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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 27, 2009
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)) |
TABLE OF CONTENTS
Item 2.02. Results of Operations and Financial Condition.
On April 28, 2009, Questcor Pharmaceuticals, Inc. (the Company) announced via press release
its results for the quarter ended March 31, 2009. 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain Officers.
On April 27, 2009, the Company entered into a new employment agreement with Dr. Steven
Halladay, the Companys Senior Vice President of Clinical and Regulatory Affairs (the Transition
Agreement). Dr. Halladay resides in Tucson, Arizona and has been commuting to the Companys
location in Northern California for the past 2 1/2 years.
Pursuant to the terms of the Transition Agreement, Dr. Halladay has agreed to continue working
in his current capacity for a period of six (6) months as a part-time employee of the Company. The
Transition Agreement provides compensation during the six (6) month period of $20,256.66 per month,
continuation of benefits and continued stock option vesting. The Transition Agreement also
provides for severance to be paid to Dr. Halladay at the end of his part-time employment in the
amount of $30,385. In addition, if Dr. Halladay completes the six (6) month
term of employment, he is eligible to receive a bonus of $75,000 if
the Company is successful with respect to its supplemental
New Drug Application for Acthar for the treatment of infantile
spasms. The description of the Transition Agreement is qualified in its
entirety by reference to the copy of the transition agreement attached hereto as Exhibit 10.1 and
incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
The information disclosed in item 2.02 is incorporated herein by this reference.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
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Exhibit No. |
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Description |
10.1
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Transition Agreement, dated as of
April 27, 2009, by and between the Company and Dr. Steven Halladay. |
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99.1
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Questcor Pharmaceuticals, Inc. press release dated April 28, 2009. |
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, 2009 |
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 |
10.1
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Transition Agreement, dated as of
April 27, 2009, by and between the Company and Dr. Steven Halladay. |
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99.1
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Questcor Pharmaceuticals, Inc. press release dated April 28, 2009. |
exv10w1
Exhibit 10.1
April 27, 2009
Dr. Steven C Halladay
Questcor Pharmaceuticals, Inc.
3260 Whipple Road
Union City, CA 94587
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Re: |
Transition Agreement |
VIA HAND DELIVERY |
Dear Dr. Halladay:
This letter agreement (Agreement) sets forth the terms of your change in status from your
current role as a full-time employee of Questcor Pharmaceuticals, Inc. (the Company) to a new
role as a part-time employee of the Company for a six month transition period:
1. Transition Date. May 1, 2009 will be designated as your transition date (the Transition
Date). Until the Transition Date, you shall continue to use your best efforts to perform your
currently assigned duties and responsibilities. During your continued full-time employment through
the Transition Date, you will receive your regular base salary and continue in the benefits
programs which you are currently enrolled. The Company will also reimburse you, in accordance with
its standard practices, for any expenses incurred in the performance of your currently assigned
duties and responsibilities that are currently in place at Questcor. Of course, you must continue
to comply with all of the Companys policies and procedures during your continued employment.
2. Post-Transition Date. On the Transition Date, you will continue to be an employee and an
officer of the Company under the terms set forth in this Agreement. Your title will remain the
same, but nothing in this Agreement or any other agreement between you and the Company shall limit
the Companys ability to hire one or more persons to perform the same or similar functions that you
currently perform or the functions set forth on Schedule 1. You agree to work part-time (less than
30 hours per week) and your compensation will be a gross amount of $20,256.66 per month ($10,128.33
gross semi-monthly) less all applicable payroll deductions and withholdings. This compensation
shall be paid to you semi-monthly on the Companys regular payroll dates. The Company will also
reimburse you, in accordance with its standard practices, for any expenses incurred in the
performance of your post-Transition Date duties and responsibilities. The term of your
post-Transition Date employment will be for a period (the Transition Period) commencing on the
Transition Date and ending on the Transition Ending Date which shall be the date that is: (a) six
months after the Transition Date; (b) if you become employed for 32 hours or more per week by any
other employer, whether or not a competitor of the Company, before the six month anniversary of the
Transition Date, the day before your employment with that other employer starts, or (c) the date
the Company ends the Transition Period in accordance with Paragraph 9(b) of this Agreement. A
description of your duties and responsibilities during the Transition Period is set forth on
Schedule 1. All duties and responsibilities assigned during the Transition Period may be
conducted from either of your homes or from our offices in Union City.
3. Continued Vesting. All of your grants under the Companys 2006 Equity Incentive Award Plan
(the 2006 Plan) are set forth on Schedule 2. As a result of your continuous service as
an employee, all your stock options to purchase the Companys Common Stock shall continue to vest
until the Transition Ending Date. After the Transition Ending Date, in accordance with your stock
SCHEDULE 1
option agreements (the Option Agreements) and the 2006 Plan, you will have ninety (90) days
to exercise your vested stock options, subject to certain exceptions as set forth in the Option
Agreements and the 2006 Plan. Unless a Change of Control occurs during the Transition Period as
provided in the Change of Control agreement dated on October 16, 2006, upon the Transition Ending
Date, all of your unvested stock options will terminate immediately. For purposes of
clarification, since your title will not change during the Transition Period, you will continue to
be an executive officer of the Company under Section 16 of the Securities Exchange Act of 1934.
Additionally, you will continue to be subject to the Companys Insider Trading Compliance Program.
4. Other Benefits. Until the Transition Ending Date, you will be eligible to participate in
all the Companys benefits plans to which you are currently entitled, including, but not limited
to, medical, dental and vision insurance, as well as life, accidental death and disability
insurance and Exec-U-Care program. You will continue to accrue paid vacation at your current rate
during the Transition Period and will receive regular paid holidays. Until the Transition Ending
Date, you will also continue to be eligible to participate in the Companys 401(k) Plan, Section
529 College Savings Program and Employee Stock Purchase Plan. As required, you will be covered
under the provisions of COBRA during the Transition Period and the Company will cover your COBRA
insurance payments if any during the period of time in which you are an active, part-time employee.
5. Accrued Salary and Vacation. You will continue to receive regular pay on the Companys
regular paydays during the Transition Period as provided in Paragraph 2. On the Transition Ending
Date, the Company will pay you for all accrued but unpaid salary and all accrued and unused
vacation earned through the Transition Ending Date, subject to standard payroll deductions and
withholdings. The Company will also pay you for any approved expenses incurred but not yet paid as
of the Transition Ending Date. You are entitled to these payments by law.
6. Transition Ending Date Benefits. If you: (a) timely sign and date this Agreement; (b)
allow it to become effective and fully perform under its terms, (c) sign and date the Transition
Ending Date Release attached hereto as Exhibit A on or within 21 days after the Transition
Ending Date, and (d) allow the Transition Ending Date Release to become effective and do not revoke
it; then after your Transition Ending Date, the Company will pay you the sum of $30,385. However,
in the event that the Transition Ending Date is less than six months from the Transition Date
because you became Re-employed with another company as provided in Paragraphs 2 and 9(a), then the
Company will pay you a pro rata portion of the $30,385 based on the total number of days you worked
during the Transition Period. The Transition Ending Date payment shall be made on the
8th day following your execution Exhibit A, provided you have not revoked the Transition
Ending Date release within the revocation period provided by law.
7. Approval Bonus. If (a) you remain employed with Questcor through October 31, 2009 (the six
month anniversary of the Transition Date), (b) you are involuntarily terminated by operation of
your submitting a binding request to Questcor to extend the term of this Agreement pursuant to
Section 14 and Questcor not accepting such request to extend the term, and (c) Questcor receives a
letter from the FDA indicating that by December 31, 2010 (1) Acthar NDA 22-432 Supplement for
Infantile Spasm (IS) is approved as of the date of the letter from the FDA, and (2) Questcor can
initiate marketing of Acthar for IS subject only to submission of final printed labeling (FPL),
then you will receive an additional bonus of $75,000 subject to applicable withholding (the
Approval Bonus). Payment of the Approval Bonus shall be made within 30 days of the date that
conditions (1) and (2) immediately above are both met; provided however that the payment of any
amount pursuant to this Paragraph 7 shall be delayed as necessary until such time as you have also
undergone a Separation from Service as defined in Treas. Reg. 1.409A-1(h), but in no event
shall any payment pursuant to this Paragraph 7 be made later than 14 months after the date of such
Separation from Service.
8. Proprietary Information and Inventions. You agree that the Proprietary Information and
Inventions Agreement between you and the Company (the Proprietary Information Agreement shall
remain in full force and effect following the date of this Agreement and the Transition Ending Date
in accordance with its terms.
9. Other Work Activities.
(a) You have no duty to mitigate any compensation you receive from this Agreement. Throughout
the Transition Period, you may engage in employment, consulting, or other work relationships in
addition to your work for the Company, provided that such other employment, consulting, or work
relationships do not interfere with your continuing obligations to the Company or otherwise create
a conflict of interest with the Company. The Company will make reasonable arrangements to enable
you to perform your work for the Company at such times and in such a manner so that it will not
interfere with other activities in which you may engage. Notwithstanding the foregoing, in the
event you are employed by a third party as a consultant or as an employee for 32 or more hours per
week (Re-employment), you agree to notify the Company in writing. If this Re-employment occurs,
then your Transition Ending Date shall be the day before that Re-employment starts.
(b) In order to protect the trade secrets and confidential and proprietary information of the
Company, you agree that, during the Transition Period, you will notify the Company, in writing,
before you obtain competitive employment, perform competitive work for any business entity, or
engage in any other work activity which you reasonably believe is or may be competitive with the
Company. You also agree to, and you will obtain the Companys written consent before engaging in
any such activity which you reasonably believe may constitute competitive activity. If you
engage in such competitive activity during the Transition Period without the Companys prior
written consent, or otherwise breach a material term of this Agreement (which, for purposes of
clarity, shall include your obligation to provide notice of Re-employment under Paragraph 9(a)) or
a material term of the Proprietary Information Agreement, then, in addition to any other remedies,
the Company may end the Transition Period, and shall pay you all accrued but unpaid salary and
vacation as of the end of the Transition Period. You shall not be entitled to any further payments
under Paragraph 6 of this Agreement. However, the Change of Control Agreements dated October 16,
2006 and amended December 17, 2008 (Change in Control Agreement) previously executed by you shall
remain in effect solely as they may relate to any Change in Control occurring prior to the
Transition Ending Date.
10. Other Compensation or Benefits.
(a) General Compensation or Benefits. You acknowledge that, except as expressly
provided in this Agreement, you are not entitled to receive and will not receive from the Company
any additional compensation or benefits, including but not limited to salary, bonuses, severance,
or employee benefits either during your continued employment or after the Transition Ending Date.
By way of example, but not limitation, you acknowledge and agree that you are not eligible for any
bonus compensation for 2009, and upon the termination of your employment on the Transition Ending
Date, you will not be entitled to receive any severance pay notwithstanding the
terms of that certain Severance Agreement between you and the Company dated October 16, 2006
and later amended in an agreement dated December 17, 2008, both of these agreements are hereby
terminated and of no further force or effect, and you hereby waive any right to any compensation or
benefits under these agreements.
(b) Change in Control Compensation or Benefits. From the date of this Agreement up
until and including your Transition Ending Date, you shall be entitled to receive any Change in
Control benefits to which you become entitled during such period pursuant to the terms of your
Change in Control Agreement dated October 16, 2006 and amended December 17, 2008 (Change in
Control Agreement).
11. Return of Company Property. You agree to return to the Company, on the Transition Ending
Date or earlier if requested by the Company, all Company documents (and all copies thereof) and
other property of the Company in your possession or control. You agree that you will make a
diligent and timely search to locate any such documents, property and information. In addition, if
you have used any personally owned computer, server, or e-mail system to receive, store, review,
prepare or transmit any Company confidential or proprietary data, materials or information, then
you agree to provide the Company, no later than the Transition Ending Date, with a computer-useable
copy of all such information and then permanently delete and expunge such Company confidential or
proprietary information from those systems without retaining any reproductions (in whole or in
part); and you agree to provide the Company access to your system as requested to verify that the
necessary copying and/or deletion is done. Your timely compliance with this Section 10 is a
precondition to your eligibility for the Transition Ending Date Benefits.
12. Nonsolicitation. In order to protect the trade secrets and confidential and proprietary
information of the Company, you agree that during your continued employment, and for one year
following the Transition Ending Date, you will not, either directly or through others, solicit or
attempt to solicit any employee of the Company to terminate his or her relationship with the
Company in order to become an employee, consultant or independent contractor to or for any other
person or entity.
13. Nondisparagement. You agree not to disparage the Company or the Companys officers,
directors, employees, shareholders, parents, subsidiaries, affiliates, and agents, in any manner
likely to be harmful to them or their business, business reputation or personal reputation and the
Company agrees not to disparage you in any manner likely to be harmful to your business, business
reputation or personal reputation; provided that the parties may respond accurately and fully to
any question, inquiry or request for information when required by legal process.
14. Extension and Termination. This agreement shall continue until the Transition Ending
Date. In the event the parties elect to extend the Transition Period beyond November 1, 2009,
they may do so by entering into a separate written agreement.
15. Release.
(a) General Release. In exchange for the consideration provided by this Agreement
that both you and the Company are not otherwise entitled to receive, and for the mutual promises
contained herein, you and the Company hereby generally and completely release, acquit and forever
discharge each other, along with each others predecessors and successors and their respective
directors, officers, employees, shareholders, partners, agents, attorneys, insurers, affiliates
and assigns (collectively, the Released Parties), of and from any and all claims,
liabilities and obligations, both known and unknown, that arise from or are in any way related to
events, acts, conduct, or omissions occurring at any time prior to and including the date that you
sign this Agreement (collectively, the Released Claims).
(b) Scope of Release. The Released Claims include, but are not limited to: (a) all
claims arising out of or in any way related to your employment with the Company, or the termination
of that employment; (b) all claims related to your compensation or benefits from the Company,
including salary, bonuses, commissions, other incentive compensation, severance payments, fringe
benefits, or any other ownership or equity interests in the Company (excluding those provided in
Paragraph 15(c) below); (c) all claims for breach of contract, wrongful termination, and breach of
the implied covenant of good faith and fair dealing; (d) all tort claims, including but not limited
to claims for fraud, defamation, emotional distress, and discharge in violation of public policy;
and (e) all federal, state, and local statutory claims, including but not limited to claims for
discrimination, harassment, retaliation, attorneys fees, or other claims arising under the federal
Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990 (as
amended), the federal Age Discrimination in Employment Act of 1967 (as amended) (the ADEA), and
the California Fair Employment and Housing Act (as amended).
(c) Exceptions. Notwithstanding the foregoing, the following are not included in the
Released Claims (the Excluded Claims):
(i) any rights or claims for indemnification you may have pursuant to any written
indemnification agreement with the Company to which you are a party, the charter, bylaws, or
operating agreements of the Company, by virtue of any insurance policy or under applicable law;
(ii) any rights which are not waivable as a matter of law;
(iii) the Change of Control agreement dated October 16, 2006 and the Amendment to Change of
Control Agreement dated February 13, 2007;
(iv) any rights you have under (i) the 2006 Stock Option Plan; (ii) the Non-Statutory Stock
Option Agreement and (iii) the Incentive Stock Option Agreements you signed;
(v) any rights you have to employment or disability benefits, or to COBRA; or
(vi) any claims arising from the breach of this Agreement.
(vii) In addition, nothing in this Agreement prevents you from filing, cooperating with, or
participating in any investigation or proceeding before the Equal Employment Opportunity
Commission, the Department of Labor, the California Department of Fair Employment and Housing, or
any other government agency, except that you hereby waive your right to any monetary benefits in
connection with any such claim, charge, investigation or proceeding. You hereby represent and
warrant that, other than the Excluded Claims, you are not aware of any claims you have or might
have against any of the Released Parties that are not included in the Released Claims.
16. ADEA Waiver. You hereby acknowledge that you are knowingly and voluntarily waiving and
releasing any rights you may have under the ADEA, and that the consideration given for the waiver
and release you have given in this Agreement is in addition to anything of value to which you were
already entitled. You further acknowledge that: (a) your waiver and release do not apply to any
rights or claims that may arise after the date you sign this Agreement; (b) you should consult with
an attorney prior to signing this Agreement (although you may voluntarily decide not to do so); (c)
you have twenty-one (21) days to consider this Agreement (although you may choose voluntarily to
sign this Agreement sooner); (d) you have seven (7) days following the date you sign this Agreement
to revoke this Agreement (in a written revocation sent to and received by the Companys Chief
Executive Officer); and (e) this Agreement will not be effective until the date upon which the
revocation period has expired, which will be the eighth day after you sign this Agreement, provided
that you do not revoke it (the Effective Date).
17. Section 1542 Waiver. In giving the release herein, which includes claims which may be
unknown to you at present, you acknowledge that you have read and understand Section 1542 of the
California Civil Code, which reads as follows:
A general release does not extend to claims which the creditor does
not know or suspect to exist in his or her favor at the time of
executing the release, which if known by him or her must have
materially affected his or her settlement with the debtor.
For the purpose of implementing a full and complete release and discharge of the Released Parties,
you hereby expressly waive and relinquish all rights and benefits under that section and any law or
legal principle of similar effect in any jurisdiction with respect to your release of claims in
this Agreement, including your release of unknown and unsuspected claims.
18. Entire Agreement. Nothing in this Agreement shall affect the terms of the Indemnification
Agreement you entered into with the Company on October 16, 2006, which shall continue in full force
and effect. All of your initial offer letter, your Severance Agreement dated October 16, 2006 and
the subsequent Severance Agreement that was amended on December 17, 2008 are completely superseded
by this Agreement and are no longer of any force or effect. Except as expressly stated above, this
Agreement, including all exhibits, and the documents anticipated by this Agreement, constitute the
complete, final and exclusive embodiment of the entire agreement between you and the Company with
regard to the subject matter hereof. This Agreement supersedes any and all other agreements,
whether oral, implied or written, between you and the Company on its subject matter. It is entered
into without reliance on any promise or representation, written or oral, other than those expressly
contained herein. It may not be modified except in a written agreement approved by the Board and
signed by you and a duly authorized officer of the Company. Each party has carefully read this
Agreement, has been afforded the opportunity to be advised of its meaning and consequences by his
or its respective attorneys, and signed the same of his or its own free will. Any ambiguity in
this Agreement shall not be construed against either party as the drafter.
19. Successors and Assigns. This Agreement will bind the heirs, personal representatives,
successors, assigns, executors and administrators of each party, and will inure to the benefit of
each party, its heirs, successors and assigns.
20. Applicable Law. This Agreement will be deemed to have been entered into and will be
construed and enforced in accordance with the laws of the State of California without regard to
conflict of laws principles. The parties agree that venue for any legal action relating to
this Agreement will be Alameda County, California.
21. Severability; Waiver of Breach. If any provision of this Agreement is determined to be
invalid or unenforceable, in whole or in part, this determination will not affect any other
provision of this Agreement and the provision in question shall be deemed modified so as to be
rendered enforceable in a manner consistent with the intent of the parties, insofar as possible
under applicable law. Any waiver of a breach of this Agreement, or rights hereunder, shall be in
writing and shall not be deemed to be a waiver of any successive breach or rights hereunder.
22. Counterparts. This Agreement may be executed in two counterparts, each of which will be
deemed an original, all of which together constitutes one and the same instrument. Facsimile
signatures are as effective as original signatures.
23. Section 409A Provisions. Notwithstanding any provision herein to the contrary, all
payments required to be made by Questcor to you pursuant to this Agreement (other than payments of
the Approval Bonus under Section 7) shall be made by March 15, 2010. The foregoing provisions are
intended to comply with the requirements of Section 409A so that none of the severance payments and
benefits to be provided hereunder will be subject to the additional tax imposed under Section 409A,
and any ambiguities herein will be interpreted to so comply. The Company and you agree to work
together in good faith to consider amendments to this Agreement and to take such reasonable actions
which are necessary, appropriate or desirable to avoid imposition of any additional tax or income
recognition prior to actual payment to you under Section 409A.
24. Attorneys Fees. If any action is brought to enforce the terms of this Agreement, the
prevailing party will be entitled to recover its reasonable attorneys fees, costs and expenses
from the other party, in addition to any other relief to which the prevailing party may be
entitled.
If this Agreement is acceptable to you, please sign below within twenty-one (21) days of your
receipt of this Agreement, and return the fully signed original to me. If you do not sign this
Agreement within the aforementioned timeframe and promptly return it to me, or if you sign this
Agreement but then timely revoke this Agreement under Paragraph 14 above, then this Agreement will
be of no force or effect.
We wish you the best and look forward to continuing to work with you prior to and during the
Transition Period.
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Sincerely,
QUESTCOR PHARMACEUTICALS, INC.
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By: |
/S/ Don M. Bailey
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Don Bailey |
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President & Chief Executive Officer |
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UNDERSTOOD AND AGREED:
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/S/ Steven C. Halladay
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Steven C Halladay |
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Date: April 27, 2009
exv99w1
Exhibit 99.1
QUESTCOR REPORTS FIRST QUARTER 2009 RESULTS
UNION CITY, Calif. April 28, 2009 Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today
reported financial results for the first quarter ended March 31, 2009. Net sales for the first
quarter of 2009 totaled $23.3 million compared to $19.1 million for the same period of 2008. Net
income applicable to common shareholders for the first quarter of 2009 was $7.7 million, or $0.11
per diluted common share, compared to $1.3 million, or $0.02 per diluted common share. During the
first quarter of 2008, the Company completed the repurchase of all remaining shares of its Series A
Preferred Stock, and as a result recorded a one-time, after-tax deemed dividend of $5.2 million or
$0.07 per diluted common share; excluding that one-time item, first quarter of 2008 earnings would
have been $0.09 per diluted common share.
Our first quarter results reflect a sizable increase in new infantile spasms (IS) and multiple
sclerosis (MS) prescriptions compared to the first quarter of 2008, said Don M. Bailey, President
and CEO. Additionally, we executed our previously announced MS sales force expansion plan during
the quarter, not only hiring and training our expanded sales force but also completing all
territory realignments. While new MS prescriptions shipped in the first quarter of this year more
than tripled from the first quarter of 2008, as expected, MS sales in this years first quarter
were similar to those in the fourth quarter of 2008.
Mr. Bailey continued, During the quarter, we submitted our supplemental New Drug Application
(sNDA) to add the treatment of infantile spasms to the Acthar® Gel (Acthar) label. We look forward
to working with the FDA on this important submission. In addition, we continued to generate strong
cash flow from operations, which funds our research and our patient assistance programs, as well as
our sales force expansion and stock buyback program. We repurchased 1.3 million shares during the
quarter and had approximately one dollar per share in cash, cash equivalents and short-term
investments as of March 31, 2009.
First Quarter Operating Highlights:
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Shipped 1,429 vials of Acthar to Questcors specialty distributor during the first
quarter of 2009. These shipments compare to fourth quarter 2008 shipments of 1,510 vials
and first quarter 2008 shipments of 1,260 vials. |
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Submitted the sNDA to the FDA seeking approval to add the treatment of infantile spasms
to the Acthar label. |
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Completed the expansion of the sales force to 30 sales representatives plus managers.
In April all sales personnel began calling on physicians who treat MS flares. |
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Continued pursuit of the nephrology market. A leading medical institution began
enrolling patients in a study using Acthar to treat nephrotic syndrome, a condition
characterized by excessive loss of protein from the kidneys into the urine that can lead to
serious consequences, including end stage renal disease. This condition is already in the
labeling for Acthar. Preliminary results from this dosing study are expected to be
available in early 2010. |
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Continued to invest in additional research to better understand the therapeutic benefit
of Acthar in current and new therapeutic applications, which may potentially expand the
total number of patients who could benefit from treatment with Acthar. More than a dozen
clinical and pre-clinical studies are expected to begin by the end of 2009. |
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Continued to support the Acthar patient assistance programs, administered by the
National Organization for Rare Disorders (NORD). These and other support programs have now
provided both co-pay financial assistance and free drug with commercial value of over $26
million to patients since September 2007. |
Financial Condition and Share Repurchase Program
At March 31, 2009, Questcors cash, cash equivalents and short-term investments totaled
approximately $61.1 million, and accounts receivable totaled $8.9 million. The Companys short-term
investments are comprised of high quality credit instruments including foreign guaranteed bank
debt, U.S. government agency instruments and commercial paper.
During the first three months of 2009, Questcor generated approximately $12.1 million in cash from
operations. The Company used $6.8 million to repurchase 1.3 million shares of common stock in open
market transactions under the Companys share repurchase program. As of March 31, 2009, the Company
had 2.2 million shares remaining under this program.
Medicaid Rebates and Government Chargebacks
A portion of Acthar sales is for patients covered under Medicaid and other government-related
programs. As required by Federal regulations, Questcor provides rebates related to product
dispensed to Medicaid patients. In addition, certain other government-supported agencies are
permitted to purchase Acthar for a nominal amount from Questcors specialty distributor, which then
charges the discount back to Questcor. These rebates and chargebacks are estimated by Questcor each
quarter and are deducted from gross sales in the determination of Questcors net sales.
The rebate requests for a quarter are generally received and paid in the subsequent quarter. A
greater percentage of infants than adults are eligible for Medicaid, which results in fewer MS
patients than IS patients participating in the Medicaid program. As a result of the increased
proportion of MS to IS prescriptions in the first quarter, the Medicaid rebate amounts as a
percentage of gross sales were 26% in the first quarter of 2009 compared to 28% for the first
quarter of 2008. However, Questcor estimated a higher level of Medicaid usage in the first quarter
of 2009 than in the fourth quarter of 2008 due to higher utilization of Medicaid among IS patients
in this years first quarter.
Income Taxes
The Companys first quarter 2009 effective tax rate for financial reporting purposes was
approximately 37.4%, versus approximately 41% for the first quarter of 2008.
Regulatory Activity and Product Development
Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome
and many other conditions. Acthar is not 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.
2
Questcor is currently pursuing FDA 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
believes that it will also qualify for a seven-year exclusivity period during which the FDA is
prohibited from approving any other adrenocorticotropic hormone (ACTH) formulation for IS unless
the other formulation is demonstrated to be clinically superior to Acthar. Questcor submitted its
sNDA on March 13, 2009.
Mr. Bailey added, Our previous decision to focus on Acthar has prompted the creation of a new
position, Chief Medical Officer (CMO), and the restructuring of our clinical and regulatory
department. While we search for a permanent CMO to join our leadership team, Carol Braun Trapnell,
MD joined us in April as acting Chief Medical Officer. Dr. Trapnells primary responsibility will
be interacting with the Food and Drug Administration (FDA) regarding our sNDA submission. Dr.
Trapnell has been consulting with us on the submission for the past few months and brings over 20
years of experience in drug development, which includes more than a decade of experience reviewing
regulatory submissions during her tenure at the FDA. Dr. Steven Halladay, our senior vice
president of clinical and regulatory affairs, who was instrumental in the preparation of the sNDA,
will remain actively involved on this project supporting Dr. Trapnell.
2009 Outlook
Due to the expansion of our sales and marketing effort in the MS market, and the expansion of our
research support for Acthar, we continue to expect to significantly increase our operating expenses
during 2009 as compared to 2008. This investment is positioning Questcor to capitalize on the MS
and other growth opportunities in future years, added Mr. Bailey. As expected, MS prescription
activity in the first quarter was similar to the activity in the fourth quarter of 2008 as we
engaged in a significant sales force expansion and training effort and realigned our sales
territories. We are anticipating that MS sales will grow throughout the remainder of the year as
our new sales team gradually becomes fully productive. However, many factors may impact the actual
sales levels, operating income, and net income that we achieve in 2009.
For the year ending December 31, 2009, the Company is reiterating the following operating metric
guidance that was, except for the share count forecast, originally provided on February 24, 2009:
|
|
|
Overall gross margin of approximately 92% to 94%. |
|
|
|
Sales, general and administrative expense of approximately $33 million to $36 million,
which includes all marketing expenses but excludes non-cash FAS 123R stock-based
compensation expense. This significant increase from 2008 is due to an expanding sales
force and a robust marketing program for MS. |
|
|
|
Research and development expenses of approximately $11 million to $13 million (excluding
non-cash FAS 123R stock-based compensation expense). |
|
|
|
Non-cash FAS 123R stock-based compensation expense of approximately $3 million to $4
million. |
|
|
|
For financial reporting purposes, income tax expense will be recorded at a combined
federal and state tax rate of approximately 36% to 40%. |
|
|
|
Diluted weighted average shares of 68 million to 71 million. These amounts include the
impact of repurchases during first quarter of 2009 of common stock under Questcors stock
repurchase plan but do not include an estimate of any future repurchases of common stock by
Questcor. |
3
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, Corporate
Development; Dave Medeiros, Senior Vice President, Pharmaceutical Operations; 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 800-257-1836 from the U.S. or
303-262-2141 from outside the U.S. 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
800-405-2236 for domestic callers and 303-590-3000 for international callers, both using passcode
11130428#. An archived webcast will also be available at www.questcor.com for 90 days.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets two commercial products,
H.P. Acthar® Gel (Acthar) and Doral®. Acthar (repository corticotropin injection) is an
injectable drug that is approved for the treatment of certain disorders with an inflammatory
component, 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. Questcor also markets 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 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:
|
|
|
Questcors ability to continue to successfully implement its Acthar-centric business
strategy, including its expansion in the MS marketplace; |
|
|
|
Questcors ability to manage its sales force expansion; |
|
|
|
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; |
|
|
|
Questcors ability to operate within an industry that is highly regulated at both the
Federal and state level; |
|
|
|
Regulatory changes or actions including Federal or State health care reform
initiatives; |
|
|
|
Questcors ability to accurately forecast the demand for its products; |
|
|
|
The gross margin achieved from the sale of its products; |
|
|
|
Questcors ability to estimate the quantity of Acthar used by government entities and
Medicaid-eligible patients; |
4
|
|
|
That the actual amount of rebates and chargebacks related to the use of Acthar by
government entities and Medicaid-eligible patients may differ materially from Questcors
estimates; |
|
|
|
Its expenses and other cash needs for upcoming periods; |
|
|
|
The inventories carried by Questcors distributors, specialty pharmacies and hospitals; |
|
|
|
Volatility in Questcors monthly and quarterly Acthar shipments and end-user demand; |
|
|
|
Questcors ability to obtain finished goods from its sole source contract manufacturers
on a timely basis if at all; |
|
|
|
Questcors ability to attract and retain key management personnel; |
|
|
|
Questcors ability to utilize its NOLs to reduce income taxes on taxable income; |
|
|
|
Research and development risks, including risks associated with Questcors sNDA for IS
and its preliminary work in the area of nephrotic syndrome; |
|
|
|
Uncertainties regarding Questcors intellectual property; |
|
|
|
The uncertainty of receiving required regulatory approvals in a timely way, or at all; |
|
|
|
Uncertainties in the credit and capital markets and the impact a further deterioration
of these markets could have on Questcors investment portfolio; |
|
|
|
As well as the risks discussed in Questcors annual report on Form 10-K for the year
ended December 31, 2008 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.
CONTACT: Questcor Pharmaceuticals, Inc.
Don Bailey
510-400-0776
dbailey@Questcor.com
EVC Group, Inc.
Investors
Doug Sherk
415-896-6820
Media
Steve DiMattia
646-201-5445
5
Questcor Pharmaceuticals, Inc.
Consolidated Statements of Income
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Net sales |
|
$ |
23,298 |
|
|
$ |
19,132 |
|
Cost of sales (exclusive of amortization of purchased
technology) |
|
|
1,510 |
|
|
|
1,319 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
21,788 |
|
|
|
17,813 |
|
Gross margin |
|
|
94 |
% |
|
|
93 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
7,253 |
|
|
|
5,066 |
|
Research and development |
|
|
2,456 |
|
|
|
1,971 |
|
Depreciation and amortization |
|
|
118 |
|
|
|
122 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
9,827 |
|
|
|
7,159 |
|
|
|
|
|
|
|
|
Income from operations |
|
|
11,961 |
|
|
|
10,654 |
|
Other income: |
|
|
|
|
|
|
|
|
Interest income |
|
|
267 |
|
|
|
364 |
|
Other income, net |
|
|
1 |
|
|
|
11 |
|
Gain on sale of product line |
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
|
293 |
|
|
|
375 |
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
12,254 |
|
|
|
11,029 |
|
Income tax expense |
|
|
4,580 |
|
|
|
4,488 |
|
|
|
|
|
|
|
|
Net income |
|
|
7,674 |
|
|
|
6,541 |
|
Deemed dividend on Series A preferred stock |
|
|
|
|
|
|
5,267 |
|
|
|
|
|
|
|
|
Net income applicable to common shareholders |
|
$ |
7,674 |
|
|
$ |
1,274 |
|
|
|
|
|
|
|
|
Net income per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.12 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.11 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
Shares used in computing net income per share
applicable to common shareholders: |
|
|
|
|
|
|
|
|
Basic |
|
|
65,498 |
|
|
|
69,946 |
|
|
|
|
|
|
|
|
Diluted |
|
|
67,963 |
|
|
|
74,103 |
|
|
|
|
|
|
|
|
6
Questcor Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,661 |
|
|
$ |
13,282 |
|
Short-term investments |
|
|
51,399 |
|
|
|
42,169 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and short-term investments |
|
|
61,060 |
|
|
|
55,451 |
|
Accounts receivable, net of allowance for doubtful accounts of $46 and $62
at March 31, 2009 and December 31, 2008, respectively |
|
|
8,853 |
|
|
|
10,418 |
|
Inventories, net |
|
|
2,487 |
|
|
|
2,459 |
|
Prepaid income taxes |
|
|
356 |
|
|
|
3,316 |
|
Prepaid expenses and other current assets |
|
|
1,219 |
|
|
|
1,101 |
|
Deferred tax assets |
|
|
6,154 |
|
|
|
6,252 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
80,129 |
|
|
|
78,997 |
|
Property and equipment, net |
|
|
435 |
|
|
|
450 |
|
Purchased technology, net |
|
|
3,595 |
|
|
|
3,669 |
|
Goodwill |
|
|
299 |
|
|
|
299 |
|
Deposits and other assets |
|
|
710 |
|
|
|
710 |
|
Deferred tax assets |
|
|
5,021 |
|
|
|
5,021 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
90,189 |
|
|
$ |
89,146 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,303 |
|
|
$ |
4,302 |
|
Accrued compensation |
|
|
966 |
|
|
|
1,896 |
|
Sales-related reserves |
|
|
12,332 |
|
|
|
11,825 |
|
Other accrued liabilities |
|
|
1,152 |
|
|
|
1,702 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
18,753 |
|
|
|
19,725 |
|
Lease termination and deferred rent liabilities |
|
|
1,424 |
|
|
|
1,500 |
|
Other non-current liabilities |
|
|
27 |
|
|
|
29 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
20,204 |
|
|
|
21,254 |
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, no par value, 7,500,000 shares authorized; none outstanding |
|
|
|
|
|
|
|
|
Common stock, no par value, 105,000,000 shares authorized; 64,610,130
and 65,970,653 shares issued and outstanding at March 31, 2009 and December
31, 2008, respectively |
|
|
78,552 |
|
|
|
84,028 |
|
Accumulated deficit |
|
|
(8,731 |
) |
|
|
(16,405 |
) |
Accumulated other comprehensive income |
|
|
164 |
|
|
|
269 |
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
69,985 |
|
|
|
67,892 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
90,189 |
|
|
$ |
89,146 |
|
|
|
|
|
|
|
|
7
Questcor Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,674 |
|
|
$ |
6,541 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
1,045 |
|
|
|
1,933 |
|
Deferred income taxes |
|
|
|
|
|
|
4,488 |
|
Amortization of investments |
|
|
(43 |
) |
|
|
(209 |
) |
Depreciation and amortization |
|
|
118 |
|
|
|
122 |
|
Gain on sale of product line |
|
|
(25 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,565 |
|
|
|
5,745 |
|
Inventories |
|
|
(28 |
) |
|
|
17 |
|
Prepaid income taxes |
|
|
2,960 |
|
|
|
(366 |
) |
Prepaid expenses and other current assets |
|
|
(118 |
) |
|
|
(378 |
) |
Accounts payable |
|
|
1 |
|
|
|
971 |
|
Accrued compensation |
|
|
(930 |
) |
|
|
(1,162 |
) |
Sales-related reserves |
|
|
507 |
|
|
|
1,831 |
|
Income taxes payable |
|
|
|
|
|
|
(1,303 |
) |
Other accrued liabilities |
|
|
(550 |
) |
|
|
(316 |
) |
Other non-current liabilities |
|
|
(78 |
) |
|
|
(147 |
) |
|
|
|
|
|
|
|
Net cash flows provided by operating activities |
|
|
12,098 |
|
|
|
17,767 |
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(29 |
) |
|
|
(6 |
) |
Purchase of short-term investments |
|
|
(24,193 |
) |
|
|
(13,341 |
) |
Proceeds from the sale and maturities of short-term investments |
|
|
15,000 |
|
|
|
6,186 |
|
Proceeds from sale of product line |
|
|
25 |
|
|
|
|
|
Changes in deposits and other assets |
|
|
|
|
|
|
(4 |
) |
|
|
|
|
|
|
|
Net cash flows used in investing activities |
|
|
(9,197 |
) |
|
|
(7,165 |
) |
|
|
|
|
|
|
|
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Issuance of common stock, net |
|
|
250 |
|
|
|
378 |
|
Repurchase of Series A preferred stock |
|
|
|
|
|
|
(10,348 |
) |
Repurchase of common stock |
|
|
(6,772 |
) |
|
|
(6,201 |
) |
|
|
|
|
|
|
|
Net cash flows used in financing activities |
|
|
(6,522 |
) |
|
|
(16,171 |
) |
|
|
|
|
|
|
|
Decrease in cash and cash equivalents |
|
|
(3,621 |
) |
|
|
(5,569 |
) |
Cash and cash equivalents at beginning of period |
|
|
13,282 |
|
|
|
15,939 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
9,661 |
|
|
$ |
10,370 |
|
|
|
|
|
|
|
|
8