Possis Medical, Inc. (NASDAQ:POSS), Minneapolis a, developer,
manufacturer and marketer of pioneering medical devices used in
endovascular procedures, has reported results for its fiscal 2007 third
quarter.
For the third quarter ended April 30, 2007, Possis delivered net
sales of $16.2 million, a 7 percent increase from fiscal 2006
third-quarter sales of $15.2 million. The company reported third-quarter
net income on a generally accepted accounting principles (GAAP) basis of
$44,000, or $0.00 per diluted share, improved from a GAAP net loss of
$278,000, or $0.02 per diluted share, for the prior-year period. This
includes stock-based compensation expense of $669,000, net of tax, or
$0.04 per diluted share, and $820,000, net of tax, or $0.05 per diluted
share, for the fiscal 2007 and 2006 third quarters, respectively. As
adjusted to eliminate the effect of stock-based compensation expense,
net income (non-GAAP) was $713,000, or $0.05 per diluted share in the
third fiscal quarter of 2007 compared to net income of $542,000, or
$0.03 per diluted share, in the third quarter of fiscal 2006.
Due to the recent AngioJet Ultra Thrombectomy System launch,
Possis' expense for sales returns has increased from approximately
1 percent of gross revenue to 3.3 percent of gross revenue in the fiscal
2007 third quarter. This increase is due to the expected rise in returns
of customers' disposable product inventory usable only with the
previous generation AngioJet System. At the customer's request,
these returns are often delayed 30 to 60 days until the customer is
fully trained and converted to the new Ultra System. Gross revenue in
the third quarter increased 9 percent to $16.8 million, versus the same
period one year ago; gross revenue was up 5 percent sequentially from
the fiscal 2007 second quarter. Possis anticipates that sales returns
will moderate as the Ultra System becomes the preferred thrombectomy
system. Please refer to the table on page 7 for additional details on
revenue and sales returns. "Year over year, we delivered revenue
growth in spite of higher sales returns. We did, however, come up
somewhat short of our guidance," said Robert G. Dutcher, CEO of
Possis Medical. "Possis is in the midst of a growth recovery phase
and at a pivotal transition in our business. As we convert from the
legacy AngioJet Systems to the new Ultra Consoles, we're going to
market with a whole new product lineworking to turn over an installed
base of over 1,800 drive units and prior-generation catheters and pumps.
This transition is expected to result in increased sales returns, higher
manufacturing start-up costs, and a higher ratio of capital equipment
versus disposable product sales that will impact gross margins and
product sales mix while we focus on the Ultra System near-term."
"Our focus as a company is long term and strategic, and an
important part is to place Ultra Consoles and secure complete market
access for additional Ultra Catheter Set designs. These are future
revenue generators and keys to growth. It's encouraging that Ultra
Console placements and sales exceeded our expectations for the third
quarter and early indications are that Ultra System disposable usage
will significantly exceed historic usage rates."
Continued Dutcher, "Moreover, the FDA just recently cleared
our AngioJet Ultra Spiroflex catheter set for blood clot removal in
coronary conduits. This approval means our flagship Ultra Spiroflex
catheter set is now approved for both coronary and peripheral thrombus
removal, an important forward step in establishing the Ultra System.
Additionally, the FDA cleared our FETCH Aspiration Catheter specifically
for coronary vasculature use, on top of its original clearance for
generic arteries. These two newest indications further broaden the
on-label scope of our product family and offer physicians a more
complete solution for treating coronary thrombus."
In the fiscal 2007 third quarter, Possis sold 36 new AngioJet Ultra
Consoles and 15 prior-generation drive units worldwide. Total U.S. drive
units in the field, which contributes to catheter usage and sales,
increased sequentially to 1,777 at the end of the fiscal 2007 third
quarter from 1,719 units at the end of the fiscal 2007 second quarter.
Of total U.S. drive units in the field, 109 are the new AngioJet Ultra
consoles.
For the third quarter, Possis' gross profit margin was 68
percent, versus 71 percent in the year-ago third quarter. The quarterly,
year-over-year decrease was primarily due to the impact of higher
start-up costs for new products and customer conversion to the Ultra
System. Average selling prices remained firm across the company's
product lines. Selling, general and administrative expenses (SG&A)
increased by $869,000 from the year-earlier third quarter, to $9.2
million. Sales force commissions and a sales force operating at full
staff contributed to the rise.
Fiscal 2007 third-quarter research and development (R&D)
spending decreased by $498,000 from the prior-year period to $2.4
million. The year-over-year decrease is due to the timing of specific
expenses for R&D initiatives as several new products are now moving
to market release. R&D spending represented 14.6 percent of
third-quarter revenue. On April 30, 2007, cash, cash equivalents, and
marketable securities totaled $43.3 million. On December 19, 2006,
Possis' board of directors authorized the company to repurchase up
to $15 million of its common stock over the two years ending December
31, 2008. During the third quarter, Possis repurchased $1.88 million, or
149,738 shares, of common stock at an average price of $12.54 per share.
Based on market conditions, Possis plans to repurchase additional shares
going forward to offset dilution from stock-based compensation programs.
For the nine-month period ended April 30, 2007, net sales increased 4
percent and totaled $47.6 million, versus $45.8 million in the prior
year.
The company reported a net loss of $16,000 for the nine months on a
GAAP basis, including stock-based compensation expense of $2 million,
net of tax, or $0.12 per diluted share. GAAP net income for the
prior-year nine months was $330,000, or $0.02 per diluted share,
including stock-based compensation expense of $2.3 million, net of tax,
or $0.13 per diluted share. As adjusted to eliminate the effect of
stock-based compensation expense, net income (non-GAAP) for the fiscal
2007 nine months was $2.0 million, or $0.11 per diluted share, compared
to $2.6 million, or $0.14 per diluted share, for fiscal 2006.
AngioJet Product Update
Said Dutcher, "Possis continues to be the established leader
in the thrombus management space. Through ongoing new product
introductions and additional clinical science, we have returned to
growth and our goal remains to leverage our proven technology and market
strength to provide physicians and hospitals with a broader portfolio of
endovascular treatment options."
AngioJet Ultra System
During the third quarter, Possis initiated the full market release
of its new AngioJet Ultra Thrombectomy System. Leading up to full-market
release, the Ultra System was broadly evaluated by experienced AngioJet
operators in several hospitals across the country. According to Possis,
cathlab staff found the Ultra System to be much faster to set up and
significantly easier to use than the previous generation AngioJet
System, while retaining the same therapeutic effectiveness and physician
response has been overwhelmingly positive.
Ultra Spiroflex Thrombectomy Set
Possis' new Ultra Thrombectomy System combines catheters and
pump sets into a single disposable device called a Thrombectomy Set. The
Spiroflex catheter was approved for coronary use with the previous
generation AngioJet System in January 2007. Recently, the FDA approved
the Ultra Spiroflex thrombectomy set for coronary use with the Ultra
System. The Ultra Spiroflex thrombectomy set is now cleared for both
coronary and peripheral use.
Said Dutcher, "Approval of the Ultra Spiroflex thrombectomy
set demonstrates the continued forward progress we're making with
our new Ultra System."
Spiroflex Catheters
In April 2007, the FDA approved Possis' AngioJet Spiroflex VG
rapid exchange catheter for thrombus removal in coronary conduits. First
introduced in July 2006 for removing thrombus in larger peripheral
arteries, the recent FDA approval allows the Spiroflex VG catheter to be
marketed for use in saphenous vein bypass grafts in the heart and larger
native coronary arteries.
Sharing the same platform technology, Possis' Spiroflex and
Spiroflex VG catheters are the company's most flexible and
maneuverable rapid exchange catheters. The Spiroflex and Spiroflex VG
catheters are now approved for thrombus removal in both coronary and
peripheral arteries. The Spiroflex catheter is uniquely suited for
thrombus removal in smaller native coronary arteries, while the
Spiroflex VG catheter provides more power and is specifically designed
for thrombus removal in bypass grafts in the heart and larger peripheral
and coronary arteries. According to Possis, interventions in saphenous
vein bypass grafts represent approximately 15 percent of all coronary
interventions. These bypass grafts are generally larger in diameter than
native coronary arteries and often contain larger, more difficult to
remove thrombus.
Non-AngioJet Products
Possis continues to make progress with its strategy to leverage the
company's enterprise strengths by bringing new endovascular
products to market. So far in fiscal 2007, Possis has introduced two new
non-AngioJet products; the Fetch Aspiration Catheter and the
SafeSeal" Hemostasis Patch. Both products have been well received
by customers and their combined sales represented 4 percent of total
revenue in the fiscal third quarter. In May 2007, the FDA approved the
company's application to specifically label the Fetch Aspiration
Catheter for use in coronary arteries, in addition to peripheral
arterial use.
Said Dutcher, "We're very pleased with this new, more
specific indication from the FDA. The Fetch aspiration catheter can now
be marketed more directly for the removal of fresh, soft, emboli and
thrombus from arteries in the coronary and peripheral vasculature. While
the AngioJet System remains the gold standard in thrombectomy, the Fetch
catheter provides physicians with a quick and simple means to aspirate
small amounts of fresh coronary thrombus."
"Our early success with the Fetch catheter has allowed us to
further position Possis as the complete solution for thrombus treatment.
Combined, our comprehensive product offering provides safe and effective
devices to remove thrombus throughout the body's vascular system
and positions Possis well for future growth."
As noted in Possis' second-quarter earnings release, the
initial market evaluation of the GuardDOG Occlusion Guidewire System
demonstrated its utility in temporarily occluding blood flow through a
vascular treatment field, offering physicians greater control when
employing endovascular catheter treatments such as AngioJet
thrombectomy. This initial clinical experience also highlighted the
market's desire for an even more flexible guidewire shaft. Further
development work towards this goal is proceeding, and Possis expects to
continue the initial clinical evaluation starting in the fiscal 2007
fourth quarter. Full U.S. market release of the GuardDOG System,
comprising a 0.035" diameter guidewire and later a 0.014"
guidewire, is expected later this calendar year. Clinical Science Update
Coronary Thrombectomy
Possis' JETSTENT clinical trial of AngioJet thrombectomy in
heart attack patients with large thrombus has enrolled 155 patients to
date at seven active sites, mostly in Europe, continuing toward the next
interim milestone of 225 patients expected later this calendar year.
Additionally, Possis continues its collaboration with a leading clinical
researcher and trialist to combine all suitable published clinical
experience with the AngioJet System in treating acute coronary syndrome
patients into a single large clinical dataset for a more sophisticated
meta-analysis of the safety and benefit of AngioJet thrombectomy in such
patients. The company expects this effort will be presented or published
later in 2007.
Finally, Possis continues to promote the important findings from
Dr. George Sianos and the Thoraxcenter in Rotterdam, the Netherlands.
This work shows that in heart attack patients, AngioJet thrombectomy to
remove large thrombus before placement of a drug-eluting stent (DES) is
associated with significantly lower rates of death, repeat heart attack
and stent thrombosis. Sianos' work was presented at four major
medical meetings in 2006, most recently the November annual meeting of
the American Heart Association. Additionally, it was also presented to
the Circulatory Systems Advisory Panel meeting convened by FDA in
December, and has been accepted by a major U.S. medical journal for
publication later this year.
Said Dutcher, "We believe these key results demonstrate that
unresolved thrombus at the time a drug-eluting stent is placed is a
significant cause of subsequent stent thrombosis; and that AngioJet
thrombectomy has an essential role to play in reducing overall rates of
stent thrombosis nationwide."
Peripheral Arterial Thrombus and Venous Thromboembolic (VTE)
Disease
Possis continues to develop several significant new clinical
science initiatives to support its peripheral vascular product
offerings. The company's new PEARL registry (PEripheral use of
AngioJet Rheolytic Thrombectomy with Mid-Length Catheters) is now
actively enrolling patients, with 52 enrolled to date. PEARL is a
Web-based registry of patient treatments and outcomes using the
mid-length DVX and Xpeedior AngioJet catheters. Eventually, PEARL will
involve 20 or more high-volume peripheral AngioJet thrombectomy centers,
and become a source of future case studies, scientific presentations,
and publications on the uses and clinical value of AngioJet treatment in
a variety of peripheral vascular disease challenges. The company plans
to include clinical experience with its GuardDOG product in the PEARL
registry as well. In addition, Possis expects the initial clinical
experiences with GuardDOG System will be the subject of scientific
presentations and publications. Several new articles have appeared in
recent medical literature presenting AngioJet thrombectomy and Power
Pulse" Spray for the treatment of deep vein thrombosis (DVT).
Recent presentations at the January meeting of the International Society
for Endovascular Therapy in Miami, Fla., and the February meeting of the
American Venous Forum in San Diego, Calif., have provided valuable new
clinical science and favorable exposure for the value Possis AngioJet
thrombectomy brings to treating VTE. Following the recent approved
indication for venous AngioJet thrombectomy, Possis continues to expand
its investment in new clinical science work to support the growing
peripheral market.
Business Outlook
Looking ahead, Possis Medical anticipates fourth-quarter net sales
of $17 million to $18 million and GAAP net income, which includes
stock-based compensation expense, of $0.00 to $0.02 per diluted share.
After adjustment to eliminate stock-compensation expense, net income
(non-GAAP) is expected to be in the range of $0.04 to $0.06 per diluted
share. For the current fiscal year ending July 31, 2007, Possis expects
net sales of $65 million to $66 million, with a gross margin of
approximately 70 percent. Net income per diluted share, which includes
the impact of stock-based compensation expense, is expected to be in the
range of $0.00 to $0.02 per share. After adjustment to eliminate
stock-compensation expense, net income (non-GAAP) per diluted share for
the year is estimated to range between $0.16 and $0.18 per share.
For the 2008 fiscal year, Possis' preliminary guidance
anticipates sales in the low to mid $70 million range.
About Possis Medical, Inc.
Possis Medical, Inc., develops, manufactures and markets pioneering
medical devices for the large and growing cardiovascular and vascular
treatment markets. The company's AngioJet System is the
world's leading mechanical thrombectomy system with FDA approval to
remove large and small thrombus from coronary arteries, coronary bypass
grafts, peripheral arteries and veins, A-V grafts and native fistulas.
For more information, call 763/450-8011 or visit
http://www.possis.com.
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