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Fourth Quarter and Recent Highlights
November 2014, BioTimereceived authorization to begin its Renevia™ pivotal clinical trial in HIV- associated lipoatrophy, a disorder that occurs in almost half of the approximately three million people on antiretroviral therapy in the U.S. and Europe. In the trial, Renevia™ is being tested as a delivery matrix for the patient’s own fat-derived cells and injected into portions of the patient’s face where there is lipoatrophy in order to promote facial tissue reconstruction. The first patient was treated in this trial in February 2015.
December 2014, BioTimestrengthened its Board of Directors with the appointment of Angus C. Russell, former Chief Executive Officer of Shire plc, which is a leading global specialty biopharmaceutical company. The appointment of Mr. Russell followed the recent appointments to the board of Steve Carttand Mike Mulroy, who were among the top executives of Questcor Pharmaceuticals.
December 2014, BioTimeappointed Adi Mohantyas Chief Operating Officer, bringing proven leadership in biopharmaceutical product development and commercialization to the company. Mr. Mohanty is a former executive of Shire with significant experience in biopharmaceutical product development, manufacturing, and commercialization and a background in regenerative medicine.
February 2015, Asterias raised $5.5 millionthrough the sale of shares of its Series A common stock.
March 2015, Asterias Biotherapeutics(NYSE MKT: AST) initiated patient enrollment for its Phase 1/2a clinical trial of its product, AST-OPC1 (oligodendrocyte progenitor cells), in complete cervical spinal cord injury.
October 2014, the U.S. Food and Drug Administration( FDA) cleared Cell Cure's Investigational New Drug (IND) application to initiate the Phase 1/2a clinical trial of OpRegen® in patients with the severe form of age-related macular degeneration with geographic atrophy. In February 2015, the OpRegen® Phase 1/2a clinical trial opened at Hadassah University Medical Centerin Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen® consists of high purity retinal pigment epithelial cells derived from human embryonic stem cells using a proprietary directed differentiation method.
March 2015, the Icahn School of Medicineat Mount Sinai(“Mount Sinai”) launched a large-scale medical research study of asthma that uses the new ResearchKit software framework developed by Appleto enable individuals who suffer from asthma to participate in the study right from their iPhone using an Asthma Healthapp developed by Mount Sinaiin conjunction with LifeMap Solutions. The Asthma Health App is designed to facilitate asthma patient education and self-monitoring, promote positive behavioral changes, and reinforce adherence to treatment plans according to current asthma guidelines. The study tracks symptom patterns in an individual and potential triggers for these exacerbations so that researchers can learn new ways to personalize asthma treatment. The Asthma Healthapp was highlighted by Appleduring its senior management public presentation of new products on March 9, 2015and is displayed on Apple’s website and is available as a free download on the Apple App Store.
- OncoCyte completed enrollment in the initial clinical study of its urine-based PanC-Dx™ diagnostic product for bladder cancer. The goal of this clinical study was to assess the performance of OncoCyte’s proprietary diagnostic technology in detecting the most common type of bladder cancer, urothelial carcinoma (previously designated transitional cell carcinoma).
Two abstracts, summarizing clinical studies of OncoCyte’s PanC-Dx™
diagnostic products for bladder and breast cancer, were accepted for
poster presentation at the
American Association for Cancer Research(AACR) Annual Meeting being held April 18-22, 2015.
William Annettto its Board of Directors, bringing extensive experience within the biotechnology and diagnostics industry to the board. Mr. Annett is a former senior executive of Genentech and Accenture, has been CEO of six organizations, has been a successful entrepreneur, and has substantial diagnostics experience.
Fourth Quarter Financial Results
Total revenue, on a consolidated basis, for the fourth quarter of 2014
Net loss attributable to
Full Year Financial Results
Total consolidated revenue for the full year of 2014 increased to
Net loss attributable to
Cash and cash equivalents, on a consolidated basis, totaled
BioTime’s subsidiaries include: publicly-traded
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for
To receive ongoing
|BIOTIME, INC. AND SUBSIDIARIES|
|CONSOLIDATED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$||29,486,909||$||5,495,478|
|Trade accounts and grants receivable, net||1,041,856||1,115,209|
|Prepaid expenses and other current assets||1,231,789||1,160,589|
|Total current assets||32,404,557||7,949,970|
|Deferred license and consulting fees||336,833||444,833|
|Other long term assets||9,985||-|
|Intangible assets, net||38,848,396||46,208,085|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||6,803,173||$||6,722,624|
|Capital lease liability, current portion||57,500||-|
|Related party convertible debt, net of discount||60,237||-|
|Deferred license and subscription revenue, current portion||208,357||235,276|
|Total current liabilities||7,129,267||6,957,900|
|Deferred tax liabilities, net||4,514,362||8,277,548|
|Deferred rent liabilities, net of current portion||97,280||35,997|
|Capital lease, net of current portion||31,290||-|
|Other long term liabilities||27,961||195,984|
|Total long-term liabilities||5,048,874||8,509,529|
|Commitments and contingencies|
|Preferred shares, no par value, authorized 2,000,000 shares as of December 31, 2014 and 2013; 70,000 and none issued and outstanding as of December 31, 2014 and 2013, respectively||3,500,000||-|
|Common shares, no par value, authorized 125,000,000 shares as of December 31, 2014 and 2013; 83,121,698 issued and 78,227,756 outstanding as of December 31, 2014 and 67,412,139 issued and 56,714,424 outstanding as of December 31, 2013||234,842,998||203,456,401|
|Accumulated other comprehensive income||185,835||62,899|
|Treasury stock at cost: 4,893,942 and 10,697,715 shares at December 31, 2014 and 2013, respectively||(19,889,788)||(43,033,957)|
|BioTime, Inc. shareholders' equity||36,455,983||14,800,768|
|Total shareholders' equity||62,722,765||42,262,321|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||74,900,906||$||57,729,750|
|BIOTIME, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|Three Months Ended December 31 (unaudited)||Years Ended December 31,|
|Royalties from product sales||75,945||75,270||397,751||366,775|
Sale of research products and services
|Cost of sales||(222,972||)||(222,422||)||(837,052||)||(792,659||)|
|Research and development||(11,277,256||)||(9,220,014||)||(37,532,624||)||(26,609,423||)|
|Acquired in-process research and development||-||(17,458,766||)||-||(17,458,766||)|
|General and administrative||(4,791,898||)||(4,284,726||)||(17,556,102||)||(15,558,674||)|
|Total operating expenses||(16,069,154||)||(30,963,506||)||(55,088,726||)||(59,626,863||)|
|Loss from operations||(14,404,591||)||(29,293,443||)||(50,682,574||)||(55,985,186||)|
|Interest expense, net||(57,939||)||(2,611||)||(88,496||)||(578||)|
|(Loss)/gain on sale or write off of fixed assets||(217||)||-||(8,926||)||5,120|
|Other expense, net||(513,505||)||(39,665||)||(374,715||)||(209,177||)|
|Total other expenses, net||(571,661||)||(42,276||)||(472,137||)||(204,635||)|
|LOSS BEFORE INCOME TAX BENEFITS||(14,976,252||)||(29,335,719||)||(51,154,711||)||(56,189,821||)|
|Deferred income tax benefit||2,200,634||3,280,695||7,375,611||3,280,695|
|Net loss attributable to the noncontrolling interest||
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC. (1)||$||(10,567,537||)||$||(19,612,314||)||$||(36,411,660||)||$||(43,882,835||)|
|Dividends on preferred shares (2)||(52,789||)||-||(86,827||)||-|
|NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS||(10,620,326||)||(19,612,314||)||(36,498,487||)||(43,882,835||)|
|Foreign currency translation gain/(loss)||337,253||(64,841||)||124,949||119,469|
|Unrealized (loss)/gain on available-for-sale securities||(727||)||-||(2,013||)||3,000|
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|BASIC AND DILUTED NET LOSS PER COMMON SHARE (1)||$||(0.14||)||$||(0.35||)||$||(0.55||)||$||(0.81||)|
|WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED||77,957,943||56,245,189||66,466,714||54,226,219|
|(1) Basic and diluted loss per common share is calculated using "Net loss attributable to BioTime, Inc. common shareholders."|
|(2) Comprehensive loss includes foreign currency translation gain of $337,253 and $124,949 for the three and twelve months ended December 31, 2014, respectively and translation loss of $64,841 and gain of $119,469 for the same periods in the prior year, respectively which arise entirely from the translation of foreign subsidiary financial information for consolidation purposes and therefore not used in the calculation of basic and diluted loss per common share. Comprehensive loss does not include dividends on preferred shares.|
Judith Segall, 510-521-3390, ext 301
EVC Group, Inc.
Gregory Gin, 862-236-0673
Jim Dawson, 646-445-4800
Doug Sherk, 415-652-9100