-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JjqLhNMw/XHHReCrQRqkZkWO7MAAYmDdF6nVe/uCfMSh59dQzxsO1VNj+fmlj3jf 6YHdMBfhScmyEiQCk6putA== 0001104659-06-047965.txt : 20060720 0001104659-06-047965.hdr.sgml : 20060720 20060720140609 ACCESSION NUMBER: 0001104659-06-047965 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060720 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060720 DATE AS OF CHANGE: 20060720 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ENPATH MEDICAL INC CENTRAL INDEX KEY: 0000833140 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 411533300 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19467 FILM NUMBER: 06971340 BUSINESS ADDRESS: STREET 1: 15301 HGHWY 55 W CITY: PLYMOUTH STATE: MN ZIP: 55447 BUSINESS PHONE: 7635592613 FORMER COMPANY: FORMER CONFORMED NAME: MEDAMICUS INC DATE OF NAME CHANGE: 19960330 8-K 1 a06-16500_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): July 20, 2006

 

Enpath Medical, Inc.

(Exact name of registrant as specified in its charter)

 

Minnesota

(State or Other Jurisdiction of Incorporation)

 

0-19467

 

41-1533300

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

15301 Highway 55 West

 

 

Plymouth, Minnesota

 

55447

(Address of Principal Executive Offices)

 

(Zip Code)

 

(763) 559-2613

(Registrant’s telephone number, including area code)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Section 2 – Financial Information

Item 2.02   Results of Operations and Financial Disclosure

 

On July 20, 2006, Enpath Medical, Inc. (the “Company”) issued a press release reporting the results of its operations for the quarter ended June 30, 2006. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

 

The information provided pursuant to Item 2.02 of this Form 8-K is being furnished and is not “filed” for purposes of Section 18 of the Securities Act of 1934, and may not be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in that filing.

 

Section 9. - Financial Statements and Exhibits.

Item 9.01   Financial Statements and Exhibits

 

(c)           Exhibits

 

The following is furnished as an Exhibit to this Report:

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press release dated July 20, 2006, reporting results for the quarter ended June 30, 2006.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

ENPATH MEDICAL, INC.

 

 

 

Dated: July 20, 2006

By:

/s/ John C. Hertig

 

 

 

John C. Hertig

 

 

Chief Executive Officer

 

 

 

 

 

By:

/s/ Scott P Youngstrom

 

 

 

Scott P Youngstrom

 

 

Chief Financial Officer

 

2


EX-99.1 2 a06-16500_1ex99d1.htm EX-99

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Approved By:

 

Scott Youngstrom, CFO (763) 744-2314
Enpath Medical, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

Contacts:

 

Investors
EVC Group (415) 896-6820
Doug Sherk
Jennifer Beugelmans

Media
EVC Group
Steve DiMattia (646) 277-8706

 

July 20, 2006

 

Enpath Medical Reports 32% Increase in Second Quarter Revenues

Company Earns $.06 Per Share Compared with Second Quarter 2005 Loss of $.04

Conference Call Today at 1:30 PM CDT/2:30 EDT

 

MINNEAPOLIS—Enpath Medical, Inc. (Nasdaq: NPTH), a leading developer and manufacturer of proprietary products for blue-chip medical device companies operating worldwide, today reported sharply improved second quarter results.

 

Second quarter financial highlights included:

 

                  A 32% increase in revenues to $9.5 million compared with $7.2 million for the same quarter in 2005.

                  Net income of $360,000 or $0.06 per diluted share for the second quarter, compared with a net loss of $225,000, or $0.04 per share, for the same quarter of 2005.

                  A 55% increase in introducer product line revenues compared with the same quarter in 2005.

                  Gross margins of 41.7% for the second quarter, up from 38.7% from the same quarter last year.

 

For the six months ended June 30, 2006, financial highlights included:

 

                  A 37% increase in revenues to $18.9 million compared with $13.8 million for the first half of 2005.

                  Net income of $1,013,000 or $.16 per diluted share, compared with a net loss of $575,000, or $.10 per share in the first six months of 2005.

                  A 43% increase in introducer revenues compared with the same period of last year.

                  Gross margins of 40.6% for the first half of 2006, up from 37.3% in the same period of last year and only a 2.4% increase in operating expenses from 2005 to 2006.

 



 

“For the second consecutive quarter we achieved strong, profitable revenue growth primarily due to a 55% increase in introducer revenues and continued shipments of our steerable catheter products, which were launched through our two new OEM partners in the first quarter,” said John C. Hertig, chief executive officer. “The demand for introducers from a wide cross-section of customers has been so significant that we implemented a seven-day, three-shift work week production schedule during the second quarter while we awaited delivery, installation and validation of new introducer production equipment. We are just now winding down the third shift as we bring the new production capacity on-line,” Hertig added.

 

As previously announced, Enpath began shipping advanced delivery catheters to two OEM partners in the first quarter as those customers began to fill their distribution pipelines. As anticipated, revenues from the advanced delivery catheter product line, which reached $1.4 million in the first quarter of 2006, declined to $565,000 in the second quarter as the two partners established market acceptance for Enpath’s new single-use steerable catheters. The Company expects catheter revenues for the remainder of the year to gradually increase as market awareness grows and re-stocking orders are received.

 

Revenues from the stimulation leads product line for the quarter were $1.8 million, down 26% from the same quarter of 2005. Revenues from our leads and adaptors declined modestly from 2005 while our contract manufacturing and engineering services revenue dropped by 39% compared with the second quarter of 2005. One of Enpath’s larger contract manufacturing customers reduced orders during the first half of 2006 but orders now appear to have resumed at historical levels. Engineering services revenue is related to timing of projects and should rebound in the second half of 2006.

 

The Company announced it has decided not to continue to pursue its efforts to obtain FDA marketing clearance of its steroid lead for its remaining potential customer. “We were unable to accumulate enough statistical data as requested by the Food and Drug Administration in Europe within the Pre-Market Approval timeline and Enpath would have continued to incur substantial additional costs,” said Mr. Hertig. “Also, in respect to the FDA and best utilization of the Agency’s time, we made the decision that our R&D resources would be better utilized focusing on the development of our next generation product that will improve and simplify the placement of an epicardial lead.”

 

Gross margins for the quarter were 41.7% compared with 38.7% in the second quarter of 2005, and were driven primarily by efficiencies created with higher introducer production volume. Selling, general and administrative expenses totaled $1.6 million during the second quarter of 2006, a 12% increase over the second quarter of 2005. Stock-based compensation expenses as required by new accounting standards impacted our overall results by $109,000 in the second quarter and $165,000 in the first six months of 2006.

 

Research and development expenditures for the quarter increased 9% to $1.7 million, or 18.3% of revenues, compared with $1.6 million in the second quarter of 2005, or 22.1% of revenues. As provided in the guidance for the second quarter, the Company anticipated a sequential increase in R & D expenditures compared with the $1.2 million expended in the

 



 

first quarter of 2006 as it completed a number of qualification and validation activities for several new products.

 

“Enpath’s product development pipeline is full and growing,” continued Mr. Hertig. “We are finalizing a second generation valved introducer specifically designed for the pacing market that we expect to launch in the second half of 2006. In addition, we have a number of steerable catheter projects in development and we are enthusiastic about the interest in our next generation epicardial lead design which, coupled with our proprietary steerable delivery capabilities, creates an integrated system.”

 

Enpath also announced that it has been named as defendant in a patent infringement action filed by Pressure Products Medical Supplies, Inc on June 12, 2006 and venued in the United States District Court in the Eastern District of Texas. At this time, Enpath has not been officially served. The product identified as allegedly infringing the competitor’s patents is the Company’s FlowGuard™ valved introducer, which has been on the market for more than three years. Revenues from products sold that include the FlowGuard valved introducer were approximately 5% of total revenue for the six month periods ended June 30, 2006 and 2005. “We believe that this particular claim is without merit and intend to defend ourselves vigorously in this matter,” said Mr. Hertig. “Regardless, patent litigation can be expensive and the cost of defending the Company could have a material impact on future financial results.”

 

2006 Outlook and Guidance

 

                  Enpath expects second half 2006 revenues to be approximately 12-15% higher than the second half of 2005, resulting in overall revenues growth of 23-25% for full-year 2006 compared with 2005. In the second half of 2006, the Company expects introducer orders to be reduced from the substantial levels experienced in the second quarter, and accordingly, expects second half 2006 revenues to be approximately 5-7% less than in the first half of 2006. Revenues of lead products and advanced delivery catheters are expected to increase from second quarter levels during the second half of 2006.

                  During the first six months of 2006, the substantial increase in introducer production volume had a positive effect on overhead utilization which helped to improve gross margins. With the introducer volume outlook slightly lower for the remainder of 2006, gross margins may be lower than the 40.6% achieved in the first half of the year. The Company expects operating expenses to be comparable to the first half of 2006, and therefore, expects to be profitable during the second half of 2006.

                  The Company is also unable to predict the impact on second half results of the legal costs, if any, of the above referenced patent infringement matter.

 

Conference Call Today

 

The Company will host a conference call today at 1:30 PM, CDT/2:30, EDT to discuss its financial results, outlook for the remainder of 2006 and current corporate developments. To participate in the call dial (800) 257-2101 for domestic callers and (303) 205-0066 for

 



 

international callers, then provide the Company name and John Hertig as the leader’s name. A live webcast can be accessed on the Enpath Medical website, www.enpathmed.com, by clicking on the Second Quarter 2006 Conference Call window. A taped replay of the call will be available approximately one hour after the conclusion of the call until July 27, 2006, by calling (800) 405-2236 for domestic callers and (303) 590-3000 for international and referencing ID#11066187#. An audio replay of the webcast will be archived on the Enpath website www.enpathmed.com until July 20, 2007.

 

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 proprietary products include venous vessel introducers, articulating and fixed curve delivery catheters, epicardial and endocardial stimulation leads, and other products for use in pacemaker, defibrillator, catheter and infusion port procedures as well as neuromodulation markets. Its products, which are primarily finished goods, 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, 2005, 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 dependence upon a limited number of key customers for its revenue; Enpath’s ability to successfully protect its intellectual property against misappropriation or claims of infringement by third parties; the ability of Enpath’s customers to successfully develop and market therapies that utilize the Company’s advanced delivery systems; Enpath’s ability to effectively manufacture its products, specifically steerable catheters, 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; 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

 

 

 

 

 

06/30/06

 

12/31/05

 

Assets

 

 

 

 

 

Cash and cash equivalents

 

$

1,700,867

 

$

 

Inventory, receivables and prepaids

 

10,395,810

 

8,566,254

 

Other current assets

 

245,831

 

394,202

 

Property, plant and equipment, net

 

4,731,391

 

4,686,121

 

Goodwill

 

9,487,975

 

9,487,975

 

Intangible assets with finite lives and other

 

6,448,576

 

6,916,406

 

Total Assets

 

$

33,010,450

 

$

30,050,958

 

 

 

 

 

 

 

Liabilities & Shareholders’ Equity

 

 

 

 

 

Bank line of credit

 

$

 

$

 

Other current liabilities

 

4,677,462

 

2,966,933

 

Long-term liabilities

 

1,430,187

 

2,058,316

 

Shareholders’ equity

 

26,902,801

 

25,025,709

 

Total Liabilities & Shareholders’ Equity

 

$

33,010,450

 

$

30,050,958

 

 

Income Statements (Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 2006

 

June 30, 2005

 

June 30, 2006

 

June 30, 2005

 

Net sales

 

$

9,530,112

 

$

7,193,659

 

$

18,952,801

 

$

13,810,411

 

Cost of sales

 

5,555,814

 

4,413,522

 

11,265,484

 

8,663,749

 

Gross profit

 

3,974,298

 

2,780,137

 

7,687,317

 

5,146,662

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

1,739,243

 

1,592,166

 

2,942,331

 

2,970,139

 

Selling, general and administrative

 

1,634,933

 

1,466,142

 

3,094,342

 

2,922,711

 

Total operating expenses

 

3,374,176

 

3,058,308

 

6,036,673

 

5,892,850

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

600,122

 

(278,171

)

1,650,644

 

(746,188

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

(48,139

)

(61,151

)

(98,738

)

(124,153

)

Interest income

 

3,620

 

 

3,851

 

 

Other

 

(1,374

)

(6,392

)

2,424

 

(13,953

)

Total other income (expense)

 

(45,893

)

(67,543

)

(92,463

)

(138,106

)

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

554,229

 

(345,714

)

1,558,181

 

(884,294

)

Income tax (expense) benefit

 

(193,980

)

121,000

 

(545,363

)

309,503

 

Net income (loss)

 

$

360,249

 

$

(224,714

)

$

1,012,818

 

$

(574,791

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.06

 

$

(0.04

)

$

0.16

 

$

(0.10

)

Diluted

 

$

0.06

 

$

(0.04

)

$

0.16

 

$

(0.10

)

 

 

 

 

 

 

 

 

 

 

Weighted average common and common equivalent shares outstanding

 

 

 

 

 

 

 

 

 

Basic

 

6,178,509

 

5,948,430

 

6,147,895

 

5,924,135

 

Diluted

 

6,324,141

 

5,948,430

 

6,282,691

 

5,924,135

 

 


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