Cubist Pharmaceuticals Reports First Quarter 2002 Results; Company's 2001 Online Annual Report Now Available at www.cubist.com.Business Editors and Health/Medical Writers LEXINGTON, Mass.--(BW HealthWire)--May 1, 2002 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 the results for the first quarter ended March 31, 2002. Total revenues for the first quarter ended March 31, 2002 were $2,320,000 as compared to $2,379,000 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 March 31, 2002 were $20,348,000 as compared to $20,923,000 for the same period in 2001. Net loss for the quarter ended March 31, 2002 was $19,488,000, or ($0.69) per share, as compared to a net loss of $17,603,000, or ($0.63) 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 pre-marketing expenses in preparation for the anticipated launch of the Company's investigational antibiotic 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 $221,797,000 on March 31, 2002, and the Company had 28,495,451 shares outstanding. "The biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. industry faced a number of challenges during the first quarter of 2002," said Scott M. Rocklage, Ph.D., Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cubist. "Cubist was no exception. Poor sector performance, combined with disappointing clinical results across the industry, has created uncertainty in the minds of many biotech investors. We have made several recent announcements that we believe clarify our development strategy and we have reaffirmed our commitment to achieve our forecasted operating timelines." Dr. Rocklage continued, "Following the announcement of mixed results from the first of two CIDECIN 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 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 studies (CAP1), we conducted extensive market research and conferred with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to confirm our regulatory strategy of filing the 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 this year for the indication of complicated skin and soft tissue (cSST) infections. Based on positive feedback from both the marketplace and the FDA and the two successfully completed CIDECIN Phase III trials in cSST, in early March, we announced our decision to go forward with a 2002 CIDECIN NDA filing. We continue to operate on track to meet this goal. "In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified" meantime, meanwhile , we are continuing to focus on generating CIDECIN data for supplemental regulatory indications and for scientific publication. Should CIDECIN receive U.S. regulatory approval, these data will become key components of our marketing strategy. We currently have ongoing a Phase III trial investigating the safety and efficacy of CIDECIN in the treatment of vancomycin-resistant Enterococcal (VRE VRE vancomycin-resistant enterococcus. VRE Vancomycin-resistent enterococcus, see there ) infections, and are poised to begin a Phase III trial evaluating CIDECIN in the treatment of endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. and 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. . We are continuing the analysis of the data generated from the CAP1 trial and will shortly be analyzing the data from the second CAP trial, with the expectation that these data will be useful in determining whether to investigate CIDECIN as a treatment of nosocomial nosocomial /noso·co·mi·al/ (nos?o-ko´me-il) pertaining to or originating in a hospital. nos·o·co·mi·al adj. 1. Of or relating to a hospital. 2. (hospital-acquired) pneumonia. "We continue to attempt to expand our product pipeline, through our clinical research on oral formulations of 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. (OCTX) and through both our lipopeptide and target-based drug discovery programs. In addition to anticipating a CIDECIN NDA filing by the end of 2002, we hope to have chosen a final OCTX formulation, expecting to begin clinical development during 2003, and we hope to advance multiple candidates from our drug discovery efforts into formal medicinal chemistry Medicinal or pharmaceutical chemistry is a scientific discipline at the intersection of chemistry and pharmacology involved with designing, synthesizing and developing pharmaceutical drugs. programs." Dr. Rocklage concluded, "We expect these efforts to result in a steady flow of news events during 2002, a year we expect will be pivotal in our evolution towards becoming a fully integrated antiinfective biopharmaceutical company." Cubist Pharmaceuticals, Inc. is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial antimicrobial /an·ti·mi·cro·bi·al/ (-mi-kro´be-al) 1. killing microorganisms or suppressing their multiplication or growth. 2. an agent with such effects. drugs to combat serious and life-threatening bacterial and fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. . 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) (daptomycin for injection) and EDGE(TM) are trademarks of Cubist Pharmaceuticals, Inc.
CUBIST PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
UNAUDITED
March 31, December 31,
2002 2001
ASSETS
Cash, cash equivalents and investments $221,796,883 $243,134,679
Property and equipment, net 48,392,810 48,056,157
Other assets 22,920,917 23,643,359
Total assets $293,110,610 $314,834,195
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 3,150,034 $ 7,336,002
Accrued expenses 14,950,142 15,709,766
Deferred revenue 8,500,079 9,900,080
Debt and capital lease obligations 212,549,045 212,387,769
Total liabilities 239,149,300 245,333,617
Total stockholders' equity 53,961,310 69,500,578
Total liabilities and stockholders'
equity $293,110,610 $314,834,195
CUBIST PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
UNAUDITED
Three months ended
March 31,
2002 2001
Sponsored research revenues $ 2,319,728 $ 2,379,365
Operating expenses:
Research and development 12,773,429 16,413,576
General and administrative 7,574,305 4,509,746
Total operating expenses 20,347,734 20,923,322
Interest income 1,477,302 2,378,840
Interest expense (3,255,091) (1,103,062)
Other income (expense) 317,927 (334,474)
Net loss ($19,487,868) ($17,602,653)
Basic and diluted net loss per
common share ($ 0.69) ($ 0.63)
Weighted average number of common
shares for basic and diluted net
loss per common share 28,406,410 27,915,084
Additional information can be found at the Company's web site at www.cubist.com or at www.noonanrusso.com. |
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