Conceptus reports third quarter 1996 financial results.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.--(HealthWire)--Oct. 24, 1996--Conceptus, 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 ) announced today the financial results for the third quarter of 1996. The Company reported record third quarter revenues of $236,000, a 352% increase over the same period last year and a 225% increase over the second quarter of 1996. The Company also reported a net loss of $1,723,000, or $0.19 supplemental loss per share, for the third quarter of 1996, compared with $1,597,000, or $0.34 supplemental loss per share, for the same period last year. The Company also reported revenues for the nine-month period ended September 30, 1996 of $423,000, compared with $193,000 for the same period last year. For the nine months ended September 30, 1996, the Company reported a net loss of $4,817,000, or a $0.56 supplemental loss per share, compared with a net loss of $4,111,000, or a $0.97 supplemental loss per share, for the same period last year. "This quarter marked a number of important achievements and events in the growth of 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. and I am pleased to report significant progress on key internal milestones set forth at the beginning of the year," commented Kathryn Tunstall, President and Chief Executive Officer. Consistent with its distribution strategy, in July Conceptus signed a marketing agreement with Mallinckrodt Group, Inc. (NYSE NYSE See: New York Stock Exchange : MKG MkG Mit Kameradschaftlichen Grüßen (German: With Best Regards) MKG Mitsubishi Kreditbank GMBH (German branch of Mitsubishi Bank) MKG Muskegon, MI, USA - Muskegon County International Airport ), a leader in the radiology, contrast medium and catheter markets. Mallinkrodt's large direct sales force will exclusively market and distribute Conceptus's Transcervical Tubal Tubal (t `bəl), in the Bible, son of Japheth. Access Catheter (T-TAC T-TAC Transcervical tubal access catheter system Gynecology A system used to diagnose proximal tubal occlusion, for hysterosalpingography, laparoscopic chromopertubation, and intrauterine insemination. See Ectopic pregnancy. )
System to hospital centers in the Americas. Conceptus retained the
rights to market its products to its primary customer, the center-based
interventional gynecologist gynecologist /gy·ne·col·o·gist/ (-kol´ah-jist) a person skilled in gynecology. gy·ne·col·o·gist n. A physician specializing in gynecology. . During the third quarter, Mallinkrodt's sales force was trained, marketing materials were developed and in mid-September Mallinkrodt's sales activity commenced. During the quarter, Schering Health Care Limited, a leading supplier of reproductive pharmaceuticals and Conceptus's marketing partner in the U.K., increased the base of customers using the T-TAC System through the sponsoring of several well-attended physician training programs. In September, Conceptus announced the signing of a letter of intent to acquire Microgyn, Inc., a private medical device company, for a combination of cash and stock. Microgyn's lead product is designed to improve both the ease of performance and the margin of patient safety in therapeutic hysteroscopy, a growing, cost-effective alternative to the more than 600,000 hysterectomies performed in the U.S. each year. The acquisition supports Conceptus's strategy to broaden its product offering in order to effectively meet the clinical needs of the interventional gynecologist and increase the efficiency of its direct sales force. "We have also made progress toward the commercialization of the Selective Tubal Assessment to Refine Reproductive Therapy (STARRT) Falloposcopy System and the Selective Tubal 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. Procedure (S/TOP) Sterilization sterilization Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system). System," added Ms. Tunstall. In September, Conceptus received confirmation from 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. ) that its 510(k) submission for a diagnostic application of its STARRT System is the correct regulatory approach and that the agency will not require additional clinical trials. The Company expects to respond to an FDA request for additional information by the end of October. The Company recently filed an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) with the FDA to initiate a pre-hysterectomy clinical study of its S/TOP Sterilization System. The S/TOP System is designed to be an alternative to the over five million surgical sterilization surgical sterilization Mechanical sterilization Gynecology Sterilization that prevents passage of a fertilized egg to the uterus, or of sperm meeting egg; the more common form of SS is tubal ligation, but vasectomy is not uncommon. See Tubal ligation, Vasectomy. procedures performed annually worldwide. The System consists of a microcoil tubal occlusion device that is delivered non-surgically (via the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. ) 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. utilizing Conceptus's unique fallopian tube access technology. The study, which is designed to enroll twenty patients in eight centers, involves placing one S/TOP device into each fallopian tube, six to twelve weeks prior to hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries . This is done in order to evaluate in-vivo device stability and the biological mechanism of action. This new study follows the successful completion of 27 cases in a Phase I clinical feasibility study The analysis of a problem to determine if it can be solved effectively. The operational (will it work?), economical (costs and benefits) and technical (can it be built?) aspects are part of the study. Results of the study determine whether the solution should be implemented. in which the devices were placed just prior to hysterectomy. Another IDE application is expected to be submitted by the end of the year to enable Conceptus to commence in 1997 its first clinical efficacy study of the S/TOP System. Conceptus, Inc. designs, develops and markets innovative medical devices that provide minimally invasive access to the female reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus . The Company's initial focus is on the development of systems to improve the diagnosis and treatment of fallopian tube diseases. The Company is also developing a non-surgical approach to fallopian tube sterilization, the most commonly performed contraceptive procedure worldwide. 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 actual receipt of regulatory approvals and, if obtained, the timing thereof, may differ significantly from the discussion of such matters in the forward-looking statements. In addition, notwithstanding the receipt of any such approvals, the clinical efficacy of and market demand for the Company's products is subject to a number of risks and uncertainties. The principal, but by no means the only, risks and uncertainties applicable to the Company's products and its business in general are set forth in the Company's prospectus dated February 1, 1996, under the heading "Risk Factors." -0-
CONCEPTUS, INC.
(A development stage company)
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30,
9/30/96 6/30/96 9/30/95 1996 1995
Net sales 236 105 67 423 193
Cost of sales 374 235 278 768 714
Gross profit (138) (130) (211) (345) (521)
Operating expenses:
R&D and regulatory 965 915 675 2,668 1,830
Sales and marketing 763 742 572 2,109 1,304
General and
administrative 469 458 253 1,315 701
Total operating
expenses 2,197 2,115 1,500 6,092 3,835
Operating loss (2,335) (2,245) (1,711) (6,437) (4,356)
Interest income & other,
net 618 622 124 1,640 277
Interest expense (6) (6) (10) (20) (32)
Net loss (1,723) (1,629) (1,597) (4,817) (4,111)
Supplemental net loss
per share $(0.19) $(0.18) $(0.34) $(0.56) $(0.97)
Shares used in computing
supplemental net
loss per share 9,143 9,127 4,707 8,636 4,239
Condensed Balance Sheet Data
(In thousands)
September 30, December 31,
1996 1995
(Unaudited) (Audited)
Cash, cash equivalents and
short term investments 44,549 5,082
Inventory 199 54
Trade accounts receivable 229 13
Total current assets 45,356 5,599
PP&E, net 532 468
Total assets 45,898 6,092
Accounts payable & accruals 974 1,029
Current portion of debt 141 163
Total current liabilities 1,569 1,192
Long term portion of debt 54 153
Redeemable convertible preferred
stock -- 16,624
Accumulated deficit (16,799) (11,981)
Stockholders' equity (net
capital deficiency) 44,275 (11,877)
CONTACT: Conceptus, Inc., San Carlos Sanford Fitch, Chief Financial Officer, 415/802-7240 or Burns McClellan, Inc., 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 Ruth Markowitz (investors) Justin Jackson (media) 212/505-1919 |
|
||||||||||||||

`bəl)
Printer friendly
Cite/link
Email
Feedback
Reader Opinion