ANGIOTECH PHARMACEUTICALS, INC.
(Registrant's name)
Indicate by check mark whether the registrant files or will
file annual reports under cover Form 20-F or Form 40-F.
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.
If "Yes" is marked, indicate below the file number assigned to
the registrant in connection with Rule 12g3-2(b): 82-__________
.
Quill is a trademark of Quill Medical, Inc., a wholly-owned
subsidiary of Angiotech Pharmaceuticals, Inc.
©2008 Angiotech
Pharmaceuticals, Inc. All Rights Reserved.
Vascular Wrap is a trademark of
Angiotech Pharmaceuticals, Inc.
BioPince is a trademark of Medical Device
Technologies, Inc.
Skater is a trademark of PBN MEDICALS DENMARK A/S.
MultiStem
®
is a registered trademark of Athersys, Inc.
TAXUS
®
is a registered trademark of Boston Scientific
Corporation.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
ANGIOTECH PHARMACEUTICALS, INC.
Date: February 14, 2008
|
By: /s/
|
|
Name: K. Thomas Bailey
|
|
Title: Chief Financial Officer
|
Page 3 of 15
Exhibit 1
Page 4 of 15
FOR IMMEDIATE RELEASE
PRESS RELEASE
February 14,
2008
ANGIOTECH ANNOUNCES RESULTS FOR THE FOURTH QUARTER ENDED
DECEMBER 31, 2007
Vancouver, BC, February 14, 2008
Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty
pharmaceutical and medical device company, today announced unaudited interim and
annual consolidated financial results for the fourth quarter and year ended
December 31, 2007. The unaudited financial results are subject to further review
and potential adjustment as described under the section Financial
Information.
Throughout 2007, we continued to build our business with the
launch of new products, the receipt of regulatory approvals, and the
establishment of new partnerships. We expect our new product pipeline and our
portfolio of innovative currently marketed products to provide growth and
opportunity in 2008 and beyond, said Dr. William Hunter, President and CEO of
Angiotech.
With our expanded sales and marketing team in place and many
of our reorganization activities completed, we believe that we are well
positioned to achieve our targets for sales growth and gross margin improvements
in the coming year, said Tom Bailey, Chief Financial Officer of Angiotech. We
are confident that during 2008 we will begin to realize returns on the various
investments we have made in our business over the last two years.
Fourth Quarter Financial Highlights
-
Total revenue, as adjusted for non-recurring items, was $70.7 million.
Total revenue under generally accepted accounting principles (GAAP) was $71.4
million.
-
Net product sales, as adjusted, were $43.5 million, and were derived
primarily from sales of our various single use specialty medical devices as
well as from sales of medical device components to third parties. Net product
sales under GAAP were $43.9 million.
-
Royalty revenue was $27.2 million, and included $25.4 million of royalty
revenue derived from sales by Boston Scientific Corporation (BSC) of
paclitaxel-eluting coronary stent systems. The average blended royalty rates
indicated during the quarter were 7.5 percent for U.S. sales, and 5.7 percent
for sales recorded in other countries.
-
Adjusted EBITDA (earnings before interest, taxes, depreciation and
amortization, adjusted to exclude certain non-cash and non-recurring items)
was $6.8 million. Excluding research and development expenses, the significant
majority of which are discretionary and relate primarily to our Pharmaceutical
Technologies segment, adjusted EBITDA would be $20.2 million.
-
GAAP net loss and net loss per share from continuing operations were $16.8
million and $0.20, respectively.
-
Adjusted net loss from continuing operations and adjusted net loss per
share from continuing operations (GAAP net loss as adjusted to exclude certain
non-cash and non-recurring items) were $7.5 million and $0.09, respectively.
-
As of December 31, 2007, cash and long-term investments were $115.8
million and net debt was $465.8 million.
Fourth Quarter Business Highlights
-
5-FU Central Venous Catheter (CVC)
.
In December
2007 we submitted a 510(k) application to the U.S. Food and Drug
Administration (FDA) to market and sell our 5-FU CVC. We expect the clinical data from our recently completed 960
patient clinical trial, which evaluated the clinical performance of our 5-FU CVC
as compared to a market leading anti-infective CVC, to be presented by the
clinical investigators at the ISICEM 28th International Symposium on Intensive
Care and Emergency Medicine in Brussels, Belgium on March 18, 2008. Should our
5-FU CVC product candidate receive FDA marketing clearance, we would anticipate
commencing commercial launch activities in the second half of 2008.
Page 5 of 15
-
Quill SRS
:
In October 2007 we received CE Mark
approval to begin marketing the Quill Self- Retaining System (SRS) MONODERM
product line in Europe. In addition, we exceeded our stated goal of 100 Quill
SRS hospital accounts by the end of 2007, and expect to expand the number of
Quill SRS SKUs available for sale to our customers in 2008.
-
Vascular Wrap
TM
:
Enrolment
in our AV access human clinical trials in the U.S. and Europe continues and we
currently expect to complete enrolment in these studies around the end of the
first half of 2008.
-
Stem Cell Therapies
:
In December 2007 our partner,
Athersys, Inc. received authorization from the U.S. FDA to begin a Phase I
clinical trial evaluating the safety of MultiStem
®
in the treatment
of acute myocardial infarction. We have an agreement with Athersys to
co-develop and commercialize MultiStem
®
, Athersys non-embryonic
stem cell platform technology, for use in the indications of acute myocardial
infarction and peripheral vascular disease.
-
TAXUS
®
paclitaxel-eluting
stent systems
: In December 2007 our partner, BSC, announced that the
TAXUS
®
Liberte
TM
paclitaxel-eluting coronary stent
system received European CE Mark approval for use in diabetic patients.
2008 Outlook
Our financial outlook for the upcoming fiscal year ending
December 31, 2008 is presented below. Several material factors and assumptions
were used to derive our 2008 outlook, including: (i) estimates of medical
procedure and patient population growth rates for the various end markets
relating to our medical products business; (ii) estimates of the impact of
pricing changes, pricing strategies and competition with respect to certain of
our currently marketed medical products; (iii) competitive analysis and
estimates of relative market share with respect to certain key product lines;
(iv) estimates of revenue growth and customer composition relating to our sales
of medical device components to other medical products companies; (v) analysis
of the impact of our manufacturing consolidation, product sales mix and pricing
on cost of goods sold; (vi) estimates of selling, general and administrative
expenses necessary to support our revenue growth and overall business goals; and
(vii) estimates of research and clinical expenses necessary to support our
various new product development and research programs.
The outlook presented below contains estimates of certain
expenses based on non-GAAP measures, and are prepared consistent with our
current and previous presentations of our historical financial information.
Specifically, our outlook for research and clinical expenses, sales and
marketing expenses and general and administrative expenses exclude estimates for
stock based compensation expenses, for certain non-recurring expenses expected
to be incurred in the first half of 2008 related to the completion of the
consolidation of our Syracuse, NY operations, and for certain litigation related
expenses. The estimates for these certain operating expenses are inherently
unpredictable or subject to significant fluctuation for reasons unrelated to our
business performance.
The key elements of our 2008 outlook are as follows:
-
Medical Products year over year total revenue growth goal of 15% or
greater, with higher growth expected from several selected promoted brand
product lines, including Quill SRS, Skater
TM
drainage catheters,
EnSnare
®
vascular retrieval devices, and our BioPince
TM
biopsy needle franchise, among others;
-
Improvements in gross margins as compared to 2007, driven by a combination
of expected improvements in product sales mix and the expected completion of
the consolidation and closure of our operations in Syracuse, New York;
Page 6 of 15
-
Research and clinical expenses ranging from $45 to $50 million, with
expenses weighted to the first half of 2008, driven primarily by continued
clinical, manufacturing and pre-launch activities related to our 5-FU CVC and
Vascular Wrap
TM
product candidates;
-
Sales and marketing expenses ranging from $50 to $60 million, driven by
the achievement of stated sales goals and the incurrence of a full year of
certain expenses related to the 2007 expansion of our sales and marketing
personnel;
-
General and administrative expenses ranging from $40 to $45 million,
reflecting continued reductions in selected administrative expenses as
compared to 2007; and
-
Capital expenditures ranging from $12 to $15 million.
Our financial outlook is forward-looking information, and
actual results may be materially different from any results, events or
developments expressed or implied by our financial outlook. We expect our
financial results may vary from the outlook provided as a result of several key
factors, including the progress of our various research, clinical development
and product launch initiatives, the achievement of selected sales growth targets
and the timing of product sales growth, the outcome of various ongoing
partnering, business development and financing discussions, and the level of
royalty revenues we receive from our partner BSC in future periods and the
impact such results may have on our election to pursue certain discretionary
aspects of our budgeted expenses in 2008. It is expected that, at the present
time, we will have adequate cash and liquidity resources to execute our various
research, product development and growth initiatives in 2008.
Our financial outlook is provided to give investors an
assessment of our expected financial results and our future business, and may
not be appropriate for any other purposes. Given the risks, uncertainties and
assumptions associated with such information, readers are cautioned not to place
undue reliance on our financial outlook. Except as required by law, we disclaim
any obligation to update our financial outlook.
Financial Information
This press release contains the condensed financial information
derived from the preliminary unaudited interim consolidated financial statements
for the three month periods ended December 31, 2007 and 2006, and preliminary
unaudited consolidated financial statements for the years ended December 31,
2007 and 2006 as previously reported. The unaudited financial information
presented should be considered preliminary and is subject to potential
adjustments, including, but not limited to, potential adjustments to certain tax
related items, pending the conclusion of the 2007 year-end audit. Upon
completion of the 2007 year-end audit process and the approval of our full year
2007 audited consolidated financial statements by our Board of Directors, full
audited consolidated financial statements and Managements Discussion and
Analysis for the three years ended December 31, 2007, will be filed with the
relevant regulatory agencies, as well as posted on our website at
www.angiotech.com.
We completed the acquisition of the operations of American
Medical Instruments Holdings, Inc. (AMI) on March 23, 2006. Because of the
timing of the AMI acquisition, our operating results for the twelve month period
ended December 31, 2006 include AMIs results of operations from the period of
March 24, 2006 to December 30, 2006, as compared to the current twelve month
period which reflects combined results for the full year. As a result, our
results for the twelve months ended December 31, 2007 do not reflect a
comparable operating period as compared to the nine months ended December 31,
2006.
Amounts, unless specified otherwise, are expressed in U.S.
dollars. Financial results are reported under GAAP unless otherwise noted. All
per share amounts are stated on a diluted basis unless otherwise noted.
Use of Certain Non GAAP Financial Measures
Certain financial results presented in this press release
include non-GAAP measures that exclude certain items. Adjusted net loss from
continuing operations, adjusted net loss per share from continuing operations
and adjusted earnings before interest, taxes, depreciation and amortization
(Adjusted EBITDA) exclude certain non-cash and non-recurring items such as
acquisition related amortization charges, acquired in-process research and development relating to license agreements
and acquisitions,stock-based compensation expense,
Page 7 of 15
foreign exchange gains or
losses relating to translation of foreign currency cash and investment balances
and other non-recurring items. Adjusted net loss from continuing operations,
adjusted net loss per share from continuing operations and adjusted EBITDA also
exclude litigation expenses related to defending intellectual property claims.
Revenue, as adjusted, excludes non-recurring, non-operating revenue derived from
license agreements and other license revenue, net of license fees due to
licensors and excludes amounts accrued for costs incurred, and potential future
costs, related to our offer to accept returns of Contour Threads brand product
as part of our announced brand name consolidation and discontinuation. Adjusted
net loss from continuing operations, adjusted net loss per share from continuing
operations, revenue, as adjusted, and adjusted EBITDA do not have any
standardized meaning prescribed by GAAP and therefore may not be comparable to
similar measures presented by other issuers. Management uses these non-GAAP or
adjusted operating measures to establish operational goals, and believes that
these measures may assist investors in analyzing the underlying trends in our
business over time. Investors should consider these non-GAAP measures in
addition to, not as a substitute for, or as superior to, financial reporting
measures prepared in accordance with GAAP. We have provided a reconciliation of
these measures to GAAP in the attached tables.
The financial outlook referred to above presents certain
forward-looking, non-GAAP financial information for which at this time there is
no calculable comparable GAAP measure. As a result, such non-GAAP financial
information cannot be quantitatively reconciled to comparable GAAP financial
information. Specifically, the estimates for certain operating expenses referred
to above exclude estimates of certain expenses that are inherently unpredictable
or subject to significant fluctuation for reasons unrelated to our business
performance, including stock-based compensation expenses, certain litigation
expenses and foreign exchange gains or losses.
Conference Call Information
A conference call to discuss these financial results will be
held today, Thursday, February 14, 2008 at 8:00 AM PT (11:00 AM ET).
Dial-in information:
|
North America (toll free): (866) 510-0711
|
International: (617) 597-5379
|
Enter passcode: 91184096
|
A replay archive of the conference call will be available until
February 21, 2008 by calling (888) 286-8010 (in North America) or (617) 801-6888
(International) and entering Access Code 85112963.
A live webcast will be available to all interested parties
through the Investors section of Angiotechs website:
www.angiotech.com
.
Page 8 of 15
ANGIOTECH PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
(Unaudited)
|
|
Three months ended
|
|
Three months ended
|
|
(in thousands of
U.S.$, except share and per share data)
|
December 31, 2007
|
|
December 31, 2006
|
|
|
Reported
|
Adjustments
|
Adjusted
|
Reported
|
Adjustments
|
Adjusted
|
REVENUE
|
|
|
|
|
|
|
Royalty revenue
|
27,158
|
|
27,158
|
47,475
|
(9,000) a
|
38,475
|
Product sales, net
|
43,935
|
(401) b
|
43,534
|
44,726
|
|
44,726
|
License fees
|
266
|
(266)
c
|
-
|
1,052
|
(1,052) c
|
-
|
|
71,359
|
(667)
|
70,692
|
93,253
|
(10,052)
|
83,201
|
EXPENSES
|
|
|
|
|
|
|
License and royalty fees
|
4,527
|
|
4,527
|
6,048
|
|
6,048
|
Cost of products sold
|
24,158
|
(665) d
|
23,493
|
22,465
|
|
22,465
|
Research and development
|
13,556
|
(150) e
|
13,406
|
12,165
|
(500) e
|
11,665
|
Selling, general and administrative
|
27,180
|
(3,674) f
|
23,506
|
24,227
|
(6,229) f
|
17,998
|
Depreciation and amortization
|
8,826
|
(7,993) g
|
833
|
14,288
|
(13,316) g
|
972
|
In-process
research and development
|
125
|
(125)
h
|
-
|
|
|
|
|
78,372
|
(12,607)
|
65,765
|
79,193
|
(20,045)
|
59,148
|
Operating
(loss) income
|
(7,013)
|
11,940
|
4,927
|
14,060
|
9,993
|
24,053
|
Other income (expenses):
|
|
|
|
|
|
|
Foreign exchange gain (loss)
|
173
|
(173) i
|
-
|
(1,263)
|
1,263 i
|
-
|
Investment and other income
|
511
|
155 n
|
666
|
1,028
|
4 n
|
1,032
|
Interest expense on long-term debt
|
(12,774)
|
558 j
|
(12,216)
|
(11,891)
|
699 j
|
(11,192)
|
Loss on redemption of investments
|
-
|
-
|
-
|
126
|
(126) l
|
-
|
Loss on
extinguishment of debt
|
-
|
-
|
-
|
(9,297)
|
9,297
m
|
-
|
|
(12,090)
|
540
|
(11,550)
|
(21,297)
|
11,137
|
(10,160)
|
Income (loss) from continuing operations before
income
|
|
|
|
|
|
|
taxes and cumulative effect of change in
accounting
|
(19,103)
|
12,480
|
(6,623)
|
(7,237)
|
21,130
|
13,893
|
Income tax expense
(recovery)
|
(2,275)
|
3,149
k
|
874
|
(1,977)
|
3,880
k
|
1,903
|
Net (loss) income from continuing
operations before
|
|
|
|
|
|
|
cumulative
effect of change in accounting
|
(16,828)
|
9,331
|
(7,497)
|
(5,260)
|
17,250
|
11,990
|
Net loss from discontinued operations, net of income taxes
|
(4,448)
|
4,448
|
-
|
(6,443)
|
6,443
|
-
|
Net (loss) income for the period
|
(21,276)
|
13,779
|
(7,497)
|
(11,703)
|
23,693
|
11,990
|
|
|
|
|
|
|
|
Basic net (loss) income per common share from
continuing
|
|
|
|
|
|
|
operations
|
(0.20)
|
|
(0.09)
|
(0.06)
|
|
0.14
|
Diluted net (loss) income per common share from
|
|
|
|
|
|
|
continuing operations
|
(0.20)
|
|
(0.09)
|
(0.06)
|
|
0.14
|
Weighted average shares outstanding (000s) basic
|
85,030
|
|
85,030
|
84,984
|
|
84,984
|
Weighted average shares outstanding (000s) diluted
|
85,030
|
|
85,030
|
85,547
|
|
85,547
|
a.
|
One time revenue gain resulting from the up-front monetization of a
royalty revenue stream to be received from our collaboration and
distribution partnership with Orthovita.
|
|
|
b.
|
Amounts accrued for costs incurred, and potential future costs,
related to our offer to accept returns of Contour Threads brand product as
part of consolidation and discontinuation of the Contour Threads brand
name, coincident with the launch of our Quill SRS brand name.
|
|
|
c.
|
Non-recurring revenue relating to selected licence agreements, net of
licence fees due to licensors.
|
|
|
d.
|
Change in estimate of accounting for excess and obsolete inventory
resulting from the alignment during the fourth quarter of 2007 of
inventory policies across our various manufacturing operations.
|
|
|
e.
|
Stock-based compensation expense.
|
|
|
f.
|
Selling, general and administrative adjustments:
|
f
|
|
Three months
|
Three months
|
|
|
ended Dec. 30,
|
ended Dec.
|
|
|
2007
|
30, 2006
|
|
Stock-based compensation
expense
|
(439)
|
(799)
|
|
Termination and reorganization costs
related to facility consolidation and integration activities
|
(3,526)
|
(1,879)
|
|
Litigation expenses
relating to defending intellectual property claims
|
291
|
(3,551)
|
|
|
(3,674)
|
(6,229)
|
g.
|
Amortization of acquisition related intangible assets and medical
technologies.
|
|
|
h.
|
Non-recurring in-process research and development relating to payments
made to collaborators and licensors, including to CombinatoRx Inc. and Rex
Medical Inc., and a non-recurring license termination payment of $125,000
to Lipose Corporation made in October 2007.
|
|
|
i.
|
Foreign exchange fluctuations on foreign currency net monetary assets.
|
|
|
j.
|
Amortization of deferred financing costs.
|
|
|
k.
|
Tax effects of adjustments for the period. Comparative for 2006 also
includes non-recurring retroactive tax adjustment of $8.7 million relating
to certain tax structures previously established in the province of
Quebec, from which the previously expected benefits are not anticipated to
be realized.
|
|
|
l.
|
Loss on redemption of investments.
|
|
|
m.
|
Loss on extinguishment of the term loans related to our December 2006
senior floating rate note refinancing.
|
|
|
n.
|
Includes write off of AMI tax receivable and write off of certain
capitalized costs.
|
Page 9 of 15
ANGIOTECH PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
(Unaudited)
|
|
|
Year ended
|
|
|
Year ended
|
|
(in thousands of
U.S.$, except share and per share data)
|
|
December 31, 2007
|
|
|
December 31, 2006
|
|
|
Reported
|
Adjustments
|
Adjusted
|
Reported
|
Adjustments
|
Adjusted
|
REVENUE
|
|
|
|
|
|
|
Royalty revenue
|
116,659
|
|
116,659
|
175,254
|
(9,000) a
|
166,254
|
Product sales, net
|
170,193
|
2,579 b
|
172,772
|
138,590
|
|
138,590
|
License fees
|
842
|
(842)
c
|
-
|
1,231
|
(1,231) c
|
-
|
|
|
|
|
|
|
|
|
287,694
|
1,737
|
289,431
|
315,075
|
(10,231)
|
304,844
|
EXPENSES
|
|
|
|
|
|
|
License and royalty fees
|
18,652
|
|
18,652
|
25,409
|
|
25,409
|
Cost of products sold
|
95,529
|
(2,645) d
|
92,884
|
68,263
|
|
68,263
|
Research and development
|
53,963
|
(4,582) e
|
49,381
|
45,393
|
(2,490) e
|
42,903
|
Selling, general and administrative
|
99,713
|
(16,868) f
|
82,845
|
78,732
|
(17,262) f
|
61,470
|
Depreciation and amortization
|
33,429
|
(29,971) g
|
3,458
|
36,014
|
(32,707) g
|
3,307
|
In-process research and development
|
8,125
|
(8,125) h
|
-
|
1,042
|
(1,042) h
|
-
|
|
309,411
|
(62,191)
|
247,220
|
254,853
|
(53,501)
|
201,352
|
Operating (loss) income
|
(21,717)
|
63,928
|
42,211
|
60,222
|
43,270
|
103,492
|
Other income (expenses):
|
|
|
|
|
|
|
Foreign exchange gain(loss)
|
(341)
|
341 i
|
-
|
515
|
(515) i
|
-
|
Investment and other income
|
10,393
|
(5,422) j
|
4,971
|
6,522
|
(829) k
|
5,693
|
Interest expense on long-term debt
|
(51,748)
|
2,242 l
|
(49,506)
|
(35,502)
|
2,019 l
|
(33,483)
|
Loss on sale/write-down of investments
|
(8,157)
|
8,157 m
|
-
|
(287)
|
287 n
|
-
|
Loss extinguishment of debt
|
-
|
-
|
-
|
(9,297)
|
9,297 o
|
-
|
|
(49,853)
|
5,318
|
(44,535)
|
(38,049)
|
10,259
|
(27,790)
|
Income (loss) from continuing operations
before income
|
|
|
|
|
|
|
taxes and cumulative effect of change in accounting
|
(71,570)
|
69,246
|
(2,324)
|
22,173
|
53,529
|
75,702
|
Income tax expense (recovery)
|
(23,608)
|
17,589 p
|
(6,019)
|
10,279
|
4,933 p
|
15,212
|
Income (loss) from continuing operations before
|
|
|
|
|
|
|
cumulative effect of change in accounting
|
(47,962)
|
51,657
|
3,695
|
11,894
|
48,596
|
60,490
|
Net loss from
discontinued operations, net of income taxes
|
(11,395)
|
11,395
|
-
|
(7,708)
|
7,708
|
-
|
Cumulative effect of change in accounting
|
-
|
-
|
-
|
399
|
(399)
|
-
|
Net (loss)
income for the period
|
(59,357)
|
63,052
|
3,695
|
4,585
|
55,905
|
60,490
|
|
|
|
|
|
|
|
Basic net (loss) income per common share from
continuing
|
|
|
|
|
|
|
operations
|
(0.56)
|
|
0.04
|
0.14
|
|
0.71
|
Diluted net (loss) income per common share from
|
|
|
|
|
|
|
continuing operations
|
(0.56)
|
|
0.04
|
0.14
|
|
0.71
|
Weighted average shares outstanding (000s) basic
|
85,015
|
|
85,015
|
84,752
|
|
84,752
|
Weighted average shares outstanding (000s) diluted
|
85,015
|
|
85,390
|
85,437
|
|
85,437
|
a.
|
One time revenue gain resulting from the up-front monetization of a
royalty revenue stream to be received from our collaboration and
distribution partnership with Orthovita..
|
|
|
b.
|
Amounts accrued for costs incurred, and potential future costs,
related to our offer to accept returns of Contour Threads brand product as
part of consolidation and discontinuation of the Contour Threads brand
name, coincident with the launch of our Quill SRS brand name.
|
|
|
c.
|
Non-recurring, non-operating revenue as derived from license
agreements with Histogenics Corporation ($0.4 million in 2007), Symphony
Medical ($0.2 million in 2007) and other license revenue, net of license
fees due to licensors. In 2006, as derived from license agreements with
Baxter Heathcare Corporation ($1.0 million) and other license revenue, net
of license fees due to licensors.
|
|
|
d.
|
Change in estimate of accounting for excess and obsolete inventory
resulting from the alignment during the third and fourth quarters of 2007
of inventory policies across our various manufacturing operations, and
non-recurring supply / distribution agreement termination costs.
|
Page 10 of 15
e.
|
Research and development adjustments:
|
|
|
Year ended
|
Year ended
|
|
|
Dec. 31, 2007
|
Dec. 31, 2006
|
|
Stock-based compensation
|
(1,665)
|
(2,490)
|
|
Non-recurring license fees due to licensors
|
(419)
|
--
|
|
Termination and reorganization costs related to the
integration of AMI
|
(849)
|
--
|
|
Non-recurring supply / distribution agreement termination costs
|
(899)
|
--
|
|
Non-recurring in-process research and development expense
relating to the signing of a
|
|
|
|
technology and intellectual property
license agreement
|
(750)
|
--
|
|
|
(4,582)
|
(2,490)
|
f.
Selling, general and administrative adjustments:
|
|
Year ended
|
Year ended
|
|
|
Dec. 31, 2007
|
Dec. 31, 2006
|
|
Stock-based compensation
|
(2,642)
|
(3,609)
|
|
Termination and reorganization costs
related to the integration of AMI
|
(8,365)
|
(1,879)
|
|
Litigation expenses
relating to defending intellectual property claims
|
(5,611)
|
(11,774)
|
|
Non-recurring supply / distribution
agreement termination costs
|
(250)
|
--
|
|
|
(16,868)
|
(17,262)
|
g.
|
Amortization of acquisition related intangible assets and medical
technologies.
|
|
|
h.
|
Non-recurring in-process research and development expense relating to
payments made to licensors and collaborators, including CombinatorX Inc.
and Rex Medical Inc.
|
|
|
i.
|
Foreign exchange fluctuations on foreign currency net monetary assets.
|
|
|
j.
|
Write off of uncollectible receivable and write off of certain
capitalized costs, net of gain realized on recovery of investments.
|
|
|
k.
|
Gain on sale of Palo Alto building and gain on sale related to
disposition of Neodisc technology rights to NuVasive.
|
|
|
l.
|
Amortization of deferred financing costs.
|
|
|
m.
|
Net impact of loss and gain on redemption of investments of common
share holdings in Orthovita Inc. and NuVasive, Inc., respectively.
|
|
|
n.
|
Net impact of gain on redemption of investments and loss on write down
of investments.
|
|
|
o.
|
Loss on extinguishment of term loans related to our December 2006
senior floating rate note refinancing.
|
|
|
p.
|
Tax effects of adjustments a. through n. for the period, including the
reversal of tax reserves previously booked. Comparative for 2006 also
includes non-recurring retroactive tax adjustment of $8.7 million relating
to certain tax structures previously established in the province of
Quebec, from which the previously expected benefits are not anticipated to
be realized.
|
Page 11 of 15
ANGIOTECH PHARMACEUTICALS, INC.
|
CALCULATION OF ADJUSTED EBITDA
|
(Unaudited)
|
|
Three months ended
|
Year ended
December 31,
|
|
December 31,
|
(in
thousands of U.S.$)
|
2007
|
2006
|
2007
|
2006
|
|
|
|
|
|
Net income on a GAAP basis
|
(21,276)
|
(11,703)
|
(59,357)
|
4,585
|
Interest expense on long-term debt
|
12,774
|
11,891
|
51,748
|
35,502
|
Income tax expense
|
2,173
|
(5,619)
|
(23,713)
|
6,247
|
Depreciation and amortization
|
9,902
|
15,956
|
37,907
|
40,348
|
EBITDA
|
3,573
|
10,525
|
6,585
|
86,682
|
Adjustments:
|
|
|
|
|
Net loss from
discontinued operations,
|
|
|
|
|
excluding depreciation,
amortization and
|
|
|
|
|
income tax expense included
above
|
-
|
9,242
|
11,122
|
10,497
|
In-process research and development
|
125
|
-
|
8,125
|
1,042
|
Non-recurring research
and development
|
|
|
|
|
costs
|
-
|
-
|
750
|
-
|
Non-recurring revenue,
net of license fees
|
(266)
|
(10,052)
|
(426)
|
(10,231)
|
Stock-based compensation
|
589
|
1,299
|
4,306
|
5,700
|
Litigation expenses
|
(291)
|
3,551
|
5,611
|
11,774
|
Foreign exchange loss (gain)
|
(173)
|
1,263
|
340
|
(515)
|
Investment and other
income
|
(511)
|
(1,032)
|
(4,814)
|
(5,693)
|
Severance / restructuring costs
|
3,526
|
1,879
|
8,964
|
1,879
|
Supply/distribution
agreement termination
|
|
|
|
|
costs
|
-
|
-
|
2,199
|
-
|
E&O inventory
adjustment
|
665
|
-
|
2,645
|
-
|
Loss on extinguishment of debt
|
-
|
9,297
|
-
|
9,297
|
Contour threads returns
|
-
|
-
|
2,579
|
-
|
Write-off of capitalized costs
|
(401)
|
-
|
280
|
-
|
Write-off of
uncollectible tax receivable
|
-
|
-
|
2,250
|
-
|
Gain on sale of sale of
intangible assets
|
-
|
-
|
-
|
(148)
|
Gain on sale of
Palo Alto building
|
-
|
4
|
-
|
(681)
|
Gain realized on recovery of
investment
|
-
|
-
|
(7,510)
|
-
|
Accrued interest
income
|
-
|
-
|
(597)
|
-
|
Net loss on redemption of investments
|
-
|
(126)
|
8,157
|
287
|
Adjusted EBITDA
|
6,836
|
25,850
|
50,566
|
109,890
|
Page 12 of 15
ANGIOTECH PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(Unaudited)
|
|
December 31,
|
December 31,
|
(in
thousands of U.S.$)
|
2007
|
2006
|
ASSETS
|
|
|
Cash and short-term
investments
|
91,326
|
108,617
|
Accounts receivable
|
22,678
|
25,231
|
Inventories
|
33,647
|
33,619
|
Deferred income taxes
|
5,964
|
5,372
|
Other current assets
|
7,070
|
6,303
|
Assets from discontinued operations
|
-
|
2,365
|
Total current assets
|
160,685
|
181,507
|
Long-term investments
|
24,456
|
53,840
|
Property and equipment, net
|
59,187
|
59,783
|
Intangible assets, net
|
225,889
|
244,954
|
Goodwill
|
660,591
|
630,770
|
Deferred income taxes
|
-
|
4,804
|
Deferred financing costs
|
13,600
|
14,845
|
Other assets
|
6,780
|
255
|
Assets from discontinued operations
|
-
|
15,116
|
Total assets
|
1,151,188
|
1,205,874
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY
|
|
|
Current liabilities
|
67,182
|
67,950
|
Liabilities from discontinued operations
|
-
|
4,226
|
Long-term debt
|
575,000
|
575,000
|
Deferred income taxes
|
60,386
|
71,813
|
Other tax liabilities
|
2,425
|
-
|
Other long-term liabilities
|
4,614
|
4,052
|
Stockholders equity
|
441,581
|
482,833
|
Total liabilities and stockholders equity
|
1,151,188
|
1,205,874
|
Page 13 of 15
Forward Looking Statements
Statements
contained in this press release that are not based on historical fact, including
without limitation statements containing the words believes, may, plans,
will, estimate, continue, anticipates, intends, expects and similar
expressions, constitute forward-looking statements within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995 and constitute
forward-looking information within the meaning of applicable Canadian
securities laws. All such statements are made pursuant to the safe harbor
provisions of applicable securities legislation. Forward-looking statements may
involve, but are not limited to, comments with respect to our strategies or
future actions, our targets, expectations for our financial condition and the
results of, or outlook for, our operations, research development and product and
drug development. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Many such
risks, uncertainties and other factors are taken into account as part of our
assumptions underlying these forward-looking statements and include, among
others, the following: general economic and business conditions, both nationally
and in the regions in which we operate; market demand; technological changes
that could impact our existing products or our ability to develop and
commercialize future products; competition; existing governmental regulations
and changes in, or the failure to comply with, governmental regulations; adverse
results or unexpected delays in drug discovery and clinical development
processes; decisions, and the timing of decisions, made by health regulatory
agencies regarding approval of our technology and products; the requirement for
substantial funding to conduct research and development and to expand
commercialization activities or consummate acquisitions; sales numbers and
future guidance publicly provided by Boston Scientific Corporation regarding
sales of their paclitaxel-eluting coronary stent products; and any other factors
that may affect performance. In addition, our business is subject to certain
operating risks that may cause the actual results expressed or implied by the
forward-looking statements in this report to differ materially from our actual
results. These operating risks include: our ability to attract and retain
qualified personnel; our ability to successfully complete preclinical and
clinical development of our products; changes in business strategy or
development plans; our failure to obtain patent protection for discoveries; loss
of patent protection resulting from third party challenges to our patents;
commercialization limitations imposed by patents owned or controlled by third
parties; our ability to obtain rights to technology from licensors; liability
for patent claims and other claims asserted against us; our ability to obtain
and enforce timely patent and other intellectual property protection for our
technology and products; the ability to enter into, and to maintain, corporate
alliances relating to the development and commercialization of our technology
and products; market acceptance of our technology and products; our ability to
successfully manufacture, market and sell our products; the ability of Boston
Scientific Corporation to successfully manufacture, market and sell their
paclitaxel-eluting coronary stent products; the continued availability of
capital to finance our activities; our ability to achieve the financial benefits
expected as a result of the acquisition of American Medical Instruments
Holdings, Inc. (AMI); and any other factors referenced in our annual
information form and other filings with the applicable Canadian securities
regulatory authorities or the SEC.
Given these uncertainties, assumptions and
risk factors, readers are cautioned not to place undue reliance on such
forward-looking statements. We disclaim any obligation to update any such
factors or to publicly announce the result of any revisions to any of the
forward-looking statements contained in this press release to reflect future
results, events or developments
.
Quill is a trademark of Quill Medical, Inc., a wholly-owned
subsidiary of Angiotech Pharmaceuticals, Inc.
©2008 Angiotech
Pharmaceuticals, Inc. All Rights Reserved.
Vascular Wrap is a trademark of
Angiotech Pharmaceuticals, Inc.
BioPince is a trademark of Medical Device
Technologies, Inc.
Skater is a trademark of PBN MEDICALS DENMARK A/S.
MultiStem
®
is a registered trademark of Athersys,
Inc.
TAXUS
®
is a registered trademark of Boston Scientific
Corporation.
Page 14 of 15
About Angiotech Pharmaceuticals
Angiotech
Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device
company with over 1,500 dedicated employees. Angiotech discovers, develops and
markets innovative treatment solutions for diseases or complications associated
with medical device implants, surgical interventions and acute injury. To find
out more about Angiotech (NASDAQ: ANPI, TSX, ANP) please visit our website at
www.angiotech.com.
FOR ADDITIONAL INFORMATION:
|
|
Jodi Regts
|
Senior Manager, Investor Relations and Corporate
Communications
|
Angiotech Pharmaceuticals, Inc.
|
(604) 221-7930
|
jregts@angio.com
|
|
Deirdre Neary
|
Manager, Investor Relations and Corporate Communications
|
Angiotech Pharmaceuticals, Inc.
|
(604) 222-7056
|
dneary@angio.com
|
Page 15 of 15