CollaGenex Reports Record Second Quarter 2001 Results; Total Revenues Up 32% Including 27% Increase in Periostat Sales.Business Editors NEWTOWN, Pa.--(BUSINESS WIRE)--July 24, 2001 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced record revenues of $8.7 million for the second quarter of 2001, a 32% increase from $6.6 million in the second quarter of 2000. Total revenues in the second quarter of 2001 were also 24% higher than first quarter 2001 total revenues of $7.0 million. Net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of Periostat were a record $7.3 million, a 27% increase over second quarter 2000 net sales of $5.7 million and a 19% increase over first quarter 2001 net sales of $6.1 million. Continued strong Periostat(R) prescription growth, particularly in those cities where CollaGenex is conducting a direct-to-consumer (DTC DTC See: Depository Transfer Check DTC See: Depository Trust Company DTC See Depository Trust Company (DTC). ) advertising campaign for Periostat, contributed significantly to the increase in total revenues. Additionally, contract revenues relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain, and milestone fees relating to the Company's filing for regulatory approvals of Periostat in Europe also contributed to the increases in revenues. During the second quarter of 2001, prescription revenue value, a measure of estimated end user demand for Periostat, was $7.5 million and approximately equaled the Company's gross sales Gross Sales A measure of overall sales that isn't adjusted for customer discounts or returns, calculated simply by adding all sales invoices, and not including operating expenses, cost of goods sold, payment of taxes, or any other charge. . Prescription revenue value is calculated as total capsules dispensed dis·pense v. dis·pensed, dis·pens·ing, dis·pens·es v.tr. 1. To deal out in parts or portions; distribute. See Synonyms at distribute. 2. To prepare and give out (medicines). 3. to patients during the quarter multiplied by the company's gross revenue per capsule capsule In botany, a dry fruit that opens when ripe. It splits from top to bottom into separate segments known as valves, as in the iris, or forms pores at the top (e.g., poppy), or splits around the circumference, with the top falling off (e.g., pigweed and plantain). . "CollaGenex achieved outstanding revenue growth during the second quarter," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "Patients and their dentists Dentists can refer to one of the following:
adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. to our DTC advertising for Periostat, and we are reaching and sustaining higher prescription levels in the cities where we have conducted DTC advertising. As a result, in early July we launched DTC television advertisements A television advertisement, advert or commercial is a form of advertising in which goods, services, organizations, ideas, etc. are promoted via the medium of television. in seven new cities, and we will continue to advertise in TIME Magazine nationwide. We are also confident that the American Dental Association's (ADA Ada, city, United States Ada (ā`ə), city (1990 pop. 15,820), seat of Pontotoc co., S central Okla.; inc. 1904. It is a large cattle market and the center of a rich oil and ranch area. ) seal of acceptance received in June 2001 further validates the efficacy and safety of this product," added Dr. Gallagher. During the quarter, CollaGenex continued to make progress on its key research and development initiatives in an effort to advance its product pipeline. The Company is currently investigating several potential new medical applications for Periostat, including 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. . Last year, CollaGenex initiated 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 to determine the beneficial effects of Periostat in treating acne, a common inflammatory condition. "With encouraging anecdotal anecdotal /an·ec·do·tal/ (an?ek-do´t'l) based on case histories rather than on controlled clinical trials. anecdotal adjective Unsubstantiated; occurring as single or isolated event. results to date, we anticipate unblinding the results of this trial, which was carried out in an adult population with mild to moderate acne, in the near future. We are also investigating additional opportunities to treat anti-inflammatory conditions in an effort to diversify diversify To acquire a variety of assets that do not tend to change in value at the same time. To diversify a securities portfolio is to purchase different types of securities in different companies in unrelated industries. the product portfolio and expand the pipeline further in the specialty pharmaceuticals markets," stated Gallagher. The Company also has an ongoing program with The National Cancer Institute, who has initiated a Phase II trial for Metastat in patients with 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 advancement in the clinical studies is based on promising Phase I results in patients with Kaposi's Sarcoma. Additionally, the NCI See Liberate. clinical trial in brain cancer is also making solid progress in patient enrollment. "In addition to our R&D efforts, another notable event in the second quarter was the launch of Dentaplex(TM), a professionally recommended and novel nutritional supplement. This product launch broadens our product offering and is complimentary to our leading dental pharmaceutical product, Periostat," commented Dr. Gallagher. "Our activities over the last quarter and continued strong financial results show the progression towards reaching our corporate goal, which is to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. the success of Periostat through expanded indications and introduce a portfolio of novel pharmaceutical products using the IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service technology, our unique platform technology with broad patent protection in several disease-specific and mechanism-specific areas," concluded Dr. Gallagher. The net loss allocable al·lo·ca·ble adj. Capable of being allocated. Adj. 1. allocable - capable of being distributed allocatable, apportionable distributive - serving to distribute or allot or disperse to common stockholders for the second quarter of 2001 was $3.1 million, or $0.29 per basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, compared to a net loss of $2.4 million, or $0.28 per basic and diluted share, in the second quarter of 2000. During the first quarter of 2001, the net loss allocable to common stockholders was $3.1 million, or $0.33 per basic and diluted share. For the six months ended June 30, 2001, total revenues were $15.7 million, a 20% increase over the $13.1 million in total revenues recorded during the first six months of 2000. Periostat net sales, during the first six months of 2001, were $13.4 million, or 19% higher, than the $11.2 million in Periostat net sales recorded during the first half of 2000. Net loss allocable to common stockholders during the first half of 2001 was $6.2 million, or $0.62 per basic and diluted share, compared to a net loss allocable to common stockholders before the cumulative effect of a change in accounting principle of $4.8 million, or $0.57 per basic and diluted share during the first half of 2000. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market. The Company's lead product, Periostat, was approved by 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. in September 1998 and 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. In February 2001, the FDA granted marketing approval for a new tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. formulation for Periostat. CollaGenex markets Periostat to the dental community through a professional pharmaceutical sales force composed of approximately 120 sales representatives and managers. Currently, the Company's dental sales force is also marketing Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain, and Dentaplex(TM), a unique formulation of vitamins and mineral supplements developed by CollaGenex and MediNiche, Inc. to promote oral health. Research has shown that the enzyme suppression technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective connective - An operator used in logic to combine two logical formulas. See first order logic. tissues, including 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 (Metastat) and a broad range of inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; . CollaGenex is developing a series of novel, proprietary compounds known as IMPACS (Inhibitors of Multiple Proteases and Cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. ) to address these applications. The Company intends to pursue further research and development of these technologies primarily through partnerships with third parties. To receive additional information on the Company, please visit our Web site at www.collagenex.com, which is not a part of this press release. Periostat(R), Metastat(R), IMPACS(R)and Dentaplex(TM)are trademarks of CollaGenex Pharmaceuticals, Inc. CollaGenex(R)and Periostat(R)are trademarks of CollaGenex International Limited. VIOXX(R)is a trademark of Merck & Co., Inc. Financial Tables Follow
Summary Financial Data
(Unaudited)
(In thousands, except share amounts)
Three Months Ended June 30,
2001 2000
---- ----
(restated)
Statement of Operations Data
Revenues:
Product sales $ 7,267 $ 5,723
Contract revenues 1,024 878
License revenues 420 11
------------ ------------
8,711 6,612
Operating Expenses:
Cost of product sales 1,516 1,127
Research and development 874 965
Selling, general and administrative 9,070 6,669
------------ ------------
Total operating expenses 11,460 8,761
------------ ------------
Operating loss (2,749) (2,149)
Other Income (expense):
Interest income 74 165
Interest expense (2) (4)
Other expense (4) (2)
------------ ------------
Net loss (2,681) (1,990)
Preferred stock dividend 420 426
------------ ------------
Net loss allocable to common
stockholders $ (3,101) $ (2,416)
============ ============
Basic and diluted net loss per share
allocable to common stockholders
$ (0.29) $ (0.28)
============ ============
Shares used in computing basic and
diluted net loss allocable to common
stockholders
10,550,638 8,678,073
Six Months Ended June 30,
2001 2000
---- ----
(restated)
Statement of Operations Data
Revenues:
Product sales $ 13,381 $ 11,233
Contract revenues 1,899 1,528
License revenues 456 381
----------- -----------
15,736 13,142
Operating Expenses:
Cost of product sales 2,882 2,297
Research and development 1,818 1,812
Selling, general and administrative 16,547 13,436
----------- -----------
Total operating expenses 21,247 17,545
Other Income (expense):
Interest income 136 351
Interest expense (5) (8)
Other income (expense) 8 (3)
----------- -----------
Loss before cumulative effect of
change in accounting principle
(5,372) (4,063)
Cumulative effect of change in
accounting principle
-- 764
Net loss (5,372) (4,827)
Preferred stock dividend 840 849
----------- -----------
Net loss allocable to common
stockholders $ (6,212) $ (5,676)
=========== ===========
Basic and diluted net loss per
share allocable to common
stockholders before cumulative
effect of change in accounting
principle: $ (0.62) $ (0.57)
Cumulative effect of change in
accounting principle
-- (0.09)
Basic and diluted net loss per share
allocable to common stockholders $ (0.62) $ (0.66)
=========== ===========
Shares used in computing basic and
diluted net loss per share allocable
to common stockholders 9,946,992 8,664,835
Balance Sheet Data: June 30, 2001 Dec. 31, 2000
------------------ ------------- -------------
Cash, cash equivalents and
short-term investments $ 7,193 $ 5,448
Total assets 14,059 10,431
Total stockholders' equity 6,883 5,264
This news release contains 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. 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 the implementation of the Company's sales and marketing plans 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 US Securities and Exchange Commission. |
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