Micro Therapeutics Reports 2001 Third Quarter Financial Results.
- Balance sheet strengthened with completion of $56 million financing
- Company elects to have sales force in Europe
- Flagship product Onyx(R) and new product introductions featured at
conference for leading interventional neuroradiologists
Conference call scheduled today at 8:00 A.M. PDT; Simultaneous webcast at
IRVINE, Calif., Oct. 25 /PRNewswire/ --
Micro Therapeutics, Inc. (MTI) (Nasdaq: MTIX) today reported net sales of $2.1 million for the third quarter ended September 30, 2001, an increase of 46 percent from net sales of $1.4 million in the same period last year. Loss before an extraordinary charge for the quarter was $6.5 million, or $0.36 per share, compared with net loss of $3.1 million, or $0.31 per share, in the 2000 third quarter. The 2001 results include a one-time charge of $3.1 million, reflecting the accrual of the estimated fee in connection with MTI's previously announced termination of its distribution agreement with Guidant Corporation.
For the nine-month period ended September 30, 2001, net sales grew 82 percent to $6.9 million from $3.8 million in the same period last year. Loss before the extraordinary charge was $13.6 million, or $1.05 per share, compared with net loss of $8.4 million, or $0.88 per share, for the comparable period in 2000.
John Rush, MTI's president and chief executive officer, said the year over year increase in revenues is attributable to the growth of sales of Onyx(R) and significant sales growth of microcatheter and access products in the United States. Sales of Onyx in the U.S. for investigational use were driven by the commencement of two pivotal clinical trials in early 2001. In Europe, commercial sales grew primarily from the use of Onyx for the treatment of arteriovenous malformations.
"Revenues decreased slightly on a sequential basis primarily due to our decision to defer the launch of Onyx for aneurysms and reposition our overall European marketing plans," said Rush. "This was a strategic and proactive move to more directly influence our market penetration in Europe and resulted in a plan for MTI to have a dedicated sales force and terminate its current marketing agreement with Guidant Corporation. While Guidant has been a good partner for us, given the importance of the European market for our products, we feel certain that this is the best strategic business decision for MTI." Rush said that Guidant will remain onboard as MTI's European distributor through the balance of the year.
"Also pivotal in the third quarter was the completion of the financing that puts the company on more sound footing and in better control of its destiny," commented Rush. "Taken together, these actions mark an important turning point in MTI's evolution and we believe provide a stronger foundation to enhance long-term shareholder value."
As a percentage of sales, gross profit for the third quarter of 2001 improved to 54 percent from 50 percent in the corresponding quarter last year, primarily due to a shift in product mix to higher margin neuro vascular products and higher sales volumes.
For the 2001 third quarter, research and development expenses, which include clinical and regulatory operations, increased 39 percent over the same quarter last year reflecting costs associated with new product development and the U.S. pivotal clinical trials for Onyx. Selling, general and administrative expenses increased marginally.
During the quarter, the company received $49 million as part of the second and final stage of a $56 million equity financing transaction with Micro Investment, LLC, a limited liability company managed by Warburg Pincus Equity Partners, L.P. The company used a portion of the proceeds from this transaction to pay off notes held by Guidant Corporation and Century Medical, Inc., the exclusive distributor for the company's products in Japan. In connection with the early extinguishment of these notes, which occurred in September and October, the company recorded an extraordinary non-cash charge of $716,000 in the 2001 third quarter.
Cash and cash equivalents at September 30, 2001 aggregated $45 million, including the net proceeds from the recent financing. Total stockholders' equity stood at $42 million at the end of the third quarter.
Onyx(R) Liquid Embolic System (Onyx LES(R))
The Onyx liquid embolic material is delivered through MTI's proprietary micro catheters directly into a vascular malformation, such as an aneurysm or AVM. Once inside the targeted malformation, the liquid transforms into a spongy polymer mass designed to fill the malformation and reduce the risk of rupture and subsequent stroke. Onyx is non-adhesive, which enhances controllability during delivery, and it is visible under fluoroscopy-allowing clinicians a clear view of the embolization procedure in real-time.
Just subsequent to the close of the quarter, MTI presented and demonstrated Onyx and related products in two successful live cases to leading interventional neuroradiologists from around the world at LINC 2001 in Paris, France. The first case involved a large aneurysm that was successfully treated with Onyx using the new X-pedion(TM) Guidewire, Rebar Micro Catheter and new HyperGlide Balloon. The second case involved a massive AVM in the brain that was treated with Onyx and the new UltraFlow Flow Directed Catheter.
About Micro Therapeutics, Inc.
Micro Therapeutics (MTI) develops, manufactures and markets minimally invasive medical devices for the diagnosis and treatment of vascular disease. MTI's flagship product, Onyx(R), is a liquid embolic material that has been developed for use in the treatment of conditions that can lead to stroke. Onyx currently is being marketed throughout Europe and in pivotal clinical trials in the United States. MTI markets more than 130 medical devices and micro catheter products serving the neuro vascular and peripheral vascular markets.
Conference Call Information and Forward-Looking Statements
On Thursday, October 25, 2001, the company will host a conference call with industry analysts beginning at 8:00 a.m. PDT to review the results of operations for the third quarter ended September 30, 2001. Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company's revenues, margins, operating expenses, distribution arrangements, clinical studies and financing plans, and any comments the company may make about its future in response to questions from the analysts participating in the conference call. The conference call may be heard by any interested party through a live audio Internet broadcast at www.companyboardroom.com. For those unable to listen to the live broadcast, a playback of the webcast will be available at www.companyboardroom.com through 12:00 p.m. PST, Thursday, November 8, 2001.
Statements contained in this press release which are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited, to, in no particular order: effectiveness and pace of current and future product development, success of clinical testing, product demand and market acceptance, the impact of competitive products and pricing, and regulatory approval. More detailed information on these and additional factors which could affect Micro Therapeutics, Inc.'s operating and financial results are described in the company's Forms 10-QSB, 10-KSB and other reports, filed or to be filed with the Securities and Exchange Commission. Micro Therapeutics, Inc. urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. Additionally, Micro Therapeutics, Inc. undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
MICRO THERAPEUTICS, INC.
Statement of Operations Data
Three Months Ended Nine Months Ended
9/30/01 9/30/00 9/30/01 9/30/00
Net sales $2,103,072 $1,440,693 $6,888,097 $3,781,293
Cost of sales 976,832 715,789 3,472,880 2,226,328
Gross profit 1,126,240 724,904 3,415,217 1,554,965
development 2,725,234 1,958,055 7,114,692 5,343,030
Selling, general &
administrative 1,899,725 1,826,737 6,460,392 4,379,173
termination 3,100,000 -- 3,100,000 --
expenses 7,724,959 3,784,792 16,675,084 9,722,203
operations (6,598,719) (3,059,888) (13,259,867) (8,167,238)
Interest & other
net 74,570 (67,978) (298,056) (190,896)
Loss before income
item (6,524,149) (3,127,866) (13,557,923) (8,358,134)
Income tax expense -- -- 800 800
extraordinary item (6,524,149) (3,127,866) (13,558,723) (8,358,934)
of debt 716,380 -- 716,380 --
Net loss ($7,240,529) ($3,127,866) ($14,275,103) ($8,358,934)
Per share data
(basic and diluted):
extraordinary item ($0.36) ($0.31) ($1.05) ($0.88)
of debt (0.04) -- (0.06) --
Net loss ($0.40) ($0.31) ($1.11) ($0.88)
Weighted average shares
(in thousands) 17,911 9,953 12,869 9,518
Balance Sheet Data
Cash and cash equivalents $44,993,164 $9,872,561
Working capital $44,263,602 $11,191,664
Total assets $52,788,521 $16,602,932
Long-term portion of debt -- $10,979,805
Accumulated deficit ($66,877,536) ($52,602,433)
Total stockholders' equity $42,183,136 $3,118,505
MICRO THERAPEUTICS, INC.
Revenues by Segment
Three Months Ended Nine Months Ended
9/30/01 9/30/00 9/30/01 9/30/00
Peripheral blood clot
United States $698,958 $706,409 $2,132,262 $1,503,785
International 29,388 32,088 94,015 118,286
Total peripheral blood
clot therapy revenues 728,346 738,497 2,226,277 1,622,071
United States 192,850 -- 403,827 2,050
International 185,058 158,116 807,494 562,560
Total Onyx revenues 377,908 158,116 1,211,321 564,610
Micro catheter and
United States 491,501 91,942 1,332,789 244,167
International 464,979 438,161 2,047,915 1,204,668
Total micro catheter and
access product revenues 956,480 530,103 3,380,704 1,448,835
United States 40,338 13,977 69,795 145,634
International -- -- -- 143
Total other revenues 40,338 13,977 69,795 145,777
Total revenues $2,103,072 $1,440,693 $6,888,097 $3,781,293
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|Date:||Oct 25, 2001|
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