Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - QUESTCOR PHARMACEUTICALS INC | d268319d8k.htm |
 NASDAQ:
QCOR
NASDAQ:
QCOR
December 2011
December 2011
Exhibit 99.1
1 |
 2
Safe Harbor Statement
Note:
Except
for
the
historical
information
contained
herein,
this
presentation
contains
forward-looking
statements
that
have
been
made
pursuant
to
the
Private
Securities
Litigation
Reform
Act
of
1995.
These
statements
relate
to
future
events
or
our
future
financial
performance.
In
some
cases,
you
can
identify
forward-looking
statements
by
terminology
such
as
“believes,”
“continue,”
“could,”
“estimates,”
“expects,”
“growth,”
“may,”
“plans,”
“potential,”
“should,”
“substantial,”
“trends”
or
“will”
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
or
contribute
to
such
differences
include,
but
are
not
limited
to,
the
following:
our
reliance
on
Acthar
for
substantially
all
of
our
net
sales
and
profits;
reductions
in
vials
used
per
prescription
resulting
from
changes
in
treatment
regimens
by
physicians
or
patient
compliance
with
physician
recommendations;
the
complex
nature
of
our
manufacturing
process
and
the
potential
for
supply
disruptions
or
other
business
disruptions;
the
lack
of
patent
protection
for
Acthar,
and
the
possible
FDA
approval
and
market
introduction
of
competitive
products;
our
ability
to
generate
revenue
from
sales
of
Acthar
to
treat
on-label
indications
associated
with
nephrotic
syndrome,
and
our
ability
to
develop
other
therapeutic
uses
for
Acthar
including
systemic
lupus
erythematosus;
research
and
development
risks,
including
risks
associated
with
our
work
in
the
area
of
nephrotic
syndrome
and
potential
work
in
the
area
of
systemic
lupus
erythematosus,
and
our
reliance
on
third-parties
to
conduct
research
and
development
and
the
ability
of
research
and
development
to
generate
successful
results;
regulatory
changes
or
other
policy
actions
by
governmental
authorities
and
other
third
parties
in
connection
with
U.S.
health
care
reform
or
efforts
to
reduce
federal
and
state
government
deficits;
our
ability
to
receive
high
reimbursement
levels
from
third
party
payers;
an
increase
in
the
proportion
of
our
Acthar
unit
sales
comprised
of
Medicaid-
eligible
patients
and
government
entities;
our
ability
to
estimate
reserves
required
for
Acthar
used
by
government
entities
and
Medicaid-eligible
patients
and
the
impact
that
unforeseen
invoicing
of
historical
Medicaid
prescriptions
may
have
upon
our
results;
our
ability
to
operate
within
an
industry
that
is
highly
regulated
at
both
the
Federal
and
state
level;
our
ability
to
effectively
manage
our
growth,
including
the
expansion
of
our
nephrotic
syndrome
selling
effort,
and
our
reliance
on
key
personnel;
the
impact
to
our
business
caused
by
economic
conditions;
our
ability
to
protect
our
proprietary
rights;
our
ability
to
maintain
effective
controls
over
financial
reporting;
the
risk
of
product
liability
lawsuits;
unforeseen
business
interruptions;
volatility
in
our
monthly
and
quarterly
Acthar
shipments
and
end-user
demand,
as
well
as
volatility
in
our
stock
price;
and
other
risks
discussed
in
our
annual
report
on
Form
10-K
for
the
year
ended
December
31,
2010,
and
other
documents
filed
with
the
Securities
and
Exchange
Commission.
The
risk
factors
and
other
information
contained
in
these
documents
should
be
considered
in
evaluating
our
prospects
and
future
financial
performance.
Note:
Except
for
the
historical
information
contained
herein,
this
presentation
contains
forward-looking
statements
that
have
been
made
pursuant
to
the
Private
Securities
Litigation
Reform
Act
of
1995.
These
statements
relate
to
future
events
or
our
future
financial
performance.
In
some
cases,
you
can
identify
forward-looking
statements
by
terminology
such
as
“believes,”
“continue,”
“could,”
“estimates,”
“expects,”
“growth,”
“may,”
“plans,”
“potential,”
“should,”
“substantial,”
“trends”
or
“will”
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
or
contribute
to
such
differences
include,
but
are
not
limited
to,
the
following:
our
reliance
on
Acthar
for
substantially
all
of
our
net
sales
and
profits;
reductions
in
vials
used
per
prescription
resulting
from
changes
in
treatment
regimens
by
physicians
or
patient
compliance
with
physician
recommendations;
the
complex
nature
of
our
manufacturing
process
and
the
potential
for
supply
disruptions
or
other
business
disruptions;
the
lack
of
patent
protection
for
Acthar,
and
the
possible
FDA
approval
and
market
introduction
of
competitive
products;
our
ability
to
generate
revenue
from
sales
of
Acthar
to
treat
on-label
indications
associated
with
nephrotic
syndrome,
and
our
ability
to
develop
other
therapeutic
uses
for
Acthar
including
systemic
lupus
erythematosus;
research
and
development
risks,
including
risks
associated
with
our
work
in
the
area
of
nephrotic
syndrome
and
potential
work
in
the
area
of
systemic
lupus
erythematosus,
and
our
reliance
on
third-parties
to
conduct
research
and
development
and
the
ability
of
research
and
development
to
generate
successful
results;
regulatory
changes
or
other
policy
actions
by
governmental
authorities
and
other
third
parties
in
connection
with
U.S.
health
care
reform
or
efforts
to
reduce
federal
and
state
government
deficits;
our
ability
to
receive
high
reimbursement
levels
from
third
party
payers;
an
increase
in
the
proportion
of
our
Acthar
unit
sales
comprised
of
Medicaid-
eligible
patients
and
government
entities;
our
ability
to
estimate
reserves
required
for
Acthar
used
by
government
entities
and
Medicaid-eligible
patients
and
the
impact
that
unforeseen
invoicing
of
historical
Medicaid
prescriptions
may
have
upon
our
results;
our
ability
to
operate
within
an
industry
that
is
highly
regulated
at
both
the
Federal
and
state
level;
our
ability
to
effectively
manage
our
growth,
including
the
expansion
of
our
nephrotic
syndrome
selling
effort,
and
our
reliance
on
key
personnel;
the
impact
to
our
business
caused
by
economic
conditions;
our
ability
to
protect
our
proprietary
rights;
our
ability
to
maintain
effective
controls
over
financial
reporting;
the
risk
of
product
liability
lawsuits;
unforeseen
business
interruptions;
volatility
in
our
monthly
and
quarterly
Acthar
shipments
and
end-user
demand,
as
well
as
volatility
in
our
stock
price;
and
other
risks
discussed
in
our
annual
report
on
Form
10-K
for
the
year
ended
December
31,
2010,
and
other
documents
filed
with
the
Securities
and
Exchange
Commission.
The
risk
factors
and
other
information
contained
in
these
documents
should
be
considered
in
evaluating
our
prospects
and
future
financial
performance. |
 3
Questcor
A biopharmaceutical company
whose product, Acthar, helps patients with
serious, difficult-to-treat medical conditions
A biopharmaceutical company
whose product, Acthar, helps patients with
serious, difficult-to-treat medical conditions |
 4
Questcor Overview
Flagship Product:
Flagship Product:
•
Profitable, cash flow positive, $209M* in cash, debt-free
•
Profitable, cash flow positive, $209M* in cash, debt-free
•
19 approved indications
•
19 approved indications
Key Markets:
Key Markets:
•
Multiple Sclerosis, Nephrotic Syndrome, Infantile Spasms
•
Combined market opportunity exceeds $1.5 billion
•
Multiple Sclerosis, Nephrotic Syndrome, Infantile Spasms
•
Combined market opportunity exceeds $1.5 billion
Strategy:
Strategy:
•
Grow Acthar sales in each key market
•
Develop on-label Lupus markets for Acthar
•
Grow Acthar sales in each key market
•
Develop on-label Lupus markets for Acthar
Financials:
Financials:
* As of 12/7/11 |
 5
History of Acthar
1952
First
Approved
1950
1950
1978
MS Flare Indication Added
2000
2000
2001
Questcor Acquires
Acthar
2010
Label Modernized
19 Indications
2007
Questcor Changes
Strategy
2010
2010 |
 6
Significant Barriers to Entry |
 7
QCOR Strategy –
Sell More Acthar
Multiple Sclerosis (MS)
Multiple Sclerosis (MS)
Nephrotic Syndrome (NS)
Nephrotic Syndrome (NS)
Infantile Spasms (IS)
Infantile Spasms (IS)
Systemic Lupus Erythematosus
Systemic Lupus Erythematosus |
 8
Acthar and MS
•
Neurodegenerative
disorder
•
Acute treatment for
relapses
•
Treatment for 1-2
weeks*
•
$40K-$50K/Rx
Acthar
Acthar
when
when
“Steroids are
“Steroids are
not suitable”
not suitable”
*Based on prescriptions written |
 9
MS Scripts-Record of Consistent
Growth
New Paid Rxs
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 chart. Yellow numbers in the bars
show the number of MS sales people making calls at the end of the
quarter. |
 10
Monthly MS Scripts Have 160% CAGR
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 chart. |
 11
•
Doubled sales force: 38 to 77 sales reps Nov 2010
•
Q3-2011 results
–
Q3-11 new, paid Rxs up 174% vs. Q3-10
–
MS about 65% of QCOR net sales*
•
Estimated $150M annualized run-rate*
–
About 450 prescribers in Q3
–
September was a record month
•
October-November 2011
–
615-625 new, paid Rxs
–
Holiday season might impact prescription trends
•
Doubled sales force: 38 to 77 sales reps Nov 2010
•
Q3-2011 results
–
Q3-11 new, paid Rxs up 174% vs. Q3-10
–
MS about 65% of QCOR net sales*
•
Estimated $150M annualized run-rate*
–
About 450 prescribers in Q3
–
September was a record month
•
October-November 2011
–
615-625 new, paid Rxs
–
Holiday season might impact prescription trends
MS Trends
*Based on Company estimates as of 9/30/11
|
 12
•
Characterized by excessive spilling of protein from the
kidneys into the urine (proteinuria)
•
Can result in end-stage renal disease (ESRD), dialysis,
transplant
•
Significant unmet need
–
Few treatment options
•
Treatment for 4-6+ months*
–
Longer course of therapy creates future vial demand
•
$150K-250K/Rx
•
Characterized by excessive spilling of protein from the
kidneys into the urine (proteinuria)
•
Can result in end-stage renal disease (ESRD), dialysis,
transplant
•
Significant unmet need
–
Few treatment options
•
Treatment for 4-6+ months*
–
Longer course of therapy creates future vial demand
•
$150K-250K/Rx
Acthar and Nephrotic Syndrome (NS)
*Based on prescriptions written |
 13
NS Scripts –
Off to a Good Start
New Paid Rxs
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 chart. Yellow
numbers
in
the
bars
show
the
number
of
NS
sales
people
making
calls
at
the
end
of
the
quarter.
Q3’
11
included
expansion
and
training
of
new
sales
people. |
 14
NS Market Size |
 15
•
Initiated sales efforts in early March 2011
–
Q1 2011 new, paid NS Rxs: 18
–
Q2 2011 new, paid NS Rxs: 45
–
Q3 2011 new, paid NS Rxs: 60
•
Expanded NS selling effort: 5 to 28 NS during Q3
•
Planned sales calls to increase in Q4 by 7X over Q2
•
October-November 2011
–
83-87 new, paid Rxs
–
Holiday season might impact prescription trends
•
Initiated sales efforts in early March 2011
–
Q1 2011 new, paid NS Rxs: 18
–
Q2 2011 new, paid NS Rxs: 45
–
Q3 2011 new, paid NS Rxs: 60
•
Expanded NS selling effort: 5 to 28 NS during Q3
•
Planned sales calls to increase in Q4 by 7X over Q2
•
October-November 2011
–
83-87 new, paid Rxs
–
Holiday season might impact prescription trends
NS Trends |
 16
•
Treatment Resistant Idiopathic Membranous
Nephropathy
•
Dose response trial
–
Randomized, double blinded 3 arm study with 2 different dosage
regimens of Acthar and placebo
–
n=84 (approximate), 35 centers (approximate)
–
Endpoint is reduction of proteinuria
•
Trial milestones
–
“First look”
data available early 2013
–
Final reporting late 2013
•
Treatment Resistant Idiopathic Membranous
Nephropathy
•
Dose response trial
–
Randomized, double blinded 3 arm study with 2 different dosage
regimens of Acthar and placebo
–
n=84 (approximate), 35 centers (approximate)
–
Endpoint is reduction of proteinuria
•
Trial milestones
–
“First look”
data available early 2013
–
Final reporting late 2013
NS
Phase
IV
Company
Sponsored
Study |
 17
•
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 |
 18
•
FDA approval 10/15/10
•
Crisis therapy
•
Treatment for 2-4 weeks*
•
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
•
FDA approval 10/15/10
•
Crisis therapy
•
Treatment for 2-4 weeks*
•
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
*Based on prescriptions written |
 19
•
Acthar currently used to treat 40-50% of IS patients
•
Targeting select institutions
–
Promotion effort being narrowed as market is maturing
–
Creates selling time for Acthar MS reps to target NS
•
Significant variability in quarterly Rxs
•
Q3-2011 new, paid Rxs within historic range
•
October-November 2011
–
88-92 new, paid Rxs
–
New, paid Rxs above historic range
•
Acthar currently used to treat 40-50% of IS patients
•
Targeting select institutions
–
Promotion effort being narrowed as market is maturing
–
Creates selling time for Acthar MS reps to target NS
•
Significant variability in quarterly Rxs
•
Q3-2011 new, paid Rxs within historic range
•
October-November 2011
–
88-92 new, paid Rxs
–
New, paid Rxs above historic range
IS Trends |
 20
•
Specialty Sales Force
–
Main focus on MS (time split is ~ 80%/15%/5% on MS/NS/IS)
–
77 representatives, 13 regional managers, one national director
•
Nephrology Sales Force
–
Focus 100% on Nephrotic Syndrome
–
28 representatives, 4 regional managers, one national director
•
Combined Forces targeted to call on
–
>4,000 neurologists
–
>3,000 nephrologists
–
About 100 key children’s hospitals
•
Specialty Sales Force
–
Main focus on MS (time split is ~ 80%/15%/5% on MS/NS/IS)
–
77 representatives, 13 regional managers, one national director
•
Nephrology Sales Force
–
Focus 100% on Nephrotic Syndrome
–
28 representatives, 4 regional managers, one national director
•
Combined Forces targeted to call on
–
>4,000 neurologists
–
>3,000 nephrologists
–
About 100 key children’s hospitals
Total Acthar Sales Force |
 21
Immediate
Acthar
Growth
Opportunities
*Represents estimated net sales market opportunity based on internal company estimates
|
 22
•
High unmet need
•
Serious health risk if unsuccessfully treated
•
Difficult to treat
•
Multiple on-label indications for Acthar
–
Exacerbations
–
Maintenance therapy
–
Lupus nephritis
•
Large patient population
•
High unmet need
•
Serious health risk if unsuccessfully treated
•
Difficult to treat
•
Multiple on-label indications for Acthar
–
Exacerbations
–
Maintenance therapy
–
Lupus nephritis
•
Large patient population
Systemic
Lupus
Erythematosus
(Lupus) |
 23
Financials
Profitable
Profitable
Debt Free
Debt Free
Cash Flow Positive
Cash Flow Positive |
 24
Q3-2011 Financial Results
Net Sales ($M)
Net Sales ($M)
Gross Margin
Gross Margin
Operating Income ($M)
Operating Income ($M)
Fully Diluted, GAAP EPS
Fully Diluted, GAAP EPS
$59.8
$59.8
94%
94%
$33.6
$33.6
$0.35
$0.35
$31.3
$31.3
93%
93%
$16.8
$16.8
$0.18
$0.18
Q3-2011
Q3-2011
Q3-2010
Q3-2010
Record Net Sales (up 91%) and Solid Earnings (EPS up 94%)
Record Net Sales (up 91%) and Solid Earnings (EPS up 94%)
•
Third quarter vials shipped: 2,910
•
Third quarter cash flow from operations: $32.6M
•
Channel inventory estimated to be within historic range
•
Medicaid reserves continue to appear adequate
•
No shares repurchased |
 25
Questcor is Cash Flow Positive
Debt-free balance sheet
Debt-free balance sheet
*After return of $78 million of cash to shareholders through
share repurchases.
Cash / ST Investments
Cash / ST Investments
Accounts Receivable
Accounts Receivable
$209M*
$209M*
$27M
$27M
12/7/11
12/7/11 |
 26
26
Share Repurchases: 15 Million Shares
•
2.2 Million Preferred share buyback
•
13.2 Common share buyback
•
$78 million returned to shareholders in stock
buybacks
•
63.6 million shares currently outstanding
•
4.3 million shares remain on buyback authorization
•
2.2 Million Preferred share buyback
•
13.2 Common share buyback
•
$78 million returned to shareholders in stock
buybacks
•
63.6 million shares currently outstanding
•
4.3 million shares remain on buyback authorization
Repurchased shares significantly improved EPS
Repurchased shares significantly improved EPS |
 27
•
Sustain effort and momentum with MS
•
Sustain effort and momentum with NS
•
Maintain and gradually grow IS sales
•
Explore Systemic Lupus Erythematosus (Lupus) as another
vertical market
•
Develop other markets for Acthar
–
Acthar is its own pipeline with many other on-label
and many possible other therapeutic uses
–
Further define and develop the unique
characteristics of Acthar
•
No business development efforts planned
•
Sustain effort and momentum with MS
•
Sustain effort and momentum with NS
•
Maintain and gradually grow IS sales
•
Explore Systemic Lupus Erythematosus (Lupus) as another
vertical market
•
Develop other markets for Acthar
–
Acthar is its own pipeline with many other on-label
and many possible other therapeutic uses
–
Further define and develop the unique
characteristics of Acthar
•
No business development efforts planned
Go Forward Plan -
Sell More Acthar |
 28
Investment Highlights |
 29
NASDAQ:
QCOR
NASDAQ:
QCOR
December 2011
December 2011
29 |