Celera Reports Third Quarter Fiscal 2007 Results.ROCKVILLE, Md. -- Celera Group (NYSE NYSE See: New York Stock Exchange :CRA See Community Reinvestment Act. ), an Applera Corporation business, today reported a net loss of $4.5 million, or $0.06 per share, for the third quarter of fiscal 2007, compared to a net loss of $23.3 million, or $0.31 per share, for the third quarter of fiscal 2006. The third quarter fiscal 2007 results included a tax benefit of approximately $0.4 million for R&D credits. The third quarter fiscal 2006 results included a $20.9 million pre-tax charge for restructuring costs associated with the decision to exit small molecule drug discovery and development and the integration of Celera Diagnostics into Celera. The third quarter fiscal 2006 results also included a $3.1 million pre-tax gain from the sale of an investment. All per share amounts refer to Applera Corporation-Celera Group Common Stock. "I'm encouraged by the progress Celera continues to make in increasing product sales and developing its product portfolio," said Tony L. White, Chairman, President and Chief Executive Officer of Applera Corporation. "Our scientific findings continue to generate peer review publications, allowing us to focus on the translation of these discoveries into commercialization opportunities." "We're pleased that the menu for the m2000[TM] system is expanding in Europe with the registration of a Real-Time[TM] assay for monitoring hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. ," said Kathy Ordonez, President of Celera. "We are also continuing to make progress in moving our genetic findings forward as evidenced by the agreement we entered into with LabCorp[R] this week regarding its planned commercialization of two breast cancer tests that incorporate Celera discoveries." Financial Highlights * Reported revenues for the third quarter of fiscal 2007 were $9.8 million, compared to $8.9 million for the third quarter of fiscal 2006. The increase was primarily due to higher diagnostic-related licensing and royalty revenues, partially offset by lower equalization In communications, techniques used to reduce distortion and compensate for signal loss (attenuation) over long distances. revenue. Reported revenues for the Group are comprised of product sales, equalization payments Equalization payments are cash payments made in some federal systems of government from the federal government to state or provincial governments with the objective of offsetting differences in available revenue or in the cost of providing services. , and license and collaboration revenues. Product sales consist primarily of shipments to our partner, Abbott, at cost. Revenues from items that are outside of the alliance with Abbott are also reported in this category. Equalization payments result from an equal sharing of alliance profits and losses between the alliance partners and vary each period depending on the relative income and expense contribution of each partner. * R&D expenses for the third quarter of fiscal 2007 were $13.0 million, compared to $20.4 million in the prior year quarter. SG&A expenses for the third quarter of fiscal 2007 decreased to $7.1 million from $8.3 million in the prior year quarter. These expense reductions were primarily due to the decision to exit small molecule drug discovery and development in the third quarter of fiscal 2006. * At March 31, 2007, the Group's cash and short-term investments were approximately $565 million, compared to approximately $567 million at December 31, 2006. Supplemental Financial Information * For the third quarter of fiscal 2007, total end-user revenues increased 21 percent to $24.3 million from $20.0 million in the prior year quarter. These end-user revenues included products sold through the alliance with Abbott and revenues from our unpartnered new genetic tests. Increased sales of HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. RealTime and HIV viral load HIV viral load AIDS A measure of the amount of HIV RNA in blood, expressed as number of copies/mL of plasma. See AIDS, HIV. assays used on the m2000 system, high resolution human leukocyte antigen human leukocyte antigen n. Abbr. HLA A gene product of the major histocompatibility complex; these antigens have been shown to have a strong influence on human allotransplantation, transfusions in refractory patients, and certain disease products, the ViroSeq[TM] HIV-1 Genotyping system, and sales of Fragile X analyte specific reagents (ASRs) all contributed to the year-over-year growth. These increases were partially offset by lower sales of our hepatitis C virus
Business and Scientific Developments * In April, Celera and Laboratory Corporation of America[R] Holdings (LabCorp) (NYSE:LH) announced that they signed an agreement granting LabCorp a license to Celera's breast cancer metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to and estrogen/progesterone receptor discoveries. The license agreement allows LabCorp to select from among Celera's genomic findings to develop and commercialize two molecular oncology laboratory service tests. This follows the presentation of data by Celera scientists in February at the 24th annual Miami Breast Cancer Conference in Miami Beach Miami Beach, city (1990 pop. 92,639), Dade co., SE Fla., on an island between Biscayne Bay and the Atlantic Ocean; inc. 1915. It is connected to Miami by four causeways. , FL, supporting Celera's multi-gene expression prognostic constellation as a predictor of distant metastasis in Tamoxifen-treated breast cancer patients. * In April, scientists at Celera and various collaborators published data from the Atherosclerosis Risk in Communities Study on the prediction of coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). (CHD CHD coronary heart disease. ChD abbr. Latin Chirurgiae Doctor (Doctor of Surgery) CHD, n.pr See disease, coronary heart. CHD canine hip dysplasia. ) risk using a genetic risk score in the American Journal of Epidemiology. This study demonstrated the concept of aggregating information from multiple single nucleotide polymorphisms into a risk score and indicates that this risk score can improve prediction of incident CHD. * In April, scientists from Celera and Seattle Genetics (Nasdaq:SGEN SGEN Signal/System Generator ) presented data from two studies on CD133/prominin-1 at the annual American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational meeting in Los Angeles Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. , CA. CD133 is a cell-surface marker cell-surface marker, n an antigenic area on the surface of a cell that identifies that cell as a particular type. for blood stem/progenitor cells that has also been identified as a cancer stem cell Cancer stem cell hypothesis states that tumors arise from cells termed cancer stem cells that have properties of adult stem cells, particularly the abilities to self-renew and differentiate into multiple cell types, and that these cells persist in tumors as a distinct population marker in various cancers. Both studies showed the potential therapeutic use of antibody drug conjugates (ADCs) targeted to CD133 utilizing Seattle Genetics' ADC (1) See A/D converter. (2) (Apple Display Connector) A peripheral connector from Apple that combines digital video display, USB and power in one cable. technology in the treatment of various solid tumors. Seattle Genetics selected CD133 for further investigation in August 2005 as part of the collaboration between the two companies that was started in July 2004. * In April, Abbott received CE marking for a real-time PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) (polymerase chain reaction polymerase chain reaction (pŏl`ĭmərās') (PCR), laboratory process in which a particular DNA segment from a mixture of DNA chains is rapidly replicated, producing a large, readily analyzed sample of a piece of DNA; the process is ) test for monitoring hepatitis B (HBV HBV hepatitis B virus. HBV abbr. hepatitis B virus ) viral load in patients, allowing the test to be marketed in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . This test detects nearly all known forms of HBV genotypes and enables physicians to better manage patient therapy. The Abbott RealTime HBV assay has been developed for use on the Abbott m2000 system, an automated instrument for DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic testing in molecular laboratories. * In February, Celera published data in Human Molecular Genetics Human Molecular Genetics is a semimonthly scientific journal published by The Oxford University Press. See: Official Site from its research studies identifying several candidate genetic markers associated with late-onset Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. (LOAD), including markers in multiple genes that have never been associated with LOAD. Two of these genes are PCK PCK Pedagogical Content Knowledge (knowledge of how to teach a subject) PCK Phosphoenolpyruvate Carboxykinase PCK Polycystic Kidney Disease PCK Phua Chu Kang (Singapore sitcom character) 1, a gene that regulates blood glucose levels blood glucose level, n level of glu-cose in the bloodstream, normally about 70 to 115 mg/dL after fasting overnight. Higher levels may indicate diseases such as diabetes mellitus. , and GALP GALP Glyceraldehyde 3-phosphate GALP Good Automated Laboratory Practices , a gene that is modulated by insulin and regulates food intake, suggesting a link between Alzheimer's disease and irregular glucose/insulin levels. * Innogenetics N.V., Ghent, Belgium, brought a patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. suit against Abbott in September 2005 covering the U.S. sale of HCV genotyping products. Innogenetics did not name Celera as a party in this lawsuit, but Celera has an interest in these products and in the outcome of the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. because the products are manufactured by Celera and sold through its alliance with Abbott. In September 2006, a jury in Madison, Wisconsin Madison is the capital of the U.S. state of Wisconsin and the county seat of Dane County. It is also home to the University of Wisconsin–Madison. The 2006 population estimate of Madison was 223,389, making it the second largest city in Wisconsin, after Milwaukee, and found that the sale of these products willfully willfully adv. referring to doing something intentionally, purposefully and stubbornly. Examples: "He drove the car willfully into the crowd on the sidewalk." "She willfully left the dangerous substances on the property." (See: willful) infringed a U.S. patent owned by Innogenetics. In January 2007, the U.S. District Court for the Western District of Wisconsin ruled in favor of Innogenetics' request for a permanent injunction permanent injunction n. a final order of a court that a person or entity refrain from certain activities permanently or take certain actions (usually to correct a nuisance) until completed. , and as such, ordered Abbott to withdraw its products from the market. The court also reversed the jury verdict of willful infringement, ruled that Abbott did not willfully infringe Innogenetics' patent, and denied Innogenetics' request for enhanced damages and attorneys' fees. Abbott is appealing the judgment as both Abbott and Celera believe that Innogenetics' patent is invalid and that the alliance's HCV genotyping ASRs do not infringe Innogenetics' patent. On March 8, 2007, the Court of Appeals for the Federal Circuit issued an order denying Abbott's motion for a stay of the permanent injunction during the appeal process. Celera Outlook Celera anticipates that its fiscal 2007 financial performance will be affected by demand for current and new diagnostic products, timing of the anticipated approval of the m2000 system in the U.S., and potential revenue from technology licenses and collaborations. Subject to the inherent uncertainty associated with these factors, Celera has the following expectations regarding its financial performance for fiscal 2007: * Total reported revenues are anticipated to be unchanged from the previous outlook of $43 - $48 million. This includes revenues from licensing and collaborations, which are anticipated to be $10 - $15 million. * Both R&D and SG&A expenses are anticipated to be at or slightly below the previous outlook of $50 - $55 million for R&D expenses, and $30 - $35 million for SG&A expenses. * Net loss from operations is anticipated to be at or slightly below the previous outlook of $18 - $25 million. * Celera expects cash used to fund operations, anticipated growth in placements of the m2000 system, and cash costs related to the fiscal 2006 restructuring to be at or slightly below the previous outlook of $10 - $20 million. This does not include any proceeds that might be received from the sale of Celera's small molecule facilities in South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , CA. * Total end-user revenues recognized through Celera's alliance with Abbott and total revenue from unpartnered new genetic tests are anticipated to be at or near the lower end of the previous outlook of $105 - $115 million, depending on the timing of the approval, and consequent uptake, of the m2000 system in the U.S. If the m2000 system is not approved for marketing in the U.S. in the fourth quarter of fiscal 2007, end-user revenues are anticipated to be below this range. Other risks and uncertainties that may affect Celera's financial performance are detailed in the Forward-Looking Statements section of this release. The comments in the Outlook section of this press release reflect management's current outlook. The Company does not have any current intention to update this Outlook and plans to revisit the outlook for its businesses only once each quarter when financial results are announced. Conference Call & Webcast A conference call with Applera Corporation executives will be held today at 11:00 a.m. (ET) to discuss these results and other matters related to the businesses. The call will be formatted to focus on each of the Applera businesses separately. The Applied Biosystems Applied Biosystems, Inc. (formerly NASDAQ: ABIO) is the original name of a pioneer biotechnology company founded in 1981 in Foster City, California, among the Silicon Valley cities of the southern San Francisco Bay Area. Group portion of the call will start at 11:00 a.m. (ET). The Celera Group portion of the call will start at 11:45 a.m. (ET), or immediately following the end of the Applied Biosystems portion of the call, if later. During each segment, the management team will make prepared remarks and answer questions from securities analysts and investment professionals. Investors, securities analysts, representatives of the media and other interested parties who would like to participate should dial 617.614.4076 and enter passcode 49256898 at any time from 10:45 a.m. until the end of the call. This conference call will also be webcast. Interested parties who wish to listen to the webcast should visit the "Investors & Media" section of www.applera.com, www.celera.com, or www.appliedbiosystems.com. A digital recording will be available approximately two hours after the completion of the conference call on April 26 until May 11, 2007. Interested parties should call 617.801.6888 and enter passcode 64007230. Applera also encourages stockholders to submit questions for management consideration by e-mail in advance of the conference call. Such questions, which should be brief and reasonably related to the releases, may be submitted to inna.kats@applera.com. While management cannot commit to answer all such submissions, it will endeavor to do so during the available time of the conference call. About Applera Corporation and Celera Applera Corporation consists of two operating groups. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and is developing diagnostic products based on these markers as well as other known markers. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products, and it is also developing new diagnostic products outside of this alliance. Through its genomics and proteomics research efforts, Celera is also discovering and validating therapeutic targets, and it is seeking strategic partnerships to develop therapeutic products based on these discovered targets. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids Nucleic acids The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits. (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which we refer to as "applied markets," such as the fields of: human identity testing (forensic and paternity testing paternity testing see parentage testing. ); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of over $1.9 billion during fiscal 2006. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at http://www.celera.com. Forward-Looking Statements Certain statements in this press release, including the Outlook section, are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "should," "anticipate," and "intend," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 provides a "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of Celera's business include but are not limited to: (1) Celera is an early-stage company and may not achieve profitability when expected, if at all; (2) Celera's business is substantially dependent on maintaining its existing strategic alliance with Abbott Laboratories and entering into new collaborations, alliances, and similar arrangements with other companies, which may not be successful; (3) Celera does not have the resources necessary to develop therapeutic products and therefore will not be able to participate in the development or commercialization of therapeutic products other than through collaborations or licensing arrangements with other companies; (4) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products and targets for the development of new therapeutics, which may not be successful; (5) clinical trials of therapeutic or diagnostic products may not proceed as anticipated, may take several years and be very expensive, and may not be successful; (6) diagnostic or therapeutic products may not receive required regulatory clearances or approvals; (7) the diagnostic and therapeutic industries are very competitive, and new therapeutic or diagnostic products may not be accepted and adopted by the market; (8) demand for diagnostic or therapeutic products may be adversely affected if users of these products cannot receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (9) the U.S. Food and Drug Administration has issued a draft interpretation of the regulations governing the sale of Analyte Specific Reagent products which could prevent or delay Celera's or its collaborators' or licensees' sales of these products and harm Celera's business; (10) Celera relies on access to biological materials and related clinical and other information for some of its research and development efforts, and such materials and information may be in limited supply or inaccessible to Celera; (11) Celera may be subject to product liability or other claims as a result of the testing or use of therapeutic or diagnostic products, including those commercialized through collaborators or licensees; (12) Celera relies on scientific and management personnel having the necessary training and technical backgrounds and also on collaborations with scientific and clinical experts at academic and other institutions who may not be available to Celera or who may compromise the confidentiality of Celera's proprietary information; (13) Celera may be subject to liabilities related to its use, manufacture, sale, and distribution of hazardous materials; (14) Celera's ability to protect its intellectual property is uncertain, its ability to protect its trade secrets is limited, Celera is subject to the risk of infringement claims, and it may need to license intellectual property from third parties to avoid or settle such claims; (15) Celera is dependent on the operation of computer hardware, software, and Internet applications and related technology; (16) an adverse outcome in legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. involving Abbott could harm Celera's business and subject it to liabilities; (17) legal, ethical, and social issues related to the use of genetic information could adversely affect demand for Celera's diagnostic products; (18) future acquisitions by Celera may not be successful, may divert management from operations, may cause dilution, and may result in impairment or other charges; (19) the outcome of the existing stockholder litigation is uncertain; (20) Celera has limited commercial manufacturing experience and capabilities and relies on a single manufacturing facility for manufacturing its diagnostic products; (21) Celera relies on a single supplier or a limited number of suppliers for key components of certain of its diagnostic products; (22) Celera's principal facilities are subject to the risk of earthquakes, which could interrupt operations; and (23) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law. Copyright 2007 Applera Corporation. All Rights Reserved. AB(Design) and Celera and ViroSeq are registered trademarks, and Applied Biosystems and Applera are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries. RealTime and m2000 are trademarks of Abbott Laboratories or its subsidiaries in the U.S. and/or certain other countries. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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