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): November
15, 2010
BIOTIME,
INC.
(Exact
name of registrant as specified in its charter)
California |
1-12830 |
94-3127919 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1301
Harbor Bay Parkway, Suite 100
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.
Section 2-Financial Information
Item 2.02- Results of Operations and Financial Condition
On November 15, 2010 BioTime, Inc. issued a press release announcing its financial results for the three and nine month periods ended September 30, 2010. 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 November 15, 2010 |
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. |
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|
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Date: November 15, 2010
|
By: |
/s/ Robert W. Peabody |
||
Robert W. Peabody, |
||||
Chief Financial Officer |
Exhibit Number |
Description |
99.1 |
Press release dated November 15, 2010 |
Exhibit 99.1
BioTime Announces Third Quarter 2010 Financial Results and Recent Corporate Developments
82% Increase in Total Revenue Year-over-Year for the Quarter
92% Increase in Total Revenues Year to Date over Last Year
ALAMEDA, Calif.--(BUSINESS WIRE)--November 15, 2010--BioTime, Inc. (NYSE Amex: BTX) today reported financial results for the quarter ended September 30, 2010 and provided an update on recent corporate developments.
For the nine months ended September 30, 2010, total revenue (including royalty income, revenue recognition of deferred license fees, grant income, and sale of research products) was $2,261,375, up 92% from $1,175,827 for the same period one year ago. These increases in revenue are primarily attributable to our receipt of $1,182,857 of our $4.7 million research grant from the California Institute of Regenerative Medicine in quarterly installments during the three quarters of 2010. Net loss from operations was $2.46 million for the three months ended September 30, 2010 and $6.1 million for the nine months ended September 30, 2010, compared to $2.93 million and $5.25 million for the three and nine months ended September 2009. Increases in net loss from operations during 2010 reflect increases in research and development as we continued to expand our stem cell research program, and also reflect increases in other operating expenses.
Net cash used in operating activities was $4.9 million for the nine months ended September 30, 2010 and $3.4 million for the nine months ended September 30, 2009 respectively.
Taking into account a non-recurring, non-cash charge of $2.14 million of financing expenses related to raising capital through BioTime stock purchase warrants the net loss for the three months ended September 30, 2010 was $4.7 million, or ($0.11) per share, compared to a net loss of $3.6 million or ($0.11) per share for the three months ended September 30, 2009, and net loss for the nine months ended September 30, 2010 was approximately $8.2 million, compared to a net loss of approximately $6.6 million for the nine months ended September 30, 2009.
For the three months ended September 30, 2010, total revenue (including royalty income, revenue recognition of deferred license fees, grant income, and sale of research products) was $815,284, up 82% from $446,993 for the same period one year ago. In the three months ended September 30, 2010 we recognized revenues of $108,523 from the sale of stem cell lines and associated growth media to researchers in Asia and in the US. These totals include revenues that were recognized from our wholly owned subsidiary in Singapore (ES Cell International, Pte Ltd) for consideration received from a biotechnology subsidiary of one of the world’s largest healthcare companies. This company is evaluating certain GMP cell lines to ascertain whether they might be useful for their internal research and possible commercial purposes. If the GMP cell lines successfully meet the evaluation criteria, there will be further possibilities for revenues and / or licensing arrangements.
For the three and nine months ended September 30, 2010, BioTime recognized $215,094 and $727,388, respectively, in royalty revenue from the sale of Hextend®, BioTime’s proprietary physiologically balanced blood plasma volume expander for treating low blood volume, a condition often caused by blood loss during surgery or by trauma. This compares to royalty revenue from the sale of Hextend of $225,518 and $799,910 during the three and nine month periods, respectively, ended September 30, 2009. The decrease in royalties reflects a decrease in sales to the United States Armed Forces, which was partially offset by an increase in sales to hospitals in the United States and South Korea.
Cash and cash equivalents totaled $25.4 million as of September 30, 2010, compared with $12.2 million as of December 31, 2009. During the nine months ended September 30, 2010, BioTime received $18,673,192 in net cash from financing activities, including $543,662 received in connection with the exercises of 368,702 options and $18,129,530 received in connection with the exercises of 9,906,393 warrants.
“The third quarter marked a time not only of growth in revenues, but significantly, the first launch of many of our stem cell products for the research markets. Many of these products are primitive progenitors to the many cell types of the human body and proprietary products of BioTime,” said Michael D. West, Ph.D., BioTime’s President and CEO. “By year end we plan to be offering nearly 300 research products, most of which are not offered by any other manufacturer. Our next priority will be to increase market awareness of the advantage of the ACTCellerate™ cell lines for the reproducible generation of human cell types for research related to drug discovery and cell-based therapy.”
“We also were notified of the award of $733,000 in research grants from the Qualifying Therapeutic Discovery Program,” continued Dr. West. “This funding, together with the $4.7 million grant from the California Institute of Regenerative Medicine and funds received from the exercise of warrants, will facilitate the scale-up of both our stem cell research product business and our cellular therapy programs. Some of these prospective cellular therapies, such as OpRegen™ for the treatment of age-related macular degeneration, recently optioned to Teva Pharmaceutical Industries, are targeted to degenerative diseases associated with an aging US population.”
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine through its wholly owned subsidiary Embryome Sciences, Inc. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and market Cell Cure’ OpRegen™ retinal cell product for the treatment of age-related macular degeneration (AMD). BioTime's subsidiary, OrthoCyte Corporation, is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the therapeutic applications of stem cell technology in cancer. BioTime's Singapore subsidiary, ES Cell International Pte Ltd, has been at the forefront of advances in human embryonic stem ("hES") cell technology, having been one of the earliest distributors of hES cell lines to the research community. ESI has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for potential use in therapeutic product development. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, Embryome Sciences, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, and ESI 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 the company 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company 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://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0
BIOTIME, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
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September 30, |
December 31, |
||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 25,421,594 | $ | 12,189,081 | |||
Inventory | 49,478 | 38,384 | |||||
Notes receivable | 252,608 | - | |||||
Prepaid expenses and other current assets | 983,933 | 138,547 | |||||
Total current assets | 26,707,613 | 12,366,012 | |||||
Equipment, net of accumulated depreciation of $698,390 and $54,291, for 2010 and 2009, respectively | 353,292 | 131,133 | |||||
Deferred license and consulting fees | 1,971,638 | 880,000 | |||||
Deposits | 51,900 | 55,926 | |||||
Goodwill | 983,970 | - | |||||
Intangible assets, net | 11,224,113 | - | |||||
TOTAL ASSETS | $ | 41,292,526 | $ | 13,433,071 | |||
LIABILITIES AND EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable and accrued liabilities | $ | 712,184 | $ | 530,958 | |||
Deferred grant income | 263,397 | 263,397 | |||||
Deferred license revenue, current portion | 323,823 | 367,904 | |||||
Total current liabilities | 1,299,404 | 1,162,259 | |||||
LONG-TERM LIABILITIES: | |||||||
Deferred license revenue, net of current portion | 1,085,225 | 1,223,823 | |||||
EQUITY: | |||||||
Preferred shares, no par value, authorized 1,000,000 shares; none issued | - | - | |||||
Common stock, no par value, authorized 75,000,000 shares; issued and outstanding 45,326,154 and 33,667,659 shares at September 30, 2010 and December 31, 2009, respectively | 96,050,102 | 59,722,318 | |||||
Contributed capital | 93,972 | 93,972 | |||||
Accumulated other comprehensive loss | (2,363) | - | |||||
Accumulated deficit | (60,984,987) | (52,769,891) | |||||
Total shareholders' equity | 35,156,724 | 7,046,399 | |||||
Noncontrolling interest | 3,751,173 | 4,000,590 | |||||
Total equity | 38,907,897 | 11,046,989 | |||||
TOTAL LIABILITIES AND EQUITY | $ | 41,292,526 | $ | 13,433,071 | |||
BIOTIME, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
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Three Months Ended | Nine Months Ended | |||||||||||
September 30, |
September 30, |
September 30, |
September 30, |
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REVENUES: | ||||||||||||
License fees | $ | 73,255 | $ | 73,226 | $ | 204,439 | $ | 219,678 | ||||
Royalties from product sales | 215,094 | 225,518 | 727,388 | 799,910 | ||||||||
Grant income | 418,412 | 144,899 | 1,208,602 | 151,699 | ||||||||
Sale of research products | 108,523 | 3,350 | 120,946 | 4,540 | ||||||||
Total revenues | 815,284 | 446,993 | 2,261,375 | 1,175,827 | ||||||||
EXPENSES: | ||||||||||||
Research and development | (1,808,357) | (744,201) | (4,397,109) | (1,909,619) | ||||||||
General and administrative | (1,464,631) | (2,637,133) | (3,961,375) | (4,520,317) | ||||||||
Total expenses | (3,272,988) | (3,381,334) | (8,358,484) | (6,429,936) | ||||||||
Loss from operations | (2,457,704) | (2,934,341) | (6,097,109) | (5,254,109) | ||||||||
OTHER INCOME/(EXPENSES): | ||||||||||||
Interest expense, net | (127) | (653,664) | (285) | (1,326,367) | ||||||||
Gain/(loss) on sale of fixed assets | 950 | (1,159) | 950 | (1,159) | ||||||||
Modification cost of warrants | (2,142,201) | - | (2,142,201) | - | ||||||||
Other income (loss) | (202,224) | 14,409 | (225,868) | 17,296 | ||||||||
Total other income (expenses), net | (2,343,602) | (640,414) | (2,367,404) | (1,310,230) | ||||||||
NET LOSS | (4,801,306) | (3,574,755) | (8,464,513) | (6,564,339) | ||||||||
Less: Net loss attributed to the noncontrolling interest | $ | 130,144 | $ | - | $ | 249,417 | $ | - | ||||
Net loss attributable to BioTime, Inc. | $ | (4,671,162) | $ | (3,574,755) | $ | (8,215,096) | $ | (6,564,339) | ||||
Foreign currency translation gain/(loss) | 3,548 | - | (2,363) | - | ||||||||
COMPREHENSIVE NET LOSS | $ | (4,667,614) | $ | (3,574,755) | $ | (8,217,459) | $ | (6,564,339) | ||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.11) | $ | (0.11) | $ | (0.22) | $ | (0.24) | ||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED | 42,653,125 | 31,283,312 | 38,010,958 | 27,912,812 |
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com