Possis Medical, Inc. Reports Third-Quarter Results; Meets Earnings Guidance; Maintains Strong Balance Sheet; Preparing for New Product Introductions and Clinical Studies.MINNEAPOLIS -- Possis 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 :POSS), today reported sales of $15.1 million for the third fiscal quarter ended April 30, 2005, versus $19.3 million for the year-ago period. U.S. AngioJet(R) Rheolytic(TM) Thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. 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. for the three months were $14.7 million, compared with $18.9 million in the year-ago period and $15.6 million for the fiscal 2005 second quarter. Net income per diluted share for the third quarter was $0.06 versus $0.16 in the prior-year period. Net income per diluted share was consistent with the Company's previously issued guidance. The Company's cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has position rose to $42.2 million at the April quarter end from $41.6 million at the end of the fiscal 2005 second quarter. The increase was primarily due to positive operating cash flow Operating cash flow Earnings before depreciation minus taxes. Measures the cash generated from operations, not counting capital spending or working capital requirements. partially offset by $1.6 million invested to repurchase 172,000 shares of common stock during the quarter. "The year-over-year decrease in sales and earnings was due to the AiMI study's impact on coronary customer order patterns," said Robert G. Dutcher, Possis Medical CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Despite these pressures, we met our guidance--delivering profitability for the 17th consecutive quarter--expanded our customer base, maintained a strong balance sheet, and continued to invest in and make progress on new product introductions." During the third quarter, Possis expanded its installed base of U.S. drive units by 3 percent sequentially, and as of April 30, 2005, had 1,461 drive units in the field domestically. Peripheral product sales in the third quarter grew 23 percent year over year, and the Company believes the decline in coronary product sales has stabilized, based on the most recent coronary customer order trends. Said Dutcher, "With the impact of the AiMI study largely behind us, we are confident that Possis will return to growth beginning in our fiscal 2005 fourth quarter. We anticipate building top-line sales gains and double-digit bottom-line growth in fiscal 2006. We believe in Possis' future and growth prospects, and that confidence is reflected in part by our continuing share repurchase Share Repurchase A program by which a company buys back its own shares from the marketplace, reducing the number of outstanding shares. This is usually an indication that the company's management thinks the shares are undervalued. program." The Company's gross margin rate was 72 percent in the third quarter, compared to 75 percent a year ago and 74 percent in the second quarter of fiscal 2005. Possis sold 44 U.S. drive units in the quarter, versus 79 in the prior-year period and 49 in the second quarter of fiscal 2005. The average catheter utilization rate per installed drive unit, a measure of recurring usage, was 7.8 in the third quarter, compared to 8.3 in the second quarter of fiscal 2005, and 10.8 in the prior-year period. Selling, general and administrative expenses (SG&A) decreased 7 percent compared to the year-ago period. The decrease is due mainly to a reduction in incentives and commissions, offset partially by sales force expansion and increased employee medical benefit costs. Third-quarter R&D expense increased by approximately $181,000 from the prior-year period, largely due to the timing of expenses incurred for various R&D projects, including the development of the next-generation Ultra Console and Combined System for the catheter and pump set disposables. Said Dutcher, "The prior three quarters have been challenging, but we have never wavered in our strong belief in the safety, effectiveness and advantages of our pioneering AngioJet System, and we continue to invest in clinical studies, new products and applications to advance the technology." Product Trials to Drive Future Growth Possis is in the final stages of planning a new AngioJet System clinical study in heart attack patients with visible thrombus thrombus /throm·bus/ (throm´bus) pl. throm´bi a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction. . This will be an international, multi-center, prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial of the AngioJet System followed by direct stenting Stent´ing n. 1. An opening in a wall in a coal mine. versus direct stenting alone in patients with thrombus-containing ST-elevation myocardial infarction myocardial infarction: see under infarction. (STEMI STEMI ST-Segment Elevation Myocardial Infarction ) lesions. The co-principal investigators will be Dr. David Antoniucci of Florence, Italy, and Dr. Antonio Columbo, of Milan, Italy. Said Dr. Antoniucci, "Our single-center Florence experience employed a specific thrombectomy technique different from what has been more common in the U.S. We expect this new study will confirm our initial results and the efficacy of AngioJet thrombectomy in acute myocardial infarction acute myocardial infarction ( Added Dr. Columbo, "Building on the reported success of Dr. Antoniucci's experience with the AngioJet System to treat STEMI lesions, we expect that the new multi-center study, employing the already-proven Florence technique, will confirm more broadly the clinical value of the AngioJet System in treating thrombus-containing STEMI lesions, when appropriate patient selection is applied." The new study will specify the use of drug-eluting stents In cardiology, a drug-eluting stent is a stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation. This prevents scar-tissue–like growth that, together with clots (thrombus), could otherwise block the stented in all patients. Said Dutcher, "We believe there is a growing appreciation for the value of removing thrombus with the AngioJet System before deploying a drug-eluting stent. We are pleased that this new study brings these two key technologies together to address the serious medical challenge posed by thrombosed thrombosed /throm·bosed/ (throm´bozd) affected with thrombosis. throm·bosed adj. 1. Clotted. 2. Of, being, or characterizing a blood vessel that is the seat of thrombosis. STEMI lesions." A meeting of study investigators is taking place this week at the Paris Course on Revascularization meeting in France. Possis anticipates that the study will be conducted at 10 high-volume STEMI treatment centers, and enroll about 500 patients. Added Dutcher, "We are also actively working with key U.S. interventional cardiologists at leading centers to define additional U.S. clinical research to study AngioJet thrombectomy in coronary vessels, specifically including saphenous vein saphenous vein n. Either of two main superficial veins of the leg, one larger than the other, that begin at the foot. Saphenous vein A long vein in the thigh or calf commonly used for bypass grafts. grafts. We will announce these plans as they are finalized See finalization. ." He concluded, "These new prospective trial initiatives, combined with our ongoing efforts to present real-world registry experience of AngioJet System use in coronary thrombus, including STEMI patients, are designed to demonstrate the benefit of AngioJet System treatment for intracoronary thrombus." In addition, the Company is continuing to work with key clinical researchers to define the parameters of future clinical studies of the AngioJet System for treating deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. (DVT See deep vein thrombosis. ) and pulmonary embolism Pulmonary Embolism Definition Pulmonary embolism is an obstruction of a blood vessel in the lungs, usually due to a blood clot, which blocks a coronary artery. (PE), and currently expects to conduct an FDA-approved 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) clinical trial of one or both of these applications, starting in fiscal 2006. New Product Releases Over the past several quarters, Possis has focused its R&D efforts on specific new and enhanced products, and several are now poised for market introduction. The Company is making considerable progress in its growing portfolio of AngioJet System catheters: --Following on the success of the first rapid exchange version of the XMI (1) (XML Metadata Interchange) An XML-based representation of a UML model. XMI is used to transfer UML diagrams between various modeling tools. See UML. (2) An earlier high-speed bus from Digital that was used in large VAX machines. (R) catheter, a new generation design featuring several improvements including an atraumatic atraumatic /atrau·mat·ic/ (a?traw-mat´ik) not producing injury or damage. atraumatic not producing injury or damage. atraumatic adjective Without injury soft tip and more flexible shaft A flexible shaft is a device for transmitting rotary motion between two objects which are not fixed relative to one another. It consists of a rotating wire rope or coil which is flexible but has some torsional stiffness. is currently in limited market release. Early customer feedback for this new XMI-RX Plus catheter has been positive and a full market release is expected at the end of our fiscal 2005 fourth quarter. --In addition, the first rapid exchange version of the companion XVG(R) catheter, the XVG-RX, is in late phase development, and is scheduled to be introduced in fiscal 2006. --Also, Possis has entered limited market release with the new DVX DVX Digital Voice Exchange DVX Dvd Extended DVX Device Driver (TM) catheter for use in peripheral arteries Peripheral Arteries are the arteries (specifically arterioles and capillaries) which are furthest from the heart (mouth, hands, and feet). In some cases blockages in the peripheral arteries may be treated with catheterization and balloon dilatation instead of surgery. . The DVX catheter was conceived and designed in response to requests for more effective removal of older, tougher thrombus, especially in larger peripheral arteries. Customer response to this new product has been very favorable as well. The GuardDOG(R) 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. system, a balloon guidewire temporary occlusion system designed to work with AngioJet, System is in late development phase work for both 0.014" and 0.035" diameter guidewire platforms. The Company anticipates that these models will be introduced in the first half of fiscal 2006, depending on the schedule needed to complete the remaining development testing and to obtain appropriate regulatory clearances. Finally, the Company expects the next generation AngioJet Ultra console to be submitted to the 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. in a pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement by the end of the summer. The new Ultra console, along with the new integrated catheter and pump sets, is designed to improve ease of use by significantly reducing the steps required to prepare the system for patient treatment. Approval is expected during the second half of fiscal 2006. Outlook For the current year ended July 31, 2005, the Company expects sales to be approximately $65 million, with gross margins in the low- to mid-70s, as a percent of sales. Net income per diluted share is estimated to be in the range of $0.32-$0.35. For the 2006 fiscal year, Possis' preliminary guidance anticipates sales in the range of $69-$74 million, with gross margins in the mid-70s, as a percent of sales. Preliminary estimates for diluted EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. in fiscal 2006 are in the range of $0.40-$0.50 per share. The EPS guidance for fiscal 2006 excludes the impact of implementing FAS No. 123(R), which requires all companies to measure compensation expense for all share-based payments (including employee stock options) at fair value and recognize the expense over the related service period. "We are pleased both to be projecting upcoming growth and at the number of promising trials and new product launches that we have as we move forward," concluded Dutcher. The Company will host a conference call on Wednesday, May 25, 2005 at 9:30 a.m. Central Time. Bob Dutcher, Chairman, President & CEO, and Jules Fisher Jules Fisher (born November 12, 1937) in Norristown, Pennsylvania is a prolific, award-winning, lighting designer and producer. He is credited with lighting designs for more than 200 productions over the course of his 40 year career in Broadway and off-Broadway shows, as well , CFO See Chief Financial Officer. , will discuss the third-quarter operating results, as well as update the Company's product development, clinical and regulatory initiatives. To join the conference call, dial 888-889-7567 (toll - 517-645-6377) by 9:25 a.m., and give the password "Conference" and leader "Mr. Bob Dutcher." A Webcast of the conference call can be accessed through www.possis.com, under the Investors tab. The Webcast can also be accessed through www.fulldisclosure.com, for individual investors. Institutional investors Institutional Investor A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. can access the Webcast through a password-protected site at www.streetevents.com. An archived Webcast will be available for 30 days. A replay of the conference call will be available from noon Central Time on Wednesday, May 25 through Friday, May 27 at 11:59 p.m. Central Time. Dial toll-free 1-866-485-0036 (toll - 203-369-1608). Possis Medical, Inc. develops, manufactures and markets pioneering medical devices for the large and growing cardiovascular and vascular treatment markets. The AngioJet(R) Rheolytic(TM) Thrombectomy System is marketed in the 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. for blood clot blood clot n. A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network. removal from native coronary arteries Coronary arteries The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches. , leg arteries, coronary bypass coronary bypass Surgical treatment for coronary heart disease to relieve angina pectoris and prevent heart attacks. It became widely used in the 1960s. One or more blood vessels—usually an artery in the chest or a vein from the leg—are transplanted to create grafts and AV dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. access grafts. Some of the statements in this press release constitute "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. ." These statements include our estimates of future revenue, gross margins, expenses, earnings per share, new product introductions, clinical studies, and the impact of the results of the AiMI trial. There are a number of risks and uncertainties that could cause the assumptions upon which we base these forward-looking statements to be inaccurate and could cause our actual results to differ materially from those expressed in the forward-looking statements. Our actual results could vary if our sales and marketing efforts are not effective in re-establishing coronary product usage, if we are not able to effectively manage new product development timelines, and if we are unable to generate suitable clinical data to support growing use of the AngioJet System in coronary and peripheral applications. These and other factors that could impact our future results are described in more detail in Exhibit 99 to the our Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended July 31, 2004, filed with the Securities and Exchange Commission.
POSSIS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME
FOR THE THREE AND NINE MONTHS ENDED April 30, 2005 AND 2004
(UNAUDITED)
Three Months Ended Nine Months Ended
April 30, April 30, April 30, April 30,
2005 2004 2005 2004
------------ ------------ ------------ ------------
Product sales $15,101,977 $19,329,399 $48,772,849 $52,380,364
Cost of sales and
other expenses:
Cost of medical
products 4,155,261 4,781,377 12,743,018 12,567,753
Selling, general
and admini-
strative 6,858,222 7,379,482 21,126,743 20,753,549
Research and
development 2,589,657 2,408,544 7,631,492 6,514,655
------------ ------------ ------------ ------------
Total cost of
sales and
other
expenses 13,603,140 14,569,403 41,501,253 39,835,957
---------------------------------------------------
Operating income 1,498,837 4,759,996 7,271,596 12,544,407
Interest income 320,095 197,748 913,228 518,670
Loss on sale of
securities (121,105) -- (101,074) (34,033)
------------ ------------ ------------ ------------
Income before
income taxes 1,697,827 4,957,744 8,083,750 13,029,044
Provision for
income taxes 682,000 1,862,051 3,205,886 4,87,951
------------ ------------ ------------ ------------
Net Income 1,015,827 3,095,693 4,877,864 8,141,093
Other
comprehensive
income, net of
tax
Unrealized gains
(loss) on
securities 9,000 (155,000) 4,000 (4,000)
------------ ------------ ------------ ------------
Comprehensive
income $1,024,827 $2,940,693 $4,881,864 $8,137,093
============ ============ ============ ============
Weighted average
number of common
shares
outstanding:
Basic 17,405,676 18,002,188 17,722,145 17,850,256
Diluted 17,871,140 19,791,622 18,470,555 19,397,477
Net income per
common share:
Basic $0.06 $0.17 $0.28 $0.46
============ ============ ============ ============
Diluted $0.06 $0.16 $0.26 $0.42
============ ============ ============ ============
AngioJet Key Business Indicators
----------------------------------------------------------------------
Q3-04 Q4-04 Q1-05 Q2-05 Q3-05
----------------------------------------------------------------------
U.S. AngioJet Revenue -
$(000) $18,899 $19,650 $17,199 $15,585 $14,690
----------------------------------------------------------------------
U.S. Drive Units Sold 79 59 49 49 44
----------------------------------------------------------------------
U.S. Drive Units in the
Field 1,255 1,317 1,371 1,422 1,461
----------------------------------------------------------------------
U.S. Catheter Utilization 10.8 10.8 9.3 8.3 7.8
----------------------------------------------------------------------
Gross Margin % 75% 76% 75% 74% 72%
----------------------------------------------------------------------
EPS Diluted - After Tax $0.16 $0.18 $0.11 $0.09 $0.06
----------------------------------------------------------------------
POSSIS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
ASSETS April 30, July 31,
2005 2004
------------ ------------
CURRENT ASSETS
Cash and cash equivalents $3,203,322 $8,411,784
Marketable securities 39,017,483 39,759,403
Trade receivables (less allowance for
doubtful accounts and returns of $632,000
and $536,000 respectfully) 7,655,043 10,232,180
Inventories 6,123,597 5,389,653
Prepaid expenses and other assets 671,407 958,616
Deferred tax asset 890,000 890,000
------------ ------------
Total current assets 57,560,852 65,641,636
PROPERTY AND EQUIPMENT, net 5,063,387 5,073,775
OTHER ASSETS
Deferred tax assets 12,371,596 15,103,949
Other assets 421,421 201,341
------------ ------------
TOTAL ASSETS $75,417,256 $86,020,701
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Trade accounts payable $1,438,776 $1,791,694
Accrued salaries, wages, and commissions 2,313,249 4,228,804
Other liabilities 2,410,531 2,222,465
------------ ------------
Total current liabilities 6,162,556 8,242,963
COMMITMENTS AND CONTINGENCIES
Other liabilities 421,421 160,536
SHAREHOLDERS' EQUITY
Common stock-authorized, 100,000,000
shares of $.40 par value each; issues and
outstanding, 17,280,663 and 18,254,942
shares, respectively 6,912,265 7,301,977
Additional paid-in capital 75,167,465 88,434,540
Unearned compensation (24,000) (15,000)
Accumulated other comprehensive loss (132,000) (136,000)
Retained deficit (13,090,451) (17,968,315)
Total shareholders' equity 68,833,279 77,617,202
------------ ------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $75,417,256 $86,020,701
============ ============
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion