Imagyn Medical Inc. reports record 1996 sales of $9.3 million.LAGUNA NIGUEL, Calif.--(BW HealthWire)--Feb. 13, 1997--Imagyn Medical Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IGYN) Thursday reported financial results for the quarter and year ended Dec. 31, 1996. For the quarter, the company reported revenue of $2,649,000 compared with revenue of $830,000 for the fourth quarter of 1995. Net loss for the period was $1,345,000, or 16 cents per share Cents per share The amount of a mutual fund's dividend or capital gains distributions that a shareholder will receive for each share owned. , compared with net income of $1,333,000, or 25 cents per share, for the 1995 period. The financial results for the fourth quarter of 1995 and year ended Dec. 31, 1995 included a one-time payment to the company of $3.5 million, which was recorded as other operating income Operating Income The profit realized from a business' own operations. Notes: This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit. , in connection with granting of various marketing rights for certain products. There were no such payments to the company during the quarter or year ended Dec. 31, 1996. For the year ended Dec. 31, 1996, the company reported record revenue of $9,371,000, compared with revenue of $2,243,000 for 1995. Net loss for the period was $4,408,000, or 61 cents per share, compared with $2,645,000, or 59 cents per share for 1995. The increase in the company's sales in 1996 was principally the result of sales of the company's MicroLap(r) products to 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. Surgical Corp. under an exclusive international and co-exclusive domestic distribution agreement which was consummated in late 1995. In 1996, the company recorded sales of approximately $8 million to U.S. Surgical, approximately fifty percent of which were sales of its proprietary MicroLap microlaparoscope and the balance of which were sales of MicroLap accessory products including nonproprietary, mechanical instrumentation and disposable products Disposable products are items that are not intended by the manufacturer to be reused more than once or a few times as compared to more permanent serviceable and reusable items. Some products that have disposable versions are:
The company does not anticipate a continuation of sales of nonproprietary products to U.S. Surgical in 1997. All sales by the company to U.S. Surgical are at distributor transfer prices and do not reflect the actual end user sales prices for these products. The company expects to begin shipments of a new model microlaparoscope to U.S. Surgical in the second quarter of 1997 and has reached an agreement with U.S. Surgical for a twelve month purchase commitment for this new microlaparoscope. As a result of the planned introduction of the new microlaparoscope, the company does not anticipate sales of its current model MicroLap microlaparoscope to U.S. Surgical during the first quarter of 1997. As a result of these factors, and the company's transition from primarily an OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and product provider to a direct supplier of products, the company anticipates that aggregate sales of its products for the next fiscal quarter will be below the comparable period in the prior year and that operating costs operating costs npl → gastos mpl operacionales associated with direct marketing and sales activities will contribute to a larger loss from operations than in the prior comparable period. In October 1996, the company launched its new MicroSpan(tm) microhysteroscopy system in the United States through a limited number of direct sales representatives. Initial response to the MicroSpan system from clinicians has been favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. , however, longer than expected sales cycles and the lack of adequate levels of specifically established third party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. for office based microhysteroscopy procedures has contributed to lower than expected sales of the company's MicroSpan products to date. The company is in the process of recruiting additional personnel for its direct U.S. sales force to expand the geographic sales coverage for its MicroSpan product line. The company's direct U.S. sales force currently consists of eight sales representatives. Imagyn recently entered into an exclusive provider agreement with Medical Alliance Inc. (MAI MAI Mail (File Name Extension) MAI Multilateral Agreement on Investment MAI Maius (Latin: May) MAI Ministerul Administratiei si Internelor (Romanian) ), under which MAI will use the MicroSpan microhysteroscopy system in its physician office mobile surgical business. MAI provides temporary surgical facilities for use in conjunction with physicians' offices in 46 states, thereby providing the company with expanded access Expanded access refers to the inclusion of patients in a clinical trial for a new therapeutic treatment or chemical entity, where those patients would not satisfy the enrolment criteria for the scientific study in progress. to the physician office market. In addition, MAI has over 125 mobile medical services contracts with managed care organizations covering 16 million lives. Under the terms of the exclusive provider agreement, the company's MicroSpan system will be the system of choice for microhysteroscopy procedures under these managed care contracts. On Jan. 31, 1997, the company received 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. approval for its Ovation(tm) linear everting e·vert tr.v. e·vert·ed, e·vert·ing, e·verts To turn inside out or outward. [Back-formation from Middle English everted, turned upside down, from Latin 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. system for the diagnosis of 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. occlusions. The company is currently in the process of planning for the market introduction of the Ovation system on a limited basis commencing late in the second quarter of 1997. Imagyn designs, develops and markets micro-invasive, cost-effective devices for diagnosis and treatment of gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. and reproductive disorders. Imagyn's proprietary technology platform, based on micro-optics and micro-access devices, provides physicians with the ability to atraumatically access and visualize the abdomial cavity, the uterus, and the 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. . Imagyn's proprietary, disposable micro-access devices enable physicians to perform certain procedures outside the hospital without the need for general anethesia. The discussion in this news release regarding the company's anticipated results of operations, relationship with U.S. Surgical, MicroLap system sales System sales is a business term used in the franchising industry. Franchisors provide supplies, marketing and administration services to franchisees in return for a part of the franchisees' revenues. Some franchisors also operate some outlets directly. , and MicroSpan and Ovation product system introductions and sales, includes forward-looking information that involves risks and uncertainties, including uncertainties associated with the regulatory approval and introduction of the company's products; the ability of the company's products to achieve market acceptance; availability of third party reimbursement; the effect of competitive products, and pricing and other risks. The company's actual results may differ significantly from the results discussed in the 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. as a result of these and other factors. -0-
IMAGYN MEDICAL INC.
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(in thousands, except per-share data)
(unaudited)
Three Months Ended Year Ended
Dec. 31, Dec. 31,
1996 1995 1996 1995
Net Sales $ 2,649 $ 830 $ 9,371 $ 2,243
Cost of sales 1,961 843 6,579 1,811
Gross profit 688 (13) 2,792 432
Costs and expenses:
Sales and marketing 1,364 1,441 4,039 3,296
Research and development 693 468 2,708 1,811
General and administrative 799 364 2,265 1,253
Total expenses 2,856 2,273 9,012 6,360
Other operating income 0 3,500 0 3,500
Profit/(Loss) from operations (2,167) 1,214 (6,219) (2,428)
Other income (expense) 828 119 1,826 (217)
Net income/(Loss) $(1,345) $ 1,333 $(4,408) $(2,645)
Net loss per share $ (0.16) $ 0.25 $ (0.61) $ (0.59)
Weighted average shares 8,541 5,288 7,195 4,573
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Dec. 31,
1996 1995
(unaudited)
Cash, cash equivalents and cash
investments $ 45,712 $ 9,340
Working capital 44,010 10,431
Total assets 51,955 12,024
Redeemable preferred stock 0 9,936
Accumulated deficit (24,951) (20,543)
Stockholders' equity/(deficit) 48,889 (97)
CONTACT: Imagyn Medical Inc., Laguna Niguel J. C. MacRae, 714/362-2500 |
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