2000-11-02T07:04:00.000-08:00

Obesity, Diabetes Ups Risk of Birth Defects
NEW YORK (Reuters Health) - Obese women who also have type 2 diabetes are about three times more likely than non-obese non-diabetic women to deliver a child with a birth defect, researchers report.

These at-risk women were at greatest risk--seven times more likely--of giving birth to a child with a craniofacial defect such as cleft palate, or abnormal limb development, according to findings published in the November issue of Epidemiology.

According to the study authors, obesity and diabetes may act in combination to raise the risk of birth defects. About 65% of major birth defects among women who were both obese and diabetic were caused by the interaction of these two factors, the investigators estimate.

``We found that the joint exposure to obesity and diabetes led to a threefold increased risk of all major defects,'' according to Dr. Lynn L. Moore and colleagues from the Boston University School of Medicine in Massachusetts.

The study defined obesity as a body mass index (BMI) of at least 28. BMI is a measure of a person's weight in relation to their height.

Nearly 6% of all women with type 2 diabetes had babies with major defects, compared with 1.34% of women without diabetes. Craniofacial and musculoskeletal defects were the most common types of problems, researchers found.

Obese women without diabetes were not more likely to deliver a child with a birth defect, although certain types of defects were more common. Similarly, normal-weight women with gestational diabetes, which occurs during pregnancy, were not at increased risk of having children with major defects.

The results of the study are based on data from nearly 23,000 women.

The current findings support observations made in other studies suggesting that maternal obesity and type 2 diabetes raise the risk of congenital defects.

SOURCE: Epidemiology 2000;11:689-694.

2000-11-02T05:47:00.000-08:00

Wednesday October 25, 12:01 am Eastern Time
Press Release
SOURCE: Inverness Medical Technology, Inc.
Inverness Medical Technology, Inc. Announces Record Earnings and Revenues
Third Quarter EPS $0.11 per Share; Revenues Up 30%
WALTHAM, Mass., Oct. 25 /PRNewswire/ -- Inverness Medical Technology, Inc. (Amex: IMA - news) today announced a profit of $3.1 million, or 11 cents per fully diluted share for the three months ended September 30, 2000. This compares to a loss of $1.8 million, or 11 cents per fully diluted share, in the third quarter of 1999. Net revenues for the quarter were $43.0 million, compared to $33.1 million for the year ago period, representing an increase of 30%.

Revenues related to diabetes self-management products, primarily blood glucose monitoring systems and supplies, were $29.4 million in the third quarter of 2000, an increase of 54% from $19.1 million in the third quarter of 1999. Diabetes related revenues in the quarter accounted for 68% of total net revenues compared to 58% in the third quarter of 1999. Gross margins increased to 42% for the quarter, compared to 34% in the year earlier period, due mainly to the leverage realized through increased sales of the Company's electrochemical blood glucose test strips. Interest expense decreased $418,000 compared to the third quarter of 1999 due primarily to the refinancing of a portion of subordinated debt during the quarter.

Net revenues for the first nine months of 2000 increased 35% to $121.3 million compared to $89.6 million in the first nine months of 1999. Net income for the nine month period was $7.2 million or $0.26 per fully diluted share (including non-recurring income of $634,000 that added approximately $0.03 per share). In the first nine months of 1999, the Company had a net operating loss (excluding debt restructuring charges) of $8.9 million.

Commenting on Inverness's financial performance, Ron Zwanziger, Chairman and CEO, stated: ``Our diabetes blood glucose monitoring business continues to grow and drive our increased profitability. At the same time, we continue to increase our level of investment in R&D, supporting a series of product development initiatives in the diabetes self-management arena.''

More specifically, in the last month, Inverness has announced two investments in potential new product areas:

* An agreement to acquire Integ Incorporated (Nasdaq: NTEG - news), a company
that has developed a proprietary sampling technology to extract
interstitial fluid from the top layers of the skin. This technology
complements Inverness' existing programs for the development of glucose
monitoring systems that do not require blood samples.

* A development and licensing agreement with Debiotech, S.A., providing
Inverness with the exclusive right to commercialize an externally-worn
insulin pump to be developed by Debiotech. Inverness also received an
option to the exclusive right to commercialize an implantable insulin
pump using Debiotech's technology.

In addition, Inverness announced during the quarter that it received FDA clearance for its second generation electrochemical blood glucose monitoring system. The new system features a five second test time and utilizes the Company's proprietary test strips with a small blood sample size of one microliter. The new system provides users with the option of testing on the finger or arm. The system is to be marketed worldwide by LifeScan, a Johnson & Johnson company, under the LifeScan trademark ``ONE TOUCH® Ultra.''

Inverness Medical Technology, Inc. develops, manufactures, and markets innovative products focused primarily on diabetes self-management. The Company's proprietary glucose monitoring systems are marketed worldwide by LifeScan, a Johnson & Johnson company. Inverness also markets diabetes products as well as a line of women's health products to consumers through its own established retail distribution networks including Wal-Mart, CVS and Walgreens. Inverness Medical Technology, Inc.'s manufacturing facilities are located in Inverness, Scotland; Galway, Ireland; and Yavne, Israel. European headquarters are located in Munich, Germany and U.S. headquarters are located in Waltham, Massachusetts.

As previously announced, the Company will host a conference call beginning at 9:30 A.M. (Eastern Time) today, October 25th,, to discuss these results. As part of the conference call, Inverness will also discuss last week's announcement regarding the Company's agreement with Debiotech S.A.

If you would like to participate in this conference call, please dial 800-275-3210 (U.S. and Canada) or 973-628-6885 (International). Callers are advised to dial 10 minutes before the start of the call is scheduled to begin. A replay of the conference call will be available through October 27th by calling 877-375-1352 (U.S. and Canada) or 402-220-1374 (International).

A live webcast (and an on-demand replay) of the conference call will be available at www.invernessmedical.com and www.streetfusion.com .

For more information about Inverness Medical Technology, please visit our website at www.invernessmedical.com . Press releases are also available via fax by calling toll-free (888) 872-8679.

This press release contains forward-looking statements, including statements about the consummation and anticipated timing of the Integ merger, the funding of the proposed licensing and development arrangements with Debiotech, the development of a proposed insulin pump by Debiotech and its features and the market acceptance of the proposed insulin pump, the potential market opportunity for glucose monitoring systems that use interstitial fluid, the expected drivers of growth for the market opportunity, the anticipated impact of Integ's and Debiotech's technology on Inverness Medical Technology's future growth, the anticipated impact of the acquisition on Inverness Medical Technology's development programs, technological difficulties encountered in Debiotech's development process and Inverness Medical Technology's ability to manufacture sufficient quantities of the insulin pump, to obtain necessary regulatory approvals and successfully commercialize an insulin pump if Debiotech is successful in developing one.

Actual results may materially differ due to numerous factors, including without limitation conditions in the financial markets relevant to the proposed Integ merger, the receipt of stockholder and other approvals of the transaction, the operational integration associated with the transaction and other risks generally associated with such transactions, the potential market acceptance of interstitial fluid glucose monitoring systems, the competitive environment for the glucose monitoring market, the efficacy and safety of products, content and timing of submissions to and decisions by regulatory authorities, the ability to manufacture sufficient quantities of product for development and commercialization activities, the ability of Inverness Medical Technology to successfully commercialize products and the risks and uncertainties described in Inverness Medical Technology's reports filed with the Securities and Exchange Commission under the Securities and Exchange Act of 1934, as amended, including without limitation those risks and uncertainties described under ``Certain Factors Affecting Future Results'' beginning on page F-8 of Exhibit 13.1 to Inverness' Annual Report on Form 10-K for the year ended December 31, 1999.

INVERNESS MEDICAL TECHNOLOGY, AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
$000s

Three Months Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999

Net revenues $43,013 $33,146 $121,318 $89,647
Cost of sales 25,160 21,805 70,595 60,957
Gross profit 17,853 11,341 50,723 28,690
Total operating
expenses 13,173 11,163 38,389 31,196
Operating income (loss) 4,680 178 12,334 (2,506)
Interest and other
expense, net of
interest & other
income (1,455) (1,997) (4,658) (6,309)
Provision for
income taxes (147) (15) (435) (349)
Net income (loss) $3,078 $(1,834) $7,241 $(9,164)
Basic net income (loss)
per common share $0.12 $(0.11) $0.30 $(0.64)
Diluted net
income (loss)
per common share $0.11 $(0.11) $0.26 $(0.64)

INVERNESS MEDICAL TECHNOLOGY, AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
$000s

September 30, December 31,
2000 1999

ASSETS
CURRENT ASSETS:
Cash and cash equivalents $6,140 $5,234
Other current assets 40,146 34,498
Total current assets 46,286 39,732

PROPERTY, PLANT AND EQUIPMENT, NET 12,371 9,780
GOODWILL, TRADEMARKS AND
OTHER INTANGIBLE ASSETS, NET 59,473 63,282
DEFERRED FINANCING COSTS AND OTHER ASSETS, NET 1,726 2,043
Total assets $119,856 $114,837

LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES:
Current portion of notes payable $33,966 $21,483
Other current liabilities 28,865 26,922
Total current liabilities 62,831 48,405

LONG-TERM LIABILITIES:
Notes payable, net of current portion 18,894 38,892
Other long-term liabilities 445 366
Total long-term liabilities 19,339 39,258

REDEEMABLE PREFERRED STOCK 4,327 9,054
TOTAL STOCKHOLDERS' EQUITY 33,359 18,120
Total liabilities and stockholders' equity $119,856 $114,837

SOURCE: Inverness Medical Technology, Inc.

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2000-11-02T05:41:00.000-08:00

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