A.P. Pharma Reports Second Quarter Results; APF112 Phase II Clinical Package Submitted for FDA Review; Royalty Income Increases 11% Over 2Q 2002.Business Editors/Health/Medical Writers REDWOOD CITY Redwood City, city (1990 pop. 66,072), seat of San Mateo co., W Calif., on San Francisco Bay; inc. 1868. Manufactures include commmunications, electrical, electronic, and medical equipment. , Calif.--(BUSINESS WIRE)--Aug. 4, 2003 A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today reported financial results for the three months ended June 30, 2003, reflecting increased royalty income and contract revenues as well as higher research and development expenses as the Company prepares to initiate a 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 with APF APF, n the abbreviation for acidulated phosphate fluoride. 112. Current Highlights -- Second quarter royalty income increased 11% to $1,031,000. -- Extensive Biochronomer(R) and APF112 safety studies completed. -- APF112 Phase II clinical study protocol and preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. safety package submitted to 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. . -- Inguinal hernia inguinal hernia n. A hernia into the inguinal canal. inguinal hernia Surgery The prolapse of a loop of intestine into a patent inguinal canal Phase II study planned to be initiated in 3Q 2003; clinical sites selected. -- Feasibility studies The analysis of a problem to determine if it can be solved effectively. The operational (will it work?), economical (costs and benefits) and technical (can it be built?) aspects are part of the study. Results of the study determine whether the solution should be implemented. continue in the areas of ophthalmology ophthalmology (ŏf'thălmŏl`əjē), branch of medicine specializing in the anatomy, function and diseases of the eye. Ophthalmologists specialize in the medical and surgical treatment of eye disorders, vision measurements for , coatings and DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. ; new studies being initiated. -- Cash, cash equivalents and short-term investments were $12.1 million at June 30, 2003, compared with $14.1 million at December 31, 2002. Second Quarter Financial Results A.P. Pharma reported that total revenues for the second quarter of 2003 increased 15% to $1,117,000, compared with $968,000 for the second quarter of 2002, primarily due to a continuing increase in royalty income from Retin-A Micro(R) marketed by Neutrogena, a Johnson and Johnson company. Total revenues also included an increase in contract revenues for research and development work performed in connection with feasibility studies. Research and development expense for the second quarter of 2003 increased to $2,335,000 from $1,872,000 for the second quarter of 2002. This increase was due mainly to the cost of Biochronomer studies which were designed to demonstrate the biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. of the polymer, and APF112 preclinical safety studies using the enhanced APF112 formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation for the treatment of post-surgical pain as part of a plan agreed in discussions with the U.S. Food and Drug Administration (FDA). In addition, costs associated with the manufacture of GMP GMP (guanosine monophosphate): see guanine. product for human clinical trials were incurred. A comprehensive Phase II clinical package has been submitted to the FDA for review and the Company plans to initiate human clinical trials in inguinal hernia patients during the third quarter of 2003. The Company is also planning to file an IND for a second product candidate early in 2004. The net loss for the second quarter of 2003 was $1,960,000, or $0.10 per share, compared with a net loss for the second quarter of 2002 of $1,493,000, or $0.07 per share. Conference Call Information Management will be hosting an investment community conference call beginning at 11:00 a.m. Eastern Time (8:00 a.m. Pacific Time) today to discuss this announcement and to answer questions. To participate in the live call by telephone, please dial 888-803-8275 from the U.S., and 706-634-1287 from outside the U.S. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 from outside the U.S., and entering reservation number 1702289. Individuals interested in listening to the conference call via the Internet may do so by visiting www.appharma.com. A replay will be available on the Company's web site. About A.P. Pharma A.P. Pharma is a specialty pharmaceutical company focused on the development of ethical (prescription) pharmaceuticals utilizing its proprietary polymer-based drug delivery systems. The Company's primary focus is the development and commercialization of its bioerodible injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. and implantable systems under the trade name Biochronomer. Initial target areas of application for the Company's drug delivery technology include pain management, inflammation, oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. and ophthalmology applications. The Company's product development programs are funded by royalties from topical topical /top·i·cal/ (top´i-k'l) pertaining to a particular area, as a topical antiinfective applied to a certain area of the skin and affecting only the area to which it is applied. top·i·cal adj. products currently marketed by pharmaceutical partners, by proceeds from the divestitures of its cosmeceutical cos·me·ceu·ti·cal n. A cosmetic that has or is purported to have medicinal properties. and analytical analytical, analytic pertaining to or emanating from analysis. analytical control control of confounding by analysis of the results of a trial or test. standards product lines and by fees it receives from collaborative partners. For further information visit the Company's web site at www.appharma.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. Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties including, among others, uncertainty associated with timely development, approval, launch and acceptance of new products, establishment of new corporate alliances and progress in research and development programs. Other risks and uncertainties associated with the Company's business and prospects are identified in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.
A.P. Pharma, Inc.
Income Statement Highlights
(in thousands, except per share data)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2003 2002 2003 2002
Royalties $1,031 $930 $2,063 $1,833
Contract Revenues 86 38 160 86
Total Revenues 1,117 968 2,223 1,919
Operating Expenses:
Research & Development 2,335 1,872 4,537 3,369
General & Administrative 766 813 1,544 1,573
Total Operating Expenses 3,101 2,685 6,081 4,942
Operating Loss (1,984) (1,717) (3,858) (3,023)
Interest Income and Other, Net 54 175 129 379
Loss from Continuing Operations (1,930) (1,542) (3,729) (2,644)
Gain (Loss) on Disposition of
Discontinued Operations (30) 49 1,802 145
Net Loss ($1,960) ($1,493) ($1,927) ($2,499)
Basic and Diluted Loss per Share:
Loss from Continuing Operations ($0.09) ($0.08) ($0.18) ($0.13)
Net Loss ($0.10) ($0.07) ($0.09) ($0.12)
Shares used in Calculating Loss
per Share:
Basic and Diluted 20,535 20,403 20,505 20,381
A.P. Pharma, Inc.
Balance Sheet Highlights
(in thousands)
June 30, 2003 December 31,
(Unaudited) 2002 (1)
Assets
Cash, Cash Equivalents and Marketable
Securities $12,075 $14,121
Accounts Receivable, Net 1,341 1,340
Assets Held for Sale -- 225
Other Current Assets 511 280
Total Current Assets 13,927 15,966
Property, Plant & Equipment, Net 1,505 1,626
Other Non-Current Assets 477 189
Total Assets $15,909 $17,781
Liabilities and Shareholders' Equity
Current Liabilities $ 2,156 $ 1,977
Long-Term Deferred Revenues 145 345
Shareholders' Equity 13,608 15,459
Total Liabilities and Shareholders' Equity $15,909 $17,781
(1) Information derived from audited financial statements.
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