Third Wave Technologies Vida Communication
Rod Hise Stephanie Diaz (investors)
(608) 663-4010 (415) 885-2298
Tim Brons (media)
For Immediate Release
Company also issues preliminary 2005 clinical revenue guidance
MADISON, Wis., Nov. 10, 2004—Third Wave Technologies Inc. (Nasdaq: TWTI) today provided new details about the expansion of the company’s molecular diagnostic pipeline and issued preliminary guidance for 2005 clinical molecular diagnostic revenue. The pipeline includes products to be released during 2005 and multiple products in development. The company believes this pipeline will enable Third Wave to significantly extend its infectious disease offerings and introduce innovative oncology products, while building on its strong position in the genetics/pharmacogenetics market.
“During the past year, Third Wave has been successfully building one of the industry’s most valuable molecular diagnostic pipelines,” said John Puisis, president and chief executive officer of Third Wave. “Our proprietary Invader® chemistry allows us to address the growing demand in HCV, HPV and other high-value markets that are inaccessible to most other companies. The upcoming expiration of basic PCR patents provides Third Wave with additional opportunities and another level of differentiation. We believe the combination of the Invader® chemistry and PCR will provide customers with a highly sensitive, accurate and rapid solution that is even more robust than either of them alone.
“Third Wave’s pipeline will enable the company to move even more aggressively into the infectious disease market, continue to build on our strong menu of genetics and pharmacogenetics products, and enter the emerging oncology market with a new approach that is faster and easier to use than traditional methods,” Mr. Puisis said. “The product pipeline we are detailing today also illustrates the value and fundamental competitive advantages of Third Wave’s Invader® chemistry intellectual property portfolio and its continuing enhancement.”
“With the new infectious disease products being brought to market this year and the pipeline detailed today, Third Wave has positioned itself beyond the SNP detection market,” said Maneesh Arora, Third Wave’s senior vice president of commercial operations. “We now have commercial Invader® products and pipeline for chromosomal rearrangement and copy number, epigenic alterations, and viral load, along with a base chemistry platform capable of enabling applications in gene expression and microRNA.”
The following are highlights of Third Wave’s pipeline expansion:
· Cystic fibrosis microfluidic card (CF MFC)
– The CF MFC will be Third Wave’s first offering coupled with the 3M microfluidic technology and will enable clinical laboratories to forgo numerous liquid-handling steps, improving lab efficiency and shortening the time to test results.
– The CF MFC extends the Invader® chemistry’s performance, simplicity and ease of use.
– Planned timing: 2005
· Factor V Leiden and Factor II prothrombin in vitro diagnostics (IVDs)
– The company anticipates seeking FDA clearance of these two products and bringing the IVD products to market.
– FDA clearance of these products, which already are market leaders, will permit the company to market them more directly and aggressively.
– Planned timing: 2005
In addition to its near-term pipeline of genetics products, the company also has multiple products in feasibility, the most significant of which is Fragile X. The company also is evaluating the development of a product for the detection of Ashkenazi Jewish mutations.
Third Wave entered the infectious disease market during 2004 with the release of its Invader® Hepatitis C Virus (HCV) genotyping analyte-specific reagents. Early response to the reagents has been favorable, including adoptions by leading clinical laboratories that include Esoterix, TriCore, Spectrum and UCLA Medical Center, and several others. The company remains on track to release HPV detection reagents by the end of 2004. Concurrent with the release of its HPV reagents, the company also plans to seek FDA approval of the Invader® HPV assay. An abstract of data from a study by the Cleveland Clinic comparing the Invader® chemistry with a competing HPV product will be presented later this week at the annual Association of Molecular Pathology meeting in Los Angeles.
Third Wave’s menu of infectious disease products will continue to grow during 2005 to include multiple new products that the company believes are critically important in identifying and monitoring at-risk patients. These products include:
· Hepatitis C Virus (HCV) viral load
– Third Wave has previously outlined its goal of establishing a clinical trials program for an HCV viral load prototype assay by the end of 2004. The company is making significant progress advancing its HCV viral load program through feasibility and clinical studies. The company will continue the prototype program in the fourth quarter of 2004 and begin clinical studies against competitor in-market products shortly thereafter.
· Herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) detection
– These two Herpes simplex viruses cause oral herpes (HSV-1) and genital herpes (HSV-2) that in immunocompromised individuals and infants can cause central nervous system disorders, blindness, liver disease, brain infections and other illnesses.
– The product will detect the presence of and distinguish between HSV-1 and HSV-2, which is critical to the treatment of HSV patients, as HSV-2 infections have a higher recurrence rate than HSV-1.
– Planning timing: 2005
· Varicella-Zoster virus (VZV) detection
– VZV causes shingles, a painful neurological disorder that develops from the reactivation of the same virus that originally caused chickenpox in a particular patient. Individuals with compromised immune systems, including those with HIV infection, those undergoing chemotherapy or radiation therapy, or organ transplant recipients, are more likely to develop shingles.
– Planned timing: 2005
· Cytomegalovirus (CMV) detection
– CMV is the leading cause of mortality of solid organ transplant patients in the United States. It causes severe central nervous system symptomatic disease progression in immunocompromised and immunosuppressed patients, including those with AIDS and cancer, and newborns, in addition to organ transplant patients.
– Planned timing: 2005
· Epstein-Barr virus (EBV) detection
– EBV is the cause of infectious mononucleosis, which can become chronic, and is a factor in the development of lymphoma. Immunocompromised patients, particularly organ transplant recipients, and newborns are more susceptible to EBV than others.
– Planned timing: 2005
· Human herpes virus 6 (HSV-6) detection
– HSV-6 causes roseola in infants, and can cause meningitis, encephalitis and other illnesses in adults, particularly those with compromised immune systems. HSV-6 can co-infect with HIV, increasing the efficiency of that virus.
– Planned timing: 2005
The company also has the following infectious disease products in feasibility study or development: Chlamydia trachomatis and Neisseria gonorrhoeae detection, HIV viral load, Hepatitis B Virus (HBV) viral load, and Group B streptococcus.
Oncology & Chromosomal Analysis
Third Wave during the first quarter of 2004 announced the extension of its Invader® chemistry to chromosomal analysis, opening a large, existing market to the company. The company’s new approach to chromosomal analysis is easier to use and more cost-effective than traditional methods, while providing clinicians with objective, same-day results. In conjunction with this important extension of the Invader® chemistry, Third Wave also announced it is providing Invader® reagents for prenatal chromosomal analysis to UCLA and other leading institutions under an early-adopter program. The company will expand its product offerings for pre- and post-natal chromosomal analysis and enter the oncology market with its unique chemistry with the following products:
· Subtelomere Scan
– Subtelomeres are gene-rich regions near the ends of each chromosome. Rearrangement and loss of DNA from these regions has been associated with otherwise unexplained developmental delay in children. The American Academy of Neurology in 2003 published clinical practice guidelines that recommend subtelomere analysis as part of the evaluation of children ages 1-5 with global developmental delay.
– The product will enable the qualitative assessment of the subtelomere region of each chromosome.
– Planned timing: 2006-2008
· Microdeletion Syndromes
– Microdeletions syndromes are caused by extremely small chromosomal deletions that cannot be detected by traditional cytogenetics methods. Examples of microdeletion syndromes include Prader-Willi, Angelman, and DiGeorge Syndromes.
– The product will enable the qualitative assessment of the appropriate chromosomal region associated with a number of microdeletion syndromes to detect whether microdeletions have taken place.
– Planned timing: 2006-2008
The company also has the following chromosomal analysis and oncology products in feasibility or development: BCR/ABL, which is associated with chronic myeloid leukemia and is used to monitor patients receiving Gleevec® therapy; Epidermal Growth Factor Receptor (EGFR) mutations, which have been observed in many types of cancer, most notably lung and brain cancer and, in the former, are associated with increased response to the cancer treatment Iressa®; and others.
Preliminary 2005 Clinical Molecular Diagnostic Revenue Guidance
Third Wave anticipates that clinical molecular diagnostic revenue will grow to between $23-26 million in 2005, driven chiefly by the company’s core genetics, cystic fibrosis and HCV genotyping reagents. While Third Wave views the new products scheduled for release in 2005 as drivers of the long-term growth of its clinical molecular diagnostic business, the company does not anticipate significant contributions in 2005 from those products. Accordingly, the company has not included revenue from its forthcoming HPV product or other new products in its 2005 guidance. The company believes it is prudent to refrain from providing guidance about the revenue impact from these products until they have been in the market and sales trends can be reviewed. Third Wave will provide visibility on revenue from its HPV product and 2005 product launches as appropriate during the year.
The company expects to provide guidance about research revenue, gross margins and cash flow when it releases its fourth-quarter and full-year 2004 results in late February or early March 2005.
“Third Wave has accomplished three fundamental milestones that will have a dramatic impact on the future of the company,” Mr. Puisis said. “We proved to the marketplace that we can move beyond our historical market boundaries, leveraging our unique, proprietary Invader® chemistry in areas like HPV and chromosomal analysis. The second is the articulation of the expansion of our product capabilities and patent estate with the coupling of native Taq polymerase, which will soon be off patent, and the Invader® chemistry. This crude form of PCR has little utility to most clinical players, but will benefit Third Wave significantly. The third is the deal with 3M for access to its microfluidic card, which will broaden the company’s capabilities in the years to come. Third Wave is a new company with new products, pipeline and capabilities. As we continue to commercialize products and gain customer adoption, shareholders should be pleased with these past accomplishments and future prospects.”
Conference Call & Webcast
Company management will host a conference call on Thursday, Nov. 11, 2004, at 10 a.m. EST to the company’s product pipeline and preliminary 2005 clinical molecular diagnostic revenue guidance. Domestic callers should dial (800) 561-2601 and international callers should dial (617) 614-3518. The access code for both domestic and international callers is 20160059. 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 www.twt.com. The conference call, webcast and replay are open to all interested parties.
About Third Wave Technologies
Third Wave Technologies is a leader in the development and marketing of molecular diagnostics for a variety of DNA and RNA analysis applications, providing physicians and researchers with superior tools to diagnose and treat disease. Third Wave’s Invader® technology provides the company’s customers with exceptional performance, scalability and ease of use. The company offers a number of clinical products based on its Invader® technology for genetic testing related to multiple disease areas. For more information about Third Wave and its products, please visit the company’s website at www.twt.com.
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 www.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.