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): April 29, 2010
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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California
(State or Other Jurisdiction
of Incorporation)
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001-14758
(Commission File Number)
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33-0476164
(I.R.S. Employer
Identification No.) |
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3260 Whipple Road, Union City, California
(Address of Principal Executive Offices)
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94587
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)) |
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Item 2.02. |
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Results of Operations and Financial Condition. |
On April 29, 2010, Questcor Pharmaceuticals, Inc. (the Company) announced via press release
its results for the quarter ended March 31, 2010. 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.
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Item 7.01 |
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Regulation FD Disclosure. |
The information disclosed in item 2.02 is incorporated herein by this reference.
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Item 9.01. |
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Financial Statements and Exhibits. |
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Exhibit No. |
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Description |
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99.1 |
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Questcor Pharmaceuticals, Inc. press release dated April 29, 2010. |
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.
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Date: April 29, 2010 |
QUESTCOR PHARMACEUTICALS, INC.
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By: |
/s/ Gary Sawka
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Gary Sawka |
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Senior Vice President, Finance and
Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Questcor
Pharmaceuticals, Inc. press release dated April 29, 2010. |
exv99w1
Exhibit 99.1
QUESTCOR REPORTS FIRST QUARTER 2010 RESULTS
Paid Acthar Prescriptions for MS up 197% over Prior Year Quarter
Pilot Commercial Effort Launched in Nephrotic Syndrome
Prescriptions for IS Continue within Historic Range
First Quarter Net Income of $0.12 per share on $26.2 Million in Net Sales
FDA Advisory Committee to Discuss Possible Acthar Approval for IS on May 6
Conference Call Today at 4:30 p.m. ET
UNION CITY, CA, April 29, 2010 Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) today reported
improved year-over-year financial results for the first quarter ended March 31, 2010. The
Companys financial performance was driven primarily by:
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a 197% increase in the number of new paid Acthar prescriptions for the treatment of
multiple sclerosis (MS) exacerbations as compared to the first quarter of 2009. |
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a reduced rebate liability to U.S. government insurance plans due to improved Tricare
pricing and a provision in the recently passed Patient Protection and Affordable Care Act
of 2010. |
Net sales totaled $26.2 million for the quarter ended March 31, 2010 compared to $23.3 million for
the quarter ended March 31, 2009. Net income for the first quarter of 2010 was $7.9 million, or
$0.12 per diluted common share compared to $7.7 million, or $0.11 per diluted common share, for the
first quarter of 2009. Because rebates owed to government sponsored insurance plans were lower in
the first quarter of 2010, sales reserves decreased to $7.2 million compared to $9.8 million during
the first quarter of 2009. The reduction in rebates was due to improved Tricare pricing and a
provision in the recently passed Patient Protection and Affordable Care Act of 2010 which limits
Medicaid rebates to 100% of a companys average manufacturers price. Expenses were higher in the
first quarter of 2010 than in the first quarter of 2009 because of the investments that Questcor is
making in its business. These investments include an expanded sales and marketing effort to
increase Acthar sales in MS and increased research and development expenses to fund studies of
Acthar in several indications and to support the companys application for approval of Acthar for
the treatment of infantile spasms (IS).
We continue to successfully execute our growth strategies for Acthar, said Don M. Bailey,
President and CEO. For the past year and a half, we have educated neurologists on the benefits of
using Acthar to treat specific types of patients experiencing exacerbations due to MS. Based on
company estimates, we believe that net sales of Acthar for the treatment of MS now exceed Acthar
net sales for the treatment of IS, which historically has been the primary therapeutic use for
Acthar.
In addition, during the quarter, we continued to observe the filling of a modest number of
spontaneous prescriptions for Acthar for the treatment of nephrotic syndrome (NS). During the
period, 11 new paid Acthar prescriptions for NS were filled, which is in the same range as the
spontaneous, new NS commercially-paid prescriptions filled in the fourth quarter of 2009. In
addition to these new prescriptions, due to the longer treatment period for NS, we observed
refills resulting from new NS prescriptions filled in the previous quarter. We are encouraged by
the potential for this expanded use of Acthar for NS, an on-label indication. Therefore, we have
initiated, starting in early April, a pilot sales program calling on approximately 60 out of an
estimated 7,000 nephrologists, Mr. Bailey added.
Questcor continues to experience fluctuations in quarterly demand for Acthar to treat IS. During
the first quarter of 2010, prescription levels for Acthar for the treatment of IS, while lower than
the level in the first quarter of 2009, were within the normal historic range. We are preparing
for the May 6th FDA Advisory Committee meeting, where the possible approval of Acthar
for the treatment of IS will be discussed, Mr. Bailey concluded.
MS, IS and NS Sales
During the first quarter of 2010, Questcor shipped 1,446 vials of Acthar compared to 1,429 vials
for the first quarter of 2009. Because Acthar prescriptions are filled at specialty pharmacies,
the Company does not receive complete information regarding either the number of prescriptions or
the number of vials by therapeutic area for all of the patients being treated with Acthar.
However, Questcor is able to monitor trends in payer mix for new Acthar prescriptions based on data
it receives from its reimbursement support center. Questcor estimates that at least 90% of new
Acthar prescriptions are processed by this support center, but that very few refill prescriptions
are processed at this center.
In order to help investors better understand the trends in sales of Acthar for each of its three
principal therapeutic uses (MS, IS, and NS), Questcor has grouped new prescriptions processed by
its reimbursement center into two groupsPaid and Fully Rebated. Paid prescriptions include
those prescriptions for which Questcor retains at least 70% of the price charged to its
distributor. Fully Rebated prescriptions are those for which Questcor has recorded a liability
approximately equal to or greater than the price charged to its distributor. From time to time
during the past two years, the rebate liability for some government insurance programs has shifted.
Therefore, the prescriptions that fall into the Paid and Fully Rebated categories have also
shifted over time as follows:
Paid prescriptions include all prescriptions in the following payer categories:
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CommercialFor all time periods. |
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TricareFor 2008 and 2010. |
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Medicaid Managed CareFor all time periods (see Note 1 below). |
Fully Rebated prescriptions include:
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Those reimbursed by fee-for-service Medicaid insurance and other state programs that are
eligible for full rebates as Medicaid Waivers Programs for all time periods. |
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TricareFor 2009. |
The following tables show, for each of the three principal Acthar therapeutic uses, the number of
new prescriptions shipped grouped into Paid and Fully Rebated. (Note that the columns in this
table differ from the table in Questcors March 1, 2010 earnings release because of the improved
level of Tricare pricing effective January 1, 2010.):
Multiple Sclerosis New Prescriptions
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Paid |
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Fully Rebated |
Q1-08 |
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24 |
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5 |
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Q2-08 |
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35 |
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1 |
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Q3-08 |
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51 |
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5 |
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Q4-08 |
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68 |
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3 |
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Total 2008 |
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178 |
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14 |
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Q1-09 |
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78 |
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8 |
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Q2-09 |
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125 |
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17 |
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Q3-09 |
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141 |
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19 |
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Q4-09 |
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213 |
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15 |
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Total 2009 |
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557 |
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59 |
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Q1-10 |
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232 |
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11 |
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Infantile Spasms New Prescriptions
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Paid |
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Fully Rebated |
Q1-08 |
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100 |
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38 |
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Q2-08 |
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117 |
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47 |
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Q3-08 |
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116 |
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67 |
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Q4-08 |
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106 |
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56 |
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Total 2008 |
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439 |
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208 |
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Q1-09 |
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104 |
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75 |
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Q2-09 |
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93 |
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68 |
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Q3-09 |
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61 |
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58 |
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Q4-09 |
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95 |
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45 |
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Total 2009 |
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353 |
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246 |
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Q1-10 |
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91 |
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46 |
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Nephrotic Syndrome New Prescriptions
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Paid |
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Fully Rebated |
Q1-09 |
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1 |
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0 |
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Q2-09 |
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3 |
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1 |
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Q3-09 |
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2 |
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0 |
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Q4-09 |
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14 |
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3 |
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Total 2009 |
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20 |
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4 |
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Q1-10 |
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11 |
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0 |
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Notes: (1) Because the recent health care legislation made Medicaid Managed Care prescriptions
rebate eligible effective 3/23/10, a rebate liability for the few prescriptions estimated to be
filled between 3/23/10 and 3/31/10 was accrued in the first quarter of 2010. During Q1-2010, the
Company, like all other pharmaceutical companies, did not have the ability to accurately identify
specific Medicaid Managed Care prescriptions so it is possible that a few prescriptions identified
as Paid in Q1-10 may subsequently be reclassified as Fully Rebated. Beginning in the second
quarter of 2010 Questcor is enhancing and refining its processes for identifying specific Medicaid
Managed Care prescriptions. A rebate liability will be taken for this category of prescriptions in
future quarters as appropriate. |
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Historical trend information is not necessarily indicative of future results. |
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The total number of vials associated with an individual prescription varies by the condition
being treated and by patient. |
As the above tables illustrate, the use of Acthar in the treatment of exacerbations
associated with MS is continuing to expand, commented Steve Cartt, Executive Vice President and
Chief
Business Officer. This growth is a direct result of our sustained commercial effort in the
MS market. Our first quarter MS sales were particularly strong during March 2010 and this strength
has continued during April. Furthermore, our MS sales are now benefitting from the revised
government Tricare pricing for Acthar which became effective January 1, 2010.
Sales ReservesMedicaid, Tricare and VA Adjustments
As required by federal regulations, the Company has provided rebates to state Medicaid programs for
Acthar dispensed to Medicaid patients covered under fee-for-service and other full rebate eligible
insurance plans. As a result of the recently passed health care legislation entitled the Patient
Protection and Affordable Care Act of 2010, effective January 1, 2010, the effective Medicaid
rebate for Acthar was reduced from 110% to 100% of the amount Questcor receives for Medicaid
prescriptions. However, effective March 23, 2010, these rebates have been extended to Acthar
dispensed to Medicaid patients covered under managed care insurance plans.
The Department of Defense (DOD) operates a prescription drug program through its Tricare Management
Administration (Tricare). Effective January 1, 2010, new pricing for Acthar went into effect for
purchases by Tricare and Veterans Administration (VA) medical centers. While VA sales were
immaterial in the first quarter of 2010, 13 Tricare prescriptions were filled, up slightly from the
level experienced in the third and fourth quarters of 2009 (see Note 1 above).
The impact of these changes on Questcors first quarter results was discussed earlier in this press
release.
Cash, Accounts Receivable and Share Repurchase Program
At April 23, 2010, Questcors cash, cash equivalents and short-term investments totaled
approximately $80 million, and accounts receivable totaled approximately $11 million.
During the first quarter, the Company did not repurchase any shares under its share repurchase
program. As of March 31, 2010, Questcor had 62.0 million shares of common stock outstanding, with
5.1 million shares remaining under its common stock repurchase program.
Conference Call Details
The Company will host a conference call today to discuss these results at 4:30 p.m. ET. Don Bailey,
President and Chief Executive Officer; Steve Cartt, Executive Vice President and Chief Business
Officer; Dr. David Young, Chief Scientific Officer; Dave Medeiros, Senior Vice President,
Pharmaceutical Operations; Dr. Jason Zielonka, Senior Vice President and Chief Medical Officer; and
Gary Sawka, Senior Vice President, Finance and Chief Financial Officer will host the call.
To participate in the live call by telephone, please dial 877-941-9205 for domestic participants
and 480-629-9039 for international participants. Participants are asked to call the above numbers
5-10 minutes prior to the starting time. The call will also be webcast live at
www.questcor.com. An audio replay of the call will be available for 7 days following the
call. This replay can be accessed by dialing 800-406-7325 for domestic callers and 303-590-3030 for
international callers, both using passcode 4285207#. An archived webcast will also be available at
www.questcor.com.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company focused on diseases and disorders for
which there is significant unmet medical need. Questcors primary drug is H.P. Acthar®
Gel (repository corticotropin injection). H.P. Acthar Gel (Acthar) is an injectable drug that is
approved for the treatment of certain disorders, including the treatment of exacerbations
associated with multiple sclerosis (MS) and to induce a diuresis or a remission of proteinuria in
the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus.
In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms
(IS), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare
autoimmune-related childhood neurological disorder. For more information, 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 may, will, if,
should, forecasts, expects, plans, anticipates, believes, estimates, predicts,
potential, or continue 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:
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Questcors ability to continue to successfully implement its
Acthar-centric business strategy, including its expansion in the MS marketplace and
other therapeutic areas; |
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FDA approval of and the market introduction of competitive products and
our inability to market Acthar in IS prior to approval of IS as a labeled indication; |
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Questcors ability to operate within an industry that is highly regulated
at both the Federal and state level; |
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Regulatory changes or other policy actions by governmental authorities
and other third parties as recently adopted U.S. healthcare reform legislation is
implemented; |
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Questcors ability to accurately forecast the demand for its products; |
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Questcors ability to receive high reimbursement levels from third party
payers; |
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Questcors ability to estimate the quantity of Acthar used by government
entities and Medicaid-eligible patients; |
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That the actual amount of rebates and chargebacks related to the use of
Acthar by government entities, including the Department of Defense Tricare network,
and Medicaid-eligible patients may differ materially from Questcors estimates; |
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Questcors expenses and other capital needs for upcoming periods; |
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The inventories carried by Questcors distributors, specialty pharmacies
and hospitals; |
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Volatility in Questcors monthly and quarterly Acthar shipments and
end-user demand; |
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The complex nature of Questcors manufacturing process and the potential
for supply disruptions or other business disruptions; |
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Questcors ability to attract and retain key management personnel; |
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Research and development risks, including risks associated with
Questcors sNDA for IS and its preliminary work in the area of nephrotic syndrome; |
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Uncertainties regarding Questcors intellectual property; |
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The uncertainty of receiving required regulatory approvals in a timely
way, or at all; |
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The impact to Questcors business caused by economic conditions; |
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Questcors limited pipeline for new products and its ability to identify
product acquisition candidates and consummate transactions on terms acceptable to the
Company; and |
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Other risks discussed in Questcors annual report on Form 10-K for the
year ended December 31, 2009 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.
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.
For more information, please visit www.questcor.com or www.acthar.com.
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CONTACT: |
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Questcor
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Investors
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Media |
Don Bailey
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EVC Group
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EVC Group |
dbailey@Questcor.com
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Barbara Domingo, 415-896-6820
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Chris Gale, 646-201-5431 |
510-400-0776
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Douglas Sherk, 415-896-6820 |
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Questcor Pharmaceuticals, Inc.
Consolidated Statements of Income
(In thousands, except per share amounts)
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Three Months Ended |
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March 31, |
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2010 |
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2009 |
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Net sales |
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$ |
26,244 |
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$ |
23,298 |
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Cost of sales (exclusive of amortization of purchased technology) |
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1,998 |
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1,510 |
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Gross profit |
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24,246 |
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21,788 |
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Gross margin |
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92 |
% |
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94 |
% |
Operating expenses: |
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Selling, general and administrative |
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9,376 |
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7,253 |
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Research and development |
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2,747 |
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2,456 |
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Depreciation and amortization |
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125 |
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118 |
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Total operating expenses |
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12,248 |
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9,827 |
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Income from operations |
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11,998 |
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11,961 |
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Other income: |
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Interest and other income, net |
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96 |
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268 |
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Gain on sale of product rights |
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25 |
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Total other income |
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96 |
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293 |
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Income before income taxes |
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12,094 |
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12,254 |
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Income tax expense |
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4,242 |
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4,580 |
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Net income |
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$ |
7,852 |
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$ |
7,674 |
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Net income per share: |
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Basic |
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$ |
0.13 |
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$ |
0.12 |
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Diluted |
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$ |
0.12 |
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$ |
0.11 |
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Shares used in computing net income per share: |
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Basic |
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61,893 |
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65,498 |
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Diluted |
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63,566 |
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67,963 |
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Questcor Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except share amounts)
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March 31, |
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December 31, |
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2010 |
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2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
39,428 |
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$ |
45,829 |
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Short-term investments |
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38,599 |
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29,878 |
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Total cash, cash equivalents and short-term investments |
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78,027 |
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75,707 |
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Accounts receivable, net of allowance for doubtful
accounts of $77 at March 31, 2010 and December 31, 2009 |
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13,397 |
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14,833 |
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Inventories, net |
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3,350 |
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3,378 |
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Prepaid expenses and other current assets |
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1,150 |
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1,162 |
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Deferred tax assets |
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8,166 |
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8,180 |
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Total current assets |
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104,090 |
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103,260 |
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Property and equipment, net |
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483 |
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|
407 |
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Purchased technology, net |
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3,298 |
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|
|
3,372 |
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Goodwill |
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|
299 |
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|
299 |
|
Deposits and other assets |
|
|
710 |
|
|
|
710 |
|
Deferred tax assets |
|
|
3,392 |
|
|
|
3,392 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
112,272 |
|
|
$ |
111,440 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,653 |
|
|
$ |
12,921 |
|
Accrued compensation |
|
|
1,719 |
|
|
|
2,140 |
|
Sales-related reserves |
|
|
13,502 |
|
|
|
14,922 |
|
Income taxes payable |
|
|
3,919 |
|
|
|
477 |
|
Other accrued liabilities |
|
|
907 |
|
|
|
1,751 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
23,700 |
|
|
|
32,211 |
|
Lease termination and deferred rent liabilities and other
non-current liabilities |
|
|
1,145 |
|
|
|
1,226 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
24,845 |
|
|
|
33,437 |
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, no par value, 7,500,000 shares
authorized; none outstanding |
|
|
|
|
|
|
|
|
Common stock, no par value, 105,000,000 shares
authorized; 62,040,454 and 61,726,609 shares issued and
outstanding at March 31, 2010 and December 31, 2009,
respectively |
|
|
69,342 |
|
|
|
67,793 |
|
Retained earnings |
|
|
18,076 |
|
|
|
10,224 |
|
Accumulated other comprehensive income (loss) |
|
|
9 |
|
|
|
(14 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
87,427 |
|
|
|
78,003 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
112,272 |
|
|
$ |
111,440 |
|
|
|
|
|
|
|
|
Questcor Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,852 |
|
|
$ |
7,674 |
|
Adjustments to reconcile net income to net cash provided
by operating activities: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
1,029 |
|
|
|
1,045 |
|
Amortization of investments |
|
|
147 |
|
|
|
(43 |
) |
Depreciation and amortization |
|
|
125 |
|
|
|
118 |
|
Gain on sale of product rights |
|
|
|
|
|
|
(25 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,436 |
|
|
|
1,565 |
|
Inventories |
|
|
28 |
|
|
|
(28 |
) |
Prepaid income taxes |
|
|
|
|
|
|
2,960 |
|
Prepaid expenses and other current assets |
|
|
12 |
|
|
|
(118 |
) |
Accounts payable |
|
|
(9,268 |
) |
|
|
1 |
|
Accrued compensation |
|
|
(421 |
) |
|
|
(930 |
) |
Sales-related reserves |
|
|
(1,420 |
) |
|
|
507 |
|
Income taxes payable |
|
|
3,442 |
|
|
|
|
|
Other accrued liabilities |
|
|
(844 |
) |
|
|
(550 |
) |
Other non-current liabilities |
|
|
(81 |
) |
|
|
(78 |
) |
|
|
|
|
|
|
|
Net cash flows provided by operating activities |
|
|
2,037 |
|
|
|
12,098 |
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(127 |
) |
|
|
(29 |
) |
Purchase of short-term investments |
|
|
(10,831 |
) |
|
|
(24,193 |
) |
Proceeds from maturities of short-term investments |
|
|
2,000 |
|
|
|
15,000 |
|
Net proceeds from sale of product rights |
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
Net cash flows used in investing activities |
|
|
(8,958 |
) |
|
|
(9,197 |
) |
|
|
|
|
|
|
|
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Issuance of common stock, net |
|
|
520 |
|
|
|
250 |
|
Repurchase of common stock |
|
|
|
|
|
|
(6,772 |
) |
|
|
|
|
|
|
|
Net cash flows provided by (used in) financing activities |
|
|
520 |
|
|
|
(6,522 |
) |
|
|
|
|
|
|
|
Decrease in cash and cash equivalents |
|
|
(6,401 |
) |
|
|
(3,621 |
) |
Cash and cash equivalents at beginning of period |
|
|
45,829 |
|
|
|
13,282 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
39,428 |
|
|
$ |
9,661 |
|
|
|
|
|
|
|
|