Conceptus Reports Record Net Sales up 63%, Files Updated Label Claims With FDA.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 reported financial results for the three months ended March 31, 2005. 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 for the first quarter of 2005 were $3.9 million, up 63% compared with net sales of $2.4 million for the first quarter of 2004 and up 7% compared with net sales of $3.6 million for the fourth quarter of 2004. These results exceeded the Company's first quarter net sales guidance of $3.5 million to $3.7 million. The net loss for the first quarter of 2005 was $6.4 million, or $0.25 per share, compared with the net loss for the first quarter of 2004 of $7.1 million, or $0.31 per share, and was comparable to the net loss for the fourth quarter of 2004 of $6.4 million, or $0.25 per share. The net loss for the first quarter of 2005 was less than the Company's first quarter guidance of $7.0 million to $7.5 million. The increase in net sales for the first quarter of 2005 is attributable to higher world-wide commercial sales of Essure resulting from increases in utilization and penetration as well as a U.S. price increase implemented during the quarter. The Company enrolled 168 physicians into the U.S. Essure 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. program, bringing the total number of U.S. physicians that perform the Essure procedure to 1,849 as of March 31, 2005. Gross profit for the first quarter of 2005 was $2.1 million, or 55% of net sales. This compares favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. with gross profit for the first quarter of 2004 of $0.3 million, or 11% of net sales. 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. in the fourth quarter of 2004 was 51%. The increase in gross profit margin is related to lower product cost associated with the outsourcing of production and to higher sales volume. Research and development expenses were $1.0 million for the first quarter of 2005, compared with $1.3 million for the first quarter of 2004 and $0.8 million for the fourth quarter of 2004. The year-over-year decline in R&D expenses reflects decreased product development expenditures. The sequential-quarter increase is related to changes in accounting for clinical expenditures. Selling, general and administrative expenses were $7.7 million for the first quarter of 2005, up from $6.1 million for the first quarter of 2004 and consistent with the $7.7 million for the fourth quarter of 2004. The year-over-year increase was primarily due to higher advertising expenditures related to the company's direct to consumer campaign, costs associated with Sarbanes-Oxley compliance, as well as increased head count in the company's field sales force. Cash, cash equivalents, short-term investments and restricted cash were $24.3 million as of March 31, 2005, compared with $48.2 million as of March 31, 2004 and $32.3 million as of December 31, 2004. For the first quarter of 2005 the Company's cash burn was $8.0 million, compared with $6.4 million for the first quarter of 2004 (excluding the impact of the PIPE financing) and $5.0 million for the fourth quarter of 2004. The increase in cash burn in the first quarter of 2005 is attributable to higher inventory levels and payments of certain non-recurring and seasonal items common in the first quarter. "Our financial results reflect the excellent progress we made across all areas of our business during the first quarter," said Mark Sieczkarek, president and chief executive officer of Conceptus. "We have been successful in our efforts to support our physicians in the implementation of the newly issued CPT CPT See: Carriage Paid To code into many private payer systems, increased our field sales force staffing, made further inroads inroads Noun, pl make inroads into to start affecting or reducing: my gambling has made great inroads into my savings inroads npl to make inroads into [+ into Kaiser Permanente Kaiser Permanente is an integrated managed care organization, based in Oakland, California, founded in 1945 by industrialist Henry J. Kaiser and physician Sidney R. Garfield. , and continue a successful regional direct to consumer campaign aimed at creating awareness of Essure. On the regulatory front, we announced during the first quarter that we filed a Pre-market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement with the U.S. Food and Drug Administration (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. ) for new labeling containing four and five-year effectiveness ratings that are consistent with our three-year effectiveness rating currently on the Essure label. We believe eventual approval of this supplement will further validate the long-term safety and efficacy of this revolutionary, non-invasive approach to permanent birth control." The Company also announced financial guidance for the second quarter of 2005 and reaffirmed the full-year guidance provided on January 13, 2005. Conceptus expects net sales in the second quarter of 2005 to be $4.1 million to $4.3 million and net sales for the full-year to be $17.0 to $18.0 million. The net loss for the second quarter of 2005 is expected to be $6.5 million to $6.7 million and the net loss for the year to be $23.0 million to $24.0 million, or $0.89 to $0.91 per share. Conceptus also announces that it has recently filed an additional PMA supplement with the FDA seeking early termination of the Essure post approval study, based upon the positive, statistically significant interim data. As a condition to FDA approval to market Essure, the Company was required to perform this post-approval study to determine the placement rate in a large number of newly trained physicians. Although the Company does not know whether the FDA will approve this supplement, one of the claims the Company is asking to include in its labeling is an updated successful bilateral placement rate greater than 90%, which is a significant increase from the 86% rate derived from the prior clinical study data. Conference Call Management will host an investment-community conference call beginning at 4:30 p.m. Eastern Time today to discuss the 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 7:30 p.m. Eastern Time April 26, 2005 through 11:59 p.m. Eastern Time on April 28, 2005 by dialing (800) 642-1687 (domestic) or (706) 645-9291 (international) and entering conference ID number 5562391. 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 catheter /cath·e·ter/ (kath´e-ter)1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. . 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 blockage of intestine, urethra, etc. See obstruction under anatomical location, e.g. intestinal, urethral. blockage Wax, see there in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen abdomen, in humans and other vertebrates, portion of the trunk between the diaphragm and lower pelvis. In humans the wall of the abdomen is a muscular structure covered by fascia, fat, and skin. 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 99.8% effective at 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 more than 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 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. , the accuracy of which is necessarily subject to risks and uncertainties. The guidance regarding anticipated net sales and net loss for the second quarter and full year of 2005, approval by the FDA of our PMA supplements, 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 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, decisions by insurance companies, delays by regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , scientific advances by third parties 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.
Conceptus, Inc.
Condensed Consolidated Statements of Operations
(unaudited, In thousands, except per share amounts)
Three Months Ended
March 31,
2005 2004
-------- --------
Net sales $3,871 $2,381
Cost of goods sold 1,727 2,120
Gross profit 2,144 261
Operating expenses:
Research and development 966 1,299
Selling, general and administrative 7,737 6,124
Total operating expenses 8,703 7,423
Operating loss (6,559) (7,162)
Interest and other income, net 190 34
Net loss $(6,369) $(7,128)
Basic and diluted net loss per share $(0.25) $(0.31)
Weighted-average shares used in computing basic
and diluted net loss per share 25,687 23,099
Conceptus, Inc.
Condensed Consolidated Balance Sheets
(unaudited, In thousands)
March 31, December 31,
2005 2004
--------- ------------
Cash, cash equivalents, short-term investments
and restricted cash $24,320 $32,271
Accounts receivable, net 2,102 2,067
Inventories, net 2,950 2,022
Other current assets 1,410 937
--------- ---------
Total current assets 30,782 37,297
Property and equipment, net 1,355 1,322
Intangible assets, net 1,700 1,750
Other assets 1,752 1,808
--------- ---------
Total assets $35,589 $42,177
========= =========
Total liabilities 4,612 5,183
--------- ---------
Common stock and additional paid in capital 220,675 220,323
Accumulated deficit (189,698) (183,329)
--------- ---------
Total stockholders' equity 30,977 36,994
--------- ---------
Total liabilities and stockholders' equity $35,589 $42,177
========= =========
|
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion