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): July 13, 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.

Commencing on July 13, 2012, Questcor Pharmaceuticals, Inc. will utilize an updated presentation for investor relations purposes.

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 Exhibit 99.1, 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 No.

 

Description

99.1   Questcor Pharmaceuticals, Inc. Investor Presentation.

 


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: July 13, 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. Investor Presentation.
Questcor Pharmaceuticals, Inc. Investor Presentation
NASDAQ:
QCOR
July 13, 2012
JMP Securities Healthcare Conference
NASDAQ:
NASDAQ:
QCOR
QCOR
July 13, 2012
July 13, 2012
JMP Securities Healthcare Conference
JMP Securities Healthcare Conference
Exhibit 99.1
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.


Flagship Product:
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*:
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:
Grow Acthar sales in each key market
Developing Rheumatology and other on-label markets
Grow Acthar sales in each key market
Developing Rheumatology and other on-label markets
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
6/30/12
Questcor Overview
3


Paid Rxs (estimated)
Shipped 4,710 vials in Q2-2012
Compares to 4,111 vials in Q1-12 and 2,430 in Q2-11
Channel inventory level in the normal range on 6/30/2012
Paid Rxs (estimated)
Shipped 4,710 vials in Q2-2012
Compares to 4,111 vials in Q1-12 and 2,430 in Q2-11
Channel inventory level in the normal range on 6/30/2012
Q2 2012 Rx 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
May
2012
June
2012
Q2 -2012
NS
94
103
115-120
312-317
MS
339
365
400-410
1104-1114
IS
31
32
30-35
93-98
PM/DM
0
3
3
6
4


5
Expand Nephrotic Syndrome promotion effort
Expand Multiple Sclerosis promotion effort
Maintain Infantile Spasm promotion effort
Initiate pilot Rheumatology promotion activity
Develop other markets for Acthar
Expand Nephrotic Syndrome promotion effort
Expand Multiple Sclerosis promotion effort
Maintain Infantile Spasm promotion effort
Initiate pilot Rheumatology promotion activity
Develop other markets for Acthar
Strategic Plan-
Focus on the Embedded Pipeline in Acthar
Acthar
is
its
own
pipeline
with
many
on-label
and
new
indications
Further
define
and
develop
the
unique
characteristics
of
Acthar


David Young, Pharm.D., Ph.D.
Chief Scientific Officer
David Young, Pharm.D., Ph.D.
David Young, Pharm.D., Ph.D.
Chief Scientific Officer
Chief Scientific Officer
6


Making A Significant Investment in Research   
Breakouts exclude chemistry & manufacturing expense; *Estimated
7


8
Clinical use of Acthar
Nonclinical research
Clinical research
On-label indications 
Proteinuria in nephrotic syndrome (NS), multiple sclerosis (MS)
flares, infantile spasms, lupus
Off-label indications
Diabetic nephropathy, traumatic brain injury, autism, MS
maintenance treatment
Clinical use of Acthar
Nonclinical research
Clinical research
On-label indications 
Proteinuria in nephrotic syndrome (NS), multiple sclerosis (MS)
flares, infantile spasms, lupus
Off-label indications
Diabetic nephropathy, traumatic brain injury, autism, MS
maintenance treatment
Academic Clinical Interest in Acthar:
~ 30 Investigator Initiated Studies
Understanding Acthar: clinical use
Understanding Acthar: clinical use


9
Understanding the biological properties of Acthar
Specific biochemical pathways, cells, and  tissues
Immunomodulation and anti-inflammatory
On-label indications
Proteinuria in NS, MS flares, Lupus
New indications
Nephrology (eg, diabetic nephropathy)
Indications with autoimmune/inflammatory  component (eg,
neurology, cardiovascular, hematology, pulmonary)
Understanding the biological properties of Acthar
Specific biochemical pathways, cells, and  tissues
Immunomodulation and anti-inflammatory
On-label indications
Proteinuria in NS, MS flares, Lupus
New indications
Nephrology (eg, diabetic nephropathy)
Indications with autoimmune/inflammatory  component (eg,
neurology, cardiovascular, hematology, pulmonary)
Questcor Acthar R&D Efforts:
> 30 Preclinical and Clinical Studies
Understanding Acthar:
science of how it works and clinical use


10
WHY will Acthar be difficult to copy?
WHY is Acthar different than steroids?
WHY does Acthar work in multiple indications?
HOW can Acthar's use be expanded?
WHY will Acthar be difficult to copy?
WHY is Acthar different than steroids?
WHY does Acthar work in multiple indications?
HOW can Acthar's use be expanded?
Some Questions We Have Been Addressing


11
Acthar  History
1968-1973
DESI review
= steroid label
> 50 indications
1950
1950
indication added
2000
2000
0
2001-2003
Questcor acquires Acthar Gel
(MR), FDA approves
manufacturing
2010
Infantile spasms approved,
Label modernized
steroid
& 19 indications
2009-Present
Expanding Acthar Gel
(MR) research
2010
2010
1996
Manufacturing
problems
Powder –
DC
1952-7
ACTH Powder
& MR
NDAs -
DC
MR = modified release product (eg, Acthar Gel)
DC = Discontinued
1984
ACTH Powder
ANDA (Watson) -
DC
2007
Questcor changes
Acthar Gel (MR)
strategy
1952 Acthar
Gel (MR)
Acthar
1950
1978 MS


12
Porcine ACTH differs from humans by 1 amino
acid
Acthar is extracted from the pituitary of pigs
Peptide composition is being investigated -
multiple peptides exist in Acthar
Porcine ACTH differs from humans by 1 amino
acid
Acthar is extracted from the pituitary of pigs
Peptide composition is being investigated -
multiple peptides exist in Acthar
Chemistry Overview Of Acthar Gel
Extraction process is a trade secret
Manufacturing processes are trade secrets


13
Many Biologically Active Peptides in Pituitary (>100)
How many active peptides
are in Acthar?


14
Acthar is complex mixture of active peptides that we
are only beginning to identify and understand
Acthar acts like a combination product
Multiple Peptides
Multiple Pharmacological Properties
Multiple Indications            Difficult to copy
Acthar is complex mixture of active peptides that we
are only beginning to identify and understand
Acthar acts like a combination product
Multiple Peptides
Multiple Pharmacological Properties
Multiple Indications            Difficult to copy
How Does Acthar Work?


15
Old Paradigm -
ACTH and Acthar Biology
Defined by Steroidogenic Activity
Adrenal cortex
Anterior Pituitary
Hypothalamus
ACTH
Corticotropin Releasing
Factor (CRF)
Steroidogenesis
Indirect regulation of inflammation,
immune function and CNS actions
via increased glucocorticoids
(adrenocorticotropic effects)
Steroidogenesis occurs through the
binding to the melanocortin
receptor subtype 2 (MC2R)
Steroids
Acthar
Cortisol


16
Ligand
MC1R
MC2R
MC3R
MC4R
MC5R
Acthar
++
++
++
++
+
Endogenous Agonist,
ACTH(1-39)
++
++
++
++
+
ACTH(1-24)
++
+++
++
++
+
6
-Methylprednisolone
Inactive
Inactive
Inactive
Inactive
Inactive
Prednisolone
Inactive
Inactive
Inactive
Inactive
Inactive
Note:  All compounds were tested in the same series of 3'-5'-cyclic adenosine monophosphate (cAMP) assays
conducted using recombinant cell lines stably expressing cloned human melanocortin receptors MC1R to MC5R.
+++, ++, and + respectively denote high, moderate, and low potency relative to the potency of ACTH(1-39) at the MC2R.
Functional
Potency
at
Melanocortin
Receptor
(MCR)
Subtypes
Relative
to
that
of
the
Endogenous
Agonist
ACTH(1-39)
at
MC2R


17
5
Melanocortin
Receptors
(MCRs)
Distributed
Throughout the Body
Immune Cells
CNS
Adrenal Gland
Kidney
Cortisol
Cytokines
Glial Regulation
Decrease Proteinuria


New Paradigm -
Acthar Peptides
Indirect & Direct Pharmacological Effect
Immune Cells
CNS
Adrenal Gland
Glial Regulation
Cortisol
Cytokines
Decrease
Proteinuria
Kidney
18


19
Receptor binding results
In vitro and in vivo pharmacology studies
investigating Acthar's immunomodulation and
anti-inflammatory effect
In vivo disease animal models
Clinical evidence
Receptor binding results
In vitro and in vivo pharmacology studies
investigating Acthar's immunomodulation and
anti-inflammatory effect
In vivo disease animal models
Clinical evidence
Acthar has Unique Biological and Clinical
Properties –
Different than Steroids


20
Continuing our research to prevent an equivalent 
competitive product (company sponsored R&D)
Expanding research to improve market penetration for
on-label indications (investigator initiated and
company sponsored R&D)
Expanding research to move into new indication
markets (company sponsored R&D)
Numerous abstracts and publications of investigator
initiated and company sponsored research anticipated
over the next 12 months
Continuing our research to prevent an equivalent 
competitive product (company sponsored R&D)
Expanding research to improve market penetration for
on-label indications (investigator initiated and
company sponsored R&D)
Expanding research to move into new indication
markets (company sponsored R&D)
Numerous abstracts and publications of investigator
initiated and company sponsored research anticipated
over the next 12 months
Conclusion:
Increasing Research Investment


July 13, 2012
July 13, 2012
JMP Securities Healthcare Conference
JMP Securities Healthcare Conference
NASDAQ:
QCOR
NASDAQ:
NASDAQ:
QCOR
QCOR
21