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| SPNC > SEC Filings for SPNC > Form 10-Q on 11-May-2009 | All Recent SEC Filings |
11-May-2009
Quarterly Report
Item 2. Management's Discussion and Analysis of Results of Operations and
Financial Condition (Cont'd)
In October 2005, we received 510(k) clearance from the FDA to incorporate
several new features (80-Hz capability, "continuous on" lasing and lubricous
coating) into our entire CLiRpath product line. The launch of this CLiRpath
Turbo product line, to replace the CLiRpath catheters, was completed in the
third quarter of 2006. In October 2006, we received FDA clearance to market our
Turbo Elite® product line, which added improved pushability, trackability and
ablation capability as a result of an improved outer jacket and inner guidewire
lumen, as well as additional laser fibers in most sizes, to our CLiRpath Turbo
lines. Full transition to this product line was substantially completed in early
2007.
In July 2007, we received clearance from the FDA to market our
Turbo-Booster®product for the treatment of arterial stenoses and occlusions in
the leg. The Turbo-Booster functions as a guiding catheter facilitating directed
ablation of blockages in the main arteries at or above the knee. The
Turbo-Booster combined with Turbo Elite laser catheters allows for removal of
large amounts of plaque material within the superficial femoral artery (SFA) and
popliteal artery. This approval represented a broader indication for use as
compared to previous labeling of the existing peripheral laser catheters. We
began a limited market launch of the Turbo-Booster product in the third quarter
of 2007, and a full launch was completed in the fourth quarter of 2007.
In May 2008, we completed the acquisition of the endovascular business of Kensey
Nash Corporation (KNC). Pursuant to an Asset Purchase Agreement among us and
KNC, we purchased from KNC all of the assets related to KNC's QuickCat™,
ThromCat® and SafeCross®product lines for $11.7 million in cash, including
acquisition costs of $0.8 million and including a first milestone payment of
$1.0 million paid to KNC in October 2008. The primary reason for the acquisition
of these product lines was to leverage our existing sales organization while
extending our product offering in the area of thrombus management. Under the
terms of the Agreement, we will pay KNC an additional $6 million once cumulative
sales of the acquired products reach $20 million, and up to $7 million is
payable based on various product development and regulatory milestones
associated with the next generation ThromCat devices.
We simultaneously entered into a Manufacturing and License Agreement pursuant to
which KNC will manufacture for us the endovascular products acquired by us under
the Asset Purchase Agreement, and we will purchase such products exclusively
from KNC for specified time periods. Revenue from these products subsequent to
the acquisition date are included in our reported Vascular Intervention
disposable products revenue. Additionally, we and KNC also entered into a
Development and Regulatory Services Agreement pursuant to which KNC will conduct
work to develop, on our behalf, certain next-generation SafeCross and ThromCat
products at KNC's expense. We will own all intellectual property resulting from
this development work. If clinical studies are required to obtain regulatory
approval from the FDA for those next-generation products, the costs will be
shared equally by us and KNC. KNC additionally will be responsible, at its own
expense, for regulatory filings with the FDA that are required to obtain
regulatory approval from the FDA for the next-generation products.
On September 4, 2008, we were jointly served by the FDA and the Immigration and
Customs Enforcement (ICE) with a search warrant issued by the United States
District Court, District of Colorado. The search warrant requested information
and correspondence relating to: (i) the promotion, use, testing, marketing and
sales regarding certain of the company's products for the treatment of in-stent
restenosis, payments made to medical personnel and an identified institution for
this application, (ii) the promotion, use, testing, experimentation, delivery,
marketing and sales of catheter guidewires and balloon catheters manufactured by
certain third parties outside of the United States, (iii) two post-market
studies completed during the period from 2002 to 2005 and payments to medical
personnel in connection with those studies and (iv) compensation packages for
certain of the company's personnel. We are cooperating with the appropriate
authorities regarding this matter. See Part II, Item 1, "Legal Proceedings" and
Note 11, "Commitments and Contingencies" for a discussion of this and other
legal proceedings in which we are involved.
Item 2. Management's Discussion and Analysis of Results of Operations and
Financial Condition (Cont'd)
In December 2008, we received clearance from the FDA for the Quick-Cross®
Extreme® product line, which represents an extension of our Quick-Cross support
catheters. We launched this product line in December 2008. The FDA clearance
followed the recent receipt of the CE Mark in Europe and approval to market
these products in Canada. The Quick-Cross Extreme product line is intended for
use to guide and support a guide wire during access of the vasculature, allow
for wire exchanges and provide a conduit for the delivery of saline solutions or
diagnostic contrast agents. The Quick-Cross Extreme is designed to facilitate
the crossing of blockages in the legs and features a braided catheter and an
angled tip. The braided catheter jacket improves strength and pushability while
the angled tip allows for quicker access into branched anatomy. This was an
upgrade to the previous Quick-Cross product line and is available for 0.035"
guide wire compatibility in 65 cm, 90 cm, 135 cm, and 150 cm lengths.
In December 2008, we also received clearance from the FDA to market our
Cross-Pilot™ laser support catheter. We launched the product during the first
quarter of 2009 within the United States, Europe and Canada. The Cross-Pilot is
a laser support catheter for the 0.9 mm Turbo Elite laser ablation catheter. The
Cross-Pilot was designed to provide additional support for reaching distal
lesions. The braid reinforced catheter construction and hydrophilic coating
allow for better pushability through distal vessels and the angled tip allows
for quicker access to branched anatomy. The Cross-Pilot Laser Support Catheter
is currently offered in 125 cm length and straight and angled tip
configurations.
Results of Operations
Financial Results by Geographical Segment
Our two reporting segments consist of United States Medical, which includes the
United States and Canada, and International Medical, which includes Europe, the
Middle East, Asia Pacific, Latin America and Puerto Rico.
For the three months ended March 31,
(in thousands) 2009 2008
Revenue
United States $ 23,528 86 % $ 21,258 89 %
International 3,775 14 2,573 11
Total revenue $ 27,303 100 % $ 23,831 100 %
For the three months ended March 31,
(in thousands) 2009 2008
Net (loss) income
United States $ (3,231 ) $ (624 )
International 394 219
Total net loss $ (2,837 ) $ (405 )
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