Penederm Reports Fourth Quarter and Fiscal 1997 Financial Results; Adds $10 Million Equity Line of Credit.FOSTER CITY, Calif.--(BW HealthWire)--Jan. 29, 1998--Penederm Incorporated (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DERM n. 1. The integument of animal; the skin. 2. (Anat.) See Dermis. ) today reported financial results for the fourth quarter and fiscal year ended December 31, 1997. For the year ended December 31, 1997, total revenues increased 210% to $9,005,000 from $2,905,000 in 1996. Net loss was $12,717,000 ($1.59 per share) in 1997, compared to a net loss of $7,643,000 ($1.05 per share) in 1996. Cash and investments totaled $5,621,000 at December 31, 1997. Product sales increased to $6,341,000 in 1997, compared to $2,258,000 in 1996, primarily due to the commercial launch of the Company's first two pharmaceutical products, Mentax and Avita. License fee revenues increased from $647,000 in 1996 to $2,664,000 in 1997 due to the timing and scope of partnering arrangements. In the fourth quarter the Company announced partnering arrangements with a division of Mylan Laboratories, Inc. for the co-promotion of Mentax to primary care physicians and with a subsidiary of Allergan Incorporated for the distribution of its Mentax and Avita products in Central and South America South America, fourth largest continent (1991 est. pop. 299,150,000), c.6,880,000 sq mi (17,819,000 sq km), the southern of the two continents of the Western Hemisphere. . Research and development expenses in 1997 increased 31% to $6,950,000 as a result of the Company initiating 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 human clinical studies of its combination product (project name 501 cream) for the treatment of skin fungal fungal /fun·gal/ (fun´g'l) fungous; pertaining to fungi. fun·gal or fun·gous adj. 1. Of, relating to, resembling, or characteristic of a fungus. 2. conditions. The studies involve 32 clinical sites and approximately 1,600 patients. Sales and marketing expenses increased 614% to $10,103,000 from $1,414,000 in 1996 due to the commercial launch of its two pharmaceutical products. For the fourth quarter ended December 31, 1997, revenues were $2,214,000, compared to revenues of $943,000 in the fourth quarter of 1996. Net loss in the fourth quarter 1997 was $4,745,000 ($.58 per share), compared to a net loss of $1,726,000 ($.24 per share) in the fourth quarter of 1996. "We are entering 1998 with several new initiatives completed or near completion. First, our co-promotion arrangement with Mylan adds approximately 100 sales representatives to the Mentax promotion effort. Second, 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. recently approved a one-week treatment label claim to Mentax which will help differentiate the product in the topical antifungal antifungal /an·ti·fun·gal/ (-fung´gal) 1. destructive to fungi, or suppressing their reproduction or growth; effective against fungal infections. 2. an agent that so acts. class. Third, we announced yesterday our collaboration with Alpharma, Inc. on the Acticin scabies scabies (skā`bēz), highly contagious parasitic skin disease caused by the itch mite (Sarcoptes scabiei). The disease is also known as itch. product. Finally, our sales force transition from a contract selling organization to an employee-based, internally managed sales force to represent our pharmaceutical products to dermatologists is nearing completion, stated Lloyd H. Malchow, President and Chief Executive Officer of Penederm. During 1998 we are also looking forward to the launch of the gel formulation of Avita currently scheduled for the end of the first quarter, and the completion of pivotal studies and the filing of an 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 on the combination product for the treatment of skin fungal conditions. The NDA filing is currently scheduled for the second half of 1998. All of these events should make 1998 another year of substantial progress," continued Malchow. The Company also announced that on January 21, it entered into an agreement with an investment group for an equity line which allows the Company to access up to $10 million through sales of its common stock over a two-year period. The decision to draw any funds and the timing for any such draw is solely at the Company's discretion. Should the Company draw upon the equity line, any shares sold will be at a discount to the average trading price Trading price The price at which a security is currently selling. of the Company's common stock over a specified period of time preceding the sale of shares. Drawing under the equity line is subject to the satisfaction of certain conditions, including registration of the shares, a minimum trading price per share, and certain limitations on the number of shares of the Company's common stock being held by the investment group at any point in time. No assurances can be given that the Company will be able to obtain funds when and if it desires to do so. Penederm is a pharmaceutical company that specializes in development and marketing of dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. products. The Company has launched MENTAX, a once-a-day prescription topical cream for treatment of skin fungus, and AVITA, a prescription acne acne, common inflammatory disease of the hair follicles and sebaceous glands characterized by blackheads, whiteheads, pustules, nodules and, in the more severe forms, by cysts and scarring. The lesions appear on the face, neck, back, chest, and arms. cream product. The Company has initiated pivotal phase III human clinical trials of a combination product (project name: 501 cream) for the treatment of skin fungal conditions. Products for nail fungus and psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the are in earlier stages of clinical development, along with next-generation MENTAX skin treatment line extensions. The Company also markets its patented Topicare Delivery Compounds as specialty ingredients to major cosmetic companies for incorporation into their commercial products. Any statements contained in this release that relate to future plans, events or performance, including the scheduled product launch date and product development activities, are 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. that involve risks and uncertainties, including, but not limited to, product development and market acceptance risks, product manufacturing risks, risks associated with the establishment and management of a sales force, the impact of competitive products and pricing, the results of current and future licensing and other collaborative relationships, the results of financing efforts, developments regarding intellectual property rights and 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. , risks of product nonapproval or delays or post-approval reviews by the FDA or foreign regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , and other risks identified in the Company's most recent 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. and other Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undo reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. -0-
PENEDERM INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
1997 1996 1997 1996
Revenues
Product sales $ 1,135 $ 513 $ 6,341 $ 2,258
Licensing revenues 1,079 430 2,664 647
Total revenues 2,214 943 9,005 2,905
Costs and expenses:
Cost of product sales 526 341 2,661 1,472
Sales and marketing 3,074 457 10,103 1,414
Research and development 2,521 1,152 6,950 5,292
General and
administrative 924 807 2,432 2,903
Total costs and expenses 7,045 2,757 22,146 11,081
Loss from operations (4,831) (1,814) (13,141) (8,176)
Interest income, net 86 88 424 533
Net loss $(4,745) $ (1,726) $(12,717) $(7,643)
Basic and diluted net
loss per share $ (0.58) $ (0.24) $ (1.59) $ (1.05)
Number of shares used in
computing basic and
diluted net loss per
share 8,147 7,299 7,995 7,275
CONTACT: Penederm Incorporated Michael A. Bates Bates , Katherine Lee 1859-1929. American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911. , 415/358-0100 www.businesswire.com/cnn/derm.htm |
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