(Source: Canada Newswire)

VANCOUVER, Nov. 9 /CNW/ - Angiotech Pharmaceuticals, Inc.
(NASDAQ: ANPI, TSX: ANP) today announced its financial results for
the third quarter ended September 30, 2009.
"We were pleased to observe continued strong sales growth in our
Proprietary Medical Products business during the quarter, driven
primarily by increasing market adoption of our Quill(TM) SRS product
line," said Dr. William Hunter, President and CEO of Angiotech. "In
addition, our solid early results from our recent commercial launch
of the Option(TM) Inferior Vena Cava Filter and our preparations for
a potential 2010 launch of our 5-FU anti-infective product
candidates leave us increasingly optimistic about the opportunity to
further accelerate growth in our Proprietary Medical Products
business in 2010 and beyond."
Third Quarter Financial Highlights
- Total revenue was $63.2 million.
- Net product sales were $48.7 million. Sales of our Proprietary
Medical Products were $14.7 million, or 30% of total product
sales.
Sales of our Base Medical Products were $34.0 million, or 70% of
total
product sales.
- Royalty revenue was $14.5 million.
- Research and development expenses were $4.6 million.
- Selling, general and administrative expenses were $17.9
million.
- Net loss and net loss per share for the quarter were $7.8
million and
$0.09, respectively.
- As of September 30, 2009, cash and short-term investments were
$53.8
million and net debt was $521.2 million.
Selected Non-GAAP Financial Measures
- Certain financial measures in this press release are prepared
according to United States Generally Accepted Accounting
Principles
("GAAP"). In addition, certain financial measures presented below
and
in the appendix of this press release are non-GAAP, or adjusted,
financial measures that exclude certain items. Management uses
certain
non-GAAP, or adjusted, financial measures to establish
operational
goals, and believes that these measures may assist investors in
evaluating the results of our business and analyzing the
underlying
trends in our business over time. Investors should consider these
non-
GAAP adjusted financial measures in addition to, and not as a
substitute for, or as superior to, financial measures prepared in
accordance with GAAP. A reconciliation of the Company's non-GAAP
adjusted financial measures to the corresponding GAAP financial
measures, and an explanation of the Company's use of these non-
GAAP
adjusted financial measures and of the excluded items, is
included in
the Appendix of this press release.
- Adjusted EBITDA (earnings before interest, taxes, depreciation
and
amortization, adjusted to exclude certain non-cash and non-
recurring
items) was $15.3 million;
- Adjusted research and development expenses were $4.1 million;
- Adjusted selling, general and administrative expenses were
$17.1
million; and
- Adjusted net income and adjusted net income per share for the
quarter
were $0.1 million and $0.00, respectively.
Third Quarter Highlights
Proprietary Medical Products. Certain of our product lines, which
we refer to as our Proprietary Medical Products, are marketed and
sold by our two direct sales groups. We believe certain of these
product lines may contain technology advantages and thereby may
provide for more substantial revenue growth potential as compared to
our overall product portfolio. Our significant currently marketed
Proprietary Medical Products include (i) our Quill(TM) SRS wound
closure product line, which is marketed and sold by our Surgical
Products Sales Group, and (ii) our Option(TM) Inferior Vena Cava
("IVC") Filter, HemoStream(TM) chronic dialysis catheter, Skater(TM)
line of drainage catheters, BioPince(TM) full core biopsy device,
EnSnare(TM) retrieval device and V+Pad(TM) hemostatic pad, which are
marketed and sold by our Interventional Products Sales Group. Our
Proprietary Medical Products continued to demonstrate higher revenue
growth as compared to our overall product portfolio in the third
quarter, consistent with recent prior quarters. Revenue for these
products in the third quarter of 2009 increased by 33% as compared
to the third quarter of 2008 and by 9% as compared to the second
quarter of 2009. Excluding the impact of foreign currency changes
between the respective periods, the revenue growth figures indicated
above would have been 36% and 8%, respectively.
Base Medical Products. Certain of our product lines, which we
refer to as our Base Medical Products, represent more mature
finished goods product lines in the ophthalmology, biopsy and
general surgery areas, or medical device components manufactured by
us and sold to other third-party medical device manufacturers who
assemble those components into finished medical devices. Sales of
our Base Medical Products are supported by a small group of direct
sales personnel, as well as a network of independent sales
representatives and medical product distributors. Revenue from our
Base Medical Products tends to exhibit greater volatility or slower
relative growth, particularly our sales of components to third party
medical device manufacturers, which may be impacted by customer
concentration and business issues that certain of our large
customers may face, as well as to a more limited extent by economic
and credit market conditions.
Revenue from our Base Medical Products declined by 4% in the
third quarter of 2009 as compared to the third quarter of 2008, and
increased by 1% as compared to the second quarter of 2009. Excluding
the impact of foreign currency changes, revenue would have declined
by 3% as compared to the third quarter of 2008 and would have been
flat as compared to the second quarter of 2009.
The decline in our Base Medical Products sales as compared to the
third quarter of 2008 is due primarily to lower sales of medical
device components to other third party medical device manufacturers,
generally relating to certain customers that have postponed or
cancelled orders, or implemented inventory reduction programs in
response to changing economic and credit market conditions, and more
particularly relating to cancelled orders for surgical needles by
one of our largest customers. Manufacturing of surgical needles, as
of November 2008, was fully transferred to our facility in
Aguadilla, Puerto Rico from our facility in Syracuse, New York. We
believe that the closure of our Syracuse production facility in
November and the finalization of our move of surgical needle
production to Aguadilla, combined with the difficult economic and
credit market environment, may have continued to negatively impact
our Base Medical Product sales during the third quarter of 2009 as
compared to the third quarter of 2008. We currently expect that
certain of our customers may increase their order levels later in
2009 or in 2010, however, there can be no assurance that we will
record sales of surgical needles to these customers at levels
observed in prior periods.
Royalty Revenue. We derive additional revenue from royalties paid
to us by partners that develop, market and sell products
incorporating certain of our proprietary technologies. Currently,
the substantial majority of our royalty revenues are derived from
sales by Boston Scientific Corporation ("BSC") of TAXUS(R) coronary
stent systems incorporating the drug paclitaxel. TAXUS stents have
been evaluated by the industry's most extensive randomized,
controlled clinical trial program, with patient follow-up out to
five years in some cases. BSC's controlled clinical trial results
have been supplemented by data on more than 35,000 patients enrolled
in post-approval registries. To date, over 4.6 million TAXUS stents
have been implanted globally.
Royalty revenue derived from sales of TAXUS stent systems by BSC
for the third quarter of 2009 decreased by 29% as compared to the
third quarter of 2008, and decreased by 14% as compared to the
second quarter of 2009. The decrease in royalty revenues received
from BSC is primarily due to the entry of new competitors into the
drug-eluting coronary stent market during the second half of 2008
and the resulting shifts in market share among these competitors
over the past four consecutive quarters.
Royalty revenue for the third quarter of 2009 was based on BSC's
net sales for the period April 1, 2009 to June 30, 2009 of $226
million, of which $96 million was in the United States, compared to
BSC net sales of $298 million, of which $144 million was in the
United States, for the same period in 2008, and compared to BSC net
sales of $252 million, of which $119 million was in the United
States, for the period January 1, 2009 to March 30, 2009 from which
our second quarter royalty revenue was derived. The average gross
royalty rate earned in the third quarter of 2009 on BSC's net sales
was 6.2% for sales in the United States and 6.1% for sales in other
countries.
Option Inferior Vena Cava Filter. In June 2009, we announced that
the United States Food and Drug Administration ("FDA") had granted
510(k) clearance for the Option IVC Filter, for use in both
permanent and retrievable indications. In August 2009, we announced
the commercial launch of the Option IVC Filter in the United States.
The Option IVC Filter was licensed in March 2008 from our partner
Rex Medical L.P.
IVC filters are implanted in patients that are at high risk for
developing pulmonary embolism, which can be a life threatening
condition. IVC filters are implanted in the inferior vena cava and
are designed to catch clot material to prevent it from reaching the
lungs, while allowing blood to continue to flow normally. In 2008,
there were approximately 220,000 IVC filters implanted in the United
States.
We believe the Option IVC Filter may have a number of potential
competitive benefits, which include a unique filter design that may
reduce the potential for filter migration after implantation,
thereby making the product safer for patients, insertion potential
through either the femoral or jugular route, which may make the
product easier for a physician to use, and the use of non-
thrombogenic material, which may reduce the risk of blood clots
occurring in the filter. We also believe the unique design of the
Option IVC Filter may allow physicians to remove or retrieve the
device from patients more easily, or after longer periods of time
have passed, as compared to existing competitive IVC filters.
The Option IVC Filter was approved based upon the results of a
United States multi-center prospective clinical trial. The purpose
of the clinical trial was to evaluate the device's safety and
efficacy in preventing pulmonary emboli, and to assess the ability
to retrieve the device from the body up to 175 days following
implantation. The results, representing a total of 100 patients,
were presented at the 2009 Society of Interventional Radiology in
San Diego, CA on March 9, 2009. Successful filter implantation was
achieved in 100% of the subjects and the retrieval success rate in
the study was 92.3%. Clinical success, which was achieved in 88% of
subjects, was defined as placement of the filter without subsequent
pulmonary embolism, significant filter migration or embolization,
symptomatic caval thrombosis or other complications requiring filter
removal or invasive intervention.
Quill SRS. In August 2009, we announced the launch of a new
series of our proprietary Quill SRS products specifically designed
for laparoscopic, or minimally invasive, gynecology procedures,
including hysterectomies and myomectomies.
In 2008, there were approximately 750,000 hysterectomies
performed in the United States, of which approximately 130,000 were
performed laparoscopically. In addition, there were approximately
72,000 myomectomies performed in the United States to remove uterine
fibroid tumors. Angiotech's proprietary Quill SRS technology may
offer significant advantages in wound closure in certain
laparoscopic surgical procedures, whether performed manually or
through robotic assistance. We believe the primary potential
advantage of Quill SRS in certain laparoscopic procedures is the
ability to use Quill SRS to close a wound without having to tie
knots. The exercise of tying knots can be particularly challenging
and time-consuming when surgeons operate in a smaller surgical
field, as is the case for most laparoscopic surgical procedures. A
second potential advantage for Quill SRS in these procedures is
minimizing or eliminating the need for a third hand to maintain
tension on the suture, as may be required with a traditional
suturing technique in order to deal with tissue recoil. A third
potential advantage of Quill SRS in these procedures is the ability
of Quill SRS to maintain the tension along the length of the wound,
which may provide hemostatic benefits and thereby eliminate or
minimize the need for standard hemostatic sutures. Patients may also
benefit as a result of these potential advantages through reduced
surgical times, and therefore reduced time under anesthesia, and
health care facilities and payors may also benefit from the
potential to reduce operating room time needed, or the total cost of
material needed, to complete such surgical procedures.
Our new Quill SRS product codes for laparoscopic gynecology
procedures are available in our polydioxanone (PDO) suture material
in size -0- with 7 cm by 7 cm and 14 cm by 14 cm lengths, and
include our newly designed 36 mm needles. The use of Quill SRS in
laparoscopic gynecological surgery was first reported by James
Greenberg, MD, and Jon Einarsson, MD, MPH, of the Centre for Women's
Surgery at Brigham & Women's/Faulkner Hospitals and Harvard Medical
School Boston, Massachusetts in the Journal of Minimally Invasive
Gynecology, in November 2008. The results of this small feasibility
study looked at the application of Quill SRS in myomectomy and total
laparoscopic hysterectomy vaginal cuff closures. This publication
was then followed by up by a podium presentation at the American
Association of Gynecologic Laparoscopists (AAGL) annual meeting in
the fall of 2008 confirming that there were no post operative issues
or complications from the use of Quill SRS in a patient series that
had grown to 150 patients as of that date.
ZILVER(R) PTX(R) - CE Mark Approval. In August 2009, we announced
that our partner Cook Medical Inc. ("Cook"), had reported CE Mark
approval and commercial launch of the ZILVER PTX paclitaxel-eluting
peripheral vascular stent in Europe. The ZILVER PTX stent, which is
under evaluation in clinical trials being conducted by Cook, is a
specialized stent product incorporating our proprietary paclitaxel
technology and is designed for placement in diseased arteries in the
limbs to restore blood flow. Cook licenses the rights to use
paclitaxel with peripheral stents and certain other non-coronary
medical devices from us. Subject to the terms of our license
agreement with Cook, we are entitled to receive royalty payments
upon the commercial sale of paclitaxel-eluting peripheral vascular
stent products, including the ZILVER PTX stent.
Financial Information
---------------------
This press release contains financial data derived from the
unaudited consolidated interim financial statements for the three
and nine month periods ended September 30, 2009, and 2008. Full
unaudited consolidated interim financial statements and Management's
Discussion and Analysis for the three and nine month periods ended
September 30, 2009 and 2008 will be filed with the relevant
regulatory agencies, as well as posted on our website at
www.angiotech.com.
Amounts, unless specified otherwise, are expressed in U.S.
dollars. Financial results are reported under U.S. GAAP unless
otherwise noted. All per share amounts are stated on a diluted basis
unless otherwise noted.
Conference Call Information
---------------------------
A conference call to discuss these financial results will be held
today, Monday, November 9, 2009 at 8:00 AM PT (11:00 AM ET).
Dial-in information:
North America (toll-free): (800) 599-9829
International: (617) 847-8703
Enter Passcode: 64385781
An archived replay of the call will be available until November
16, 2009.
North America (toll-free): (888) 286-8010
International: (617) 801-6888
Enter Passcode: 36157253
A live webcast will be available to all interested parties
through the Investors section of Angiotech's website:
www.angiotech.com/investors
ANGIOTECH PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Nine Months Ended
September 30 September 30
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2009 2008 2009 2008
[restated] [restated]
-------------------------------------------
REVENUE
Royalty revenue $ 14,531 $ 21,405 $ 48,638 $
75,871
Product sales, net 48,660 46,502 141,976
144,761
License fees 53 453 25,503
558
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63,244 68,360 216,117 221,190
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--------
EXPENSES
License and royalty fees 2,463 3,452 7,937
11,484
Cost of products sold 25,958 24,772 75,606
77,430
Research and development 4,596 10,658 17,526
45,468
Selling, general and
administration 17,924 23,370 59,102
77,100
Depreciation and amortization 8,285 8,560 24,845
25,577
In-process research and
development - - -
2,500
Write-down of goodwill - 599,400 -
599,400
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59,226 670,212 185,016 838,959
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--------
Operating income (loss) 4,018 (601,852) 31,101
(617,769)
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--------
Other income (expenses):
Foreign exchange (loss) gain (518) 1,009 (1,227)
1,569
Investment and other
income (expense) 46 187 74
1,630
Interest expense on
long-term debt (9,286) (10,790) (28,971)
(33,851)
Write-down / loss on
investments - (1,901) -
(12,561)
Write-down and other deferred
financing charges - (13,544) (643)
(13,544)
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--------
Total other expenses (9,758) (25,039) (30,767)
(56,757)
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--------
(Loss) / income before
income taxes (5,740) (626,891) 334
(674,526)
Income tax expense (recovery) 2,062 (4,513) 7,569
(10,314)
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--------
Net loss $ (7,802) $(622,378) $ (7,235)
$(664,212)
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--------
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--------
Basic and diluted net loss
per common share $ (0.09) $ (7.31) $ (0.08) $
(7.80)
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--------
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--------
Basic and diluted weighted
average number of common
shares outstanding
(in thousands) 85,136 85,122 85,125
85,117
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ANGIOTECH PHARMACEUTICALS INC.