Cell Pathways, Inc. Reports Fourth Quarter and 2000 Financial Results.Business Editors HORSHAM, Pa.--(BW HealthWire)--Feb. 26, 2001 Cell Pathways, Inc. (Nasdaq:CLPA CLPA CC-Link Partner Association CLPA Club Loisirs et Plein Air (Montpellier, France) CLPA Child Labour Programme of Action (national plan to eliminate child labour in South Africa) ) today reported fourth quarter and year-end financial results for the periods ended Dec. 31, 2000. The Company reported a net loss in the fourth quarter of 2000 of $5.7 million, or $201,000 more than the same period in 1999. For the fourth quarter of 2000, net loss per share was $0.19 on approximately 29.7 million common shares outstanding versus a net loss of $0.21 per share on approximately 25.9 million common shares outstanding for the fourth quarter of 1999. The Company reported a net loss for the year ended Dec. 31, 2000 of $26.9 million or $7.3 million more than the same period in 1999. Net loss per share in 2000 was $0.96 on approximately 28.0 million common shares outstanding versus a loss of $0.79 per share on approximately 24.8 million shares outstanding in 1999. During the fourth quarter of 2000 the Company increased its cash position through the sale of 3.2 million shares of Common Stock for net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $23.1 million. The Company ended the year with $49.5 million in cash and cash equivalents. In the fourth quarter of 2000, the Company recognized revenue, representing $330,000, from its agreement with Aventis Pharmaceuticals Inc. ("Aventis") in marketing Nilandron(R) (nilutamide nilutamide /ni·lu·ta·mide/ (ni-loo´tah-mid) a nonsteroidal antiandrogen used as an antineoplastic in the treatment of prostatic carcinoma. ) for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. which commenced during the fourth quarter of 2000. For the fourth quarter of 2000, research and development ("R&D") expenses were $5.7 million, or $1.1 million higher than the same period of 1999. This increase was due principally to commitments to purchase raw materials for the production of Aptosyn(TM) (exisulind), the Company's lead drug, for clinical and commercial purposes. General and administrative ("G&A") expenses were $1.1 million in the fourth quarter of 2000, a decrease of $330,000 from the same period in 1999. This G&A decrease was due principally to a reduction in employee bonuses and consulting expenses offset partially by an increase in the sales and marketing expenses related to the promotion of Nilandron(R). Interest income was $715,000 in the fourth quarter of 2000 versus $455,000 for the same period in 1999. For the year ended Dec. 31, 2000, revenue was $330,000 related to the Aventis agreement for the promotion of Nilandron(R). R&D expenses were $22.3 million, an increase of $6.0 million from 1999. This increase was due principally to commitments and purchases of Aptosyn(TM) raw materials for clinical trials and commercial supply and to an increase in personnel and expenses to support the product development of Aptosyn(TM) and CP461, the Company's second drug. G&A expenses were $7.2 million in 2000, an increase of $2.4 million from 1999. This increase was due principally to expenses associated with preparations for the commercialization of Aptosyn(TM) and expenses associated with the hiring, training and support of a sales organization to promote Nilandron(R). Interest income was $2.3 million, an increase of $788,000 due to higher average cash balances in 2000 versus 1999. Commenting on the year-end results, Robert J. Towarnicki, Cell Pathways' chairman and chief executive officer, stated, "Many important developments took place in 2000 that shaped and furthered our goal of becoming a leading company in the treatment and prevention of cancer.
-- We initiated cooperative clinical trials with Aventis, Roche,
Eli Lilly, and GlaxoSmithKline. These cancer trials
investigate the use of Aptosyn(TM) in combination with each of
Taxotere(R), Xeloda(R), Gemzar(R) and Navelbine(R).
-- Throughout the year, presentations and publications by company
scientists and independent cancer researchers continued to
highlight and further elucidate the mechanism of action
targeted by the Company's Selective Apoptotic Anti-Neoplastic
Drugs ("SAANDs").
-- We received from the FDA a "not approvable" letter for our New
Drug Application for the treatment of familial adenomatous
polyposis ("FAP"). The future of the FAP program remains
uncertain. While we continue to evaluate the FAP Program,
including the regulatory and competitive environment, the
Company is focusing its resources on registration-directed
trials in multiple cancer indications.
-- Our second drug, CP461, advanced in the clinic in 2000 based
upon encouraging safety and oral bioavailability data.
-- We obtained the rights to market Nilandron(R) from Aventis,
and have trained a dedicated contract sales force. During the
fourth quarter we began promoting Nilandron(R) to urologists
for the treatment of prostate cancer. This sales effort
established the foundation of our sales and marketing
organization.
-- In November, we raised $23.1 million in a private sale of
equity improving our cash position to $49.5 million at
year-end.
-- We strengthened our senior management team with the addition
of Robert E. Bellet, M.D., senior vice president-clinical &
regulatory affairs, and Martha E. Manning, senior vice
president- general counsel & secretary. Both have considerable
experience in the pharmaceutical development business and are
strong assets for the company."
Cell Pathways, Inc., headquartered in Horsham, Pa., is a development stage pharmaceutical company focused on the research, development and commercialization of novel and unique medications to prevent and treat cancer. For additional information on Cell Pathways, Inc., visit the company's web site at http://www.cellpathways.com. Editor's Note Editor's Note (foaled in 1993 in Kentucky) is an American thoroughbred Stallion racehorse. He was sired by 1992 U.S. Champion 2 YO Colt Forty Niner, who in turn was a son of Champion sire Mr. Prospector and out of the mare, Beware Of The Cat. Trained by D. : Aptosyn(TM) is a trademark of Cell Pathways, Inc., Taxotere(R) is a registered trademark of Aventis Pharmaceuticals Inc., Xeloda(R) is a registered trademark of Roche Laboratories, Inc., Gemzar(R) is a registered trademark of Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. and Navelbine(R) is a registered trademark of GlaxoSmithKline. Certain statements made herein, and oral statements made in respect hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" , constitute "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 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. Such statements are those which express plan, anticipation, intent, contingency contingency n. an event that might not occur. or future development and/or otherwise are not statements of historical fact. These statements are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors, the absence of approved products; history of operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and the need for further financing; early stage of development; the costs, delays and uncertainties inherent in basic pharmaceutical research, drug development, clinical trials and the regulatory approval process, with respect to both the Company's current product candidates and its future product candidates, if any; dependence on the development and market acceptance of Aptosyn(TM) (exisulind) for one or more significant disease indications; limitations on, or absence of, the predictive value pre·dic·tive value n. The likelihood that a positive test result indicates disease or that a negative test result excludes disease. predictive value a measure used by clinicians to interpret diagnostic test results. of data obtained in laboratory tests, animal models and human clinical trials when planning additional steps in product development; uncertainty of obtaining regulatory approval of any compound for any disease indication; uncertainty and adversity ad·ver·si·ty n. pl. ad·ver·si·ties 1. A state of hardship or affliction; misfortune. 2. A calamitous event. arising from the action of 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. in issuing a "not approvable" letter with respect to the 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 ") submitted for Aptosyn(TM) (exisulind) for the orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the condition of familial adenomatous polyposis familial adenomatous polyposis Familial polyposis An AD condition affecting ±50,000–US, characterized by progressive development of hundreds of adenomatous colorectal polyps; progression to cancer Molecular pathology APC , a rare disease that puts those afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, at high risk of developing colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. ; the timing and scope of any approval which might be received for any compound for any indication in the future; the volatility of the market price of the Company's Common Stock; the risk of our pending class action securities litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; acceptance of any product candidate by providers of healthcare reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. ; the validity, scope and enforceability of patents; the actions of competitors; the pace of technological changes in the biopharmaceutical industry; dependence upon third parties; potential product liability claims and availability of insurance . These and other risks are detailed in the Company's reports filed from time to time under the Securities Act and/or the Securities Exchange Act, including the sections 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: "Business," "Risk Factors," "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" and "Other Events" in the Company's reports on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 1999 and Forms 10-Q and 8-K filed in 2000 as well as in registration statements on Form S-3 as may be filed from time to time. You are encouraged to read these filings as they are made. They are available over the Internet from the SEC in its EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king. database. Given the uncertainties affecting pharmaceutical companies in the development stage, current and prospective investors are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. No forward-looking statement can be guaranteed; actual future results may vary materially. Both forward-looking statements and statements of historic fact must be understood in the context of the risks referred to above which characterize the Company's development stage business. The Company undertakes no obligation to update or revise the statements made herein or the factors which may relate thereto there·to adv. 1. To that, this, or it. 2. Archaic In addition to that; furthermore. thereto Adverb Formal 1. to that or it 2. .
CELL PATHWAYS, INC.
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2000 1999
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 49,528,407 $ 32,013,118
Other current assets 1,658,229 875,433
Total current assets 51,186,636 32,888,551
OTHER ASSETS 2,894,957 2,390,420
$ 54,081,593 $ 35,278,971
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES 4,994,883 $ 3,782,312
LONG TERM LIABILITIES 457,800 33,917
STOCKHOLDERS' EQUITY
Common Stock 310,734 261,059
Additional paid-in capital 140,235,478 96,202,177
Stock subscription receivable
from issuance of Common Stock (37,000) (37,000)
Deficit accumulated during the
development stage (91,880,302) (64,963,494)
Total stockholders' equity 48,628,910 31,462,742
$ 54,081,593 $ 35,278,971
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Twelve Months Ended
December 31, December 31,
2000 1999 2000 1999
------------ ------------ ------------ ------------
REVENUES $ 329,694 $ -- $ 329,694 $ --
EXPENSES
Research and
development $ 5,730,434 $ 4,609,629 $ 22,257,805 $ 16,254,858
Selling,
general and
administrative 1,061,254 1,390,879 7,246,582 4,849,162
Operating
loss (6,461,994) (6,000,508) (29,174,693) (21,104,020)
INTEREST INCOME 715,286 454,804 2,257,885 1,470,298
NET LOSS $ (5,746,708) $ (5,545,704) $(26,916,808) $(19,633,722)
Basic and
diluted net
loss per
Common share $ (0.19) $ (0.21) $ (0.96) $ (0.79)
Shares used in
computing
basic and
diluted net
loss per
Common share 29,716,935 25,903,068 28,003,649 24,772,256
Note 1 -- As of Dec. 31, 2000 and 1999 the Company had a total of 31,073,457 shares and 26,105,894 shares of stock outstanding, respectively. Basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. net loss per common share is calculated in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System 128. Basic net loss per common share is equal to net loss divided by the weighted average common shares outstanding during the period. Diluted net loss per common share is equal to net loss divided by the sum of weighted average common shares outstanding during the period plus common stock equivalents. The Company's basic and diluted per share amounts are the same since the effect of common stock equivalents would be anti-dilutive. |
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