A.P. Pharma Reports First Quarter Results; Human Clinical Trials Underway with Two Product Candidates.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)--April 28, 2004 A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today reported financial results for the three months ended March 31, 2004. Current and Financial Highlights -- A Phase 2 human clinical trial is ongoing with APF APF, n the abbreviation for acidulated phosphate fluoride. 112 for the treatment of post-surgical pain. -- Pre-clinical studies with APF530 for the treatment of chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. (CINV CINV Chemotherapy Induced Nausea and Vomiting ) are completed. -- A Phase 1 human clinical trial is underway in the U.K. with APF530 for the treatment of CINV. -- First quarter 2004 royalty income increased by 12% to $1.2 million, reflecting sales growth in both Retin-A Micro(R) and Carac(TM). -- A study conducted at MIT MIT - Massachusetts Institute of Technology indicating a Biochronomer(TM) formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation could advance 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. vaccine usage against viral infections and cancers was reported in the February 2004 issue of Nature Materials Nature Materials is a monthly multi-disciplinary journal aimed at bringing together cutting-edge research across the entire spectrum of materials science. The journal’s Impact Factor of 19. . -- Net cash burn for the first quarter of 2004 was $1.7 million. -- Cash, cash equivalents and short-term investments were $7.7 million at March 31, 2004. Financial Results The Company reported royalties for the first quarter of 2004 of $1,154,000, compared with $1,032,000 for the first quarter of 2003. Royalties on sales of Retin-A Micro grew by 16% over the first quarter of 2003 and royalties on sales of Carac grew by 4% over the first quarter of 2003. Total revenues for the first quarter of 2004 increased 7% to $1,180,000 compared with $1,106,000 in the comparable year-ago period. Royalties represented 98% of total revenues in the first quarter of 2004, compared with 93% of total revenues in the first quarter of 2003. Research and development expense for the first quarter of 2004 increased by $833,000 or 38% to $3,035,000, reflecting the costs of clinical and pre-clinical studies on two product candidates incorporating the Company's proprietary Biochronomer bioerodible drug delivery system. Part 2 of the Phase 2 human clinical study using APF112 for the treatment of post-surgical pain is ongoing. The product is designed to provide pain relief for a sustained period of time following surgery, and to reduce or eliminate the need for opioid-like products. APF112 contains the local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. mepivacaine and has been shown in Part 1 of the Phase 2 clinical study to sustain blood drug levels for up to 72 hours. Wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by in all patients was observed to be normal and no adverse events were reported. The second part of the Phase 2 trial is a 90-patient blinded study comparing two doses of APF112 with current standard treatments for post-surgical pain. The end points for the trial include a visual analog score of pain intensity, the standard means of measuring pain, and reduction in use of opioid-type medication by patients. The Company also completed pre-clinical studies and has initiated a Phase 1 human clinical trial in the U.K. using APF530 for the treatment of chemotherapy-induced nausea and vomiting. APF530 contains the anti-emetic granisetron, and is designed to provide three to five days of continuous relief from chemotherapy-induced nausea and vomiting following a single subcutaneous injection Noun 1. subcutaneous injection - an injection under the skin injection, shot - the act of putting a liquid into the body by means of a syringe; "the nurse gave him a flu shot" . The loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the in the first quarter of 2004 was $2,550,000, compared with a loss from continuing operations in the first quarter of 2003 of $1,798,000. The gain on disposition of discontinued operations Discontinued operations Divisions of a business that have been sold or written off and that no longer are maintained by the business. in the first quarter of 2003 represents the net gain on the sale of the Company's 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 division. 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, April 28, 2004, 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., or 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 6968039. 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 for 30 days. 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, anti-nausea, 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 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 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 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
March 31, March 31,
2004 2003
Royalties $1,154 $1,032
Contract Revenues 26 74
Total Revenues 1,180 1,106
Operating Expenses:
Research & Development 3,035 2,202
General & Administrative 724 778
Total Operating Expenses 3,759 2,980
Operating Loss (2,579) (1,874)
Interest and Other, Net 29 76
Loss from Continuing Operations (2,550) (1,798)
Loss from Discontinued Operations (50) (54)
Gain on Disposition of Discontinued Operations 1 1,886
Net Income (Loss) $(2,599) $34
Basic and Diluted Earnings (Loss) Per Share:
Loss from Continuing Operations $(0.12) $(0.09)
Net Income (Loss) $(0.13) $0.00
Shares used in Calculating Earnings (Loss)
Per Share:
Basic 20,653 20,475
Diluted 20,653 20,516
A.P. PHARMA, INC.
Balance Sheet Highlights
(in thousands)
March 31, 2004 December 31,
(Unaudited) 2003
Assets
Cash, Cash Equivalents and Marketable
Securities $7,744 $9,484
Accounts Receivable, Net 1,466 1,340
Other Current Assets 421 434
Total Current Assets 9,631 11,258
Property, Plant & Equipment, Net 1,349 1,430
Other Non-Current Assets 287 467
Total Assets $11,267 $13,155
Liabilities and Stockholders' Equity
Current Liabilities $2,519 $1,892
Stockholders' Equity 8,748 11,263
Total Liabilities and Stockholders' Equity $11,267 $13,155
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