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
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