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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): October 25, 2006
Critical Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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000-50767
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04-3523569 |
(State or Other Jurisdiction
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(Commission
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(IRS Employer |
of Incorporation)
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File Number)
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Identification No.) |
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60 Westview Street, Lexington, Massachusetts
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02421 |
(Address of Principal Executive Offices)
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(Zip Code) |
Registrants telephone number, including area code: (781) 402-5700
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
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))
Item 1.01. Entry Into a Material Definitive Agreement.
Offering and Placement Agent Arrangements
On
October 26, 2006, we entered into definitive agreements to sell
7,455,731 shares of common
stock and warrants to purchase 3,727,865 shares of common stock for an aggregate purchase
price of $20.0 million. The warrants to purchase common stock have an
exercise price of $2.62 per
share and will be exercisable at any time on or before October 26, 2011. The common stock, warrants
and shares issuable upon exercise of the warrants are covered by our Registration Statement on Form
S-3 (File No. 333-136910) filed on August 25, 2006 with the Securities and Exchange Commission
under the Securities Act of 1933, as amended. In connection with this offering, on October 26,
2006, we entered into a placement agent agreement with Lazard Capital Markets LLC, pursuant to
which Lazard agreed to act as our placement agent and we agreed to
pay a fee of $1.2 million upon the closing
of the offering.
In connection with the registered offering and placement agent arrangements, we are filing as
exhibits to this current report on Form 8-K the following documents:
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as Exhibit 1.1, the placement agent agreement, by and between us and Lazard,
including as Exhibit A thereto the form of subscription agreement entered into by us
and the investors in the offering; |
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as Exhibit 4.1, the form of warrant agreement to be
entered into by us with
the warrant agent, including as Exhibit A thereto the form of warrant to be issued to
investors in the offering; and |
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as Exhibits 5.1 and 23.1, the legal opinion and consent of Wilmer Cutler Pickering
Hale and Dorr LLP, relating to the shares of common stock and the warrants to be issued
and sold in the offering and the shares of common stock issuable upon exercise of the
warrants. |
The foregoing summary of the terms of the placement agent agreement and the warrants, is subject
to, and qualified in its entirety by, such agreements, which are attached as exhibits to this
current report on Form 8-K and are incorporated herein by reference.
Consulting Agreement with M. Cory Zwerling.
On October 25, 2006, we entered into a consulting agreement with M. Cory Zwerling, one of our
directors, under which Mr. Zwerling agreed to provide us services related to commercial sales,
marketing and business development initiatives and other such related projects as mutually agreed
upon by us and Mr. Zwerling. Under the consulting agreement, we have agreed to pay Mr. Zwerling
$1,800 per day and granted Mr. Zwerling an option to purchase 200,000 shares of our common stock
under our 2004 Stock Incentive Plan. This option has an exercise price of $2.63 per share and will
vest in 36 equal monthly installments commencing on November 25, 2006. In addition, 50% of the then
unvested options will vest upon a change of control or specified transactions as set forth in the
consulting agreement. We have also agreed to pay Mr. Zwerling $49,000 for consulting performed
prior to October 25, 2006. The consulting agreement has a term of twelve months and automatically
renews on a month-to-month basis. We may terminate the consulting agreement upon three business
days prior written notice to Mr. Zwerling. Mr. Zwerling may terminate the consulting agreement
upon thirty days prior written notice.
The foregoing summary of the terms of the consulting agreement is subject to, and qualified in its
entirety by, the consulting agreement, which is attached to this Current Report on Form 8-K as
Exhibit 10.1 and is incorporated herein by reference.
Separation Agreement with Walter Newman, Ph.D.
On October 25, 2006, Walter Newman, Ph.D. resigned from his position as our Senior Vice President
of Research and Development and Chief Scientific Officer, effective October 31, 2006. In
connection with Dr. Newmans departure, we entered into a separation agreement with Dr. Newman on
October 25, 2006, which is revocable by Dr. Newman for a period of seven days. Under the
separation agreement, we agreed to pay Dr. Newman the following lump sum amounts in November 2006
pursuant to the employment agreement we entered into with Dr. Newman on December 21, 2004:
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$269,500, representing Dr. Newmans annual base salary; and |
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$67,375, representing 10/12 of Dr. Newmans maximum cash bonus for 2006. |
We also agreed that, for a period of up to twelve months, we would reimburse Dr. Newman for 80% of
the premiums for continued health coverage for Dr. Newman and his dependents and for the cost of
the premiums for life insurance and disability insurance for Dr. Newman. In addition, under the
separation agreement, we agreed to accelerate 50% of Dr. Newmans unvested stock options as of
October 31, 2006.
The foregoing summary of the terms of the separation agreement is subject to, and qualified in its
entirety by, the separation agreement, which is attached to this Current Report on Form 8-K as
Exhibit 10.2 and is incorporated herein by reference.
Item 2.02 Results of Operations and Financial Condition
On October 27, 2006, we disclosed our preliminary expectations with respect to information relating
to our results of operations for the quarter ended September 30, 2006.
We disclosed that:
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We expect to recognize revenue from product sales, net of any discounts and rebates,
of approximately $1.9 million in the third quarter of 2006. |
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We had approximately $40.2 million in cash, cash equivalents and short-term
investments at September 30, 2006, compared to $82.8 million as of December 31, 2005. |
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We anticipate our net cash expenditures for the quarter ended September 30, 2006 to
be approximately $12.0 million. |
Our financial statements for the quarter ended September 30, 2006 are not yet available. Our
preliminary expectations with respect to our results are based upon management estimates and are
subject to quarterly review procedures and final recommendations and adjustments. Actual operating
results may differ from our expectations, and those differences may be material. The foregoing
discussion of our expectations regarding our results for the third quarter of 2006 is not
necessarily indicative of expected future results.
Item 2.05. Costs Associated with Exit or Disposal Activities.
On October 26, 2006, we announced a plan to focus our resources on the commercialization of our
controlled-release formulation of zileuton, or zileuton CR, for the chronic treatment of asthma and
on the clinical development of the intravenous formulation of zileuton and to significantly reduce
our net cash expenditures through lower spending on our existing sales force as well as on our
discovery and research programs.
As part of this new business strategy, we plan to eliminate 63 positions. The planned headcount
reduction reflects a downsizing of our sales force that markets ZYFLO® (zileuton tablets). We plan
to retain a respiratory sales force of approximately 18 representatives who will be focused on
continued promotion to prescribing physicians within the major markets across the United States and
increasing prescriptions from our existing base of prescribers. The planned headcount reductions
also include 20 employees in our research and development group. Following completion of the
restructuring, which we expect to complete by December 31, 2006, we expect to have approximately 59
employees.
We believe that the feedback from physicians to date indicates that ZYFLOs current dosing regimen
of four times daily will continue to make it difficult to gain broad acceptance in the asthma
market. With the twice-daily formulation, we expect increased usage by prescribing physicians
while offering patients another treatment option for their asthma.
We plan to take the following steps to prepare for the commercialization of zileuton CR:
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conduct clinical studies in preparation for commercial launch to build zileuton CRs
market position, following approval; |
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pursue a co-promotion arrangement to expand our promotional resources to respiratory specialists, including allergists and pulmonologists, and primary care physicians; |
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implement a publication strategy that includes the presentation of data from the
pivotal studies of zileuton CR at major medical conferences and in various scientific
and medical journals; and |
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initiate a clinical trial to evaluate a life-cycle extension strategy to enhance the
intellectual property position of zileuton and provide for possible development
opportunities in other inflammatory conditions. |
With respect to our intravenous formulation of zileuton, we plan to initiate a Phase IIb clinical
trial in the first half of 2007 with our intravenous formulation of zileuton in asthma patients, while seeking a
co-development arrangement for this product candidate.
We are also completing certain preclinical work in our alpha-7 program through a small team of
scientists. Following completion of this work, we plan to seek a collaborator for our alpha-7
nicotinic receptor agonist program and do not currently plan to conduct clinical trials with the
alpha-7 program without entering into such an arrangement. In collaboration with MedImmune, Inc.,
we expect to continue to support the development of HMGB1 antibodies for chronic and acute
inflammatory diseases.
Based on our operating plans and the anticipated effects of the restructuring, we believe that our
available cash and cash equivalents and anticipated cash received from product sales and
anticipated payments received under collaboration agreements, together with the proceeds we receive
from the offering, will be sufficient to fund anticipated levels of operations into the second half
of 2008.
In connection with the implementation of our restructuring plan, we expect to record charges of
$3.0 million to $4.0 million in the fourth quarter of 2006 related to employee severance benefits,
outplacement services, automobile lease termination fees and impairment of assets. With respect to
the headcount reductions to be implemented in the fourth quarter of 2006, we expect to incur
charges associated with severance benefits of approximately $1.6 million. In addition, as a result
of these headcount reductions, we expect to record in the fourth quarter of 2006 an automobile
lease termination fee of $252,000, an outplacement service fee of $28,000 and an impairment charge
of approximately $1.5
million for laboratory equipment, computer equipment and furniture and fixtures for which the
future use is currently uncertain. We expect to record these restructuring charges as $204,000 of
general and administrative expense, $2.2 million of research and development expense and $1.0
million of sales and marketing expense.
Item 2.06. Material Impairments.
In connection with our restructuring plan, we expect to record an impairment charge of
approximately $1.5 million for laboratory equipment, computer equipment and furniture and fixtures
for which the future use is currently uncertain. As part of our restructuring plan, we eliminated
20 positions in our research and development group. Due to this reduction in force, we concluded
that a substantial portion of the assets that relate to our research function will be impaired.
Item 8.01
Offering
On October 26, 2006, we entered into definitive
agreements to sell approximately 7,455,731 shares of common
stock and warrants to purchase approximately 3,727,865 shares of common stock for an aggregate purchase
price of approximately $20.0 million. The warrants to purchase
common stock have an exercise price of $2.62 per
share and will be exercisable at any time on or before October 26, 2011.
We expect that the net proceeds of the offering, excluding the proceeds, if any, from the exercise
of the warrants issued in the offering, will be approximately
$18.5 million after deducting the placement
agents fees and all estimated offering expenses that are payable by us. We currently intend to
use these proceeds to fund our efforts to obtain FDA approval for zileuton CR, to prepare for
commercial launch of zileuton CR, to fund development of our intravenous formulation of zileuton
and for other general corporate purposes.
This current report does not constitute an offer to sell or the solicitation of an offer to buy any
or our securities and these securities cannot be sold in any state in which such offer,
solicitation or sale would be unlawful prior to registration or qualification under the securities
laws of such state.
Press
Release
The
information in the press release attached as Exhibit 99.1 is
incorporated herein by reference, but shall not be deemed
filed for purposes of Section 18 of the
Securities Exchange Act of 1934 or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933 or the
Exchange Act, except as expressly set forth by specific reference in
such a filing.
Risk Factors
We are providing as Exhibit 99.2 an updated description of the risks and uncertainties that could
materially affect our business, financial condition and results of operations.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The Exhibit Index attached to this Report is incorporated herein by reference.
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: October 27, 2006 |
CRITICAL THERAPEUTICS, INC.
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By: |
/s/ Frank E. Thomas |
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Frank E. Thomas |
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President |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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1.1
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Placement Agent Agreement by and between the Company and Lazard
Capital Markets LLC dated October 26, 2006 including as Exhibit A
thereto the form of subscription agreement entered into by the Company
and the Investors in the Offering |
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4.1
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Form of Warrant Agreement to be entered into by the Company with the
Warrant Agent, including as Exhibit A thereto the form of warrant to
be issued to Investors in the Offering |
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5.1
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Opinion of Wilmer Cutler Pickering Hale and Dorr LLP |
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10.1
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Consulting Agreement between the Company and M. Cory Zwerling dated
October 25, 2006 |
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10.2
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Separation Agreement between the Company and Walter Newman, Ph.D.
dated October 25, 2006 |
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23.1
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Consent of Wilmer Cutler Pickering Hale and Dorr LLP (included in
Exhibit 5.1) |
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99.1
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Press Release Issued by the Company
on October 27, 2006 |
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99.2
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Risk Factors |