Conceptus Provides 2005 Financial Guidance, Reaffirms 2004 Guidance.SAN CARLOS San Carlos (săn kär`lōs), residential city (1990 pop. 26,167), San Mateo co., W Calif.; inc. 1925. The chief manufactures are plastic products, hardware, and machine parts. , Calif. -- Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus. , Inc. (Nasdaq:CPTS CPTS Certified Penetration Testing Specialist (network security) CPTS Comptroller Squadron CPTS Computer Program Test Specifications CPTS Catastrophe Personnel Tracking System CPTS Claims Procedure Training Specialist ), developer of the non-incisional permanent birth control procedure Essure(R), today provided financial guidance for 2005 and reiterated its prior guidance for 2004. The Company provides the following guidance for 2005: --Net sales are expected to be $17.0 million to $18.0 million, up 48% to 57%, compared with the mid-point of Company guidance for 2004 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 $11.4 million to $11.6 million. --Gross margins are expected to be 57% to 59% for 2005, compared to gross margins of 38% estimated for 2004. The company anticipates that gross margins will improve throughout the year, in particular reflecting the benefits of product cost-reduction programs that began in 2004 and a price increase that was announced earlier this month. --Operating expenses are anticipated to be $33.0 million to $34.0 million during 2005. Conceptus is in the process of hiring additional sales professionals and practice development personnel in order to support the expected growth in net sales. The Company also expects to incur additional costs associated with direct-to-consumer (DTC DTC See: Depository Transfer Check DTC See: Depository Trust Company DTC See Depository Trust Company (DTC). ) marketing and the implementation of procedures required by Section 404 of the Sarbanes-Oxley Act See SOX. . --The net loss for 2005 before non-cash stock option expenses is expected to be $23.0 million to $24.0 million, or $0.89 to $0.91 per share. This compares with Company guidance for a net loss in 2004 of $25.8 million to $26.3 million or $1.03 to $1.05 per share. --Conceptus anticipates first quarter 2005 net sales to grow moderately over the fourth quarter of 2004 to a range of $3.5 million to $3.7 million, reflecting the typical revenue cycle in the medical device industry. In addition, the Company expects increased expenses across all categories, resulting in a net loss for first quarter 2005 of $7.0 million to $7.5 million, or $0.27 to $0.29 per share. The Company is currently estimating the impact of adopting the most recent Financial Accounting Standards Board Financial Accounting Standards Board (FASB) Board composed of independent members who create and interpret Generally Accepted Accounting Principles (GAAP). amendments regarding the treatment of stock options as a non-cash compensation expense and this guidance is therefore provided without this impact. Conceptus also confirmed its previous guidance for the fourth quarter of 2004, as disclosed on October 1, 2004. --Net sales for the fourth quarter of 2004 are expected to be at the upper end of the range of $3.4 million to $3.6 million. This represents growth of more than 55%, compared with net sales of $2.25 million in fourth quarter of 2003. Net sales for 2004 will be in line with previous guidance of $11.4 million to $11.6 million. --Net loss for the fourth quarter of 2004 is estimated to be $6.2 million to $6.7 million. This represents an estimated 25% to 31% improvement from the $9.0 million net loss in the fourth quarter of 2003. "During 2005 we will continue to focus on growing our top line, and have identified three primary goals to support our sales growth, both for 2005 and beyond," commented Mark Sieczkarek, President and Chief Executive Officer of Conceptus. "First, in the area of reimbursement, we intend to complete the implementation of the newly-effective CPT CPT See: Carriage Paid To code for the Essure procedure by focusing on assisting private payers to adopt the code and appropriate payment schedules into their systems. This will dramatically increase the efficiency and accuracy of payments to physicians who perform the procedure and ultimately result in increased utilization as reimbursement barriers continue to dissipate. Second, we are increasing the number of our sales territories and are implementing a formal practice development program for physicians as they begin to perform Essure in the office setting. These programs will allow us to pursue a balanced approach to penetration and utilization growth. And third, we will continue to work with our strategic partners to increase our reach in the market. During 2005 we will be analyzing the results of our DTC test marketing program in Chicago, which will help us to evaluate the next steps in our ongoing work to increase patient and physician awareness. "With gross margin improvements and prudent investments in our operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , particularly those expenses that will drive revenues, we will reduce our net loss in 2005 while moving efficiently towards profitability," Mr. Sieczkarek concluded. Conceptus plans to host an investment-community conference call in March 2005 to discuss financial results for fourth quarter 2004, to review 2005 financial guidance and to answer questions. The scheduling of the call will allow sufficient time for the Sarbanes-Oxley Section 404 audit procedures to be completed and the opinion to be rendered on the financial statements by the Company's external auditors. Participation information will be provided closer to the date of the conference call. About Essure The Essure procedure deploys a soft micro-insert into the fallopian tube fallopian tube (fəlō`pēən), either of a pair of tubes extending from the uterus to the paired ovaries in the human female, also called oviducts, technically known as the uterine tube. through the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. using a minimally invasive transcervical tubal Tubal (t `bəl), in the Bible, son of Japheth. access catheter. Once in place, the device is designed to elicit tissue
growth in and around the micro-insert to form an occlusion occlusion /oc·clu·sion/ (o-kloo´zhun)1. obstruction. 2. the trapping of a liquid or gas within cavities in a solid or on its surface. 3. or blockage in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia Anesthesia, General Definition General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs. . A woman is able to return home about 45 minutes after the procedure is completed. There is a three-month waiting period after the procedure during which women must use another form of birth control. Essure is 99.80% effective after three years of follow-up. About Conceptus Conceptus, Inc. manufactures and markets Essure, an innovative medical device and procedure, designed to provide a non-incisional alternative to tubal ligation ligation /li·ga·tion/ (li-ga´shun) the application of a ligature. tubal ligation sterilization of the female by constricting, severing, or crushing the uterine tubes. , which is the leading form of birth control worldwide. The availability of Essure in the U.S. is expected to open up a market currently occupied by incisional tubal ligation and vasectomy vasectomy, male sterilization by surgical excision of the vas deferens, the thin duct that carries sperm cells from the testicles to the prostate and the penis. , which combined account for over 1 million procedures annually. Additional information about the Essure procedure is available at www.Essure.com or by calling the Essure Information line at 1-877-ESSURE1. Additional information about Conceptus is available at www.conceptus.com or by calling 1-877-ESSURE2. Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Guidance provided for the fourth quarter of 2004 and the year 2005 in net sales, gross profit, operating expenses and net loss as well as the effect of CPT code reimbursement on commercialization efforts, increases in sales territories, implementation of a practice development effort, strategic alliances and market demand for our product, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors such as strategic planning decisions by management, re-allocation of internal resources, decisions by insurance companies, delays by regulatory authorities, scientific advances by third parties, year end financial audit activities and introduction of competitive products, as well as those factors set forth in the Company's 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. and most recent Quarterly Report on Form 10-Q Form 10-Q See 10-Q. , and other filings with the Securities and Exchange Commission. |
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