e8vk
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): November 12, 2007
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
California
|
|
001-14758
|
|
33-0476164 |
(State or Other Jurisdiction
|
|
(Commission File Number)
|
|
(I.R.S. Employer |
of Incorporation)
|
|
|
|
Identification No.) |
|
|
|
|
|
3260 Whipple Road Union City, California
|
|
|
|
94587 |
(Address of Principal Executive Offices)
|
|
|
|
(Zip Code) |
Registrants telephone number, including area code: (510) 400-0700
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):
o |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)) |
|
o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 2.02. Results of Operations and Financial Condition.
On November 12, 2007, Questcor Pharmaceuticals, Inc. (the Company) announced via press
release its results for the quarter ended September 30, 2007. A copy of the Companys press
release is attached hereto as Exhibit 99.1. In accordance with General Instruction B.2. of
Form 8-K, the information in Item 2.02 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.
(c) Exhibits.
|
|
|
|
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
|
|
|
|
|
99.1 |
|
|
Press release furnished by Questcor Pharmaceuticals, Inc. dated November 12, 2007, relating to the Companys results for the quarter ended
September 30, 2007, referred to in Item 2.02 above. |
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: November 13, 2007 |
|
QUESTCOR PHARMACEUTICALS, INC. |
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ George Stuart |
|
|
|
|
|
|
George Stuart
Senior Vice President, Finance and
Chief Financial Officer
|
|
|
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
|
|
99.1
|
|
Press release furnished by Questcor Pharmaceuticals, Inc. dated November 12, 2007, relating
to the Companys results for the quarter ended September 30, 2007. |
exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
QUESTCOR REPORTS THIRD QUARTER RESULTS
Now Cash Flow Positive from Operations
Union City, CA November 12, 2007 Questcor Pharmaceuticals, Inc. (AMEX:QSC) today reported its
financial results for the third quarter ended September 30, 2007. As previously announced on
August 27, 2007, Questcor has implemented a new strategy and business model for its principal
product, H.P. Acthar® Gel, a natural form of adrenocorticotropic hormone (ACTH). The
goal of this new strategy is to make manufacturing and distribution of Acthar economically viable
on a stand-alone basis, thus enabling Questcor to continue ensuring the long-term availability of
this important product. Based on third quarter results, Questcor may now be in a position to fund
important research and development projects, including any future clinical trials that could be
required by the FDA.
Demand by patients utilizing Acthar for infantile spasms (IS) and opsoclonus myoclonus syndrome
(OMS) has remained at approximately the same levels experienced prior to the implementation of the
new strategy. Questcor has also seen a positive pattern of insurance coverage and expanded use of
the safety net programs for Acthar patients. As a result, Questcor is not aware of a single IS or
OMS patient requiring Acthar that has been denied treatment. While the trend in ordering and
insurance reimbursement has resulted in higher net sales, as Questcor expected, since the
implementation of its new business model, overall unit demand for Acthar has decreased
significantly. In addition, Questcor is now profitable and generating positive cash flows. For
the third quarter of 2007, total net sales were $14.8 million.
Since the close of the third quarter, the consistent level of ordering and insurance reimbursement
experienced since the implementation of the new strategy in August has continued. However, future
Acthar orders may be impacted by several factors: inventory practices at specialty and hospital
pharmacies; use of the patient assistance programs; the overall pattern of usage by the healthcare
community, including Medicaid and other government entities; and the
reimbursement policies of insurance companies. Further, as discussed in more detail below, net
sales in future quarters may be reduced to a greater extent than in the third quarter by Medicaid
rebates and government chargebacks.
Steve Cartt, Questcors Executive Vice President, Corporate Development, noted, We are pleased
that most patients using Acthar have successfully obtained coverage from their insurance plans. So
far, very few patients have been denied coverage by their insurance plan for this important
product. Those few who have had coverage denied by their insurance plan have been provided drug
through the National Organization for Rare Disorders (NORD), an advocacy group for patients
afflicted with rare disorders, which provides assistance programs for patients who are otherwise
unable to afford their treatments. We have significantly increased our support for NORD and its
critically important patient assistance programs, and, as a result, we are not aware of any patient
requiring Acthar that has been denied access. This will continue to be a key objective of our
business model going forward.
Don Bailey, Questcors Interim President, commented, The overriding goal of our new strategy is to
ensure the continued long-term availability of Acthar. The consistent pace of orders for Acthar
and the high level of insurance coverage have been positive and we are encouraged that these trends
are continuing up to the date of this report. We are also pleased to see expanded utilization of
the patient assistance and co-pay assistance programs, which are sponsored by Questcor and
independently operated by NORD.
Mr. Bailey continued, The initial results of our new strategy have allowed Questcor to become
profitable with positive cash flows. If these positive trends continue, Questcor will achieve its
goal of assuring the continued availability of Acthar.
Questcor believes that financial stability may allow the company to fund important research and
development activities that could advance scientific and medical knowledge regarding the treatment
of neurological disorders such as IS. These activities could result in improved treatment
algorithms for these devastating disorders. The treatment of IS, for example, has not changed
significantly in decades, partly because research and development funding has been severely
limited. Questcors research may include basic science investigation into Acthars efficacy in IS,
as well as efforts to optimize the clinical use of this unique therapeutic agent. Much is still
not fully understood about Acthar, a complex biologic product consisting of the
2
39-amino-acid peptide ACTH and multiple peptide fragments. The healthcare community would like to
better understand how Acthar affects certain rare neurological disorders, such as IS and OMS. Such
exploration has the potential to not only enhance clinical outcomes for patients by improving how
Acthar is used but may also result in a better understanding of the disorders themselves. In
addition, Questcor is examining ways to optimize key Acthar manufacturing processes, building on
its substantial investments over the last few years in modernizing the manufacture of Acthar.
Acthar is currently approved in the U.S. for the treatment of multiple sclerosis exacerbations and
other conditions. No drug is approved in the U.S. for the treatment of IS, a potentially
life-threatening disorder that typically begins in the first year of life. However, pursuant to
guidelines published by the American Academy of Neurology and the Child Neurology Society, many
child neurologists use Acthar to treat infants afflicted with this condition.
In June 2006 Questcor submitted a Supplemental New Drug Application (sNDA) to the Food and Drug
Administration (FDA) and is currently pursuing formal agency approval for Acthar in the treatment
of IS. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS. As a
result of this Orphan Designation, if Questcor is successful in obtaining FDA approval for the IS
indication, Questcor will also qualify for a seven year exclusivity period during which the FDA is
prohibited from approving any other ACTH formulation for IS unless the other formulation is
demonstrated to be clinically superior to Acthar.
On November 9, 2007, Questcor met with the FDA to further discuss its sNDA seeking approval of
Acthar for the treatment of IS. At the meeting, the FDA concurred with Questcors suggested
pathway to preparing a complete application for FDA review. This will involve submission of
additional information to the FDA. Dr. Steven Halladay, Questcors Senior Vice President, Clinical
and Regulatory Affairs, commented Our discussions with the FDA were very helpful and we have been
pleased by the supportive and constructive nature of the dialogue. Questcor and the FDA have
agreed on the next steps to move the Acthar IS application forward.
Dave Medeiros, Questcors Senior Vice President, Pharmaceutical Operations, commented on Questcors
development pipeline, Development efforts on QSC-001, Questcors proprietary orally dissolving
tablet, or ODT, formulation of hydrocodone and acetaminophen for the treatment of moderate to
moderately severe pain, progressed well in the quarter. Currently, our
3
goal is to enter pivotal trials during 2008. Additionally, we have made progress on other
development projects.
Total net sales were $14.8 million and $22.7 million, respectively, for the three and nine month
periods ended September 30, 2007 as compared to $4.0 million and $9.4 million for the same periods
in 2006. Net sales of Acthar were $14.6 million and $21.8 million, respectively, for the three and
nine month periods ended September 30, 2007 as compared to $3.8 million and $9.0 million for the
same periods in 2006. In addition, the gross profit margin percent increased to 90 percent for the
quarter ended September 30, 2007 as compared to 77 percent for the same period in 2006.
George Stuart, Questcors Senior Vice President, Finance and Chief Financial Officer commented, A
portion of Acthar sales are for patients covered under Medicaid and other government related
programs. Questcor provides rebates and discounts related to product dispensed to Medicaid
patients and purchased by certain government agencies. These Medicaid rebates and government
chargebacks are estimated by Questcor each quarter and result in a reduction in Questcors net
sales. Questcors estimates of Medicaid rebates and government chargebacks during the quarter
ended September 30, 2007 were based primarily on activity prior to the implementation of Questcors
new strategy, which occurred in late August. The amount of Medicaid rebates and government
chargebacks may increase and represent a greater percentage of sales in periods subsequent to the
quarter ended September 30, 2007.
In connection with the implementation of the new Acthar strategy, coupled with recent
clarifications to the Medicaid statute and regulations, Questcor, after extensive review of the
statute and regulations and consultation with its regulatory legal counsel, prospectively modified
how it determines the per unit amount of its Medicaid rebates to conform with the statute. The
modification was implemented commencing in August 2007 and communicated to the administrators of
the Medicaid program in September 2007. The modification increased net sales and net income
applicable to common shareholders by $4.5 million, or $0.07 and $0.06 per fully diluted share, for
the three and nine month periods ended September 30, 2007, respectively. However, for periods
after September 30, 2007, the amount of Medicaid rebates and government chargebacks that reduce
Questcors net sales may result in minimal, if any, net sales revenue to Questcor from products
used by Medicaid patients and certain government entities.
4
Selling, general and administrative expenses were $3.3 million and $13.6 million, respectively, for
the three and nine month periods ended September 30, 2007 as compared to $4.2 million and $12.6
million for the three and nine month periods ended September 30, 2006. The decrease in expenses
for the quarter ended September 30, 2007 was due primarily to the reduction of Questcors field
organization from 45 sales representatives to 10 product service consultants and 3 medical science
liaisons during the second quarter of 2007. Questcor expects the reduction of its field
organization to generate annual cash savings of between $4.0 million and $5.0 million. Other cost
reductions are expected to increase the annual cash savings to a range of $5.0 million to $6.0
million.
Research and development expenses were $1.3 million and $3.4 million, respectively, for the three
and nine month periods ended September 30, 2007, as compared to $0.5 million and $1.6 million for
the three and nine month periods ended September 30, 2006. The increase was due primarily to
expenses associated with Questcors continued efforts to advance important development projects and
the addition of Questcors clinical and development leadership team during the fourth quarter of
2006.
Questcor had an insignificant tax rate on its net income for the three and nine month periods ended
September 30, 2007. This results from Questcors ability to use its net operating loss
carryforwards (NOLs) to offset most of its pre-tax income. As of December 31, 2006, Questcor had
federal and state NOLs of $101.4 million and $34.6 million, respectively. Questcors NOLs may be
subject to substantial annual limitations due to the ownership change limitations provided by the
Internal Revenue Code and similar state provisions. Questcor is currently evaluating whether there
have been any historical changes in ownership that would limit the future use of its NOLs.
Net income applicable to common shareholders totaled $8.4 million, or $0.12 per fully diluted
share, for the third quarter of 2007, compared to a net loss applicable to common shareholders of
$(1.5) million, or $(0.03) per share, for the third quarter of 2006. Net income applicable to
common shareholders totaled $3.1 million, or $0.04 per fully diluted share, for the nine month
period ended September 30, 2007, compared to a net loss applicable to common shareholders of $(6.8)
million, or $(0.12) per share, for the same period in 2006.
As of September 30, 2007, Questcor had 69.3 million common shares and 2.2 million Series A
preferred shares outstanding. As of November 9, 2007, Questcor had cash, cash equivalents and
5
short-term investments of $15.2 million and its accounts receivable balance totaled $22.6 million.
Since the implementation of the new Acthar strategy, Questcor estimates that end user demand for
Acthar has been 425 to 475 vials per month. Of this demand, Questcor estimates that approximately
30 percent of vials are used by patients covered by Medicaid and other government related programs.
For periods after September 30, 2007, the amount of Medicaid rebates and government chargebacks
that reduce Questcors net sales may result in minimal, if any, net sales revenue to Questcor from
products used by Medicaid patients and certain government entities. As discussed above, Questcor
has experienced a consistent level of ordering and insurance reimbursement for Acthar since the
inception of the new strategy. While the consistent pattern of ordering and insurance
reimbursement are continuing to date, future Acthar orders may be impacted by inventory practices
at specialty and hospital pharmacies, greater use of the safety net established for Acthar
patients, the pattern of usage by the healthcare community and reimbursement policies of insurance
companies.
About Questcor Questcor Pharmaceuticals, Inc.® (AMEX: QSC) develops and sells
pharmaceutical products. Questcors products include H.P. Acthar® Gel (repository
corticotropin injection) and Doral® (quazepam), which is indicated for the treatment of
insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early
morning awakenings. For more information, please visit
www.questcor.com.
Note: Except for the historical information contained herein, this press release contains
forward-looking statements that involve risks and uncertainties. Such statements are subject to
certain factors, which may cause Questcors results to differ from those reported herein. Factors
that may cause such differences include, but are not limited to, Questcors ability to continue to
successfully implement the new strategy and business model for Acthar, Questcors ability to
identify and hire a permanent Chief Executive Officer, Questcors ability to accurately forecast
the demand for its products, the gross margin achieved from the sale of its products, Questcors
ability to enforce its product returns policy, Questcors ability to estimate the quantity of
Acthar used by government entities and Medicaid eligible patients, that the actual amount of
rebates and discounts related to the use of Acthar by government entities and Medicaid eligible
patients may differ materially from Questcors estimates, the sell-through by Questcors
distributors, the expenses and other cash needs for upcoming periods, the inventories carried by
Questcors distributors, Questcors ability to obtain finished goods from its sole source contract
manufacturers on a timely basis if at all, Questcors potential future need for additional funding,
Questcors ability to utilize its net operating loss carry forwards to reduce income taxes on
taxable income, research and development risks, uncertainties regarding Questcors intellectual
property and the uncertainty of receiving required regulatory approvals in a timely way, or at all,
other research, development, and regulatory risks, and the ability of Questcor to acquire products
and, if acquired, to market them successfully and find marketing partners where appropriate, as
well as the risks discussed in Questcors annual report on Form 10-K for the year ended December
31, 2006 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 Questcors
prospects and future financial performance.
6
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
hereof or to reflect the occurrence of unanticipated events.
CONTACT INFORMATION:
Questcor Pharmaceuticals, Inc.
IR2@Questcor.com
Don Bailey
Steve Cartt
510-400-0700
EVC Group
Doug Sherk
Julie Huang
646-443-6963
7
Questcor Pharmaceuticals, Inc.
Consolidated Statements of Operations
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net product sales |
|
$ |
14,809 |
|
|
$ |
4,045 |
|
|
$ |
22,654 |
|
|
$ |
9,384 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales (exclusive of amortization of purchased
technology) |
|
|
1,534 |
|
|
|
945 |
|
|
|
3,298 |
|
|
|
2,223 |
|
Selling, general and administrative |
|
|
3,322 |
|
|
|
4,171 |
|
|
|
13,619 |
|
|
|
12,582 |
|
Research and development |
|
|
1,264 |
|
|
|
544 |
|
|
|
3,355 |
|
|
|
1,632 |
|
Depreciation and amortization |
|
|
125 |
|
|
|
94 |
|
|
|
373 |
|
|
|
218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
6,245 |
|
|
|
5,754 |
|
|
|
20,645 |
|
|
|
16,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
8,564 |
|
|
|
(1,709 |
) |
|
|
2,009 |
|
|
|
(7,271 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
164 |
|
|
|
137 |
|
|
|
555 |
|
|
|
469 |
|
Other income (expense), net |
|
|
(1 |
) |
|
|
51 |
|
|
|
239 |
|
|
|
29 |
|
Gain on sale of product rights |
|
|
|
|
|
|
|
|
|
|
448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
|
163 |
|
|
|
188 |
|
|
|
1,242 |
|
|
|
498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) before income taxes |
|
|
8,727 |
|
|
|
(1,521 |
) |
|
|
3,251 |
|
|
|
(6,773 |
) |
Income tax expense |
|
|
102 |
|
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
8,625 |
|
|
|
(1,521 |
) |
|
|
3,149 |
|
|
|
(6,773 |
) |
Allocation of undistributed earnings to Series A preferred stock |
|
|
261 |
|
|
|
|
|
|
|
95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) applicable to common shareholders |
|
$ |
8,364 |
|
|
$ |
(1,521 |
) |
|
$ |
3,054 |
|
|
$ |
(6,773 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share applicable to common shareholders basic and diluted |
|
$ |
0.12 |
|
|
$ |
(0.03 |
) |
|
$ |
0.04 |
|
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net income (loss) per share applicable
to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
69,192 |
|
|
|
56,870 |
|
|
|
68,986 |
|
|
|
55,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
69,224 |
|
|
|
56,870 |
|
|
|
69,985 |
|
|
|
55,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
Questcor Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
10,592 |
|
|
$ |
18,425 |
|
Accounts receivable, net of allowance for doubtful accounts
of $52 and $55 at September 30, 2007 and December 31, 2006,
respectively |
|
|
14,149 |
|
|
|
1,783 |
|
Inventories, net |
|
|
2,568 |
|
|
|
2,965 |
|
Prepaid expenses and other current assets |
|
|
628 |
|
|
|
811 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
27,937 |
|
|
|
23,984 |
|
Property and equipment, net |
|
|
570 |
|
|
|
665 |
|
Purchased technology, net |
|
|
4,042 |
|
|
|
3,965 |
|
Goodwill |
|
|
299 |
|
|
|
299 |
|
Deposits and other assets |
|
|
738 |
|
|
|
722 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
33,586 |
|
|
$ |
29,635 |
|
|
|
|
|
|
|
|
LIABILITIES, PREFERRED STOCK AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,926 |
|
|
$ |
2,154 |
|
Accrued compensation |
|
|
716 |
|
|
|
1,019 |
|
Sales-related reserves |
|
|
2,141 |
|
|
|
2,784 |
|
Income taxes payable |
|
|
102 |
|
|
|
|
|
Other accrued liabilities |
|
|
846 |
|
|
|
521 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
5,731 |
|
|
|
6,478 |
|
Lease termination and deferred rent liabilities |
|
|
2,027 |
|
|
|
1,961 |
|
Other non-current liabilities |
|
|
10 |
|
|
|
18 |
|
Preferred stock, no par value, 7,500,000 shares authorized;
2,155,715 Series A shares issued and outstanding at September
30, 2007 and December 31, 2006 (aggregate liquidation preference
of $10,000 at September 30, 2007 and December 31, 2006) |
|
|
5,081 |
|
|
|
5,081 |
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Common stock, no par value, 105,000,000 shares authorized;
69,291,641 and 68,740,804 shares issued and outstanding at
September 30, 2007 and December 31, 2006, respectively |
|
|
106,826 |
|
|
|
105,352 |
|
Accumulated deficit |
|
|
(86,107 |
) |
|
|
(89,256 |
) |
Accumulated other comprehensive gain |
|
|
18 |
|
|
|
1 |
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
20,737 |
|
|
|
16,097 |
|
|
|
|
|
|
|
|
Total liabilities, preferred stock and shareholders equity |
|
$ |
33,586 |
|
|
$ |
29,635 |
|
|
|
|
|
|
|
|
9