropathy (not on-label)

•

Treatment for 4-6 months (based on prescription data)

•

$150K-250K/Rx

Acthar and NS

•

Available November 2010

•

Case series showed response from Acthar for refractory idiopathic

membranous nephropathy (on-label)

–

9 of 11 patients met response criteria

•

Positive signal received in diabetic nephropathy trial (not on-label)

–

9 of 15 patients on Acthar met response criteria and none have required

dialysis

–

0 of 13 patients on Acthar progressed to ESRD within 7 months (2

patients

only 4 months into treatment)

–

4 of 10 patients

who chose not to receive Acthar had dialysis within 7 months

•

Available November 2010

•

Case series showed response from Acthar for refractory idiopathic

membranous nephropathy (on-label)

–

9 of 11 patients met response criteria

•

Positive signal received in diabetic nephropathy trial (not on-label)

–

9 of 15 patients on Acthar met response criteria and none have required

dialysis

–

0 of 13 patients on Acthar progressed to ESRD within 7 months (2

patients

only 4 months into treatment)

–

4 of 10 patients

who chose not to receive Acthar had dialysis within 7 months

Proof of Concept Data

•

Dose ranging trial for idiopathic membranous nephropathy

–

$5-7M multi-center trial, n=100

–

Reduction of proteinuria is endpoint

•

Presently designing a study in collaboration with FDA for diabetic

nephropathy

–

Dose ranging trial

–

If successful, Phase III trial would follow

•

Dose ranging trial for idiopathic membranous nephropathy

–

$5-7M multi-center trial, n=100

–

Reduction of proteinuria is endpoint

•

Presently designing a study in collaboration with FDA for diabetic

nephropathy

–

Dose ranging trial

–

If successful, Phase III trial would follow

R&D Effort in NS

•

Nov 2010 ASN meeting

–

First meeting with commercial team presence

–

Data presented via podium/posters

–

30+ doctor advisory board meeting

•

Hired/hiring 5 reps to sell Acthar to nephrologists

–

Develop selling process and generate sales

–

Expand sales force if sales increase

•

Nov 2010 ASN meeting

–

First meeting with commercial team presence

–

Data presented via podium/posters

–

30+ doctor advisory board meeting

•

Hired/hiring 5 reps to sell Acthar to nephrologists

–

Develop selling process and generate sales

–

Expand sales force if sales increase

NS Business Plan

•

MS -

Build on sales momentum,

lots of market headroom

•

IS -

Incremental market

share growth

•

NS -

Establish Acthar

as a therapeutic alternative

in this sizeable market

•

MS -

Build on sales momentum,

lots of market headroom

•

IS -

Incremental market

share growth

•

NS -

Establish Acthar

as a therapeutic alternative

in this sizeable market

Immediate Acthar

Growth Opportunities

*Represents estimated net sales market opportunity based on internal company estimates

** Represents approximate current net sales annualized run rate

based on internal company estimates

Financials

Profitable

Debt Free

Cash Flow Positive

Quarterly Results -

Q3 2010

Net Sales ($M)

Gross Margin

Operating Inc ($M)

EPS

$31.3

93%

$16.8

$0.18

$13.9

86%

$1.8

$0.02

Q3 -

2010

Q3 -

2010

Q3 -

2009

Q3 -

2009

Record Sales and Solid Earnings

Up several million $ vs Q3-10

Up 66% vs Q409

Within historic range

Promotion effort starting now

91 new/paid IS Rxs

Preliminary Q4 Information

353 new/paid MS Rxs

7 new/paid NS Rxs

Expenses

Questcor is Cash Flow Positive

Debt-free balance sheet

*After return of $67 million of cash to shareholders through share repurchases.

Cash / ST Investment

Accounts Receivable

$115m*

$11m

12/31/10

•

Expanded sales force to pursue MS/IS

•

Dedicated pilot NS sales team starting January 2010

•

Develop other markets for Acthar

–

Acthar

is its own pipeline with 15 other on-label

and many possible other therapeutic uses

–

Further defining and developing the unique

characteristics of Acthar

•

No business development efforts planned

•

Expanded sales force to pursue MS/IS

•

Dedicated pilot NS sales team starting January 2010

•

Develop other markets for Acthar

–

Acthar

is its own pipeline with 15 other on-label

and many possible other therapeutic uses

–

Further defining and developing the unique

characteristics of Acthar

•

No business development efforts planned

Go Forward Plan -

Sell More Acthar

•

Questcor is streamlined, focused & profitable

•

Acthar has sustainable competitive advantages

•

Focus on substantial growth in MS sales

•

Recent IS approval/label modernization

•

Significant upside with NS

•

Market sizes have good growth potential

•

Cash flow positive/no debt

•

Questcor is streamlined, focused & profitable

•

Acthar has sustainable competitive advantages

•

Focus on substantial growth in MS sales

•

Recent IS approval/label modernization

•

Significant upside with NS

•

Market sizes have good growth potential

•

Cash flow positive/no debt

Investment Highlights

NASDAQ:

QCOR

NASDAQ:

QCOR

J A N U A R Y 2 0 1 1

Attached files

QUESTCOR PHARMACEUTICALS INC Reports

Also read