Critical Therapeutics Reports Fourth Quarter and Full Year 2004 Financial Results.LEXINGTON Lexington. 1 City (1990 pop. 225,366), seat of Fayette co., N central Ky., in the heart of the bluegrass region; inc. 1832, made coextensive with Fayette co. 1974. , Mass. -- Critical Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. , Inc. (Nasdaq: CRTX), a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases, today reported financial results for the fourth quarter and year ended December December: see month. 31, 2004. For the three months ended December 31, 2004, the net loss was $11.2 million, or $0.47 per common share, based on approximately 23.7 million weighted average common shares outstanding. This compares with a net loss of $11.1 million, or $13.63 per common share, for the three months ended December 31, 2003, based on approximately 816,000 weighted average common shares outstanding. The increase in common shares outstanding principally resulted from the issuance of new shares in connection with the Company's initial public offering (IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard. ) on May 27, 2004 and the conversion of all outstanding preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. to common stock. The Company has completed manufacturing scale-up in preparation for the U.S. introduction of its version of ZYFLO Zileuton (Zyflo) A medication that interferes with the biosynthetic pathway that produces leukotrienes; used to help prevent asthma attacks. Mentioned in: Leukotriene Inhibitors Zyflo® Zileuton, see there (R) Filmtab(R) (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic. Zileuton (Zyflo) tablets) for asthma asthma (ăz`mə, ăs`–), chronic inflammatory respiratory disease characterized by periodic attacks of wheezing, shortness of breath, and a tight feeling in the chest. A cough producing sticky mucus is symptomatic. . Paul Rubin, M.D., Critical Therapeutics' president and chief executive officer, stated, "We are on track to submit our supplemental new drug application for ZYFLO to the U.S. Food and Drug Administration by the end of the first quarter of 2005. In addition, we are seeking to broaden our zileuton franchise beyond asthma through the development of new formulations targeting a range of disease indications." Recent Highlights Since the end of the third quarter of 2004, Critical Therapeutics has: --Completed enrollment in its Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of ZYFLO in patients with moderate to severe acne acne, common inflammatory disease of the hair follicles and sebaceous glands characterized by blackheads, whiteheads, pustules, nodules and, in the more severe forms, by cysts and scarring. The lesions appear on the face, neck, back, chest, and arms. . The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled trial, which is evaluating safety and efficacy, enrolled 100 patients. The Company expects to have top line data from this trial by the end of the second quarter of 2005. --Signed an exclusive agreement with Beckman Coulter This article needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , Inc., licensing certain intellectual property rights to Critical Therapeutics' proprietary High Mobility Group Protein 1 (HMGB1) technology. Beckman Coulter intends to use the HMGB1 technology to develop an immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. for the detection and management of inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; . Elevated levels of HMGB1, a pro-inflammatory cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). , have been linked to several diseases, including rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , sepsis Sepsis Definition Sepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms. and septic shock Septic Shock Definition Septic shock is a potentially lethal drop in blood pressure due to the presence of bacteria in the blood. Description Septic shock is a possible consequence of bacteremia, or bacteria in the bloodstream. . --Signed a long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. supply agreement with Rhodia Pharma Solutions for the production of the active pharmaceutical ingredient (API (Application Programming Interface) A language and message format used by an application program to communicate with the operating system or some other control program such as a database management system (DBMS) or communications protocol. ) used in various formulations of zileuton, including ZYFLO. The API will be manufactured at Rhodia's facilities in the United Kingdom. --Initiated a placebo-controlled Phase II clinical trial of CTI-01, the Company's anti-inflammatory an·ti-in·flam·ma·to·ry or an·ti·in·flam·ma·to·ry adj. Reducing inflammation by acting on body mechanisms. an compound, in patients undergoing major cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease involving cardiopulmonary bypass cardiopulmonary bypass n. A procedure to circulate and oxygenate the blood during heart surgery involving the diversion of blood from the heart and lungs through a heart-lung machine and the return of oxygenated blood to the aorta. (CPB CPB see cardiopulmonary bypass. CPB Cardiopulmonary bypass. See Port-Access cardiopulmonary bypass. ), such as coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. and/or valve replacement or repair. In addition to evaluating safety, this double-blind trial will examine the efficacy of the compound in preventing organ damage following CPB in up to 150 patients at multiple centers in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . --Received U.S. patent No. 6,846,842 B2, entitled en·ti·tle tr.v. en·ti·tled, en·ti·tling, en·ti·tles 1. To give a name or title to. 2. To furnish with a right or claim to something: , "Pyruvate pyruvate /py·ru·vate/ (pi´roo-vat) a salt, ester, or anion of pyruvic acid. Pyruvate is the end product of glycolysis and may be metabolized to lactate or to acetyl CoA. py·ru·vate n. Ester Composition and Method of Use for Resuscitation resuscitation /re·sus·ci·ta·tion/ (-sus?i-ta´shun) restoration to life of one apparently dead. cardiopulmonary resuscitation After Events of Ischemia Ischemia Definition Ischemia is an insufficient supply of blood to an organ, usually due to a blocked artery. Description Myocardial ischemia is an intermediate condition in coronary artery disease during which the heart tissue is and Reperfusion re·per·fu·sion n. The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack. ." The patent encompasses broad methods of use for CTI-01, and/or other related compounds, to counteract ischemia and reperfusion injury reperfusion injury damage to renal blood vessels during periods of hypotension does not become apparent until reperfusion occurs in the recovery stage of the vascular incident. resulting from a variety of conditions. "I am very pleased with the efficiency and success of our drug discovery initiatives," Dr. Rubin said. "We are building a strong pipeline of product candidates aimed at modulating cytokine production. The most advanced compound in this program, CTI-01, has reached Phase II clinical testing, and we expect clinical candidates for our HMGB1 and alpha-7 programs to be identified in the second half of 2005." Financial Results Revenue for the three months ended December 31, 2004, increased to approximately $1.0 million, compared with revenue of $620,000 for the three months ended December 31, 2003. This revenue resulted from the Company's collaboration Working together on a project. See collaborative software. agreement with MedImmune, Inc. The Company is amortizing the initial $12.5 million payment from MedImmune and quarterly payments made by MedImmune for certain Critical Therapeutics' employees working on the program over the initial 41-month term of the agreement. The Company recognizes revenue under this agreement based on cumulative costs incurred to date versus an estimate of total costs for the program. As of December 31, 2004, Critical Therapeutics had approximately $78.8 million in cash and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments, compared with $86.2 million at September 30, 2004 and $40.1 million at December 31, 2003. The Company used approximately $7.4 million in cash during the three months ended December 31, 2004 to fund its operations and capital expenditures. The increase in cash since December 31, 2003 resulted primarily from the proceeds from the Company's IPO and from the issuance of preferred stock prior to the IPO, offset in part by cash used to fund operations during 2004. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the three months ended December 31, 2004 were $12.5 million, compared with $10.8 million for the three months ended December 31, 2003, an increase of approximately 15 percent. In addition, total operating expenses in the fourth quarter increased approximately $3.7 million, or 42 percent, compared to the third quarter of 2004. The increase in operating expenses in the fourth quarter of 2004, as compared to these previous periods, reflects costs related to enrolling patients in the Company's ongoing Phase II study of ZYFLO in moderate to severe acne and increased manufacturing costs related to the technology transfer and scale-up of production at the Company's third party manufacturers of ZYFLO and the controlled release formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of zileuton. Research and development costs during the fourth quarter of 2004 decreased $609,000, or 6 percent, to $8.9 million, from $9.5 million for the three months ended December 31, 2003. Research and development costs principally related to the development of the Company's pipeline of drug candidates, including all formulations of zileuton, which the Company licensed in late 2003 and early 2004. The decrease in research and development expenses resulted from certain payments to third parties under licensing agreements on zileuton paid in 2003 that did not recur in 2004, offset in part by higher discovery and development costs on the Company's product candidates in the fourth quarter of 2004. General and administrative expenses increased approximately $2.3 million, or 173 percent, to $3.6 million in the fourth quarter of 2004, compared with $1.3 million for the three months ended December 31, 2003. This increase primarily was attributable to certain costs related to building the Company's sales and marketing organization to support the expected launch of ZYFLO in late 2005, as well as an increase in the number of employees performing general and administrative functions after the Company's IPO. Non-cash stock-based compensation expense totaled $1.5 million for the three months ended December 31, 2004, compared with $2.8 million for the three months ended December 31, 2003. Stock-based compensation expense varies each period and is calculated based upon a number of variables such as the number of underlying securities, the price of the Company's stock and the vesting Vesting The process by which employees accrue non-forfeitable rights over employer contributions that are made to the employee's qualified retirement plan account. Notes: period associated with each grant. For the year ended December 31, 2004, revenue increased to $4.4 million, compared with $1.0 million for the year ended December 31, 2003. The net loss available to common stockholders for the year ended December 31, 2004 was $33.3 million, or $2.28 per common share. This compares with a net loss available to common stockholders of $22.4 million, or $33.99 per common share, for the year ended December 31, 2003. Results for 2004 include total operating expenses of $36.5 million, compared with $21.2 million for the year ended December 31, 2003, an increase of 72 percent, resulting from increased costs of advancing our pipeline of product candidates. Non-cash stock-based compensation expense was $3.6 million for the year ended December 31, 2004, compared with $5.1 million for the year ended December 31, 2003. Financial Guidance For the three months ending March 31, 2005, net cash expenditures are expected to be between $11 million and $12 million. For the year ended December 31, 2005, the Company is projecting net cash expenditures of between $45 million and $50 million, net of cash received from any product sales and payments received under collaboration agreements. The increase in expenditures will be focused on building the Company's commercial organization and sales force to prepare the Company for its expected launch of ZYFLO in the asthma market in the fourth quarter of 2005 and continued investment in the Company's research and development programs to support upcoming milestones. Conference Call Information Critical Therapeutics will hold a conference call for investors to discuss the Company's fourth quarter and full year 2004 financial results, strategy and upcoming milestones. Investors and other interested parties can access the call as follows:
Date: Thursday, February 17, 2005
Time: 5:00 p.m. ET
Dial-in: (800) 967-7185 (domestic)
(719) 457-2634 (international)
Webcast: www.crtx.com
A replay of the conference call will be available from approximately 8:00 p.m. ET February 17, 2005 until midnight ET February 23, 2005. To hear the replay, dial (888) 203-1112 from the U.S. and Canada and (719) 457-0820 from other locations. The replay passcode is 4479009. To access the replay via webcast, visit www.crtx.com, click on "Investors" and then on "Webcasts & Presentations." About Critical Therapeutics Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company is developing a sales and marketing infrastructure in connection with its in-licensed product, ZYFLO(R), a tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. formulation of zileuton. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of chronic diseases that frequently lead to hospitalization hospitalization /hos·pi·tal·iza·tion/ (hos?pi-t'l-i-za´shun) 1. the placing of a patient in a hospital for treatment. 2. the term of confinement in a hospital. . For more information, please visit www.crtx.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including statements regarding the progress and timing of our drug development programs and related trials, including, without limitation, the availability of top-line data from the Phase II trial of ZYFLO(R) in moderate to severe acne; the timing of regulatory approvals and product launches; the efficacy of our drug candidates; our strategy, future operations, financial position, future revenues, projected costs, including our net cash expenditures for 2005, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc : conducting clinical trials, including the timing and success of patient enrollment; the results of preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; the timing and success of submission, acceptance and approval of our regulatory filings; our heavy dependence on the commercial success of ZYFLO(R) tablets and the controlled-release formulation of zileuton; 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 drug candidates and our discoveries. These and other risks are described in greater detail in the "Factors That May Affect Future Results" section of our most recent Report on Form 10-Q Form 10-Q See 10-Q. and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize ma·te·ri·al·ize v. ma·te·ri·al·ized, ma·te·ri·al·iz·ing, ma·te·ri·al·iz·es v.tr. 1. To cause to become real or actual: By building the house, we materialized a dream. , 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 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 dis·claim v. dis·claimed, dis·claim·ing, dis·claims v.tr. 1. To deny or renounce any claim to or connection with; disown. 2. To deny the validity of; repudiate. 3. 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. Filmtab(R) is a registered trademark of the Abbott Group of Companies.
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
in thousands except share
and per share data 2004 2003 2004 2003
----------------------------------------------------------------------
Revenue under
collaboration agreement $964 $620 $4,436 $1,021
Operating expenses:
Research and development 8,900 9,509 25,578 17,458
General and
administrative 3,563 1,305 10,878 3,771
Total operating expenses 12,463 10,814 36,456 21,229
Operating loss (11,499) (10,194) (32,020) (20,208)
Other income, net 320 63 926 98
Net loss (11,179) (10,131) (31,094) (20,110)
Accretion of dividends and
offering costs on
preferred stock 0 (989) (2,209) (2,264)
Net loss available to
common stockholders ($11,179) ($11,120) ($33,303) ($22,374)
----------------------------------------------------------------------
Net loss per share
available to common
stockholders ($0.47) ($13.63) ($2.28) ($33.99)
----------------------------------------------------------------------
Basic and diluted
weighted-average common
shares outstanding 23,735,544 815,840 14,631,371 658,204
----------------------------------------------------------------------
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
December 31, December 31,
in thousands 2004 2003
----------------------------------------------------------------------
Assets:
Current assets:
Cash and cash equivalents $28,780 $40,078
Amount due under collaboration agreement 16 2,500
Short-term investments 50,049 0
Prepaid expenses and other 1,851 430
Total current assets 80,696 43,008
Fixed assets, net 2,205 1,556
Other assets 213 490
Total assets $83,114 $45,054
----------------------------------------------------------------------
Liabilities and Stockholders' Equity (Deficit):
Current liabilities:
Current portion of long-term debt $837 $552
Accounts payable 4,218 323
Accrued license fees 0 4,460
Accrued expenses 2,741 977
Revenue deferred under collaboration
agreement 8,543 11,478
Total current liabilities 16,339 17,790
Long-term debt, less current portion 1,367 720
Redeemable convertible preferred stock 0 51,395
Stockholders' equity (deficit):
Common stock 24 2
Additional paid-in capital 130,374 11,156
Deferred stock-based compensation (6,101) (8,536)
Due from stockholders 0 (40)
Accumulated deficit (58,527) (27,433)
Accumulated other comprehensive loss (362) 0
Total stockholders' equity (deficit) 65,408 (24,851)
Total liabilities and stockholders' equity
(deficit) $83,114 $45,054
----------------------------------------------------------------------
CRITICAL THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Twelve Months Ended
December 31,
in thousands 2004 2003
----------------------------------------------------------------------
Cash flows from operating activities:
Net loss ($31,094) ($20,110)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization expense 1,092 482
Loss on disposal of fixed assets 278 0
Loss on conversion of warrants 46 0
Stock-based compensation expense 3,562 5,072
Forgiveness of notes receivable 185 0
Changes in assets and liabilities:
Amount due under collaboration agreement 2,484 (2,500)
Prepaid expenses and other (1,421) (622)
Other assets 277 0
Accounts payable 3,895 (94)
Accrued license fees and other expenses (2,211) 5,267
Revenue deferred under collaboration
agreement (2,935) 11,479
Net cash provided by (used in) operating
activities (25,842) (1,026)
Cash flows from investing activities:
Purchases of fixed assets (2,019) (1,492)
Proceeds from sales and maturities of short-term
investments 7,200 0
Purchases of short-term investments (57,611) 0
Net cash used in investing activities (52,430) (1,492)
Cash flows from financing activities:
Net proceeds from issuance of convertible
preferred stock 28,050 27,906
Net proceeds from the initial public offering of
common stock 37,817 0
Proceeds from exercise of stock options 175 6
Repurchase of restricted common stock 0 (1)
Proceeds from notes receivable 0 145
Proceeds from long-term debt 1,623 1,388
Repayments of long-term debt (691) (387)
Net cash provided by financing
activities 66,974 29,057
Net increase (decrease) in cash and cash
equivalents (11,298) 26,539
Cash and cash equivalents at beginning of period 40,078 13,539
Cash and cash equivalents at end of period $28,780 $40,078
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