SOUTH SAN FRANCISCO, Calif., Oct. 7 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. today reaffirmed its guidance for revenue in excess of $60 million for 2008.
"We continue to make progress in both our HIV and Oncology programs," said William Young, Monogram chief executive officer. "Our revenues have been at record levels in the first half of this year and we reaffirm our guidance for revenues to be greater than $60 million for the year, growth of over 40% over 2007. We expect further revenue growth in 2009 from Trofile(TM), our patient selection assay for the CCR5 antagonist class of HIV drugs."
"We also expect HERmark(TM), our recently launched breast cancer assay, to contribute to revenue in 2009," continued Young. "Our oncology sales team is in place and initial HERmark tests have been performed for patients determined by existing technologies to be HER2-negative. As our prior clinical data suggests, these patients include some who have now been reclassified by HERmark as HER2 positive. We are pleased with the reaction to date of the oncology community to HERmark. We expect to enhance HERmark during 2009 with clinical data related to Herceptin response upon completion of our clinical studies, which are progressing well, and with the introduction of an additional marker that may provide an indication of Herceptin(R) resistance, for example in patients where combination therapy may be appropriate. Development work on VeraTag(TM) assays for heterodimers of HER1:HER2 and HER2:HER3, the HER1:HER1 homodimer as well as for p95, a truncated form of HER2, and the HER3/PI3K complex is proceeding well and we expect to present data on several of these assays later in 2008."
About Monogram
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking, including statements regarding the performance, demand and outlook for our products, including our Trofile and HERmark assays, our projected revenues, the potential for enhancements to our HERmark assay, the development of additional assays based on the VeraTag platform, the results and timing of clinical studies on our products and the presentation or publication of data from such studies. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties relating to the performance and acceptance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the risk that our VeraTag assays, including HERmark, may not predict response to particular therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional VeraTag studies, the risk that our VeraTag technology may not accurately measure other proteins or protein complexes, our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether existing levels of reimbursement will be reviewed and reduced by third party payers, including Medicare; whether the draft guidance on Multivariate Index Assays issued by the FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, G.E. and other debt agreements; potential Nasdaq proceedings to delist our common stock, our ability to regain compliance with Nasdaq listing requirements, the impact of a possible reverse split of the shares of our common stock, the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of Monogram
Biosciences, Inc., +1-650-624-4576, amerriweather@monogrambio.com, or
Jeremiah Hall of Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@fkhealth.com
Web site: http://www.monogrambio.com/
