Celera decreases second-quarter net loss to $6.1 million

April 15, 2016

Business Developments In July, BHL launched a laboratory developed test for Cytochrome 2C19 (CYP2C19) that identifies carriers of genetic variants that may impact the effectiveness of the anti-platelet drug, Plavix? (or clopidogrel). Effectiveness of Plavix depends on its activation by the CYP2C19 gene in the cytochrome P450 system, which converts the drug to its active form. Depending on the presence of certain 2C19 genetic variants, a person may be more or less effective at converting Plavix into its active (or usable) form. The Food and Drug Administration recently placed a warning on the Plavix label to inform clinicians that they should consider an alternative treatment depending on a person's 2C19 genotype. BHL's new test identifies 8 variants known to be associated with Plavix metabolism. In June, Celera extended its research collaboration with Ipsen (Euronext: IPN; ADR: IPSEY) to use next-generation sequencing technology to identify genetic biomarkers for pharmacogenomic tests for growth failure patients. This followed the completion of the first phase of this project that was started in November, 2007. In June, Celera signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark. Scientific Developments In July, Celera and Horizon Discovery, Cambridge, United Kingdom, presented data at the Translational Cancer Conference in San Francisco, CA, describing the dose-dependent change in the result obtained in Celera's metastasis risk score in precisely engineered cultured cell lines treated with a phase II phosphatidylinositol 3-kinase (PI3K) drug for breast cancer. In June, Celera and its collaborators at the University of California at San Francisco published data in the journal Atherosclerosis, confirming the association of an increased risk of coronary heart disease and two variants of the LPA gene. The two LPA single nucleotide polymorphisms are Ile4399Met, a polymorphism in the protease-like domain of LPA, and rs10455872, a SNP located in a non-coding region of the LPA gene.

Outlook for 2010

Celera anticipates that its 2010 financial performance may be affected by a number of factors, including acceptance and utilization of its testing services and diagnostic products, reimbursement practices, economic pressures and the healthcare system generally, and competitive pressures, including disruption to the business as a result of the departure of sales representatives identified in the now settled HDL litigation. Subject to the additional inherent risks and uncertainties that may affect Celera's financial performance, which are detailed in the Forward-Looking Statements section of this release, Celera expects the following for 2010:

Total revenues are anticipated to be $135 - $145 million, compared to the prior outlook of $145 - $155 million. Gross margin, as a percentage of revenue, is anticipated to be 63% - 67%, unchanged from the prior outlook. SG&A expenses are anticipated to be $85 - $95 million, compared to the prior outlook of $90 - $100 million, and R&D expenses are anticipated to be $25 - $30 million, unchanged from the prior outlook. Celera anticipates a net loss of $20 - $25 million, or $0.25 - $0.30 per share, on a non-GAAP basis, compared to the prior outlook of a net loss of $12 - $17 million, or $0.15 - $0.21 per share, on a non-GAAP basis. Amortization of intangibles relating to acquisitions and the non-cash accretion of discount recorded in interest income, which are excluded in the determination of non-GAAP earnings per share, are expected to be approximately $10 million and $1 million, respectively. Expense associated with equity awards is expected to be approximately $5.3 million, which represents approximately $0.06 per share included in the determination of Celera's expected non-GAAP loss per share. Celera expects its cash and short-term investments to be between $310 and $320 million at the end of 2010, unchanged from the prior outlook.

The comments in the "Outlook for 2010" 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.

SOURCE Celera Corporation