Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 16, 2012

 

 

QUESTCOR PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

California   001-14758   33-0476164

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

1300 Kellogg Drive, Suite D, Anaheim, California   92807
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (714) 786-4200

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 7.01. Regulation FD Disclosure.

On May 16, 2012, Questcor Pharmaceuticals, Inc. (the “Company”) announced via press release that its Board of Directors has increased the Company’s common share repurchase program authorization by an additional 5 million shares. As a result of this additional authorization and following the Company’s share repurchase activity through May 15, 2012, the Company now has 5.4 million remaining shares authorized under its repurchase program, representing approximately 9% of the Company’s currently outstanding common stock. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Also commencing on May 16, 2012, the Company will utilize an updated presentation for investor relations purposes. A copy of the updated presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference.

In accordance with General Instruction B.2. of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits.

 

Exhibit
Number
   Description
99.1    Questcor Pharmaceuticals, Inc. press release dated May 16, 2012
99.2    Presentation made by Questcor Pharmaceuticals, Inc.


SIGNATURES

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 16, 2012   QUESTCOR PHARMACEUTICALS, INC.
    By:  

/s/ Michael H. Mulroy

      Michael H. Mulroy
      Senior Vice President, Chief Financial Officer and General Counsel


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Questcor Pharmaceuticals, Inc. press release dated May 16, 2012
99.2    Presentation made by Questcor Pharmaceuticals, Inc.
Press Release

Exhibit 99.1

Questcor Pharmaceuticals Expands Repurchase Program

ANAHEIM, Calif., May 16, 2012 /PRNewswire/ — Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) announced today that its Board of Directors has increased the Company’s common share repurchase program authorization by an additional 5 million shares.

Since the beginning of 2008, the Company has returned $236 million to shareholders through the repurchase of approximately 19.2 million common and preferred shares, representing approximately 27% of its shares as of the commencement of the program. Including the additional 5 million share authorization and its repurchase activity through May 15, 2012, Questcor now has 5.4 million remaining shares authorized under its repurchase program, representing approximately 9% of the Company’s currently outstanding common stock. As of May 15, 2012, Questcor had 60.2 million common shares outstanding. On a diluted basis utilizing the treasury method, the Company would have approximately 63.2 million common shares outstanding as of May 15, 2012.

In 2012, the Company has made the following repurchases:

-798,285 shares during March 2012

-3,025,300 shares from late April through May 15, 2012. This includes 1,012,700 shares since the Company’s Form 8-K filing May 8, 2012.

Questcor executives will be meeting with investors at an investor conference on May 16, 2012. Information regarding the share repurchase program is included in the presentation that will be used at the conference. The presentation is included as an exhibit to a Form 8-K that the Company is filing this morning with the Securities and Exchange Commission.

“The Company’s previous share repurchases have been significantly accretive to earnings per share,” said Michael H. Mulroy, Chief Financial Officer of Questcor. “The most recent repurchases, like those in the past, were driven by our belief that there is a substantial difference between the intrinsic value and the market value of our common stock. This belief is based on several factors, including the following:

- Net sales and earnings per share for the quarter ended March 31, 2012 increased by more than 60% over the quarter ended September 30, 2011 – the quarter prior to the initial expansion of our nephrotic syndrome sales force from 5 to 28 Acthar specialists;

- We have gained greater confidence in the long-term potential for Acthar in the treatment of patients suffering from nephrotic syndrome;

- We are in the process of further expanding our nephrology and neurology sales forces, and similar expansions in the past have resulted in significant growth in net sales; and


- We are preparing to launch a pilot effort in rheumatology, a therapeutic area in which Acthar has a number of approved indications with sizeable markets with patients with high unmet needs.

From the beginning of 2008 through May 15, 2012, we have returned approximately 78% of our operating cash flow to shareholders by repurchasing stock at an average price of $12.26 per share. During that period, we have also been able to fund other important initiatives, including the significant expansion of our research and development activities. We have also continued our patient-support programs, providing $150 million in free Acthar through March 31, 2012. ”

Stock repurchases under this program may be made through open market or privately negotiated transactions in accordance with all applicable laws, rules and regulations. The transactions may be made from time to time and in such amounts as management deems appropriate. The number of shares to be repurchased and the timing of repurchases will be based on several factors, including the price of the Company’s common stock, general business and market conditions, and other investment opportunities. The stock repurchase program does not have an expiration date and may be limited, suspended or terminated at any time by the Board of Directors without prior notice. The authorization to repurchase shares is not a guarantee that the Company will repurchase additional shares.

About Questcor

Questcor Pharmaceuticals, Inc. is a biopharmaceutical company whose primary product helps patients with serious, difficult-to-treat medical conditions. Questcor’s primary product is H.P. Acthar® Gel (repository corticotropin injection), an injectable drug that is approved by the FDA for the treatment of 19 indications. Of these 19 indications, Questcor currently generates substantially all of its net sales from three indications: the treatment of proteinuria in idiopathic types of nephrotic syndrome, the treatment of acute exacerbations of multiple sclerosis in adults, and the treatment of infantile spasms in children under two years of age. With respect to nephrotic syndrome, the FDA has approved Acthar to “induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.” Questcor is also currently preparing to launch a pilot effort in rheumatology, as Acthar is approved for several rheumatology-related conditions including Lupus, Dermatomyositis, Polymyositis and Rheumatoid Arthritis. Questcor is also exploring the possibility of developing markets for other on-label indications and the possibility of pursuing FDA approval of additional indications not currently on the Acthar label where there is high unmet medical need. For more information about Questcor, please visit www.questcor.com.

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;

 

   

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;

 

   

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 effectively manage our growth, including the expansion of our NS selling effort, and our reliance on key personnel;

 

   

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.

Questcor undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date of this release.

For more information, please visit www.questcor.com or www.acthar.com.

CONTACT INFORMATION:

 

EVC Group      
Investors    Media   
Gregory Gin/Doug Sherk    Janine McCargo   
646-445-4801/415-568-4887    646-688-0425   
Presentation
1
May 16, 2012
Bank of America
May 16, 2012
Bank of America
NASDAQ:
QCOR
Exhibit 99.2
1


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 Lupus, 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 NS
selling effort, 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.


3
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
Questcor


Flagship Product:
Flagship Product:
Profitable, cash flow positive, $136M** in cash, debt-free
Profitable, cash flow positive, $136M** in cash, debt-free
19 approved indications
19 approved indications
Key Markets*:
Key Markets*:
Nephrotic Syndrome, Multiple Sclerosis, Infantile Spasms
Several billion dollar market opportunity
Nephrotic Syndrome, Multiple Sclerosis, Infantile Spasms
Several billion dollar market opportunity
Strategy:
Strategy:
Continue to grow Acthar sales in each key market
Develop other on-label markets for Acthar
Continue to grow Acthar sales in each key market
Develop other on-label markets for Acthar
Financials:
Financials:
*In
this
presentation,
the
terms
“Nephrotic
Syndrome,”
“Multiple
Sclerosis,”
and
“Infantile
Spasms,”
and
their
abbreviations,
refer
to
the
on-label
indications
for
Acthar
associated
with
such
conditions.
Investors
should
refer
to
the
FDA
approved
Acthar
label,
which
can
be
found
at
http://www.acthar.com/files/Acthar-PI.pdf.
**As
of
5/15/12
Questcor Overview
4


5
Questcor
Strategy
-
Pursue
Acthar
Markets
Infantile Spasms (IS)
Infantile Spasms (IS)
Multiple Sclerosis (MS)
Multiple Sclerosis (MS)
Nephrotic Syndrome (NS)
Nephrotic Syndrome (NS)
Rheumatology
Rheumatology
5


Characterized by excessive spilling of protein
from the kidneys into the urine (proteinuria)
Can result in end-stage renal disease (ESRD),
dialysis, transplant
Acthar is approved “to induce a diuresis or a
remission of proteinuria in the nephrotic syndrome
without uremia of the idiopathic type or that due to
lupus erythematosus”
Significant unmet need
Few treatment options
Goal of therapy is the significant reduction
of proteinuria
Characterized by excessive spilling of protein
from the kidneys into the urine (proteinuria)
Can result in end-stage renal disease (ESRD),
dialysis, transplant
Acthar is approved “to induce a diuresis or a
remission of proteinuria in the nephrotic syndrome
without uremia of the idiopathic type or that due to
lupus erythematosus”
Significant unmet need
Few treatment options
Goal of therapy is the significant reduction
of proteinuria
Acthar and Nephrotic Syndrome (NS)
6


7
Paid Rxs
Paid Rxs
Notes: Historical trend information is not necessarily indicative of future results.  Acthar is marketed for the on-label indication of
nephrotic
syndrome,
though
the
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. About 5% of the prescriptions in the tables
are
for
related
conditions.
Yellow
numbers
in
the
bars
show
the
number
of
NS
sales
representatives
making
calls
for
the
majority
of the quarter.Q3 ‘11 included expansion and training of new sales people.
NS Scripts-Strong Continued Growth
5
28


Neurodegenerative disorder
Acute treatment for relapses
Neurodegenerative disorder
Acute treatment for relapses
Acthar and Multiple Sclerosis (MS)
Potential
target for
ACTHAR is approved for MS exacerbations, without reference to first line or second line use but is generally positioned as
second
line
as
a
matter
of
marketing
strategy.
See
http://www.acthar.com/files/Acthar-PI.pdf
for
specific
label
information.
*Nickerson, et al (2011)
43% get better or
43% get better or
much better
much better
27% get only a
27% get only a
little better
little better
30% stay the same
30% stay the same
or get worse
or get worse
8
Patient reported
Response to IV Steroids*


9
MS Scripts-Record of Consistent Growth
78
124
141
213
231
304
323
354
508
751
886
1,000
945
Q1 '09
Q2 '09
Q3 '09
Q4 '09
Q1 '10
Q2 '10
Q3 '10
Q4 '10
Q1 '11
Q2 '11
Q3 '11
Q4 '11
Q1 '12
Notes: Historical trend information is not necessarily indicative of future results. Acthar is marketed for the on-label indication of MS
exacerbations
in
adults,
though
the
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. About 5% of the prescriptions in the tables are for related conditions.
Yellow numbers in the  bars show the number of MS sales representatives making calls for the majority of the quarter.
Notes: Historical trend information is not necessarily indicative of future results. Acthar is marketed for the on-label indication of MS
exacerbations
in
adults,
though
the
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. About 5% of the prescriptions in the tables are for related conditions.
Yellow numbers in the  bars show the number of MS sales representatives making calls for the majority of the quarter.
30
30
38
38
77
77
9
Paid Rxs


10
Monthly MS Scripts History
Notes: Historical trend information is not necessarily indicative of future results. Acthar is marketed for the on-label indication of MS
exacerbations
in
adults,
though
the
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. About 5% of the prescriptions in the tables are for related conditions.
Notes: Historical trend information is not necessarily indicative of future results. Acthar is marketed for the on-label indication of MS
exacerbations
in
adults,
though
the
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. About 5% of the prescriptions in the tables are for related conditions.
0
50
100
150
200
250
300
350
0
50
100
150
200
250
300
350
15-30
reps
30-38
reps
38-77
reps


11
FDA approval 10/15/10
Devastating, refractory form of childhood epilepsy
IS not responsive to standard anti-epileptic drugs
Unsuccessful treatment may leave infant with permanent
developmental disabilities
Considered a medical emergency
Ultra-rare orphan disorder
About half of IS patients receive Acthar via Acthar patient
support programs and Medicaid
FDA approval 10/15/10
Devastating, refractory form of childhood epilepsy
IS not responsive to standard anti-epileptic drugs
Unsuccessful treatment may leave infant with permanent
developmental disabilities
Considered a medical emergency
Ultra-rare orphan disorder
About half of IS patients receive Acthar via Acthar patient
support programs and Medicaid
Acthar and Infantile Spasms (IS)


Acthar currently used to treat 40-50% of IS patients
Targeting select institutions
Significant variability in quarterly Rxs
Last 3 quarters paid Rxs above historic range
Acthar currently used to treat 40-50% of IS patients
Targeting select institutions
Significant variability in quarterly Rxs
Last 3 quarters paid Rxs above historic range
IS Scripts
12


4 key indications on the Acthar label*
Lupus (maintenance and exacerbations)
Polymyositis/Dermatomyositis (PM/DM)
Psoriatic arthritis
Rheumatoid arthritis
High unmet need; difficult to treat
Serious health risk if unsuccessfully treated
Significant patient population (multi $B opportunity)
4 key indications on the Acthar label*
Lupus (maintenance and exacerbations)
Polymyositis/Dermatomyositis (PM/DM)
Psoriatic arthritis
Rheumatoid arthritis
High unmet need; difficult to treat
Serious health risk if unsuccessfully treated
Significant patient population (multi $B opportunity)
Rheumatology
13
*See
http://www.acthar.com/files/Acthar-PI.pdf
for
specific
label
information.


Profitable
Profitable
Debt Free
Debt Free
Cash Flow Positive
Cash Flow Positive
Financials
14


15
Growth in Shipped Vials
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
Q1-10
Q2-10
Q3-10
Q4-10
Q1-11
Q2-11
Q3-11
Q4-11
Q1-12
Shipped Vials
15


16
Q1 –
2012
Q1 –
2011
Net Sales ($M)
$96.0
$36.8
Gross Margin
94%
95%
Operating Income ($M)
$57.3
$16.4
Fully Diluted, GAAP EPS
$0.58
$0.17
Q1-2012 Financial Results
First quarter vials shipped: 4,111
First quarter cash flow from operations: $40.9M
Channel inventory estimated to be higher than fourth quarter
Medicaid reserves continue to appear adequate
798,285 shares repurchased during Q1-2012
First quarter vials shipped: 4,111
First quarter cash flow from operations: $40.9M
Channel inventory estimated to be higher than fourth quarter
Medicaid reserves continue to appear adequate
798,285 shares repurchased during Q1-2012
Record Net Sales (up 161%) and Solid Earnings (EPS up 241%)
Record Net Sales (up 161%) and Solid Earnings (EPS up 241%)


17
2.2 Million Preferred share buyback
17.0 Common share buyback
$236 million returned to shareholders in stock buybacks
Average repurchase price per share: $12.26
60.2
million shares currently outstanding
5.0 million share added to buyback authorization
5.4 million shares remain on buyback authorization
2.2 Million Preferred share buyback
17.0 Common share buyback
$236 million returned to shareholders in stock buybacks
Average repurchase price per share: $12.26
60.2
million shares currently outstanding
5.0 million share added to buyback authorization
5.4 million shares remain on buyback authorization
Share Repurchases: 19.2 Million Shares


18
3.8M shares repurchased during 2012, driven by:
Sales/EPS increase
NS market traction
Sales force expansion
Rheumatology opportunity
5M shares added to authorization
3.8M shares repurchased during 2012, driven by:
Sales/EPS increase
NS market traction
Sales force expansion
Rheumatology opportunity
5M shares added to authorization
2012 Repurchase Activity
Repurchased
Repurchased
shares
shares
significantly
significantly
improved
improved
EPS
EPS
Q1-2012
Q1-2012
EPS
EPS
accretion
accretion
from
from
share
share
repurchase:
repurchase:
24%
24%


19
5/15/12
Cash / ST Investments
$136M*
Accounts Receivable
$41M
Questcor is Cash Flow Positive
Debt-free balance sheet
Debt-free balance sheet
*After return of $236 million of cash to shareholders through share repurchases.
*After return of $236 million of cash to shareholders through share repurchases.


Paid Rxs April 2012 (estimated)
Shipped 1,350 vials in April 2012
Compares to 4,111 vials in Q1-12
Channel inventory level remained above the normal level on 4/30/2012
Operating expenses expected to be up about $10 million in Q2-
2012 over Q1-2012 and another $5 million in Q3-2012
Paid Rxs April 2012 (estimated)
Shipped 1,350 vials in April 2012
Compares to 4,111 vials in Q1-12
Channel inventory level remained above the normal level on 4/30/2012
Operating expenses expected to be up about $10 million in Q2-
2012 over Q1-2012 and another $5 million in Q3-2012
April 2012 Metrics
Notes:
Paid
Rx
information
based
on
internal
estimates.
The
table
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. About 5% of the prescriptions in the
tables are for related conditions.
Notes:
Paid
Rx
information
based
on
internal
estimates.
The
table
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. About 5% of the prescriptions in the
tables are for related conditions.
DX
April 2012
NS
90-95
MS
335-345
IS
30-35
20


How Does Acthar Work?
Acthar treats autoimmune conditions across a variety of organ systems (CNS,
kidney, etc.)
Acthar appears to modulate the immune system and associated inflammatory
response through binding to melanocortin receptors
The
primary
melanocortin
peptide
(ACTH)
in
Acthar
binds
to
all
5
melanocortin
receptors (MCR1-5); other active peptides are in Acthar as well
Indirect effect:  Acthar triggers the production of cortisol and
other adrenal
compounds through binding to MCR2 receptors
Direct effect:  Acthar acts directly at the cellular level by binding to melanocortin
receptors on immune cells and cells in the targeted tissues (e.g., kidney podocytes)
All the active ingredients of Acthar have yet to be fully characterized and the
mechanism of action and pharmacokinetic profile of Acthar are not fully known
Acthar treats autoimmune conditions across a variety of organ systems (CNS,
kidney, etc.)
Acthar appears to modulate the immune system and associated inflammatory
response through binding to melanocortin receptors
The
primary
melanocortin
peptide
(ACTH)
in
Acthar
binds
to
all
5
melanocortin
receptors (MCR1-5); other active peptides are in Acthar as well
Indirect effect:  Acthar triggers the production of cortisol and
other adrenal
compounds through binding to MCR2 receptors
Direct effect:  Acthar acts directly at the cellular level by binding to melanocortin
receptors on immune cells and cells in the targeted tissues (e.g., kidney podocytes)
All the active ingredients of Acthar have yet to be fully characterized and the
mechanism of action and pharmacokinetic profile of Acthar are not fully known
21


22
Difficult/impossible to reverse engineer ACTHAR
Not well characterized
Complex pharmacology
Not well characterized
Clinical trial(s) required
Difficult/impossible to reverse engineer ACTHAR
Not well characterized
Complex pharmacology
Not well characterized
Clinical trial(s) required
Biosimilar Pathway Difficult/Impossible


23
Market
Rx Value
Market Size*
MS
$40-50K
$1B+
NS
$150-250K
$1B+
IS
$100-125K
$100M
Rheumatology
Various
$1B+
Other
Various
Unknown
Total
$3B+
Acthar Market Opportunity
*Based on company estimates


24
Market
Approximate
Annualized Net Sales
Run Rate*
Approximate
Annualized Level of
Business**
MS
$160-175M
$160-175M
NS
$125-140M
$165-180M
IS
$40-50M
$40-50M
NS Business Already Significant
Note: Figures do not represent actual net sales ranges for the quarter ended March 31, 2012
* Figures
based
on
estimates
of
vials
shipped
to
patients
within
each
therapeutic
area
in
the
quarter,
multiplied
by
4.
** Figures represent Q1-2012 new paid prescriptions times estimated vials per script over treatment regimen, multiplied by 4.


25
Expand NS promotion effort
Expand MS promotion effort
Maintain IS promotion effort
Initiate pilot rheumatology promotion activity
Develop other markets for Acthar
No unrelated business development efforts planned
Expand NS promotion effort
Expand MS promotion effort
Maintain IS promotion effort
Initiate pilot rheumatology promotion activity
Develop other markets for Acthar
No unrelated business development efforts planned
Strategic Plan-
Focus on the Embedded Pipeline in Acthar
Acthar is its own pipeline with many other on-label indications
and many possible other therapeutic uses
Further define and develop the unique characteristics of Acthar


Rheumatology Sales Pilot
Rheumatology Sales Pilot
Number of reps TBD
Number of reps TBD
Neuro Hiring
Neuro Hiring
& Training
& Training
From 77 to
From 77 to
109 reps
109 reps
Neuro
Neuro
Sizing &
Sizing &
Alignment
Alignment
Neph Hiring &
Neph Hiring &
Training
Training
From 28 to 58
From 28 to 58
reps
reps
Neph Sizing &
Neph Sizing &
Alignment
Alignment
Sales Force Expansion-
Outlook for 2012
Q1-12
Q1-12
Q2
Q2
Q3
Q3
Q4
Q4
Q1-13
Q1-13
26


Generating more data
for on-label indications
NS
MS
IS
Lupus
Generating more data
for on-label indications
NS
MS
IS
Lupus
Investigating Acthar in
potential new indications
Diabetic nephropathy
Autism
Traumatic brain injury
ALS
Migraine
Investigating Acthar in
potential new indications
Diabetic nephropathy
Autism
Traumatic brain injury
ALS
Migraine
Over 40 Acthar R&D and Investigator
Initiated Research Studies
27
Understanding Acthar:
Understanding Acthar:
the science of how it works
the science of how it works


Acthar has sustainable competitive
Acthar has sustainable competitive
advantages-without FDA approval risk
advantages-without FDA approval risk
Acthar is approved for 19 indications-many
Acthar is approved for 19 indications-many
in large markets with sizable unmet need
in large markets with sizable unmet need
Sales in NS and MS are growing rapidly,
Sales in NS and MS are growing rapidly,
yet market penetration is low
yet market penetration is low
Developing new vertical market -
Developing new vertical market -
Rheum
Rheum
High margins provide good
High margins provide good
operating leverage
operating leverage
Profitable, cash flow positive, no debt
Profitable, cash flow positive, no debt
Investment Highlights
28


May 16, 2012
Bank of America
May 16, 2012
Bank of America
NASDAQ:
QCOR
NASDAQ:
QCOR
29


ACTH
is
a
Melanocortin
Peptide
Derived
from
Pro-opiomelanocortin
(POMC)
in
the
Pituitary
30


31
MCR
Prevalent Tissue/Cells with Receptor
MC1R
Podocytes
Renal Mesangial Cells
Endothelial Cells (Glomerular, Tubular, Vascular)
Tubular Epithelial Cells
Macrophages
Melanocytes
Immune/Inflammatory Cells
Kerantinocytes
CNS
MC2R
Adrenal Cortex (Steroidogenesis), Adipocytes
Adapted from Gong 2011, Catania 2004, Schioth 1997
Affinity of Melanocortin Peptides and
Distribution of Receptor Subtypes


32
MCR
Prevalent Tissue/Cells with Receptor
MC3R
CNS
Macrophages
MC4R
Podocytes
Renal Mesangial Cells (?)
Endothelial Cells (Glomerular, Tubular)
Tubular Epithelial Cells
CNS
MC5R
CNS
Exocrine Glands
Lymphocytes
Podocytes
Adapted from Gong 2011, Catania 2004, Schioth 1997
Affinity of Melanocortin Peptides and
Distribution of Receptor Subtypes


MOA of
Acthar in NS
Adapted From Gong 2011
Acthar,
Melanocortin Peptides
Acthar,
Melanocortin Peptides