CollaGenex Pharmaceuticals Reports Record Revenues of $14.1 Million and Net Income Allocable to Common Stockholders of $0.14 per Basic and Diluted Share in the Fourth Quarter of 2003.Business Editors/Health/Medical Writers NEWTOWN, Pa.--(BUSINESS WIRE)--Feb. 24, 2004 Net Income Allocable to Common Stockholders for the year ended December 31, 2003 was $0.38 per Diluted Share on Revenues of $52.9 Million CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today reported financial results for the fourth quarter and year ended December 31, 2003. In the fourth quarter of 2003, total revenues increased 21% to $14.1 million compared to $11.7 million in the fourth quarter of 2002. Net product sales were $13.1 million in the fourth quarter of 2003, an 18% increase over net product sales of $11.1 million recorded in the fourth quarter of 2002. Net income allocable to common stockholders for the fourth quarter of 2003 was $2.0 million, or $0.14 per basic and diluted share, compared to net income in the fourth quarter of 2002 of $688,000, or $0.06 per basic and diluted share. There were approximately 14,444,000 weighted average diluted shares outstanding during the fourth quarter of 2003 compared to approximately 11,889,000 weighted average diluted shares outstanding during the fourth quarter of 2002. Colin W. Stewart, president and chief executive officer of CollaGenex, commented, "2003 was a strong year for CollaGenex, as evidenced by the company's continued growth in revenues and earnings. Our specialty dental pharmaceutical business remains strong, with increasing acceptance of our products by the dental community. We maintained our momentum in the dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. market as well, and were pleased with the continued growth of Pandel. We also made significant progress in the clinic, with the completion of our Phase III clinical trial 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 of Periostat 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 and the publication of data from additional trials supporting the use of Periostat in dental and dermatological indications." "With an eye toward future opportunities and challenges, we strengthened our management team to ensure that we continue to have a solid foundation for the execution of our growth strategy. Notable additions include Dr. Klaus Theobald, who as chief medical officer is leading our clinical development activities on current and new products. We are also actively recruiting a senior business development executive." Mr. Stewart continued, "CollaGenex took decisive steps in 2003 to resolve the outstanding legal issues affecting the proprietary position of Periostat. The Company sought and was granted 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. preventing 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. from approving generic versions of Periostat until a federal court judge hears and decides on the merits on the merits adj. referring to a judgment, decision or ruling of a court based upon the facts presented in evidence and the law applied to that evidence. A judge decides a case "on the merits" when he/she bases the decision on the fundamental issues and considers of our case that Periostat was incorrectly denied the protections of the Hatch-Waxman Act when Periostat was approved by the FDA in 1998. Though CollaGenex previously anticipated the case would be heard in January 2004, a date has not yet been set." "In addition, we settled all 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. with West-ward Pharmaceuticals. West-ward agreed that the Periostat patents are valid and infringed by the filing of West-ward's ANDA ANDA abbr. abbreviated new drug application , and that these patents would be infringed by the manufacture and sale of a generic version of Periostat. We believe this industry acquiescence Conduct recognizing the existence of a transaction and intended to permit the transaction to be carried into effect; a tacit agreement; consent inferred from silence. by a potential generic competitor will support our patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. case against Mutual Pharmaceuticals, which has been scheduled to be heard in the Eastern District Court of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of in mid-2005." "When I accepted the stewardship of CollaGenex at the end of 2003," Mr. Stewart added, "I based my decision on the strength of the currently marketed products, the quality of the pipeline generated by the IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service and Restoraderm technologies, and the considerable opportunity to build from this strong foundation. I firmly believe that by continuing to invest in the future we can successfully build on the momentum generated to-date and maximize the long-term value of the company for our shareholders. I look forward to keeping everyone abreast of the exciting times that lay ahead." For the year ended December 31, 2003, CollaGenex achieved total revenues of $52.9 million, an 18% increase over total revenues of $44.6 million for the year ended December 31, 2002. Net product sales in 2003 were $49.0 million, a 16% increase over the $42.1 million in net product sales recorded during 2002. Net income allocable to common stockholders in 2003 was $4.8 million, or $0.38 per diluted share, compared to a net loss allocable to common stockholders of $727,000, or $0.06 per diluted share, in 2002. The weighted average diluted number of shares outstanding increased from approximately 11,235,000 in 2002 to approximately 12,836,000 in 2003. CollaGenex made significant progress with its lead product, Periostat, in 2003. Canada and Switzerland approved Periostat as a treatment for 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. , contributing to a total of 11 countries that have granted regulatory and marketing approval of Periostat. In addition, the Company initiated a multi-center, double-blinded, placebo-controlled Phase 4 clinical study to evaluate the combined efficacy of Periostat and Atridox in the treatment of adult periodontitis. The body of clinical data supporting the potential utility of Periostat in treating rosacea continued to grow. Positive data was reported from several trials, including a Phase 2 clinical study evaluating Periostat as adjunctive therapy adjunctive therapy Medtalk A therapeutic maneuver(s) with an ancillary role in treating a disease by ↓ M&M, but not part of the immediate therapy required to stabilize the Pt. Cf Adjuvant therapy. to MetroLotion and an open-label study published in Skin Med, the peer-reviewed dermatology journal. CollaGenex also made significant progress in building the Periostat franchise through the development of a new, modified release, once-daily formulation. Clinical studies conducted during 2003 established the pharmacokinetics of the Company's lead formulation and confirmed that it falls within the Company's pre-defined criteria for maximum serum concentration serum concentration Therapeutics The amount of a drug or other compound in the circulation, both bound to proteins and unbound, the latter of which generally corresponds to the theraepeutically active fraction and total dose delivered. CollaGenex expects to begin Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. of this new formulation in periodontitis and rosacea patients during the first and second quarters of 2004, respectively. The Company also advanced the clinical study of other IMPACS compounds including COL-3, its novel, non-antimicrobial tetracycline tetracycline (tĕ'trəsī`klēn), any of a group of antibiotics produced by bacteria of the genus Streptomyces. They are effective against a wide range of Gram positive and Gram negative bacteria, interfering with protein derivative. CollaGenex initiated a double-blinded, placebo-controlled Phase 2 clinical study to evaluate the safety and efficacy of this compound in treating rosacea. At higher doses, COL-3 is the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in Metastat, the Company's compound currently undergoing Phase 2 clinical studies in the treatment of HIV-related Kaposi's sarcoma Kaposi's sarcoma (käp`əshē', kəpō`sē), a usually fatal cancer that was considered rare until its appearance in AIDS patients. . This study is being sponsored by the National Cancer Institute (NCI See Liberate. ), pursuant to the Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. between CollaGenex and the NCI for Metastat. CollaGenex expects the results of this study to be announced To be announced (TBA) A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered. during the second quarter of 2004. Conference Call As previously announced, CollaGenex will hold a conference call on Tuesday, February 24, 2004, at 11:00 a.m. Eastern Standard Time to discuss the company's fourth quarter and fiscal year 2003 operating and financial results and provide a corporate update. Investors and other interested parties can access the conference call by dialing (800) 695-6803 in the U.S. or (706) 643-1452 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 the aforementioned URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. for 90 days. A dial-in replay of the call will be available until 11:59 p.m. on March 9, 2004 by dialing (800) 642-1687 and entering access code 5366311. About CollaGenex CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's 115-person professional pharmaceutical sales force markets Periostat(R), 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. 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.
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 tissues, including acne, rosacea, meibomianitis and cancer metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma , among others. CollaGenex is further evaluating Periostat, as well as the new IMPACS(R) compounds, to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm(TM) 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, in order to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties. To receive additional information on the Company, please visit our website at www.collagenex.com which does not form part of this press release. This press release contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties, which may affect the Company's business and prospects. The Company's business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including risks relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the implementation of the Company's sales and marketing plans for Periostat(R) and other products that the Company markets, the outcome and consequences of the patent litigation against Mutual and the outcome of litigation initiated by Mutual, risks that the FDA will approve generic products, such as Mutual's products, that will compete with and limit the market for Periostat, risks inherent in research and development activities, risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development, all as discussed in the Company's periodic filings with the U.S. Securities and Exchange Commission. Periostat(R), IMPACS(R) and Metastat(R) are registered trademarks, and Restoraderm(R) is a trademark, 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. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix Laboratories, Inc. Financial Statements Follow
Summary Financial Data
(In thousands, except share amounts)
Quarter Ended Year Ended
December 31, December 31,
2003 2002 2003 2002
---------- ---------- ---------- ----------
Statement of
Operations Data:
Revenues:
Net product
sales $13,121 $11,085 $49,038 $42,111
Contract
revenues 958 563 3,122 2,332
License
revenues 20 14 699 176
---------- ---------- ---------- ----------
Total
revenues 14,099 11,662 52,859 44,619
Operating Expenses:
Cost of
product sales 1,802 1,822 7,362 6,713
Research and
development 1,042 1,261 5,439 4,394
Selling,
general and
administrative 8,862 7,530 33,691 32,699
---------- ---------- ---------- ----------
Total
operating
expenses 11,706 10,613 46,492 43,806
Other Income
(Expense):
Interest income 64 22 148 77
Interest
expense -- -- -- (5)
Other income
(expense) (1) 17 (3) 17
---------- ---------- ---------- ----------
Income before taxes 2,456 1,088 6,512 902
Income tax
provision 85 -- 85 --
---------- ---------- ---------- ----------
Net income 2,371 1,088 6,427 902
Preferred stock
dividend 400 400 1,600 1,629
---------- ---------- ---------- ----------
Net income (loss)
allocable to
common
stockholders $ 1,971 $ 688 $4,827 $(727)
========== ========== ========== ==========
Net income (loss)
per basic share
allocable to
common
stockholders $ 0.14 $ 0.06 $0.40 $(0.06)
========== ========== ========== ==========
Weighted average
shares used in
computing income
(loss) per basic
share allocable to
common
stockholders 13,795,864 11,369,128 12,094,638 11,234,652
Net income (loss)
per diluted share
allocable to
common
stockholders $ 0.14 $ 0.06 $ 0.38 $(0.06)
========== ========== ========== ==========
Weighted average
shares used in
computing income
(loss) per diluted
share allocable to
common
stockholders 14,444,266 11,889,338 12,836,364 11,234,652
Selected Balance Sheet Data: December 31, December 31,
2003 2002
---------------------------- ---------- ----------
Cash and cash equivalents $32,670 $10,112
Total current assets 41,033 14,713
Total assets 43,305 17,634
Total current liabilities 9,023 8,721
Long-term liabilities 326 561
Total liabilities 9,349 9,282
Total stockholders' equity 33,956 8,352
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