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): August 9, 2011

 

 

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 (see General Instruction A.2. below):

 

¨ 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 August 9, 2011, Questcor Pharmaceuticals, Inc. (the “Company”) will utilize an updated presentation for investor relations purposes. The presentation is furnished under this Item 7.01 pursuant to Regulation FD and is included as Exhibit 99.1 to this Current Report on Form 8-K. The presentation will also be made available on the Company’s website at www.questcor.com.

In accordance with General Instruction B.2. of Form 8-K, the information in 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
Number
   Description
99.1    Questcor Pharmaceuticals, Inc. August 2011 Investor Presentation.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 9, 2011   QUESTCOR PHARMACEUTICALS, INC.
  By:  

/s/ Michael Mulroy

    Michael Mulroy, Chief Financial Officer & General Counsel


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Questcor Pharmaceuticals, Inc. August 2011 Investor Presentation.
Investor Presentation
1
1
NASDAQ:
QCOR
NASDAQ:
QCOR
August 2011
August 2011
Exhibit 99.1


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 generate revenue from sales of Acthar to treat on-label indications associated with NS,
and our ability to develop other therapeutic uses for Acthar including SLE; Research and development risks, including risks
associated with Questcor's work in the area of nephrotic syndrome and potential work in the area of SLE, 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 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; Our ability to maintain effective controls over financial reporting; The risk of product liability lawsuits;
Unforeseen business interruptions; Volatility in Questcor's monthly and quarterly Acthar shipments 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, 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 Questcor's
prospects and future financial performance.


3
Questcor
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:
Flagship Product:
Profitable, cash flow positive, $142M* in cash, debt-free
Profitable, cash flow positive, $142M* 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 market for Acthar
Grow Acthar sales in each key market
Develop on-label Lupus market for Acthar
Financials:
Financials:
* As of 7/29/11
4


History of Acthar
1952
First
Approved
1950
1950
1978
MS Indication Added
2000
2000
2001
Questcor Acquires
Acthar
2010
Label Modernized
19 Indications
2007
Questcor Changes
Strategy
2010
2010
5


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


Acthar and MS
Neurodegenerative
disorder
Acute treatment for
relapses
Treatment for 1-2   
weeks*
$40K-$50K/Rx
Inadequate
Inadequate
Response to
Response to
Steroids
Steroids
Poor
Poor
Venous
Venous
Access
Access
Problematic
Problematic
Steroid Side
Steroid Side
Effects 
Effects 
Acthar
Acthar
when
when
“Steroids are
“Steroids are
not suitable”
not suitable”
*Based on prescriptions written


9
MS
Sales
-
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.


Monthly MS Sales Are Promotion Sensitive
10


11
Doubled sales force:  38 to 77 sales reps Nov 2010
Q2-2011 results
Q2-11
new
paid
Rxs
up
147%
vs.
Q2-10
MS about 60% of QCOR net sales*
Estimated $110M annualized run-rate*
About 400 prescribers in Q2
June was a record month
July trends remain solid
Q2 sales level continuing into Q3
Doubled sales force:  38 to 77 sales reps Nov 2010
Q2-2011 results
Q2-11
new
paid
Rxs
up
147%
vs.
Q2-10
MS about 60% of QCOR net sales*
Estimated $110M annualized run-rate*
About 400 prescribers in Q2
June was a record month
July trends remain solid
Q2 sales level continuing into Q3
MS Trends
*based on Company estimates


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*
$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*
$150K-250K/Rx
Acthar and Nephrotic Syndrome (NS)
*Based on prescriptions written


NS Sales –
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.
5
Yellow numbers in the  bars show the number of NS sales
people making calls at the end of the quarter.
13


14
NS Market Size


15
Hired 5 reps to sell Acthar to nephrologists
Initiated sales efforts in early March 2011
Q1 2011 NS Scripts: 18
14 different prescribers
Q2 2011 NS Scripts: 45
37 different prescribers
4-6 month course of therapy creates future vial demand
Expanding the NS selling effort
Planned sales calls to increase in Q4 by 7X over Q2
Disruption to sales level in Q3 possible
Hired 5 reps to sell Acthar to nephrologists
Initiated sales efforts in early March 2011
Q1 2011 NS Scripts: 18
14 different prescribers
Q2 2011 NS Scripts: 45
37 different prescribers
4-6 month course of therapy creates future vial demand
Expanding the NS selling effort
Planned sales calls to increase in Q4 by 7X over Q2
Disruption to sales level in Q3 possible
NS Sales


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 patient dosed in Q3
“First look”
data available late 2012
Final reporting mid 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 patient dosed in Q3
“First look”
data available late 2012
Final reporting mid 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


Targeting select institutions
Promotion effort being narrowed as market is maturing
Creates selling time for Acthar reps to target NS
Significant variability in quarterly Rxs
Q2-2011 sales within 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 reps to target NS
Significant variability in quarterly Rxs
Q2-2011 sales within historic range
Acthar currently used to treat 40-50% of IS patients
IS Sales
19


20
*Represents estimated net sales market opportunity based on internal company estimates
** Represents approximately 4 times Q1 11 net sales by therapeutic area based on internal company estimates
Build on sales
momentum,
good market
headroom
Market size-
$500M+
Good start with
5 reps
Significantly
expanding
selling effort
Market size-
$1B+
Targeted sales
strategy
Market size-
$100M
MS
NS
IS
Immediate
Acthar
Growth
Opportunities


21
Specialty Sales Force
Main focus on MS (~80%), 15% on NS, 5% on 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 will be calling on
>4,000 neurologists
>3,000 nephrologists
about 100 key children’s hospitals
Specialty Sales Force
Main focus on MS (~80%), 15% on NS, 5% on 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 will be calling on
>4,000 neurologists
>3,000 nephrologists
about 100 key children’s hospitals
Total Acthar Sales Force


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
Q2-2011 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
$46.0
$46.0
94%
94%
$20.4
$20.4
$0.21
$0.21
$28.3
$28.3
93%
93%
$14.3
$14.3
$0.14
$0.14
Q2-2011
Q2-2011
Q2-2010
Q2-2010
Record Sales (up 62%) and Solid Earnings (EPS up 50%)
Record Sales (up 62%) and Solid Earnings (EPS up 50%)
Second quarter vials shipped: 2,430
Medicaid reserves continue to appear adequate
No shares repurchased


Questcor is Cash Flow Positive
*After return of $78 million of cash to shareholders through
share repurchases.            
Cash / ST Investments
Cash / ST Investments
Accounts Receivable
Accounts Receivable
$142M*
$142M*
$28M
$28M
7/29/11
7/29/11
Debt-free balance sheet
25


Share Repurchases: 15 Million Shares
2.2 Million Preferred share buyback
13.2 Common share buyback
$78 million returned to shareholders in stock
buybacks
62.3 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
62.3 million shares currently outstanding
4.3 million shares remain on buyback authorization
26
Repurchases significantly improve EPS


27
Sustain effort and momentum with MS
Expand NS selling effort
Maintain and gradually grow IS sales
Explore Systemic Lupus Erythematosus (Lupus) as next
vertical market
Develop other markets for Acthar
No business development efforts planned
Sustain effort and momentum with MS
Expand NS selling effort
Maintain and gradually grow IS sales
Explore Systemic Lupus Erythematosus (Lupus) as next
vertical market
Develop other markets for Acthar
No business development efforts planned
Go Forward Plan -
Sell More 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


28
Investment Highlights
Questcor has good sales momentum
Acthar has sustainable competitive advantages
Focus on substantial growth in MS and NS
New
vertical
market
Lupus
Market sizes have good growth potential
Solid financial performance and balance sheet


29
29
NASDAQ:
QCOR
NASDAQ:
QCOR
August 2011
August 2011