UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): May
12, 2014
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California |
1-12830 |
94-3127919 |
(State or other jurisdiction
|
(Commission File Number)
|
(IRS Employer Identification No.) |
1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. Such risks and uncertainties include but are not limited to those discussed in this report and in BioTime's other reports filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.
This Report and any accompanying exhibits shall be deemed “furnished” and not “filed” under the Securities Exchange Act of 1934, as amended.
Section 2 - Financial Information
Item 2.02 - Results of Operations and Financial Condition
On May 12, 2014 BioTime, Inc. issued a press release announcing its financial results for the three months ended March 31, 2014 and recent business developments. A copy of the press release is attached as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
Exhibit Number |
Description |
99.1 | Press release dated May 12, 2014 |
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
BIOTIME, INC. |
||||
Date: |
May 12, 2014 |
By |
/s/ Robert W. Peabody |
|
|
Senior Vice President,
|
Exhibit Number |
Description |
99.1 | Press release dated May 12, 2014 |
2
Exhibit 99.1
BioTime Announces First Quarter 2014 Results and Recent Developments
ALAMEDA, Calif.--(BUSINESS WIRE)--May 12, 2014--BioTime, Inc. (NYSE MKT: BTX) today reported financial results for the first quarter ended March 31, 2014 and highlighted recent corporate accomplishments.
“BioTime’s efforts in the first quarter of 2014 were focused on advancing near-term products through clinical trials while also preparing certain novel stem cell-based therapeutics for clinical trials later this year. Enrollment in three diagnostic clinical studies has remained rapid, with completion expected later in 2014. Following the successful safety trial of ReneviaTM, we have made rapid progress in preparing for the pivotal ReneviaTM trial during the second half of the year,” said Michael D. West, Ph.D., BioTime’s Chief Executive Officer. “At our subsidiary Asterias Biotherapeutics, we have been preparing to initiate a new Phase 1/2a clinical trial of OPC1 for the treatment of spinal cord injury in 2014, pending clearance from the FDA, and also preparing our VAC2 cancer vaccine for a potential clinical trial. Also in the quarter, BioTime’s subsidiary Cell Cure Neurosciences Ltd. advanced preclinical development of OpRegen® for a planned IND filing in 2014 for the treatment of age-related macular degeneration.”
“We have continued to develop our subsidiaries’ businesses,” commented Dr. West. “Shares of the Series A common stock of our subsidiary Asterias Biotherapeutics, Inc. are now scheduled to begin trading publicly this summer following Geron’s distribution of those shares to its stockholders, for which a record date of May 28th has been set. We were also pleased to recently announce that LifeMap Solutions, Inc., a newly organized subsidiary of our LifeMap Sciences, Inc., has entered into an agreement with a major medical center to create innovative mobile health (mHealth) products powered by biomedical and other personal big data.”
“As the industry leader in regenerative medicine with over 600 patents and patent applications worldwide, BioTime and its subsidiaries have assembled a broad array of strategically important regenerative medicine technologies and assets for the development of therapeutic and diagnostic products,” Dr. West continued. “Our expenditure levels were higher than usual during the fourth quarter and the recently ended first quarter, but our recent progress in streamlining our workforce through shared core resources among our subsidiaries should reduce our cash burn rate and optimize value for our shareholders during this exciting time in the company’s history. We would like to thank our long-term investors for their continued support and our collaborators at leading academic medical institutions for their help in advancing our products toward our goal of helping patients who have serious unmet medical needs.”
First Quarter and Recent Highlighted Corporate Accomplishments
Financial Results
Revenue
For the quarter ended March 31, 2014, on a consolidated basis, total revenue was $1.1 million, up $0.5 million from $0.6 million for the same period one year ago. The increase in first quarter revenue is primarily attributable to grant income awarded to BioTime’s subsidiary Cell Cure Neurosciences Ltd. from Israel’s Office of the Chief Scientist.
Expenses
Operating expenses for the three months ended March 31, 2014 were $12.1 million, compared to expenses of $8.8 million for the same period of 2013. The increase in operating expenses is primarily attributable to an increase in staffing and the expansion of research and development efforts of Asterias and the amortization expense of intangible assets recorded in connection with the Geron stem cell asset acquisition in October 2013.
Net Loss
Net loss attributable to BioTime for the three months ended March 31, 2014 was $8.1 million or $0.14 per share, compared to a net loss of $7.7 million or $0.15 per share for the same period in 2013. The increase in net loss is primarily attributed to increased research and development related activity in Asterias. This increase is to some extent offset by the $1.3 million income tax benefit recorded as of March 31, 2014 compared with none in the same period in 2013. Net losses attributable to BioTime include losses from BioTime majority owned subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents, on a consolidated basis, totaled $6.6 million as of March 31, 2014, compared with $5.5 million as of December 31, 2013.
During the three months ended March 31, 2014, BioTime and certain of its subsidiaries raised approximately $8.8 million of additional equity capital through the sale of BioTime common shares in “at-the-market” transactions through Cantor Fitzgerald & Co. (“Cantor”), as sales agent. In addition, on March 4, 2014, BioTime raised $3.5 million of equity capital through the sale of 70,000 shares of a newly authorized Series A Convertible Preferred Stock to private investors.
On May 1, 2014, BioTime received approximately $6.4 million in equity financing from current long-term investors in the Company in transactions for which Cantor acted as sales agent.
About BioTime
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime’s focus is on pluripotent stem cell technology based on human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”) cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime’s therapeutic and research products include a wide array of proprietary PureStem® progenitors, HyStem® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (a HyStem® product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. In addition, BioTime has developed Hextend®, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend® is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ HealthCare Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:
Additional information about BioTime can be found on the web at www.biotimeinc.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com
BIOTIME, INC. AND SUBSIDIARIES | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
March 31, 2014 |
December 31, |
||||||||
ASSETS | |||||||||
CURRENT ASSETS | |||||||||
Cash and cash equivalents | $ | 6,637,834 | $ | 5,495,478 | |||||
Inventory | 236,588 | 178,694 | |||||||
Trade accounts and grants receivable, net | 818,275 | 998,393 | |||||||
Prepaid expenses and other current assets | 1,554,114 | 1,277,405 | |||||||
Total current assets | 9,246,811 | 7,949,970 | |||||||
Equipment, net | 2,959,150 | 2,997,733 | |||||||
Deferred license and consulting fees | 418,958 | 444,833 | |||||||
Deposits | 428,827 | 129,129 | |||||||
Other long-term assets | 56,062 | - | |||||||
Intangible assets, net | 44,840,087 | 46,208,085 | |||||||
TOTAL ASSETS | $ | 57,949,895 | $ | 57,729,750 | |||||
LIABILITIES AND EQUITY | |||||||||
CURRENT LIABILITIES | |||||||||
Accounts payable and accrued liabilities | $ | 5,443,063 | $ | 6,722,624 | |||||
Deferred license and subscription revenue, current portion | 177,594 | 235,276 | |||||||
Total current liabilities | 5,620,657 | 6,957,900 | |||||||
LONG-TERM LIABILITIES | |||||||||
Deferred rent, net of current portion | 28,054 | 35,997 | |||||||
Deferred tax liability, net | 6,928,522 | 8,277,548 | |||||||
Other long-term liabilities | 8,441 | 195,984 | |||||||
Total long-term liabilities | 6,965,017 | 8,509,529 | |||||||
Commitments and contingencies | |||||||||
EQUITY | |||||||||
Preferred Shares, no par value, authorized 2,000,000 shares as of March 31, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of March 31, 2014 and December 31, 2013, respectively | 3,500,000 | - | |||||||
Common shares, no par value, authorized 125,000,000 shares as of March 31, 2014 and December 31, 2013; 69,617,329 issued and 59,071,192 outstanding as of March 31, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013 | 211,943,421 | 203,456,401 | |||||||
Contributed capital | 93,972 | 93,972 | |||||||
Accumulated other comprehensive income/(loss) | (44,341 | ) | 62,899 | ||||||
Accumulated deficit | (153,877,561 | ) | (145,778,547 | ) | |||||
Treasury stock at cost: 10,546,137 and 10,697,715 shares at March 31, 2014 and at December 31, 2013, respectively | (42,372,546 | ) | (43,033,957 | ) | |||||
Total shareholders' equity | 19,242,945 | 14,800,768 | |||||||
Noncontrolling interest | 26,121,276 | 27,461,553 | |||||||
Total equity | 45,364,221 | 42,262,321 | |||||||
TOTAL LIABILITIES AND EQUITY |
$ | 57,949,895 | $ | 57,729,750 | |||||
BIOTIME, INC. AND SUBSIDIARIES | ||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||
(UNAUDITED) | ||||||||||
Three Months Ended |
||||||||||
March 31, 2014 |
March 31, 2013 |
|||||||||
REVENUES: | ||||||||||
License fees | $ | 294,504 | $ | 349,824 | ||||||
Royalties from product sales | 97,886 | 107,599 | ||||||||
Grant income | 575,659 | 90,326 | ||||||||
Sale of research products | 98,586 | 66,724 | ||||||||
Total revenues | 1,066,635 | 614,473 | ||||||||
Cost of sales | (131,914 | ) | (182,749 | ) | ||||||
Total revenues, net | 934,721 | 431,724 | ||||||||
EXPENSES: | ||||||||||
Research and development | (8,405,393 | ) | (5,395,488 | ) | ||||||
General and administrative | (3,667,171 | ) | (3,416,145 | ) | ||||||
Total expenses | (12,072,564 | ) | (8,811,633 | ) | ||||||
Loss from operations | (11,137,843 | ) | (8,379,909 | ) | ||||||
OTHER INCOME/(EXPENSES): | ||||||||||
Interest (expense)/income, net | (8,384 | ) | 943 | |||||||
Loss on sale of fixed assets | (8,576 | ) | (1,523 | ) | ||||||
Other income/(expense), net | 77,746 | (28,056 | ) | |||||||
Total other income/(expenses), net | 60,786 | (28,636 | ) | |||||||
LOSS BEFORE INCOME TAX BENEFIT | (11,077,057 | ) | (8,408,545 | ) | ||||||
Income tax benefit | 1,349,026 | - | ||||||||
NET LOSS | (9,728,031 | ) | (8,408,545 | ) | ||||||
Net loss attributable to noncontrolling interest |
1,629,017 | 689,282 | ||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | (8,099,014 | ) | (7,719,263 | ) | ||||||
Foreign currency translation (loss)/gain | (104,590 | ) | 148,437 | |||||||
Unrealized loss on available-for-sale securities, net | (2,650 | ) | - | |||||||
COMPREHENSIVE LOSS | $ | (8,206,254 | ) | $ | (7,570,826 | ) | ||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.14 | ) | $ | (0.15 | ) | ||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
58,257,427 | 51,175,649 |
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com