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ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 14, 2012-- BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today reported financial results for the fourth quarter and year ended
"At the forefront of our corporate strategy is a plan to develop and acquire novel technologies in the stem cell field and to establish one of the broadest sets of capabilities in the industry. We made significant strides towards the accomplishment of that goal through further development of our products and through key strategic acquisitions in 2011. We are now positioned to focus on commercializing these emerging technologies," said
For the quarter ended
For the full year 2011, total revenue, on a consolidated basis, including royalties from product sales and other revenue, revenue recognition of deferred license fees and grant income, was
Total expense for the three months ended
Total expense for the full year ended
Net loss attributable to
Net cash used in operating activities was
Cash and cash equivalents, on a consolidated basis, totaled
Fourth Quarter and Recent Corporate Accomplishments
Advanced Near-Term Product Development
- Successfully completed ISO 10993 biocompatibility studies for HyStem®-Rx. The results of these preclinical studies demonstrated the safety and biocompatibility of HyStem®-Rx. The first clinical application of HyStem®-Rx will be for use with autologous adipose cells to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects.
- Announced plans for the development of PanC-DxTM, OncoCyte Corporation's novel diagnostic device to detect the presence of various human cancers (including cancers of the breast, lung, bladder, uterus, stomach, and colon) through blood tests administered during routine check-ups. Initial studies have indicated that PanC-DxTM may be useful for detecting a much wider range of cancer types than those detected by blood tests currently available to clinicians.
Expanded Research Product Offerings
- Announced, with
XenneX Inc., the inclusion of cell identification data in GeneCards® 3.07 available at http://www.genecards.org. The new GeneCards® identifies BioTime's ACTCellerate™ human embryonic progenitor cell lines that express specific gene expression markers and links users directly to BioTime's commercial database. GeneCards® is an integrated database of human genes that includes automatically mined genomic, proteomic, and transcriptomic information, with a major focus on functional genomics and the role of genes in diseases.
- Elected to market progenitors of muscle stem cells bearing hereditary diseases.
BioTimewill produce the products from five human embryonic stem cell lines acquired 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. When developed, the progenitor cell lines will be marketed to researchers seeking new treatment modalities for these diseases.
Advanced R&D Collaborations
- Obtained an exclusive license from
The Wistar Institutefor technology related to a gene designated as SP100. Wistar Instituteresearchers have demonstrated pivotal roles for this gene in both cancer and stem cell biology. In conjunction with the license agreement, BioTimeagreed to fund research at The Wistar Instituteto advance the technology, and will have certain rights to negotiate additional licenses for any technologies invented as a result of the research.
- Entered into a worldwide license agreement with
Cornell Universityfor the development and commercialization of technology developed at Weill Cornell Medical Collegefor the differentiation of human embryonic stem cells into vascular endothelial cells. The technology may provide an improved means of generating vascular endothelial cells on an industrial scale, and may be utilized by BioTimeand its subsidiaries in a diverse array of products, including products under development at ReCyte Therapeutics, Inc.to treat age-related vascular disease, as well as products being developed at OncoCyte Corporationtargeting the delivery of toxic payloads to the developing blood vessels of cancerous tumors.
- Entered into a Sponsored Research Agreement under which scientists at
Weill Cornell Medical Collegewill engage in research with three goals: 1) verifying the ability of progenitor cells that are derived by ReCyte Therapeutics, Inc.using its proprietary ACTCellerate™ technology to generate stable populations of vascular endothelial cells, 2) testing the functionality and transplantability of vascular endothelial cells in animal models to see if the transplanted cells generate new vascular tissue, and 3) using Hystem® hydrogels as scaffolds for the three-dimensional propagation of vascular endothelial cells into vascular tissues suitable for transplantation.
Expanded and Strengthened Management Team and Board of Directors
Andrew C. von Eschenbach, M.D. to BioTimeand OncoCyte Corporation's Board of Directors. Dr. von Eschenbachis the President of Samaritan Health Initiatives, Inc., a health care policy consultancy, and is an Adjunct Professor at University of Texas MD Anderson Cancer Center. Dr. von Eschenbachserved as Commissioner of the Food and Drug Administrationfrom September 2005to January 2009, after serving as Director of the National Cancer Instituteat the National Institutes of Health.
Peter S. Garciaas BioTime'sChief Financial Officer. Mr. Garcia served as Chief Financial Officer of six biotech and high-tech companies over the past 16 years, and was instrumental in leading multiple merger and acquisition transactions for those companies.
- Published in the peer-reviewed journal Stem Cell Research the complete genome sequence analysis of five clinical-grade human embryonic stem cell lines. "Evaluating the Genomic and Sequence Integrity of Human ES Cell Lines: Comparison to Normal Genomes" is the first such analysis of the entire genome of human embryonic stem cell lines and further establishes BioTime's lead in developing fully characterized cell lines intended for use in the manufacture of therapeutics.
- Presented at the following scientific and investor meetings: GTC 2011 5th Advances in
Stem Cell Discovery & Development Conference; Translational Strategies for Tissue Engineering Conference; and the 7th Annual New York Stem Cell Summit.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for
To receive ongoing
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||22,211,897||$||33,324,924|
|Prepaid expenses and other current assets||2,692,303||2,202,284|
|Total current assets||24,955,374||35,572,678|
|Deferred license and consulting fees||843,944||1,550,410|
|Intangible assets, net||18,619,516||15,386,905|
|LIABILITIES AND EQUITY|
|Accounts payable and accrued liabilities||$||2,681,111||$||1,929,874|
|Deferred grant income||261,777||261,777|
|Deferred license revenue, current portion||203,767||288,306|
|Total current liabilities||3,146,655||2,479,957|
|Commitments and contingencies|
|Deferred license revenue, net of current portion||899,551||1,048,757|
|Deferred rent, net of current portion||66,688||-|
|Other long-term liabilities||258,620||318,288|
|Total long-term liabilities||1,224,859||1,367,045|
|Preferred Shares, no par value, authorized 1,000,000 shares; none issued||-||-|
|Common Shares, no par value, authorized 75,000,000 shares; 50,321,962 and 47,777,701 issued, and 49,035,788 and 47,777,701 outstanding at December 31, 2011 and 2010, respectively||115,144,787||101,135,428|
|Accumulated other comprehensive (loss)/income||(122,749||)||897,338|
|Treasury stock at cost: 1,286,174 and nil shares at December 31, 2011 and 2010, respectively||(6,000,000||)||-|
|Total shareholders' equity||28,646,001||38,172,229|
|TOTAL LIABILITIES AND EQUITY||$||45,829,695||$||53,272,659|
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
|Three Months Ended
|Full Year Ended
|Sale of research products and royalty from product sales||405,729||201,682||1,323,824||1,051,071|
|Research and development||(4,113,028||)||
|General and administrative||(2,965,683||)||
|Loss from operations||(5,447,185||)||(3,752,883||)||(18,686,431||)||(9,852,133||)|
|OTHER INCOME (EXPENSES):|
|Interest income/(expense), net||104,686||(124,016||)||29,727||(124,300||)|
|(Loss)/gain on sale of fixed assets||-||(950||)||(6,246||)||-|
|Modification cost of warrants||-||
|Other income/(expense), net||80,236||157,759||219,067||(68,573||)|
|Total other income/(expense), net||$||184,922||$||32,793||$||242,548||$||(2,335,074||)|
|Net loss attributable to the noncontrolling interest||124,449||753,173||1,928,383||1,002,589|
|Net loss attributable to BioTime, Inc. (1)||$||(5,137,814||)||$||(2,966,917||)||$||(16,515,500||)||$||(11,184,618||)|
|Foreign currency translation loss||(118,207||)||899,700||(1,020,087||)||897,338|
|COMPREHENSIVE NET LOSS (2)||$||(5,256,021||)||$||(2,067,217||)||$||(17,535,587||)||$||(10,287,280||)|
|BASIC AND DILUTED LOSS PER COMMON SHARE (1)||$||(0.10||)||$||(0.06||)||$||(0.35||)||$||(0.28||)|
|WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:BASIC AND DILUTED||50,276,764||46,958,825||47,486,941||40,266,311|
(1) Basic and diluted loss per common share is calculated using "Net loss attributable to
(2) Comprehensive net loss includes foreign currency translation loss of