CollaGenex Pharmaceuticals Reports Financial Results for the First Quarter of 2005.NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. (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 :CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today reported financial results for the first quarter ended March 31, 2005. Total revenues for the first quarter of 2005 were $12.0 million compared to $13.4 million in the first quarter of 2004. Net product sales were $11.8 million in the first quarter of 2005 compared to $13.3 million in the first quarter of 2004. The decline in net product sales and total revenues for the first quarter of 2005 resulted from the Company's efforts to reduce and minimize inventory levels at its customers following a magistrate's recommendation on March 16, 2005, to deny the Company's request for a preliminary injunction A temporary order made by a court at the request of one party that prevents the other party from pursuing a particular course of conduct until the conclusion of a trial on the merits. A preliminary injunction is regarded as extraordinary relief. to prevent the launch of generic forms of Periostat(R) by IVAX IVAX Industrial Vax (Dec Computer) Pharmaceuticals Inc. and CorePharma LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control (the "Defendants"). The Company estimates that average inventories held by its wholesale customers and United Research Laboratories, Inc./ Mutual Pharmaceutical Company, Inc. ("Mutual") declined by about two weeks of sales during the quarter and were less than two weeks of sales at March 31, 2005. CollaGenex has filed objections to the magistrate's recommendation, and the Court has not issued a final decision. 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. has not yet approved any generic forms of Periostat and CollaGenex has no knowledge about when such an approval could occur. However, if one or more generic forms of Periostat are launched, the Company expects sales of Periostat, including Mutual's branded version of Periostat, to decline significantly. During the first quarter of 2005, the Company reported a net loss allocable to common stockholders of $2.5 million, or $0.17 per basic and diluted share, compared to a net loss allocable to common stockholders of $434,000, or $0.03 per basic and diluted share, in the first quarter of 2004. The net loss in the first quarter of 2005 included a charge of $844,000, which is included in the cost of product sales, to write down the value of the Company's inventories relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc its license agreement with Mutual. The Company's agreement with Mutual will terminate after a third-party generic form of Periostat has remained available for sale for a certain period of time, and Mutual will no longer be required to buy this product from CollaGenex. The net loss in the first quarter of 2004 included a charge of $2.0 million for a payment to Mutual in connection with the April 2004 settlement of all outstanding 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. between Mutual and CollaGenex. Colin Stewart The following people are named Colin Stewart
Mr. Stewart continued, "At the same time, we are very pleased with the continued progress we are making to build the Company's future as a specialty pharmaceutical company focused on the dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. market. During the first week of April, we concluded two Phase III clinical trials Noun 1. phase III clinical trial - 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 involving over 530 patients to evaluate Oracea(TM) for the treatment of rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and . The data from these studies are currently being compiled and reviewed, and we expect to announce the results from the studies in early June. If the study results are favorable, we expect to file 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 for Oracea in the third quarter of this year and, if approved by the FDA, we plan to launch Oracea during the third quarter of 2006. We also recently announced highly favorable results from a small, 13-patient proof-of-concept study that evaluated Col-3, a second-generation IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (TM) compound, for the treatment of rosacea. These clinical results and the anti-inflammatory characteristics of Col-3 support our belief that this compound has the potential to become a potent systemic treatment for acne with fewer side effects Side effects Effects of a proposed project on other parts of the firm. than existing products on the market. We are planning to commence a proof-of-concept study of Col-3 in acne patients during the second quarter." Nancy C. Broadbent, chief financial officer of CollaGenex, said, "Our results for the first quarter of 2005 reflect our efforts to manage the expected impact of generic competition for Periostat and position the Company as strongly as possible going forward. We reduced our customers' inventories by more than two weeks of sales during the quarter and expect to maintain these reduced levels. This lowered our net product sales compared to the year ago quarter, since the numbers of Periostat prescriptions were about the same in both periods. We also reduced our exposure to excess inventories of Mutual product by taking a non-cash excess inventory charge of $844,000. Our selling, general and administrative - other expenses were $373,000 lower in the first quarter of 2005, reflecting a smaller but more efficient sales force following our sales force restructuring in April 2004. At the same time, we demonstrated our commitment to developing our pipeline by increasing our R&D spending by approximately $2.7 million compared to the year-earlier quarter to fund the clinical development of Oracea, Periostat-MR(TM), Col-3 and the development of products based on our Restoraderm(TM) technology platform. With a strong financial position of approximately $36.2 million in cash, cash equivalents and short term investments at the end of the first quarter, we remain committed to continuing the development of our product pipeline." Conference Call As previously announced, CollaGenex will hold a conference call on Thursday, May 5, at 11:00 a.m. Eastern Daylight Time to discuss the Company's first quarter 2005 operating and financial results. Investors and other interested parties may access the conference call by dialing (888) 394-8045 in the U.S. or (973) 409-9260 internationally, or via a live Internet broadcast on the Company's website at www.collagenex.com. For those who cannot listen to the live broadcast, a replay will be available shortly after the call at www.collagenex.com for 90 days. Additionally, a recording of the call will be available by telephone until 11:59 p.m. on May 19, 2005 by dialing (877) 519-4471 in the U.S. or (973) 341-3080 internationally, and entering access code 5958627.
Financial Tables Follow
Summary Financial Data
Consolidated Statement of Operations:
(Unaudited)
(In thousands, except share amounts)
Three Months Ended March 31,
----------------------------
2005 2004
---- ----
Revenues:
Net product sales $ 11,836 $ 13,328
Contract revenues 39 60
License revenues 160 18
------------ ------------
Total revenues 12,035 13,406
Operating Expenses:
Cost of product sales 2,465 2,001
Research and development 4,094 1,389
SG&A, Other 7,746 8,119
SG&A, Legal Settlement - 2,000
------------ ------------
Total operating expenses 14,305 13,509
------------ ------------
Other Income (Expense):
Interest income 212 72
Other expense - (3)
------------ ------------
Net loss (2,058) (34)
Preferred stock dividend 400 400
------------ ------------
Net loss allocable to common stockholders $ (2,458) $ (434)
============ ============
Net loss per basic and diluted share
allocable to common stockholders $ (0.17) $ (0.03)
============ ============
Weighted average shares used in computing
net loss per basic and diluted share
allocable to common stockholders 14,404,677 13,970,730
============ ============
Selected Balance Sheet Data: March 31, 2005 December 31, 2004
--------------------------- ---------------- -----------------
Cash and cash equivalents $ 15,951 $ 11,889
Short-term investments 20,284 26,756
Accounts receivable 7,530 6,983
Inventories 1,575 2,692
Prepaid expenses and other current
assets 2,402 2,096
----------------- -----------------
Total current assets 47,742 50,416
----------------- -----------------
Non-current assets 1,650 1,705
----------------- -----------------
Total assets $ 49,392 $ 52,121
================= =================
Total current liabilities 10,113 10,702
Long-term liabilities 113 204
----------------- -----------------
Total liabilities 10,226 10,906
Total stockholders' equity 39,166 41,215
----------------- -----------------
Total liabilities and
stockholders' equity $ 49,392 $ 52,121
================= =================
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's professional dental pharmaceutical sales force markets Periostat, which is indicated as an adjunct to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] for the treatment of adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. . Periostat is the first and only pharmaceutical to treat periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where by inhibiting the enzymes that destroy periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. support tissues and by enhancing bone protein synthesis Protein synthesis is the creation of proteins using DNA and RNA. Biological and artificial methods for creation of proteins differ significantly.
QLT Quick Link Text USA, Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis. The Company's professional dermatology sales force markets Pandel(R), a prescription topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and licensed from Altana, Inc. Research has shown that certain unique properties of the tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective connective - An operator used in logic to combine two logical formulas. See first order logic. tissues. CollaGenex is further evaluating Periostat and other IMPACS compounds, including Oracea, to assess whether they are safe and effective in these other applications. Oracea is currently in Phase III clinical trials to evaluate its effectiveness in treating rosacea, a dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. condition. In addition, CollaGenex has acquired the Restoraderm technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. drug delivery system, and plans to develop a range of topical dermatological products with enhanced pharmacologic pharmacologic /phar·ma·co·log·ic/ (-kah-loj´ik) pertaining to pharmacology or to the properties and reactions of drugs. pharmacological, pharmacologic pertaining to pharmacology. and cosmetic properties. To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release. 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. Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects, including statements relating to the Company's intellectual property rights, its ongoing litigation with IVAX and CorePharma, results of operations, future cash position, contingency plans A plan involving suitable backups, immediate actions and longer term measures for responding to computer emergencies such as attacks or accidental disasters. Contingency plans are part of business resumption planning. and its future development efforts, may constitute forward-looking statements 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. CollaGenex' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in CollaGenex' most recent Annual Report 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 December 31, 2004 under the section "Additional Factors That May Affect Future Results" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex' expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release. Periostat(R) is a registered trademark and Periostat-MR(TM), Restoraderm(TM), IMPACS(TM) and Oracea(TM) are trademarks of CollaGenex Pharmaceuticals, Inc. All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries. Pandel(R) is a trademark of Taisho Pharmaceuticals Taisho Pharmaceutical Co., Ltd. (大正製薬株式会社 . Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered trademarks of QLT USA, Inc. |
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