QUESTCOR PHARMACEUTICALS INC - FORM 8-K - EX-99.2 - PRESENTATION SLIDES

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8-K - FORM 8-K - QUESTCOR PHARMACEUTICALS INC	d367854d8k.htm
EX-99.3 - TRANSCRIPT OF CONFERENCE CALL - QUESTCOR PHARMACEUTICALS INC	d367854dex993.htm
EX-99.1 - PRESS RELEASE - QUESTCOR PHARMACEUTICALS INC	d367854dex991.htm

NASDAQ:

QCOR

NASDAQ:

QCOR

June 14, 2012

Investor Update –

Rheumatology

June 14, 2012

Investor Update –

Rheumatology

Exhibit 99.2

Safe Harbor Statement

Note: Except for the historical information contained herein, this press release 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" 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 continue to generate

revenue from sales of Acthar to treat on-label indications associated with NS, and our ability to develop other therapeutic uses

for Acthar; Research and development risks, including risks associated with Questcor's work in the area of NS and potential

work in the area of Rheumatology, and our reliance on third-parties to conduct research and development and the ability of

research and development to generate successful results; Our ability to comply with federal and state regulations, including

regulations relating to pharmaceutical sales and marketing practices; 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 effectively manage our growth, including

the expansion of our sales force, and our reliance on key personnel; The impact to our business caused by economic conditions;

Our ability to protect our proprietary rights; The risk of product liability lawsuits; Unforeseen business interruptions and

security breaches; Volatility in Questcor's monthly and quarterly Acthar shipments, estimated channel inventory and end-user

demand, as well as volatility in our stock price; and Other risks discussed in Questcor's annual report on Form 10-K for the year

ended December 31, 2011 as filed with the Securities and Exchange Commission, or SEC, on February 22, 2012, and other

documents filed with the SEC.

The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects

and future financial performance.

Acthar Has Multiple Approved , On-Label

Rheumatology-Related Indications

Note: This presentation is intended for investors; not healthcare

providers. The full Acthar PI is available at

http://www.acthar.com/files/Acthar-PI.pfd.

Rheumatology-Related Indications in Acthar PI

As adjunctive therapy for short-term administration (to

tide the patient over an acute episode or exacerbation) in:

Psoriatic arthritis, Rheumatoid arthritis, including juvenile

rheumatoid arthritis (selected cases may require low-dose

maintenance therapy), Ankylosing spondylitis.

During an exacerbation or as maintenance therapy in

selected cases of: systemic lupus erythematosus, systemic

dermatomyositis (polymyositis).

Rheumatology: Estimated Patient Populations*

Indication

Total Estimated

US Population

Estimated Target

Acthar Population

Dermatomyositis/Polymyositis

66K

~26K

Systemic Lupus Erythematosus

250K

~50K-100K

Rheumatoid Arthritis

1.3M

~50K

Psoriatic Arthritis

500K

~40K

Juvenile Rheumatoid Arthritis

300K

Ankylosing Spondylitis

500K

*Questcor estimates

Dermatomyositis (DM) and Polymyositis (PM)

Disease State Overview and Brief Summary of

Treatment Experience with Acthar

Todd Levine, M.D.

Phoenix Neurological Associates

Director of the ALS Clinic and Co-Director of Neurophysiology at Banner Good

Samaritan Medical Center

Assistant Professor of Neurology at the University of Arizona

Member of The Myositis Association Medical Advisory Board

Dermatomyositis (DM) and Polymyositis (PM)

Disease State Overview and Brief Summary of

Treatment Experience with Acthar

Todd Levine, M.D.

Phoenix Neurological Associates

Director of the ALS Clinic and Co-Director of Neurophysiology at Banner Good

Samaritan Medical Center

Assistant Professor of Neurology at the University of Arizona

Member of The Myositis Association Medical Advisory Board

Dermatomyositis and Polymyositis: Serious

Autoimmune Disorders

•

Rare neuromuscular conditions; high unmet need

•

Both involve autoimmune inflammatory myopathies

(inflammation of muscle)

–

DM also characterized by skin manifestations

•

Treated by both Rheumatologists and Neurologists

•

Begins as insidious proximal muscle weakness that grows in

severity and can involve other organs, including lungs

–

Muscle weakness can progress to where patients require ambulation assistance,

such as a walker or wheelchair

•

Can cause sustained disability, diminished QoL, even death

•

Rare neuromuscular conditions; high unmet need

•

Both involve autoimmune inflammatory myopathies

(inflammation of muscle)

–

DM also characterized by skin manifestations

•

Treated by both Rheumatologists and Neurologists

•

Begins as insidious proximal muscle weakness that grows in

severity and can involve other organs, including lungs

–

Muscle weakness can progress to where patients require ambulation assistance,

such as a walker or wheelchair

•

Can cause sustained disability, diminished QoL, even death

DM/PM Patients Underserved By Current

Therapies

•

Current treatments include steroids, immunosuppressants,

IVIG, rituximab

–

Only Acthar and steroids are FDA-approved in the treatment of DM/PM

•

Many patients do not respond to, or are unable to tolerate,

corticosteroids and immunosuppressant therapy

•

IVIG and Rituxan are used off-label to treat resistant cases

•

There are no studies comparing any two therapies in DM/PM

•

Current treatments include steroids, immunosuppressants,

IVIG, rituximab

–

Only Acthar and steroids are FDA-approved in the treatment of DM/PM

•

Many patients do not respond to, or are unable to tolerate,

corticosteroids and immunosuppressant therapy

•

IVIG and Rituxan are used off-label to treat resistant cases

•

There are no studies comparing any two therapies in DM/PM

•

Report of 5 cases of refractory DM and PM treated with Acthar

recently published in Drug Development, Design and Therapy

•

All patients had been unresponsive and/or unable to tolerate a

variety of current therapies used to treat DM and PM

–

All had biopsy-confirmed DM or PM

–

Concomitant therapies were kept stable for 60 days prior to Acthar administration

–

Manual muscle strength testing (MMT) was performed at baseline and 3 months

•

Patients were dosed with 80U of Acthar 1-2 times per week for a

period of 12 weeks or more

–

4 patients were dosed 2x per week and 1 patient was dosed 1x per

week

–

2 patients have remained on therapy beyond 12 weeks: 1 for 8 months and another

for 4 months; both are on ongoing Acthar therapy

•

Report of 5 cases of refractory DM and PM treated with Acthar

recently published in Drug Development, Design and Therapy

•

All patients had been unresponsive and/or unable to tolerate a

variety of current therapies used to treat DM and PM

–

All had biopsy-confirmed DM or PM

–

Concomitant therapies were kept stable for 60 days prior to Acthar administration

–

Manual muscle strength testing (MMT) was performed at baseline and 3 months

•

Patients were dosed with 80U of Acthar 1-2 times per week for a

period of 12 weeks or more

–

4 patients were dosed 2x per week and 1 patient was dosed 1x per

week

–

2 patients have remained on therapy beyond 12 weeks: 1 for 8 months and another

for 4 months; both are on ongoing Acthar therapy

Acthar Treatment in DM and PM:

Patient Types and Dosing

•

All patients experienced clinically significant improvement

–

Muscle strength improved in all 5 patients

–

Skin manifestations improved in all 3 DM patients

•

All patients reported improvements with daily living activities

–

patients

who

previously

required

assisted

ambulation

were

able

ambulate

independently

–

1 patient who was previously unable to work was able to return to work

•

No significant Acthar side effects observed in these patients

•

Positive insurance coverage on this initial cohort of patients

•

All patients experienced clinically significant improvement

–

Muscle strength improved in all 5 patients

–

Skin manifestations improved in all 3 DM patients

•

All patients reported improvements with daily living activities

–

patients

who

previously

required

assisted

ambulation

were

able

ambulate

independently

–

1 patient who was previously unable to work was able to return to work

•

No significant Acthar side effects observed in these patients

•

Positive insurance coverage on this initial cohort of patients

Acthar Treatment in DM and PM:

Overall Observed Results (n=5)

Note: Since this is a small case series of only 5 patients, it may

not be fully representative of efficacy or safety in the DM/PM

population.

•

Treatment history after Dx included prednisone,

mycophenolate, azathioprine, IVIG, cyclosporine, and

methotrexate

•

Began treating patient in 2004

–

Positive response to rituximab, cyclosporine, and IVIG

–

Maintained on IVIG and cyclosporine until a relapse in 2006

•

Patient then showed brief improvement with azathioprine,

cyclosporine, IVIG

–

In 2007, patient’s strength worsened and an MRI scan of the patient’s legs showed

active inflammation

–

Patient was rechallenged with rituximab but did not show any improvement

•

Treatment history after Dx included prednisone,

mycophenolate, azathioprine, IVIG, cyclosporine, and

methotrexate

•

Began treating patient in 2004

–

Positive response to rituximab, cyclosporine, and IVIG

–

Maintained on IVIG and cyclosporine until a relapse in 2006

•

Patient then showed brief improvement with azathioprine,

cyclosporine, IVIG

–

In 2007, patient’s strength worsened and an MRI scan of the patient’s legs showed

active inflammation

–

Patient was rechallenged with rituximab but did not show any improvement

DM Patient Example: History

•

Patient received Acthar 80 U 2x/wk for 12 weeks (no titration)

–

Concomitant medication: IVIG 2 gm/kg/mo and azathioprine 200 mg/day

–

Patient tolerated Acthar treatment well with no significant side

effects

•

Positive response to Acthar treatment

–

Muscle enzymes returned to normal (800

100)

–

MMT strength improved from 3/5 to 4+/5 in upper extremity muscle

groups, her

iliopsoas from 3/5 to 4/5, and quadriceps from 3-/5 to 4+/5

•

Patient received Acthar 80 U 2x/wk for 12 weeks (no titration)

–

Concomitant medication: IVIG 2 gm/kg/mo and azathioprine 200 mg/day

–

Patient tolerated Acthar treatment well with no significant side

effects

•

Positive response to Acthar treatment

–

Muscle enzymes returned to normal (800

100)

–

MMT strength improved from 3/5 to 4+/5 in upper extremity muscle

groups, her

iliopsoas from 3/5 to 4/5, and quadriceps from 3-/5 to 4+/5

DM Patient Example: Initial Acthar Treatment

•

~6 months after completing Acthar treatment the patient

experienced increased weakness in proximal leg muscles (3+/5)

•

Patient then given tacrolimus for 6 months with no results

•

Patient then began a second course of treatment with Acthar

–

Dosed 80 U 1x per week

–

Patient noted the treatment response was not as good as previous

treatment with

Acthar 80 units 2x per week

•

Dosing changed to 2x per week and patient noted improvement

–

Leg muscles improved to 4+/5

–

No adverse events reported

–

Returned to work and is ambulating independently

–

Has continued on Acthar for 8 months

•

~6 months after completing Acthar treatment the patient

experienced increased weakness in proximal leg muscles (3+/5)

•

Patient then given tacrolimus for 6 months with no results

•

Patient then began a second course of treatment with Acthar

–

Dosed 80 U 1x per week

–

Patient noted the treatment response was not as good as previous

treatment with

Acthar 80 units 2x per week

•

Dosing changed to 2x per week and patient noted improvement

–

Leg muscles improved to 4+/5

–

No adverse events reported

–

Returned to work and is ambulating independently

–

Has continued on Acthar for 8 months

DM Patient Example: Follow-Up Acthar Treatment

DM/PM Commercial Opportunity

Steve Cartt

Chief Operating Officer

DM/PM Commercial Opportunity

Steve Cartt

Chief Operating Officer

DM/PM Represents Significant Commercial

Opportunity Due to High Unmet Need

•

~66,000 DM/PM patients in the US, based upon key

epidemiological study which found a prevalence rate of 21.5

cases per 100,000 population (Bernatsky 2009)

–

Estimate supported by Questcor survey of treating physicians (N=192)

•

Approximately 26,000 are target Acthar patients

–

~40% of patients experience active disease, significant side effects or both with

current therapies (Questcor survey, N=192)

•

Typical dosing regimen of 80U 2x per week for 12 weeks

–

5 vials of Acthar required for this “typical”

regimen

–

Some patients require a longer treatment regimen

•

~66,000 DM/PM patients in the US, based upon key

epidemiological study which found a prevalence rate of 21.5

cases per 100,000 population (Bernatsky 2009)

–

Estimate supported by Questcor survey of treating physicians (N=192)

•

Approximately 26,000 are target Acthar patients

–

~40% of patients experience active disease, significant side effects or both with

current therapies (Questcor survey, N=192)

•

Typical dosing regimen of 80U 2x per week for 12 weeks

–

5 vials of Acthar required for this “typical”

regimen

–

Some patients require a longer treatment regimen

Questcor Rheumatology Plans

•

Pilot rheumatology selling effort beginning mid-July

–

National Sales Director and manager positions (2) have been filled, with

hiring/training of 12 experienced Rheum reps in progress

–

Initial promotional effort focused on DM/PM

•

Potential to expand Rheumatology Sales Force following pilot

•

Potential roll-out of DM/PM selling effort by current

Neurology Sales Force to about 1,000 neurologists specializing

in neuromuscular disease

•

Initiate patient registry of Acthar experience in DM/PM

•

Gather clinical data in SLE, RA, PsA

•

Pilot rheumatology selling effort beginning mid-July

–

National Sales Director and manager positions (2) have been filled, with

hiring/training of 12 experienced Rheum reps in progress

–

Initial promotional effort focused on DM/PM

•

Potential to expand Rheumatology Sales Force following pilot

•

Potential roll-out of DM/PM selling effort by current

Neurology Sales Force to about 1,000 neurologists specializing

in neuromuscular disease

•

Initiate patient registry of Acthar experience in DM/PM

•

Gather clinical data in SLE, RA, PsA

Rheumatology: Estimated Patient Populations*

Indication

Total Estimated

US Population

Estimated Target

Acthar Population

Dermatomyositis/Polymyositis

66K

~26K

Systemic Lupus Erythematosus

250K

~50K-100K

Rheumatoid Arthritis

1.3M

~50K

Psoriatic Arthritis

500K

~40K

Juvenile Rheumatoid Arthritis

300K

Ankylosing Spondylitis

500K

*Questcor estimates

NASDAQ:

QCOR

NASDAQ:

QCOR

June 14, 2012

Investor Update –

Rheumatology

June 14, 2012

Investor Update –

Rheumatology

QUESTCOR PHARMACEUTICALS INC - FORM 8-K - EX-99.2 - PRESENTATION SLIDES - June 19, 2012

Attached files

QUESTCOR PHARMACEUTICALS INC Reports