Cubist Pharmaceuticals Reports Second-Quarter 2002 Results; Company Provides Additional Data on Cidecin Pneumonia Trials.Business Editors and Health/Medical Writers BIOWIRE2K LEXINGTON, Mass.--(BW HealthWire)--Aug. 5, 2002 Conference Call & Webcast Today at 10:00 am ET Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today reported results for the second quarter ended June 30, 2002. Total revenues for the second quarter ended June 30, 2002 were $2,327,000 as compared to $3,349,000 for the same period in 2001. 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 quarter ended June 30, 2002 were $21,577,000 as compared to $20,984,000 for the same period in 2001. Net loss for the quarter ended June 30, 2002 was $21,176,000 or ($0.74) per share as compared to a net loss of $16,832,000 or ($0.60) per share for the same period in 2001. Total revenues for the six months ended June 30, 2002 were $4,647,000 as compared to $5,728,000 for the same period in 2001. Total operating expenses for the six months ended June 30, 2002 were $41,925,000 as compared to $41,907,000 for the same period in 2001. Net loss was $40,664,000 or ($1.43) per share for the six months ended June 30, 2002 as compared to a net loss of $34,435,000 or ($1.23) per share for the same period in 2001. Although there was no significant change in operating expenses year over year, Selling, General and Administrative expenses increased as a percentage of total expenses, reflecting expanded headcount and an increase in marketing expenses in preparation for the anticipated launch of the Company's investigational antibiotic antibiotic, any of a variety of substances, usually obtained from microorganisms, that inhibit the growth of or destroy certain other microorganisms. Types of Antibiotics Cidecin(R) (daptomycin for injection), should CIDECIN receive regulatory approval. The increase in interest expense in 2002 relative to 2001 is a result of a $165 million convertible debt offering completed in the fourth quarter of 2001. The Company's cash and investment balance was $194,820,000 on June 30, 2002. The total number of common shares outstanding as of June 30, 2002 was 28,563,321. Cubist today also announced further analysis of data and results from its two, pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials investigating the safety and efficacy of CIDECIN in the treatment of community-acquired pneumonia community-acquired pneumonia Pneumonia caused by an infection currently present in the community; CAP is the most common cause of infectious death–US, and number 6 killer overall; of the 57% of CAPs in which a pathogen is identified, S pneumoniae (CAP) requiring 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. . Importantly, these CAP studies combined with other completed CIDECIN clinical trials have allowed the Company to build a safety database that supports a U.S. New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) filing. Earlier this year, Cubist announced results from the first CAP study (CAP1), in which CIDECIN was compared to ceftriaxone ceftriaxone /cef·tri·ax·one/ (cef?tri-ak´son) a semisynthetic, ß–resistant, third-generation cephalosporin effective against a wide range of gram-positive and gram-negative bacteria, used as the sodium salt. , the current standard of care for CAP. Analysis of the previously halted second study (CAP2) has now been completed; outcome trends from the initial analysis of 170 evaluable patients appear to be consistent with the results seen in the CAP1 study, but are not statistically meaningful given the small patient population. When data from the clinically evaluable populations in the two CAP studies are combined, CIDECIN achieved a clinical success rate of 80% versus ceftriaxone's 88% clinical success rate. Both internal and external infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. medical and regulatory reviewers have now assessed many possible factors that could have contributed to the unexpected overall outcome of the CAP1 study. Notably, the reviewers concluded that there were no substantive faults in the design, conduct or analyses of the study that could have affected the outcome. The more detailed analysis also concluded that no one factor appears to explain the difference in the cure rates of CIDECIN and ceftriaxone in the study. Cubist continues on track to file the CIDECIN NDA during the fourth quarter of 2002 for the indication of complicated skin and soft tissue infection, based on data from two pivotal Phase III trials that met their required statistical endpoint. Also included in the NDA package will be Phase II supportive data from studies that include patients treated with CIDECIN for vancomycin-resistant Enterococcal (VRE VRE vancomycin-resistant enterococcus. VRE Vancomycin-resistent enterococcus, see there ) infections, bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. and complicated urinary tract infections urinary tract infection (UTI), n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria. . Phase I data will be presented from a multitude of studies examining drug-drug interactions, renal renal /re·nal/ (re´n'l) pertaining to the kidney. re·nal adj. Of or in the region of the kidneys. Renal Relating to the kidney. and hepatic hepatic /he·pat·ic/ (he-pat´ik) pertaining to the liver. he·pat·ic adj. 1. Of, relating to, or resembling the liver. 2. Acting on or occurring in the liver. n. impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. , and special populations, including obese o·bese adj. Extremely fat; very overweight. obese characterized by obesity. obese adjective Characterized by obesity, see there; excessively fat and geriatric geriatric /ger·i·at·ric/ (jer?e-at´rik) 1. pertaining to elderly persons or to the aging process. 2. pertaining to geriatrics. ger·i·at·ric adj. 1. subjects. The NDA package will also contain a comprehensive microbiology microbiology: see biology. microbiology Scientific study of microorganisms, a diverse group of simple life-forms including protozoans, algae, molds, bacteria, and viruses. section detailing CIDECIN's in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. activity against virtually all clinically relevant Gram-positive organisms Organisms See also animals; bacteria; biology; plants; zoology. anabolism Biology, Physiology. the synthesis in living organisms of more complex substances from simpler ones. Cf. catabolism. — anabolic, adj. . "As a result of the positive feedback we've received from our special event conference calls, and given our progress towards becoming a fully integrated biopharmaceutical company, we felt it timely to begin regularly scheduled quarterly conference calls," said Scott M. Rocklage, Ph.D., Chairman and Chief Executive Officer of Cubist. "During today's inaugural call, we look forward to discussing our ongoing clinical and commercial plans for CIDECIN, our growing pipeline and other recent corporate events."
CONFERENCE CALL & WEBCAST INFORMATION
WHEN: Monday August 5, 2002 at 10:00 am ET
DOMESTIC & CANADA CALL-IN: (800) 915-4836
INTERNATIONAL CALL-IN: (973) 317-5319
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CBST&script1020&item_id=ew,651352,1&layout=6
Replay will be available for 30 days via the Internet
Cubist Pharmaceuticals, Inc. is focused on becoming a global leader in the research, development and commercialization of novel pharmaceuticals to combat serious and life-threatening infections. Cubist is evaluating the safety and efficacy of Cidecin(R) (daptomycin for injection) in the EDGE(TM) (Evaluation of Daptomycin against Gram-positive Entities) clinical trial program and has broadened its pipeline to include multiple pre-clinical drug candidates. The Company is engaged in strategic partnerships with Novartis Pharma AG for the discovery and development of novel antiinfectives and with Gilead Sciences Gilead Sciences NASDAQ: GILD is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases. for the commercialization of daptomycin in Europe. Cubist is headquartered in Lexington, MA and has operations in Vancouver, BC, Canada and Slough Slough (slou), city (1991 pop. 106,341) and borough, central England. After World War I, the residential city and its outlying area underwent rapid industrial development, owing in part to its proximity to London. , UK. Cubist Safeharbor Statement Statements contained herein that are not historical fact may be 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. within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by the Company. These factors include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company's ability to develop and commercialize its products before its competitors. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company's recent SEC filings. Cidecin(R) and EDGE(TM) are trademarks of Cubist Pharmaceuticals, Inc.
CUBIST PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
UNAUDITED
June 30, December 31,
2002 2001
ASSETS
Cash, cash equivalents and investments $194,820,168 $243,134,679
Property and equipment, net 48,954,714 48,056,157
Other assets 22,737,132 23,643,359
Total assets $266,512,014 $314,834,195
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 1,060,092 $ 7,336,002
Accrued expenses 13,676,504 15,709,766
Deferred revenue 7,100,078 9,900,080
Debt and capital lease obligations 211,404,123 212,387,769
Total liabilities 233,240,797 245,333,617
Total stockholders' equity 33,271,217 69,500,578
Total liabilities and
stockholders' equity $266,512,014 $314,834,195
CUBIST PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
UNAUDITED
Three months ended Six months ended
June 30, June 30,
2002 2001 2002 2001
Sponsored research
revenues $2,327,125 $3,348,643 $4,646,853 $5,728,008
Operating expenses:
Research and
development 14,700,047 16,576,087 27,473,476 32,989,663
General and
administrative 6,876,893 4,407,984 14,451,198 8,917,730
Total operating
expenses 21,576,940 20,984,071 41,924,674 41,907,393
Interest income 1,523,130 1,943,230 3,000,432 4,322,070
Interest expense (3,534,346) (1,095,673) (6,789,437) (2,198,735)
Other income
(expense) 84,996 (44,087) 402,923 (378,561)
Net loss ($21,176,035) (16,831,958) ($40,663,903) (34,434,611)
Basic and diluted
net loss per
common share ($0.74) ($0.60) ($1.43) ($1.23)
Weighted average
number of common
shares for basic
and diluted net
loss per
common share 28,519,475 28,026,075 28,463,255 27,970,886
For additional information, visit the Company's website at www.cubist.com or www.nrp-euro.com. |
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