BioTime (NYSE AMEX: BTX) Q1/12 Results and Highlights
Net loss was $5M or $0.10 per share, compared to a net loss of $3.4M or $0.07 per share for Q1/11.
Q1/12 total revenue (including royalties from product sales and other revenue, revenue recognition of deferred license fees and grant income), on a consolidated basis, was $631.9K, compared to a down $193K from $824.6K for Q1/11. The decrease in revenue year-over-year in Q1/12 is primarily attributable to a decrease in royalties and license fees from the sale of Hextend^®, proprietary blood plasma volume expander used in surgery and trauma care.
R&D expenses were $4.178M compared to $2.948M in Q1/11. G&A expenses were $2.37M compared to $1.9M in Q1/11. Q1/12 total expense was $6.5M, compared to a total expense of $4.9M for Q1/11. Operating expenses increased $1.6M year-over-year in Q1/11 due to increased expenses related to the amortization of patent assets from previous acquisitions, employee compensation and headcount-related costs, patent-related legal fees, and expenses related to increased efforts in the ReneviaTM (formerly HyStem^®-Rx) clinical development program slated for human clinical trials in FY12 and the PanC-Dx^TM diagnostic development program.
Net cash used in operating activities was $5.7M for Q1/12 compared to $3.4M for Q1/11, reflecting the hiring of additional staff and increased headcount-related expenses, the payout of annual bonuses, and increased expense related to R&D programs in subsidiaries. Excluding one-time discretionary expenses, which included bonuses and license payments, the net cash used in operations for Q1/12 was approximately $4.2M. A BTX subsidiary, OncoCyte Corporation, currently holds 1,286,174 in BTX common shares. The common shares are accounted for as Treasury Stock on a consolidated basis, but this investment account, currently valued at approximately $5M, is available to fund the operations of OncoCyte. Basic and diluted shares used in computing the net loss was 50.32M versus 48.3M in Q1/11.
- As of 3/31/12, BTX had cash and cash equivalents, on a consolidated basis, totaled $16.5M, compared with $22.2M as of 12/31/11. .
Advanced Near-Term Product Development
- Provided an update on the development of Renevia^TM (formerly known as HyStem^®-Rx) including the product development milestones for thelaunch of Renevia^TM in Europe, the goal of obtaining the CE mark necessaryfor marketing Renevia^TM in European Union countries by year-end 2013, and the global distribution network marketing the HyStem^® line of research products being utilized in a wide array of medical research applications;
- BTX and its subsidiary OncoCyte Corporation provided an update on the development of PanC-DxTM, a novel diagnostic device to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups. Achieved several key advances, including: the evaluation of over 50 potential cancer biomarkers discovered by OncoCyte and BTX using antibody-based technology in blood samples from a proprietary sample bank derived from over 600 donors, including patients with cancers of the breast, colon, and pancreas, as well as healthy volunteers; and the selection of seven such serum markers for monoclonal antibody production.
Expanded Revenue Opportunities:
- BTX and its subsidiary LifeMap Sciences, Inc. announced a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences. XenneX holds the exclusive, worldwide licenses to market GeneCards^® and PanDaTox. GeneCards^® is a searchable, integrated database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease-related information, on all known and predicted human genes and generates revenue from customers worldwide, including biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property. PanDaTox is a recently developed, searchable, database that can be used to identify genes and intergenic regions that are unclonable in E. coli, to aid in the discovery of new antibiotics and biotechnologically beneficial functional genes, and to improve the efficiency of metabolic engineering.
- Announced intent to transfer to LifeMap the products and technologies necessary to be the principal marketing subsidiary for BioTime research products, including ACTCellerateTM human progenitor cell lines, GMP human embryonic stem (hES) cell lines, hES cell lines carrying inherited genetic diseases, and ESpanTM growth media for progenitor cell lines for non-therapeutic uses. LifeMap will utilize its databases as part of its online marketing strategy to reach life sciences researchers at biotech and pharmaceutical companies and at academic institutions and research hospitals worldwide;
- Initiation of the manufacture of progenitors of muscle stem cells bearing hereditary diseases. BTX will produce the products from 5 hES cell lines from Reproductive Genetics Institute. The muscle cell lines display the genes for Duchenne muscular dystrophy, Emery-Dreifuss muscular dystrophy, spinal muscular atrophy Type I, facioscapulohumeral muscular dystrophy 1A, and Becker muscular dystrophy.
Advanced R&D Collaborations:
- Obtained an exclusive license from The Wistar Institute for technology related to a gene designated as SP100. Wistar Institute researchers have demonstrated pivotal roles for this gene in both cancer and stem cell biology. In conjunction with the license agreement, BioTime agreed to fund research at The Wistar Institute to advance the technology, and will receive certain rights to negotiate additional licenses for any technologies invented as a result of the research.
Expanded Board of Directors Involvement:
- Formation of a Science & Technology Committee of the BTX’s Board of Directors (BoD) to oversee the development and commercialization of technology and products in regenerative medicine and oncology. The committee will regularly report to the BoDand make recommendations as to the priorities, direction, quality, and execution for BTX’s technology and product development programs, as well as allocations of financial resources and potential acquisitions of new technology and products. The committee is chaired by director Andrew C. von Eschenbach, M.D., the former Commissioner of the US FDS and former Director of the NCI.