NPTH Enpath Medical (MM)

Revenue Increases 9% and Company Earns $0.04 Per Diluted Share MINNEAPOLIS, Oct. 20 /PRNewswire-FirstCall/ -- Enpath Medical, Inc. (NASDAQ:NPTH) today reported a 9% increase in third quarter sales to $7.7 million compared with $7.1 million in the third quarter of 2004. For the third quarter of 2005, the Company reported net income of $237,000, or $.04 per diluted share, compared with net income of $209,000, or $.03 per diluted share, in the third quarter of 2004. Gross margins in the third quarter were 36.8% compared with 39.7% in the same quarter of 2004 For the nine months ended September 30, 2005, the Company reported sales of $21.5 million, compared with $21.7 million in the same period of 2004. For the nine months ended September 30, 2005, the Company reported a net loss of $337,000, or $.06 per share, compared with a net loss of $1.3 million, or $.23 per share for the first nine months of 2004. Nine-month results for 2004 included a one-time, non-cash impairment adjustment of $2.8 million ($1.9 million after tax) related to the Company's safety needle investment. "We were very pleased with our return to profitability during the third quarter, which was supported by year-over-year growth in both of our main product categories," said James D. Hartman, chairman and CEO. "Sales of delivery systems products increased just over 2% with sales gains in all product categories except contract manufacturing which represents only 1% of our overall sales. Sales of our lead technologies product line increased 27% from $1.8 million to $2.3 million, led by the strength of our new epicardial steroid lead in Europe, which is sold through one of our distribution partners. In addition, we are encouraged by the positive accessory ordering trends that we are seeing from our largest lead technology customer whose orders had declined in 2004 due to an overstock situation." "The reduction in gross margins was primarily due to ramp-up costs associated with the steerable catheter production line within our delivery systems category," Mr. Hartman stated. "It is a complex product to manufacture but we expect it to begin to positively contribute to gross margin growth as we reach a proficient level of yield and productivity by the first of the year." Mr. Hartman continued, "We substantially reduced our sales and marketing and our general and administrative expenses while slightly increasing research and development costs compared with 2004. During the 2005 third quarter, research and development expenses increased 9% year-over-year. However, research and development expenditures declined to $1.2 million or 15.7% of sales in the third quarter compared with $1.6 million or 22.1% of sales during the second quarter of 2005. As a result we achieved net income of $237,000, or $.04 per diluted share compared with $209,000 or $.03 per diluted share in 2004 and a loss of $225,000 or $0.04 per share in the second quarter of 2005. "Although we were clearly disappointed with the conclusion by the FDA to require human clinical trials before granting marketing clearance for the Myopore Rx(TM), we have continued to explore other strategies for approval with our potential distribution partners," Mr. Hartman continued. "In addition, we also remain in talks with the FDA in an attempt to find middle ground for a modest human clinical trial that both parties would find acceptable. We will continue to pursue all avenues to find a solution to gain clearance for our device. At the same time, European sales of our steroid epicardial lead are ramping strongly as interest in our unique technology continues to build. "To date, we have one distribution partner approved to sell our steroid epicardial lead in Europe," Mr. Hartman continued. "As a result of the strong interest this partner is seeing in the product, it is now conducting physician assessments of the FasTac(TM) Flex delivery tool designed to simplify the placement of the epicardial lead. We are hopeful that these tests, if favorable, will lead to a distribution agreement for the FasTac Flex in Europe. We are working on approvals for the steroid lead in a number of other countries outside of Europe and the US to enable our partner to expand distribution of both the steroid lead and the FasTac Flex. "As announced in July, we signed a supply agreement with Bard Electrophysiology, a division of C. R. Bard, Inc. ("Bard"), to distribute our steerable catheter into the electrophysiology market," continued Mr. Hartman. "Bard has been conducting physician testing of the product and we have responded with some modest product enhancements based on physician feedback. We expect Bard to launch the product in the US before the end of the fourth quarter or early in 2006. Our product development pipeline is currently full and contains seven very active, advanced delivery introducer projects, including five with companies that are now, or soon will be, in human clinical trials. In addition, we are involved with three neuro-stimulation development projects, and are developing a next generation epicardial lead and delivery system as well as a number of enhancements to our core introducer product line. We continue to stay actively involved in the development of the new IS- 4 connector configuration, which is emerging as the new standard within the ICD industry. We believe the new standard will be ratified by the ISO in 2006," Hartman concluded. 2005 Outlook and Guidance The Company stated that it expects sales and profitability for the upcoming fourth quarter of 2005 to be comparable to sales and profitability achieved in the third quarter. Conference Call Today The management team of Enpath Medical will host a conference call to discuss the results beginning at 1:30 P.M. Central Time, today, October 20, 2005. To participate, domestic participants should dial 800-257-6607 and international participants should dial 303-262-2125. A recording of the conference call will be available approximately one hour after the conclusion of the call and can be accessed for seven days. To access the replay, please dial 1-800-405-2236 for domestic callers and 303-590-3000 for international callers; please reference the pass code 11041409#. The conference call will also be web cast live on the company's web site, http://www.enpathmed.com/ , and may be accessed by clicking on the 3rd Quarter 2005 Earnings Call icon. An audio replay will be archived on the Enpath website for one year. About Enpath Medical Enpath Medical, Inc., headquartered in Plymouth, Minnesota, is a leader in the design, development, manufacture and marketing of percutaneous delivery systems and stimulation leads technologies. Its products include venous vessel introducers, epicardial and endocardial stimulation leads, safety needles and other products for use in pacemaker, defibrillator, catheter and infusion port procedures as well as neuromodulation and hearing restoration markets. Its products are sold worldwide through partnering relationships with other medical device companies. Safe Harbor This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Certain important factors could cause results to differ materially from those anticipated by some statements made herein. All forward-looking statements involve risks and uncertainties. A number of factors that could cause results to differ materially are discussed in our Annual Report on Form 10-K for the year ended December 31, 2004, as well as in our quarterly reports on Form 10-Q and Current Reports on Form 8-K. Among the factors that could cause results to differ materially are the following: Enpath's ability to complete development of its Myopore Rx steroid epicardial lead and FasTac Flex delivery tool and obtain regulatory approval to market these devices in a number of countries without significant delay or expenditure of resources; the ability of Enpath and its distribution partners to successfully introduce the Myopore Rx and FasTac Flex; Enpath's dependence upon a limited number of key customers for its revenue; the ability of Enpath's customers to successfully develop and market therapies that utilize Enpath's advanced delivery systems; Enpath's dependence upon licensing agreements with third parties for the technology underlying some of its products; Enpath's ability to effectively manufacture its products, including the new Myopore Rx steroid lead and the FasTac Flex delivery device, in anticipated required quantities; Enpath's ability to develop or acquire new products to increase its revenues; Enpath's ability to attract and retain key personnel; introduction of competitive products; Enpath's ability to successfully protect its intellectual property against misappropriation or claims of infringement by third parties; government regulatory matters; economic conditions; and Enpath's ability to raise capital. All forward-looking statements of Enpath, whether written or oral, and whether made by or on behalf of Enpath, are expressly qualified by these cautionary statements. In addition, Enpath disclaims any obligation to update forward-looking statements to reflect events or circumstances after the date hereof. Condensed Balance Sheets Unaudited Assets 09/30/05 12/31/04 Cash and cash equivalents $609,845 $362,625 Inventory, receivables and prepaids 8,463,254 8,514,675 Other current assets 398,405 504,683 Property, plant and equipment, net 4,959,688 5,176,086 Goodwill 9,487,975 9,593,662 Intangible assets with finite lives, other 6,637,360 7,016,009 Total Assets $30,556,527 $31,167,740 Liabilities & Shareholders' Equity Bank line of credit payable $1,100,000 $881,652 Other current liabilities 3,255,686 3,280,349 Long-term liabilities 2,233,318 3,230,882 Shareholders' equity 23,967,523 23,774,857 Total Liabilities & Shareholders' Equity $30,556,527 $31,167,740 Income Statements (Unaudited) Three Months Ended Nine Months Ended Sep 30, 2005 Sep 30, 2004 Sep 30, 2005 Sep 30, 2004 Sales $7,669,486 $7,063,550 $21,479,897 $21,655,717 Cost of sales 4,846,479 4,257,739 13,510,228 13,336,078 Gross profit 2,823,007 2,805,811 7,969,669 8,319,639 Operating expenses: Research and development 1,207,206 1,111,277 4,177,345 3,293,588 Selling, general and administrative 1,169,760 1,331,868 4,092,471 4,028,765 Safety needle asset impairment - - - 2,809,199 Total operating expenses 2,376,966 2,443,145 8,269,816 10,131,552 Operating income (loss) 446,041 362,666 (300,147) (1,811,913) Other income (expense): Interest expense (73,272) (52,485) (197,425) (146,636) Interest income - 5 - 1,613 Other (7,480) (1,890) (21,433) (2,922) Total other income (expense) (80,752) (54,370) (218,858) (147,945) Income (loss) before income taxes 365,289 308,296 (519,005) (1,959,858) Income tax benefit (expense) (127,851) (98,816) 181,652 626,497 Net income (loss) $237,438 $209,480 $(337,353) $(1,333,361) Income (loss) per share Basic $0.04 $0.04 $(0.06) $(0.23) Diluted $0.04 $0.03 $(0.06) $(0.23) Weighted average shares Basic 5,973,107 5,885,853 5,940,639 5,828,670 Diluted 6,079,641 6,105,940 5,940,639 5,828,670 DATASOURCE: Enpath Medical, Inc. CONTACT: Jim Hartman of Enpath Medical, Inc., +1-763-577-2212, or Investors, Doug Sherk, +1-415-896-6820, or Jennifer Beugelmans, +1-415-896-6820, both of EVC Group, Inc. Web site: http://www.enpathmed.com/

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