Conceptus Reports Third Quarter Diluted EPS of $0.20.Results Exceed 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 and Net Income Guidance * Net sales of $34.2 million, up 29% * Non-GAAP diluted EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. of $0.29 * Cash flow from operations Cash flow from operations A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses of $10.5 million * In-office procedures increase to 65% of domestic sales MOUNTAIN VIEW, 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 Essure[R] procedure, the first proven non-incisional permanent birth control method available, today reported financial results for the three and nine months ended September 30, 2009. Net sales for the third quarter of 2009 were $34.2 million, an increase of 29% compared with net sales of $26.6 million for the third quarter of 2008. These results exceeded the Company's net sales guidance of $32.0 million to $33.5 million issued on July 22, 2009. Net income for the third quarter of 2009 was $6.2 million, or $0.20 per fully diluted share, compared with net income for the same period of 2008 of $2.0 million, or $0.06 per fully diluted share. These results were also better than the Company's net income guidance of $0.06 to $0.07 per fully diluted share issued in July 2009. The Company recorded a benefit in the third quarter of 2009 of $0.05 per fully diluted share due to the release of the Company's royalty obligations under the 2003 Settlement Agreement between Ovion and Conceptus following the $23.7 million cash acquisition of the Ovion patents. Non-GAAP net income for the third quarter of 2009 was $9.2 million, or $0.29 per fully diluted share, compared with non-GAAP net income for the prior year third quarter of $4.7 million, or $0.15 per fully diluted share. The net income (loss) for the three and nine months ended September 30, 2008 has been revised on a retrospective basis to comply with a change in accounting principle adopted January 1, 2009 with respect to the Company's outstanding convertible debt. Domestic sales of the Essure system increased 32% to $28.0 million and international sales increased 15% to $6.2 million, both compared with the prior year third quarter. Domestic sales growth reflects continued increases in both the number of physicians entering and completing training, and in the number of certified physicians performing the Essure procedure in-office. During the third quarter of 2009, the Company entered more than 510 physicians into preceptorship pre·cep·tor·ship n. A period of practical experience and training for a student, especially of medicine or nursing, that is supervised by an expert or specialist in a particular field. , certified 465 physicians and transitioned 350 physicians to performing procedures in the office setting. Domestic procedures performed in sites of minimal anesthesia represented 65% of net sales for the third quarter of 2009, compared with 62% in the second quarter of 2009. International sales growth of 15% was negatively impacted by a stronger U.S. dollar compared with a year ago. European unit volume growth was 19% compared with the third quarter of 2008. Gross profit for the third quarter of 2009 was $29.2 million, compared with $21.6 million for the third quarter of 2008. Gross profit margin Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. was 85% of net sales for the third quarter of 2009 compared with 81% in the third quarter of 2008 and 80% in the immediately preceding quarter. Gross margin benefited by 400 basis points in the third quarter of 2009 due to the release of prior royalty obligations under the Ovion patents. Total 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. for the third quarter of 2009 were $21.2 million, up from $18.0 million for the third quarter of 2008. Cash and cash equivalents were $52.2 million as of September 30, 2009, a decrease of $11.1 million from June 30, 2009 as the Company used $23.7 million for the purchase of the Ovion patents. The Company generated $10.5 million in cash from operations in the third quarter of 2009. For the nine months ended September 30, 2009, Conceptus reported net sales of $94.4 million, up 29%, compared with net sales of $73.5 million for the first nine months of 2008. Net income for the first nine months of 2009 was $1.3 million, or $0.04 per fully diluted share, compared with a net loss of $7.8 million, or $0.26 per share, for the first nine months of 2008. "We continue to focus our spending on programs aimed at expanding physician and patient awareness. And while we have increased our investment in these areas, we have also seen meaningful cost savings in other parts of the organization, including those resulting from the Ovion patent acquisition," commented Mark Sieczkarek, president and chief executive officer of Conceptus. "We are pleased this has resulted in substantial profitability and positive cash flow from operations and has led us to over-achieve our earnings target in the third quarter." Financial Guidance The Company also introduced financial guidance for the fourth quarter of 2009, and narrowed 2009 net sales and increased net income guidance ranges, as follows: * The Company expects net sales for the fourth quarter of 2009 to be $37.5 million to $38.0 million, with a full year range of $131.9 million to $132.4 million. This compares with previous full year net sales guidance in the range of $130.0 million to $133.0 million. * Conceptus anticipates fourth quarter GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). earnings per fully diluted share to be in the range of $0.19 to $0.21 and non-GAAP earnings per fully diluted share to be in the range of $0.31 to $0.33. * Full year GAAP earnings per fully diluted share is expected to be in the range of $0.23 to $0.25, which exceeds the previous GAAP earnings guidance range of $0.13 to $0.22 per fully diluted share. Full year non-GAAP earnings guidance is now $0.62 to $0.64 per fully diluted share, above the previous guidance of $0.49 to $0.58 per fully diluted share. "We are very pleased by the continued performance of our business beyond expectations in 2009," commented Mr. Sieczkarek. "Net sales have been strong all year long despite the weakened economy and now we are able to increase our diluted EPS guidance for 2009. We look forward to closing the year out on a positive note, building on the substantial momentum we have generated in the first nine months of the year." These statements are only effective as of the date of this press release and Conceptus undertakes no duty to publicly revise or update these 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. , whether as a result of new information, future developments or otherwise. Use of Non-GAAP Financial Measures The Company has supplemented its reported GAAP financial information with a non-GAAP measure of net income that excludes stock-based compensation expense, non-cash interest expense, amortization of intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. and amortization of debt issuance costs. Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the Company's business operations Business operations are those activities involved in the running of a business for the purpose of producing value for the stakeholders. Compare business processes. The outcome of business operations is the harvesting of value from assets , facilitates a better comparison of results for current periods with the Company's previous operating results, and assists management in analyzing future trends, making strategic and business decisions and establishing internal budgets and forecasts. A reconciliation of the non-GAAP net income (loss) to GAAP net income, the most directly comparable GAAP measure, is provided on the attached schedule. There are limitations in using this non-GAAP financial measure because it is not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. This non-GAAP financial measure should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company's consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge prepared in accordance with GAAP and the reconciliation of the non-GAAP financial measure provided in the attached schedule. Conference Call Management will host an investment-community conference call beginning at 4:30 p.m. Eastern time today to discuss these results and to answer questions. To participate in the live call by telephone, please dial (888) 803-8296 from the U.S., or (706) 634-1250, from outside the U.S. Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company's website, www.conceptus.com. A replay will be available on the website for 14 days. A telephone replay will be available from 6:30 p.m. Eastern time October 21, 2009 through 11:59 p.m. Eastern time on October 23, 2009 by dialing (800) 642-1687 (domestic) or (706) 645-9291 (international) and entering conference ID number 34483771. About the Essure([R]) Procedure The Essure([R]) procedure is a permanent birth control method that can be done in the comfort of a physician's office in about 13 minutes (average hysteroscopic procedure time) without hormones, cutting, burning or the risks associated with 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. or tubal Tubal (t `bəl), in the Bible, son of Japheth. 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. . Small, flexible micro-inserts are placed in the woman's fallopian tubes Fallopian tubes The narrow ducts leading from a woman's ovaries to the uterus. After an egg is released from the ovary during ovulation, fertilization (the union of sperm and egg) normally occurs in the fallopian tubes. through the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Essure is 99.8 percent effective (based on four years of follow-up) with zero pregnancies reported in clinical trials. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test to confirm that the fallopian tubes are fully blocked and that the patient can rely on Essure for permanent birth control with full confidence. Essure was FDA-approved in 2002 and more than 312,000 women worldwide have undergone the Essure procedure. Essure and Conceptus([R]) are registered trademarks of Conceptus Inc Conceptus, which is headquartered in Mountain View, California, was founded in 1992. The company began development of micro-catheter and guidewire systems that allowed physicians to access and navigate the fallopian tubes using a non-incisional approach. . About Conceptus, Inc. Conceptus, Inc. (NASDAQ: CPTS), is a leader in the design, development and marketing of innovative solutions in women's healthcare. The Mountain View, Calif.-based company manufactures and markets Essure permanent birth control. The Essure procedure is available in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Europe, Australia, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , Canada, Mexico, 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. and the Middle East. Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area. Information about Conceptus is available at www.conceptus.com. [c]2009. All rights reserved. Conceptus and Essure are registered trademarks and your Family is Complete your Choice is Clear is a service mark of Conceptus Inc. 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. Discussions regarding sales growth, financial guidance, growth in physician metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. , performances of Essure in the office setting, market development initiatives and the use of non-GAAP financials measures and 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 Strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy, including its capital and people. decisions by management, re-allocation of internal resources, recessionary pressures, decisions by insurance companies, scientific advances by third parties, 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, 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. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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