Exhibit 99.1
Critical Therapeutics Reports Financial Results
for the Quarter Ended June 30, 2007
Quarter Highlighted By FDA Approval of Twice-daily ZYFLO CR(TM) Tablets
LEXINGTON, Mass.--(BUSINESS WIRE)--Aug. 8, 2007--Critical
Therapeutics, Inc. (Nasdaq: CRTX), a biopharmaceutical company focused
on developing and commercializing innovative products for respiratory,
inflammatory and critical care diseases, today reported financial
results for the quarter ended June 30, 2007. During the second quarter
of 2007, the U.S. Food and Drug Administration (FDA) approved
twice-daily ZYFLO CR(TM) (zileuton) extended-release tablets for the
prevention and chronic treatment of asthma.
"During the first half of 2007, we made significant financial
progress with a reduction in net cash expenditures of 72 percent from
the first half of 2006," said Frank Thomas, Critical Therapeutics'
president and chief executive officer. "In addition, upfront and
milestone payments from our co-promotion partner, Dey, L.P. (DEY),
have put us in a stronger position to fund the launch of ZYFLO CR."
For the three months ended June 30, 2007, the Company posted a net
loss of $13.0 million, or $0.30 per share, based on 42.6 million
weighted average shares outstanding. This compares with a net loss of
$14.4 million, or $0.42 per share, for the same period in 2006, based
on 34.2 million weighted average shares outstanding. The increase in
common shares outstanding resulted primarily from the Company's
registered offering of 7.5 million shares in October 2006.
Sales of the Company's immediate-release formulation of zileuton,
ZYFLO(R) (zileuton tablets), in the second quarter of 2007 benefited
from the co-promotion of the product by DEY, an affiliate of Merck
KGaA in Darmstadt, Germany. DEY's 200-person sales force began
promoting ZYFLO on April 30, 2007. For the three months ended June 30,
2007, sales of ZYFLO increased 28 percent to $2.3 million, compared
with $1.8 million in the same period last year. Sales of ZYFLO in the
first quarter of 2007 totaled $2.9 million and were positively
impacted by a one-time net increase of $953,000 due to the Company
changing the way it recognizes revenue from sales of ZYFLO. Through
the end of 2006, product sales from ZYFLO were recorded when the
product was dispensed through patient prescriptions rather than when
the product was shipped to third parties. Beginning in the first
quarter of 2007, the Company began recognizing revenue from sales of
ZYFLO when the product is shipped to third-parties, less an estimate
of expected product returns, resulting in the one-time adjustment of
$953,000.
"Since the Company's restructuring in October 2006, we executed on
each of the objectives laid out at that time," Thomas continued. "This
included obtaining a co-promotion partner for ZYFLO CR; securing FDA
approval of ZYFLO CR; and preparing for the successful
commercialization of ZYFLO CR by initiating a Phase IV clinical trial
and executing on an aggressive publication strategy; and preserving
cash to support the upcoming launch of ZYFLO CR. Looking ahead, we are
laying the groundwork for a successful launch of ZYFLO CR this fall
and will continue to focus our resources on the programs that we
believe will drive shareholder value."
Cash and short-term investments as of June 30, 2007 totaled $40.5
million, compared with $46.0 million at March 31, 2007 and $49.0
million at December 31, 2006. Net cash expenditures in the second
quarter of 2007 were $5.5 million. As a result of the approval of
ZYFLO CR by the FDA, net cash expenditures in the second quarter of
2007 were positively impacted by a $4.0 million payment received from
DEY, partially offset by $3.1 million in milestone payments made to
third parties. This amount compares with net cash expenditures of
$12.4 million in the second quarter of 2006 and $3.1 million in the
first quarter of 2007, which was positively impacted by a $3.0 million
payment from DEY as a result of signing the co-promotion agreement. As
of June 30, 2007, the Company had 43.2 million common shares
outstanding, excluding warrants and stock options.
Recent Developments
Since the end of the first quarter of 2007, Critical Therapeutics
has:
-- Received approval from the FDA for the commercialization of
ZYFLO CR in the U.S. ZYFLO CR and ZYFLO are the only
FDA-approved leukotriene synthesis inhibitors for the
prophylaxis and chronic treatment of asthma in adults and
children 12 years of age and older.
-- Added an additional 200 sales representatives promoting ZYFLO
through its co-promotion agreement with DEY, thereby
continuing to increase unit volume and sales of ZYFLO.
-- Entered into a definitive agreement with DEY to co-promote
Perforomist(TM) (formoterol fumarate) Inhalation Solution,
DEY's product for Chronic Obstructive Pulmonary Disease
(COPD). A second product allows Critical Therapeutics to
increase the efficiency of its sales force, and a COPD product
should allow its sales force better access to more
pulmonologists.
-- Announced the FDA approval of DEY's COPD product, Perforomist,
which Critical Therapeutics will co-promote with DEY upon its
expected U.S. launch in the fall of 2007. Twice-daily
Perforomist is approved for the long-term maintenance
treatment of bronchoconstriction for emphysema and chronic
bronchitis.
-- Announced the enrollment of the first patient in a Phase IV
clinical trial designed to evaluate the efficacy of ZYFLO CR
in asthma patients whose symptoms are poorly controlled
despite taking moderate dose inhaled corticosteroids.
-- Continued to execute on its publication strategy to enhance
the scientific and medical understanding of the Company's
commercial and development programs through a series of
publications in peer-reviewed medical journals. Data from a
Phase III clinical trial that was conducted primarily to
assess the long-term safety of ZYFLO CR in patients on usual
care asthma therapy was published in the June issue of the
Journal of Asthma. The Phase III clinical trial assessing the
efficacy of ZYFLO CR is expected to be published during the
second half of 2007.
-- Selected an alpha-7 lead development compound and initiated
preclinical development activities with this lead candidate.
Financial Results for the Three Months Ended June 30, 2007 and
2006
Total revenue for the three months ended June 30, 2007 was $3.4
million, compared with $3.5 million for the same period in 2006.
Revenue for the second quarter of 2007 included:
-- Sales of ZYFLO that accounted for $2.3 million in revenue,
compared with $1.8 million in the second quarter of 2006. The
28 percent increase is primarily due to a 4 percent increase
in prescription volume and an 11 percent increase in the price
of ZYFLO over the second quarter of 2006.
-- Collaboration and license revenue of $1.1 million from
Critical Therapeutics' HMGB1 collaboration with MedImmune,
Inc. and its license agreements with Beckman Coulter, Inc. to
develop HMGB1 diagnostic assays and Innovative Metabolics,
Inc. to develop medical device approaches to stimulating the
vagus nerve. This compares with collaboration and license
revenue of $1.7 million in the second quarter of 2006. The
decrease is primarily associated with a decline in
collaboration revenue from MedImmune, partially offset by
revenue received from the Company's license agreement with
Innovative Metabolics. The Company's future collaboration
revenue from the MedImmune, Beckman Coulter and Innovative
Metabolics agreements will primarily be recognized in periods
when milestones are achieved, as all of the up-front payments
under these agreements have now been fully amortized or
recorded.
Total operating expenses for the three months ended June 30, 2007
totaled $16.9 million, compared with $18.6 million for the same period
in 2006.
Total operating expenses for the second quarter of 2007 included:
-- Cost of products sold that totaled $680,000, compared with
$890,000 in the second quarter of 2006. The 2006 figure
included inventory write-offs of $187,000 resulting from
excess or obsolete inventory that could no longer be used for
commercial sales. Excluding the impact of the 2006 write-off,
gross margins from products sales were $1.6 million, or 70
percent, during the three months ended June 30, 2007, compared
with gross margins from product sales of $1.1 million, or 61
percent, during the same period in 2006.
-- Research and development (R&D) expenses that totaled $10.1
million, consisting of $6.6 million in paid and accrued
milestone payments and $3.5 million of general R&D expenses.
This compares with $6.9 million in R&D expenses in the same
period of 2006. The increase of $3.2 million, or 46 percent,
is related primarily to paid and accrued milestone payments to
third parties as a result of the FDA approval of ZYFLO CR in
May 2007, partially offset by a decrease in expenses
associated with clinical trials and fewer employees performing
R&D functions. Excluding these paid and accrued milestone
payments, R&D expenses would have decreased 49 percent in the
second quarter of 2007, as compared with the second quarter of
2006.
-- Sales and marketing expenses that totaled $2.6 million,
compared with $5.7 million in the second quarter of 2006, a
decrease of $3.1 million, or 54 percent. This decrease was
primarily associated with the 2006 reduction in the Company's
sales force, partially offset by promotional and other
marketing expenses associated with the Company's co-promotion
agreement with DEY that was signed in March 2007.
-- General and administrative (G&A) expenses that totaled $3.5
million, compared with $5.1 million in the second quarter of
2006, a decrease of $1.6 million, or 31 percent. This decrease
was primarily associated with fewer employees performing G&A
functions in 2007, as well as severance paid and stock-based
compensation expense in the second quarter of 2006 in
connection with the departure of the Company's former chief
executive officer.
Financial Results for the Six Months Ended June 30, 2007 and 2006
Total revenue for the six months ended June 30, 2007 increased
$1.1 million to $6.9 million, compared with $5.8 million for the same
period in 2006, an increase of 19 percent. Product sales of ZYFLO
accounted for $5.2 million of revenue during the first half of 2007,
compared with $2.8 million during the first half of 2006, an increase
of 86 percent. Critical Therapeutics' collaboration with MedImmune and
its license agreements with Beckman Coulter and Innovative Metabolics
accounted for $1.7 million in revenue during the first half of 2007,
compared with $2.9 million from the MedImmune and Beckman Coulter
collaborations during the first half of 2006.
Total operating expenses for the six months ended June 30, 2007
decreased $12.7 million to $25.6 million, compared with $38.3 million
for the same period in 2006. This decrease was primarily due to a
reduction in the number of employees and active R&D programs as a
result of the 2006 restructurings.
Research & Development Update
Critical Therapeutics preclinical and development programs remain
on schedule with three clinical trials planned during the second half
of 2007.
ZYFLO CR Phase IV Trial
In July 2007, the Company initiated a Phase IV clinical trial
evaluating ZYFLO CR as an add-on therapy in asthma patients to support
sales and marketing efforts for ZYFLO CR. The randomized, double-blind
placebo-controlled trial in 400 patients will assess the effect of
ZYFLO CR on lung function, asthma control and symptomatic response in
adults whose asthma is not effectively controlled with moderate doses
of inhaled corticosteroids.
Zileuton Injection Program
The Company is developing an injectable formulation of zileuton
for adjunctive use in emergency room or urgent care settings for
patients experiencing acute exacerbations of asthma. The Company is on
target to initiate a Phase II clinical trial in the second half of
2007 following an earlier clinical trial in asthma patients. This
Phase II trial will be focused on identifying the optimal dose to be
tested in Phase III clinical trials.
R(+) Zileuton Program
The Company is currently examining the pharmacokinetic and
pharmacodynamic profile of the R isomer of zileuton to determine if
there are potential dosing improvements for patients. Critical
Therapeutics plans to initiate a Phase I clinical trial in the third
quarter of 2007 to pursue development of the R isomer. The successful
development of the R isomer could lead to an enhanced intellectual
property position of zileuton for the treatment of asthma and provide
for possible development opportunities in other inflammatory diseases,
including COPD and nasal polyps.
Alpha-7 Program
The Company's alpha-7 program, which is directed at the discovery
and development of novel small molecule drugs for the treatment of
inflammation, has selected a lead compound that is currently in
preclinical development. The Company believes that this innovative
anti-inflammatory approach has the potential for broad applications in
both acute and chronic inflammatory diseases and is exploring possible
collaborations with larger pharmaceutical companies to leverage the
broad potential of this pathway.
HMGB1 Program
The Company continues to collaborate with MedImmune, Inc. on the
development of a human monoclonal antibody to the cytokine HMGB1. The
collaboration has narrowed down potential clinical candidates to one
fully-human antibody that has shown efficacy in pre-clinical models of
arthritis and lupus. The joint development team expects its next step
to be the selection of a clinical candidate for the development of
HMGB1 antibodies for chronic inflammatory disease, such as rheumatoid
arthritis or lupus. The collaboration also has narrowed the potential
clinical candidates for development in acute inflammatory diseases,
such as sepsis.
Financial Guidance
As part of the DEY co-promotion partnership, Critical Therapeutics
received a $3.0 million payment upon the signing of the agreement in
the first quarter of 2007 and a $4.0 million payment upon FDA approval
of ZYFLO CR in the second quarter of 2007. The Company is amortizing
the payments over the term of the agreement along with any future
milestone payments received from DEY. The amortization of the upfront
and milestone payments will offset some or all of the co-promotion
fees paid to DEY for promoting ZYFLO and ZYFLO CR and will be included
as a reduction to sales and marketing expenses in future periods.
Critical Therapeutics will record all revenue associated with sales of
ZYFLO and ZYFLO CR and pay a co-promotion fee to DEY that will be
included in sales and marketing expenses.
Critical Therapeutics expects net cash expenditures to be between
$15 million and $17 million in the second half of 2007. For the year
ending December 31, 2007, the Company expects net cash expenditures to
be between $23 million and $25 million, an increase from its previous
guidance of between $19 million and $23 million. This increase is
primarily attributable to the Company electing to make an investment
in a second supplier for ZYFLO CR in an effort to reduce its
dependence on sole-source suppliers, enhance efficiencies in the
supply chain and reduce future product costs. The net cash expenditure
projection includes the anticipated receipt of an additional $5
million milestone payment in 2007 from the co-promotion agreement with
DEY, but excludes the impact of any future business development
agreements, such as co-development deals for the alpha-7 program or
the zileuton R(+) or injection programs.
Conference Call Information
Critical Therapeutics will hold an audio webcast and conference
call today to discuss the Company's second quarter 2007 financial
results, strategy, upcoming milestones and financial guidance.
Investors and other interested parties can access the call as follows:
Date: Wednesday, August 8, 2007
Time: 5:00 p.m. (eastern)
Dial-in: (800) 310-1961 (U.S. and Canada)
(719) 457-2692 (International)
Webcast Information: www.crtx.com
A live and archived audio webcast of the conference call also will
be available on the "Investors" section of the Critical Therapeutics
website. From the home page, click on "Investors" and then on
"Webcasts & Presentations."
About Critical Therapeutics
Critical Therapeutics, Inc. is developing and commercializing
innovative products for respiratory, inflammatory and critical care
diseases. The Company owns worldwide rights to two FDA-approved drugs
for the prevention and chronic treatment of asthma in patients 12
years of age and older: twice-daily ZYFLO CR(TM) (zileuton)
extended-release tablets and ZYFLO(R) (zileuton tablets). Critical
Therapeutics is working to develop products for acute asthma attacks
that lead patients to the emergency room and other urgent care
settings. The Company also is developing therapies directed toward the
body's inflammatory response. Critical Therapeutics is located in
Lexington, Mass. For more information, please visit www.crtx.com.
About ZYFLO CR and ZYFLO
ZYFLO CR(TM) and ZYFLO(R) are the only FDA-approved leukotriene
synthesis inhibitors for the prophylaxis and chronic treatment of
asthma in adults and children 12 years of age and older. ZYFLO CR and
ZYFLO are not indicated for use in the reversal of bronchospasm in
acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued
during acute exacerbations of asthma. ZYFLO CR uses SkyePharma PLC's
(LSE: SKP) proprietary Geomatrix(R) drug delivery technology, which
controls the amount and rate of drug released into the body.
The recommended dose of ZYFLO CR is two 600 mg extended-release
tablets twice daily, within one hour after morning and evening meals,
for a total daily dose of 2400 mg. The recommended dose of ZYFLO is
one 600 mg immediate-release tablet four times a day for a total daily
dose of 2400 mg.
Important Safety Information about ZYFLO CR and ZYFLO
ZYFLO CR and ZYFLO are contraindicated in patients with active
liver disease or transaminase elevations greater than or equal to
three times the upper limit of normal. A small percentage of patients
treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled
trials showed an increased release of a liver enzyme known as ALT and
bilirubin (an orange or yellowish pigment in bile). As a result, the
level of liver enzymes in patients treated with ZYFLO CR and ZYFLO
should be measured by a simple blood test. It is recommended that
physicians perform this test before administering ZYFLO CR and ZYFLO
and repeat the test on a regular basis while patients are on the
medication. Patients taking ZYFLO CR or ZYFLO and theophylline should
reduce the theophylline dose by 50%. Patients taking ZYFLO CR or ZYFLO
and propranolol or warfarin should be monitored and doses adjusted as
appropriate. Most common side effects associated with the use of ZYFLO
CR and ZYFLO are sinusitis, nausea and pharyngolaryngeal pain and
abdominal pain, upset stomach and nausea, respectively.
For full prescribing information for ZYFLO CR, please visit
www.zyflocr.com or call the Company's toll free telephone number
1-866-835-8216 to request medical information.
For full prescribing information for ZYFLO, please visit
www.zyflo.com or call the Company's toll free telephone number
1-866-835-8216 to request medical information.
About Perforomist(TM) Inhalation Solution
Perforomist(TM) Inhalation Solution is indicated for the
long-term, twice-daily (morning and evening) administration in the
maintenance treatment of bronchoconstriction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema.
Important Safety Information about Perforomist(TM) Inhalation
Solution
Perforomist(TM) Inhalation Solution belongs to a class of
medications known as long-acting beta(2)-adrenergic agonists (LABAs).
LABAs may increase the risk of asthma-related death. Data from a large
placebo-controlled US study comparing the safety of another LABA
(salmeterol) or placebo added to usual asthma therapy showed an
increase in asthma-related deaths in patients receiving salmeterol.
This finding with salmeterol may apply to formoterol (a LABA), the
active ingredient in Perforomist(TM) Inhalation Solution.
Perforomist(TM) Inhalation Solution should not be used in patients
with acutely deteriorating COPD or to treat acute symptoms. Acute
symptoms should be treated with fast-acting rescue inhalers.
Perforomist(TM) Inhalation Solution should not be used with other
medications containing LABAs. Do not use more than one nebule twice
daily. Perforomist(TM) Inhalation Solution should be used with caution
in patients with cardiovascular disorders. Perforomist(TM) Inhalation
Solution is not a substitute for inhaled or oral corticosteroids. The
safety and efficacy of Perforomist(TM) Inhalation Solution in asthma
has not been established. In COPD clinical trials, the most common
adverse events reported with Perforomist(TM) Inhalation Solution were
diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and
insomnia.
For full prescribing information for Perforomist(TM) Inhalation
Solution, please visit http://www.perforomist.com
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Critical Therapeutics, Inc., including,
without limitation, statements regarding the progress, timing and
success of our anticipated commercial launch of ZYFLO CR; possible
therapeutic benefits, market acceptance and future sales of ZYFLO and
ZYFLO CR; the anticipated success of our co-promotion arrangements
with DEY; the anticipated commercial launch of Perforomist; the
progress and timing of our drug development programs and related
trials; the efficacy of our drug candidates; our strategy, future
operations, financial position, future revenues, and projected costs,
including our anticipated net cash expenditures for the year and six
months ended December 31, 2007; prospects, plans and objectives of
management; and all other statements that are not purely historical in
nature, constitute "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Without limiting
the foregoing, the words "anticipate," "believe," "could," "estimate,"
"expect," "intend," "may," "plan," "project," "should," "will,"
"would" and similar expressions are intended to identify
forward-looking statements. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including risks and uncertainties relating
to: our ability to successfully market and sell ZYFLO and ZYFLO CR,
including the success of our co-promotion arrangement with DEY; our
ability to develop and maintain the necessary sales, marketing,
distribution and manufacturing capabilities to commercialize ZYFLO and
ZYFLO CR; patient, physician and third-party payor acceptance of ZYFLO
and ZYFLO CR as safe and effective therapeutic products; adverse side
effects experienced by patients taking ZYFLO or ZYFLO CR; our ability
to maintain regulatory approvals to market ZYFLO and ZYFLO CR; our
heavy dependence on the commercial success of ZYFLO and ZYFLO CR; the
success of our co-promotion arrangement with DEY for Perforomist; our
ability to successfully enter into additional strategic co-promotion,
collaboration or licensing transactions on favorable terms, if at all;
conducting clinical trials, including difficulties or delays in the
completion of patient enrollment, data collection or data analysis;
the results of preclinical studies and clinical trials with respect to
our products under development and whether such results will be
indicative of results obtained in later clinical trials; our ability
to obtain the substantial additional funding required to conduct our
research, development and commercialization activities; our dependence
on our strategic collaboration with MedImmune, Inc.; and our ability
to obtain, maintain and enforce patent and other intellectual property
protection for ZYFLO CR, our discoveries and our drug candidates.
These and other risks are described in greater detail in the "Risk
Factors" section of our most recent Quarterly Report on Form 10-Q and
other filings that we make with the Securities and Exchange Commission
(SEC). If one or more of these factors materialize, or if any
underlying assumptions prove incorrect, our actual results,
performance or achievements may vary materially from any future
results, performance or achievements expressed or implied by these
forward-looking statements.
In addition, the statements in this press release reflect our
expectations and beliefs as of the date of this release. We anticipate
that subsequent events and developments will cause our expectations
and beliefs to change. However, while we may elect to update these
forward-looking statements publicly at some point in the future, we
specifically disclaim any obligation to do so, whether as a result of
new information, future events or otherwise. These forward-looking
statements should not be relied upon as representing our views as of
any date subsequent to the date of this release.
ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.
ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc.
Perforomist(TM) is a trademark of Dey, L.P.
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
---------------------------------------------------
in thousands
except share and
per share data 2007 2006 2007 2006
======================================================================
Revenues:
Net product
sales $ 2,291 $ 1,809 $ 5,185 $ 2,831
Revenue under
collaboration
and license
agreements 1,136 1,696 1,737 2,947
- ----------------------------------------------------------------------
Total revenues 3,427 3,505 6,922 5,778
- ----------------------------------------------------------------------
Costs and
expenses:
Cost of products
sold 680 890 1,421 1,394
Research and
development
General
research and
development 3,484 6,935 6,402 16,328
Milestones
under license
agreements 6,620 - 6,620 -
Sales and
marketing 2,600 5,663 4,582 12,570
General and
administrative 3,533 5,081 6,588 8,009
- ----------------------------------------------------------------------
Total costs and
expenses 16,917 18,569 25,613 38,301
- ----------------------------------------------------------------------
Operating loss (13,490) (15,064) (18,691) (32,523)
Other income
(expense):
Interest income 564 716 1,154 1,488
Interest expense (30) (55) (69) (115)
- ----------------------------------------------------------------------
Total other
income 534 661 1,085 1,373
- ----------------------------------------------------------------------
Net loss ($12,956) ($14,403) ($17,606) ($31,150)
======================================================================
Net loss per
share ($0.30) ($0.42) ($0.41) ($0.91)
======================================================================
Basic and diluted
weighted-average
common shares
outstanding 42,571,420 34,203,598 42,513,852 34,150,432
======================================================================
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, December 31,
in thousands, except share data 2007 2006
======================================================================
Assets:
Current assets:
Cash and cash equivalents $ 39,813 $ 48,388
Accounts receivable, net 1,014 877
Amount due under collaboration agreements 31 650
Short-term investments 650 650
Inventory, net 4,385 4,048
Prepaid expenses and other 2,191 980
- ----------------------------------------------------------------------
Total current assets 48,084 55,593
- ----------------------------------------------------------------------
Fixed assets, net 1,856 2,421
Other assets 568 168
- ----------------------------------------------------------------------
Total assets $ 50,508 $ 58,182
======================================================================
Liabilities and Stockholders' Equity:
Current liabilities:
Current portion of long-term debt and
capital lease obligations $ 755 $ 1,012
Current portion of accrued license fees $ 1,788 -
Accounts payable 1,391 1,049
Accrued expenses 3,165 3,941
Deferred collaboration revenue - 675
Deferred product revenue - 1,178
Deferred co-promotion fees 6,943 -
- ----------------------------------------------------------------------
Total current liabilities 14,042 7,855
- ----------------------------------------------------------------------
Long-term debt and capital lease obligations,
less current portion 122 421
Long-term portion of accrued license fees,
less current portion 1,707 -
Stockholders' equity:
Preferred stock - -
Common stock 43 43
Additional paid-in capital 206,657 204,378
Deferred stock-based compensation (45) (99)
Accumulated deficit (172,005) (154,399)
Accumulated other comprehensive loss (13) (17)
- ----------------------------------------------------------------------
Total stockholders' equity 34,637 49,906
- ---------------------------------------------------------------------
Total liabilities and stockholders' equity $ 50,508 $ 58,182
======================================================================
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended
June 30,
---------------------
in thousands 2007 2006
======================================================================
Cash flows from operating activities:
Net loss ($17,606) ($31,150)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization expense 335 500
Amortization of premiums on short-term
investments and other 4 (1)
Loss on disposal of fixed assets 18 51
Change in reserve for inventory 279 702
Preferred stock received in license
agreement, net (400) -
Stock-based compensation expense 2,038 4,523
Changes in assets and liabilities:
Accounts receivable (137) 67
Amount due under collaboration agreements 619 (45)
Inventory (616) (1,619)
Prepaid expenses and other (1,211) 616
Accounts payable 342 (323)
Accrued expenses (776) (308)
Accrued license fees 3,495 -
Deferred collaboration revenue (675) (2,447)
Deferred product revenue (1,178) (435)
Deferred co-promotion fees 6,943 -
- ----------------------------------------------------------------------
Net cash used in operating activities (8,526) (29,869)
- ----------------------------------------------------------------------
Cash flows from investing activities:
Proceeds from sales of fixed assets 212 -
Purchases of fixed assets - (321)
Proceeds from sales and maturities of short-
term investments - 22,551
Purchases of short-term investments - (11,802)
- ----------------------------------------------------------------------
Net cash provided by investing activities 212 10,428
- ----------------------------------------------------------------------
Cash flows from financing activities:
Proceeds from exercise of stock options 295 63
Repayments of long-term debt and capital lease
obligations (556) (587)
- ----------------------------------------------------------------------
Net cash used in financing activities (261) (524)
- ----------------------------------------------------------------------
Net decrease in cash and cash equivalents (8,575) (19,965)
Cash and cash equivalents at beginning of
period 48,388 57,257
- ----------------------------------------------------------------------
Cash and cash equivalents at end of period $ 39,813 $ 37,292
======================================================================
CONTACT: Critical Therapeutics, Inc.
Linda S. Lennox, 781-402-5708
Vice President, Investor & Media Relations
llennox@crtx.com