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Biotech / Medical : Trickle Portfolio

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To: tuck who started this subject10/25/2001 2:23:11 PM
From: tuck  Read Replies (1) of 1784
 
I missed this report from TWTI a couple of days ago; looks solid. TWTI beat estimates by a penny, and beat revenue estimates in the $6 million range handily.

>>MADISON, Wis., Oct 22, 2001 /PRNewswire via COMTEX/ -- Third Wave Technologies Inc. (Nasdaq: TWTI chart, msgs) today reported financial results for the third quarter and nine-month period ended Sept. 30, 2001. For the quarter ended Sept. 30, 2001, total revenues increased to $8.2 million, an increase from $3.6 million for the same quarter in 2000. Total revenues for the nine-month period ended Sept. 30, 2001, were $28.1 million, up from $4.9 million for the same period of 2000.

Sales of Third Wave's Invader(R) genetic variation analysis products increased to $7.3 million for the quarter ended Sept. 30, 2001, an increase from $3.4 million during the same period of 2000. Product sales increased to $25.3 million for the nine months ended Sept. 30, 2001, up from $4.7 million during the same period of 2000. Product sales for the third quarter were above expectations due to increasing demand for Third Wave's proven Invader(R) product platform for genetic analysis.

"Third Wave's strong third quarter performance demonstrates continuing adoption of the Invader product platform by the world's leading clinical labs and genome researchers," said Lance Fors, Ph.D., chairman and chief executive officer of Third Wave. "Third Wave will continue to create value by accelerating its market penetration and introduction of new products, and by aggressively seeking value-added partnerships."

Total operating expenses increased to $16.0 million for the quarter ended Sept. 30, 2001, from $8.0 million for the same period in 2000. Total operating expenses for the nine months ended Sept. 30, 2001, increased to $49.9 million from $25.3 million for the same period in 2000. The increase in operating expenses resulted primarily from the company's continuing investment in its product development and commercialization activities and the increasing demand for its Invader products.

Third Wave reported a net loss attributable to common shareholders of $7.4 million, or ($0.19) per diluted share, for the quarter ended Sept. 30, 2001, compared to a net loss attributable to common shareholders of $21.0 million, or ($1.40) per diluted share, for the same period of 2000. On a pro forma basis, the net losses were ($0.19) and ($0.14) per diluted share for the quarters ended Sept. 30, 2001 and 2000, respectively. The net loss attributable to common shareholders was $19.9 million, or ($0.57) per diluted share, for the nine months ended Sept. 30, 2001, compared to a net loss attributable to shareholders of $36.9 million, or ($2.46) per diluted share, for the same period of 2000. On a pro forma basis, the net losses were ($0.54) and ($0.79) for the nine-month periods ended Sept. 30, 2001 and 2000, respectively.

Excluding exceptional charges detailed in the attached financial statements, the pro forma net loss would have been $6.3 million, or ($0.17) per diluted share, for the quarter ended Sept. 30, 2001, compared to a pro forma net loss of $3.2 million, or ($0.12) per diluted share, for the same period in 2000. Excluding exceptional charges, the net loss would have been $16.0 million, or ($0.43) per diluted share, for the nine months ended Sept. 30, 2001, compared to a net loss of $10.7 million, or ($0.43) per diluted share for the same period in 2000.

Business and Market Highlights

Product Commercialization Milestones

* Third Wave enters gene expression market with launch of Invader RNA
Assay products. Third Wave entered the gene expression market with the
launch of its first series of Invader RNA Assay products. These products
set a new standard in gene expression monitoring, offering unprecedented
accuracy, sensitivity and specificity. Invader RNA Assay products
enable the detection and quantification of even low levels of unique
mRNAs directly from total RNA or crude cell samples called cell lysates,
eliminating several costly, time-consuming steps required by other
technologies and minimizing the risk of sample contamination that
accompanies them. A total of 30 gene expression products were included
in this initial launch, all of which measure the expression levels of
genes with proven clinical relevance. The company plans to aggressively
expand its Invader RNA Assay product offerings.

* Third Wave continues aggressive commercialization of genotyping
products. Third Wave continued to aggressively execute its product
commercialization strategy during the third quarter. By the end of the
quarter, Third Wave had developed and manufactured more than 70,000
unique Invader single nucleotide polymorphism (SNP) analysis products.

* First disease-focused panel product launched. Third Wave launched its
first Invader MAP (Medically Associated Panel) product, an important
demonstration of the company's product commercialization strategy.
Virtually all of the 135 genetic variations included in the first
generation Invader MAP product are on the company's menu of more than
70,000 unique SNP analysis products for basic discovery and were moved
to the MAP product because they had recently been associated with
specific common diseases. The format of the first Invader MAP product
and the Third Wave panel products that will follow offer unmatched ease
of use because all users must do is add genomic DNA. All the reagents
are pre-mixed and dried in the bottom of each test well. We believe
this single-step, complete system approach can accelerate large-scale
basic and clinical research, and near-patient and point-of-care
molecular diagnostic applications. The product's ease of use is further
enhanced with the Invader bioinformatics CD-ROM, which transforms
instrument readings into useful genetic variation data and links it to
searchable background information on the CD-ROM and to all the relevant
public databases. As the number of biomarkers expands, the company plans
to introduce disease-specific panels, with an initial focus on
cardiovascular disease.

Technology Extension Milestones

* Genome-wide association studies with less than 1 ml of blood using
Invader with multi-plex PCR sample prep. Scientists working on the
Japanese government's SNP Initiative successfully addressed one of
genomics' most vexing challenges -- dramatically reducing the amount of
genomic DNA needed for genotyping -- by coupling Third Wave's Invader
genotyping platform with highly multi-plexed polymerase chain reactions
(PCR). Their breakthrough findings, published in the August edition of
the Journal of Human Genetics, demonstrate the Invader platform's unique
ability to enable whole-genome association studies requiring analysis of
100,000 to 400,000 or more SNPs from a standard patient blood sample.

* Invader technology successfully applied to microarray platform.
Scientists at Third Wave, Northwestern University and the University of
Wisconsin-Madison successfully applied Third Wave's Invader technology
to microarrays. The findings, published in the Aug. 15 edition of
Nucleic Acids Research, demonstrate that the accuracy, performance and
ease of use provided by the Invader technology can be coupled to the
ultra high-throughput capabilities of microarrays. The combination of
these important characteristics holds tremendous potential for
large-scale genotyping and gene expression analyses applications. An
analysis by Frost & Sullivan released publicly in June concluded that
the market for microarray applications will exceed $3.3 billion by 2004.

* Scientists at Third Wave enable structure-function analysis of genetic
sequences and method to monitor how such structures might be regulating
medically important functions. Third Wave scientists have enabled the
direct analysis of naturally occurring structures that can be formed by
RNA and DNA molecules, a dramatic departure from conventional methods
that require the linear analysis of a sequence under tightly controlled
conditions. The scientists' findings, published in the Aug. 1 edition of
Nucleic Acids Research, are a technological breakthrough with the
potential to revolutionize DNA and RNA sequence analysis. First, by
dramatically simplifying research and clinical applications by requiring
fewer probes and far less sophisticated instrumentation. Second, by
providing a method to visualize and monitor how such naturally occurring
genetic structures might be regulating biologically and medically
important functions.

Conference Call

Company management will host a conference call on Tuesday, Oct. 23, at 10 a.m. EDT to discuss third quarter results and guidance for the balance of 2001. Domestic callers should dial (888) 855-5428 and international callers should dial (719) 457-2665. The access code for both domestic and international callers is 442517. Please dial in five to 10 minutes prior to the start of conference call. A live webcast and a replay of the conference call will be available at twt.com . The conference call, webcast and replay are open to all interested parties.

About Third Wave Technologies

Third Wave Technologies develops, manufactures and markets genetic variation analysis products used in the discovery and validation of the genetic basis of disease and the delivery of personalized medicine.

The company's patented Invader(R) product platform is highly accurate, sensitive, easy to use and cost-effective, enabling the acceleration of genome and pharmaceutical research and clinical patient analysis.

Third Wave's product commercialization strategy is rooted in a simple concept: drive value creation by leveraging any one of its tens of thousands of unique research products into increasingly larger revenue and market opportunities as it moves from basic research to medical genetic to routine clinical applications. The company has established strategic collaborations in the U.S. and abroad with government agencies, pharmaceutical and biotechnology companies, academic research centers, clinical reference labs and major healthcare providers. Through these partnerships and ongoing research and development, Third Wave will continue to expand its menu of products and drive their transition from the research market to the clinical market.

For more information about Third Wave and its products, please visit the company's website at twt.com.

The company's financial results may vary significantly from quarter to quarter due to fluctuations in the demand for the company's products, timing of new product introductions and deliveries made during the quarter, the timing of research, development and grant revenues, and increases in spending, including expenses related to the company's ongoing scale up to its product development and manufacturing capabilities.

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for Third Wave from those projected. Those factors include risks and uncertainties relating to technological approaches of Third Wave and its competitors, product development, manufacturing, market acceptance, cost and pricing of Third Wave products, dependence on collaborative partners and commercial customers, successful performance under collaborative and commercial agreements, competition, the strength of the Third Wave intellectual property, the intellectual property of others and other risk factors identified in the documents Third Wave has filed, or will file, with the Securities and Exchange Commission. Copies of the Third Wave filings with the SEC may be obtained from the SEC Internet site at sec.gov. Third Wave expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Third Wave's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Third Wave Technologies, Invader and the Third Wave logo are trademarks of Third Wave Technologies, Inc.


Third Wave Technologies, Inc
Statement of Operations
(In thousands, except for per share amounts)
(Unaudited)

Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000

Revenues:
Product $7,315 $3,442 $25,305 $4,652
Grant 123 120 389 265
Development 750 -- 2,360 19
8,188 3,562 28,054 4,936

Operating expenses:
Cost of goods sold 6,365 2,905 23,309 6,458
Research and development 4,447 1,884 11,384 4,778
Selling and marketing 2,174 1,139 7,075 3,366
General and
administrative 3,053 1,845 8,178 4,111
Impairment loss -- -- -- 5,789
Merger costs -- 196 -- 804

Total operating expenses 16,039 7,969 49,946 25,306

Loss from operations (7,851) (4,407) (21,892) (20,370)

Other income (expense):
Interest income 782 590 2,895 861
Interest expense (415) (214) (oss per share -
basic and diluted $(0.19) $(1.40) $(0.57) $(2.46)
Weighted average shares
outstanding, basic
and diluted 38,335 15,053 35,046 15,005

Pro forma, net loss
per share - basic
and diluted $(0.19) $(0.14) $(0.54) $(0.79)
Pro forma weighted average
shares outstanding,
basic and diluted 38,335 27,713 37,216 25,004

* The pro forma disclosure assumes the shares associated with preferred
stock and the convertible note payable were converted to common stock
upon issuance. Additionally, the pro forma disclosure excludes
interest of $187,500 on the convertible note payable. The pro forma
disclosure is presented for illustrative purposes only, and is not
prepared in accordance with generally accepted accounting principles.

Third Wave Technologies, Inc
Reconciliation of Net Loss to Pro Forma Net Loss
(In thousands, except for per share amounts)
(Unaudited)

Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000

Net loss attributable to
common shareholders $(7,418) $(21,040) $(19,915) $(36,896)
Exceptional charges
Stock compensation
Cost of goods sold 114 219 443 548
Research and development 57 35 221 55
Selling and marketing 26 34 102 208
General and administrative 396 183 1,534 474
Total stock compensation
charges 593 471 2,300 1,285

Amortization of agreements 483 106 1,448 1,253
Impairment loss -- -- -- 5,789
Merger costs -- 196 -- 804
Interest on convertible
note payable -- -- 188 --
Deemed dividend on issuance of
convertible preferred stock -- 17,023 -- 17,023
Total exceptional charges 1,076 17,796 3,936 26,154

Net loss excluding
exceptional charges $(6,342) $(3,244) $(15,979) $(10,742)

Pro forma, net loss
per share -
basic and diluted $(0.17) $(0.12) $(0.43) $(0.43)

* The pro forma disclosure is for illustrative purposes only, and is
not prepared in accordance with generally accepted accounting
principles.

Third Wave Technologies, Inc
Balance Sheets
(In thousands, except for per share amounts)
(Unaudited)

September 30, December 31,
2001 2000

Assets:
Cash equivalents, and
short-term investments $83,700 $47,179
Other current assets 17,893 3,886
Equipment and leasehold improvements, net 31,388 17,245
Intangible assets 9,624 11,071
Other assets 3,534 3,812
Total assets $146,139 $83,193

Liabilities and shareholders' equity
Accounts payable, accrued expenses
and other liabilities $16,452 $13,635
Deferred revenue 3,536 3,628
Debt 11,941 8,891
Convertible note payable -- 10,000
Shareholders' equity 114,210 47,039
Total liabilities and shareholders' equity $146,139 $83,193<<


snip

Cheers, Tuck
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