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Angiotech Pharmaceuticals, Inc. announces financial results for the third quarter ended September 30, 2009
Monday, November 09, 2009 7:52 AM


(Source: Canada Newswire)trackingVANCOUVER, 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

----------------------------------------------------------------- --------

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

----------------------------------------------------------------- --------

59,226 670,212 185,016 838,959

----------------------------------------------------------------- --------

Operating income (loss) 4,018 (601,852) 31,101 (617,769)

----------------------------------------------------------------- --------

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)

----------------------------------------------------------------- --------

Net loss $ (7,802) $(622,378) $ (7,235) $(664,212)

----------------------------------------------------------------- --------

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Basic and diluted net loss

per common share $ (0.09) $ (7.31) $ (0.08) $ (7.80)

----------------------------------------------------------------- --------

----------------------------------------------------------------- --------

Basic and diluted weighted

average number of common

shares outstanding

(in thousands) 85,136 85,122 85,125 85,117

----------------------------------------------------------------- --------

----------------------------------------------------------------- --------

ANGIOTECH PHARMACEUTICALS INC.




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