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): November
10, 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 November 10, 2014 BioTime, Inc. issued a press release announcing its
financial results for the three and nine months ended September 30, 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 November 10, 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: |
November 10, 2014 |
By |
/s/ Robert W. Peabody |
|
|
Senior Vice President, |
|||
Chief Operating Officer, and |
||||
Chief Financial Officer |
Exhibit Number |
Description |
99.1 |
Press release dated November 10, 2014 |
Exhibit 99.1
BioTime Reports Third Quarter Results and Recent Progress
ALAMEDA, Calif.--(BUSINESS WIRE)--November 10, 2014--BioTime, Inc. (NYSE MKT: BTX), the leader in developing pluripotent stem-cell therapies and other technologies designed to address major unmet medical needs, today reported financial results for the third quarter and the nine months ended September 30, 2014, and highlighted recent corporate accomplishments.
“BioTime and its subsidiaries set in motion a rapid cadence of milestone achievements in our clinical development of therapeutic and diagnostic products during the third quarter,” said Dr. Michael D. West, CEO. “We recently obtained authorization to begin our pivotal trial of Renevia™ in Europe for HIV-related lipoatrophy; our subsidiary Asterias Biotherapeutics received clearance from the FDA to initiate a Phase 1/2a dose escalation clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury; our subsidiary Cell Cure Neurosciences received clearance from the FDA for a Phase 1/2a dose escalation clinical trial of its product, OpRegen®, in patients with the dry form of age related macular degeneration; and the FDA cleared BioTime’s Premvia™ as a Class II medical device for the management of wounds. Also, BioTime’s subsidiary OncoCyte expanded its large clinical studies of PanC-Dx™ biomarkers in the diagnosis of breast, bladder, and lung cancer. In total, we now have six products for which seven clinical studies are approved or underway. To date, the FDA has approved clinical trials of only four pluripotent stem cell therapies, and two of those, OpRegen® and AST-OPC1, belong to BioTime subsidiaries.”
“On the financial front, we raised $31 million in early October for BioTime and certain of its subsidiaries through the sale of BioTime common shares to several institutional investors. As a result, we finished October with $35 million in cash and cash equivalents within the BioTime family of companies to fund additional milestone achievements during 2015. Additionally, our subsidiary Asterias arranged non-dilutive financing for clinical trials of both of its lead products by signing two agreements: one with the California Institute for Regenerative Medicine (CIRM) for the previously announced $14.3 million award to fund a Phase 1/2a clinical trial and process development of AST-OPC1, and one with Cancer Research UK (CRUK) and its affiliate Cancer Research Technology to conduct a Phase 1/2a clinical trial of AST-VAC2, a product designed as an immunotherapy for non-small cell lung cancer. We also added two experienced executives with strong track records of shareholder value creation to our Board of Directors,” Dr. West concluded.
Third Quarter and Recent Highlights
BioTime, Inc.
Asterias Biotherapeutics, Inc. (Approximately 71% Owned by BioTime)
Cell Cure Neurosciences Ltd. (Approximately 63% Owned by BioTime on a Consolidated Basis)
OncoCyte Corporation (Approximately 75% Owned by BioTime)
LifeMap Solutions, Inc. (Approximately 75% Owned by BioTime on a Consolidated Basis)
Third Quarter Financial Results
Revenue
For the three months ended September 30, 2014, on a consolidated basis, total revenue was $1.2 million, up $0.5 million or 67% from $0.7 million for the same period of 2013. The increase in revenue is primarily attributable to increases in grant income and research products sales.
Expenses
Operating expenses for the three months ended September 30, 2014, on a consolidated basis, were $13.1 million, compared to $10.7 million for the same period of 2013. Research and development expenses were $8.8 million for the three months ended September 30, 2014, an increase of approximately $2.4 million from $6.4 million during the same period of 2013. The increase in research and development expenses is largely attributable to the amortization of intangible assets acquired by Asterias from Geron Corporation and BioTime in October 2013, and the ramp-up of the Asterias and LifeMap Solutions product development programs. Expenses of the OncoCyte and Renevia™ clinical trial programs were also a factor. General and administrative expenses remained relatively flat when compared with the third quarter of 2013 at $4.3 million.
Net Loss
Net loss attributable to BioTime for the three months ended September 30, 2014 declined to $8.3 million or $0.12 per share, compared to a net loss of $9.0 million or $0.16 per share for the same period in 2013. The decrease in net loss is primarily attributed to a $2.3 million deferred income tax benefit recorded as of September 30, 2014. There was no deferred income tax benefit recorded in the three months ended September 30, 2013. Net loss attributable to BioTime includes losses from BioTime majority owned subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.
Year-to-Date Financial Results
Revenue
For the nine months ended September 30, 2014, on a consolidated basis, total revenue was $3.4 million, up $0.9 million or 32% from $2.5 million for the year ago period. The increase in revenue is primarily attributable to a $0.9 million increase in grant income, primarily from a grant awarded to BioTime’s subsidiary Cell Cure Neurosciences Ltd. by Israel’s Office of the Chief Scientist.
Expenses
Operating expenses for the first nine months of 2014, on a consolidated basis, were $39.0 million, compared to $28.7 million for the first nine months of 2013. Research and development expenses for the nine months ended September 30, 2014 increased to $26.3 million from $17.4 million for the same period in 2013. The increase in research and development expenses during the nine months ended September 30, 2014 is generally attributable to the same factors that contributed to the increase during the third quarter. General and administrative expenses for the nine months ended September 30, 2014 were $12.8 million compared to $11.3 million for the same period of 2013. The increase in general and administrative expenses reflects in part, the ramp-up of operations of LifeMap Solutions and Asterias and a decline in spending by ESI.
Net Loss
Net loss attributable to BioTime for the nine months ended September 30, 2014 was $25.8 million or $0.41 per share, compared to a net loss of $24.3 million or $0.45 per share for the same period in 2013. The increase in net loss is primarily attributable to increased research and development activity, primarily at Asterias, LifeMap Solutions, and OncoCyte and in our clinical development of Renevia™. The increase is offset to some extent by the $5.2 million income tax benefit recorded as of September 30, 2014. There was no income tax benefit recorded in the nine months ended September 30, 2013. Net loss attributable to BioTime includes losses from BioTime’s 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 $7.4 million as of September 30, 2014, compared with $5.5 million as of December 31, 2013. The cash on hand at September 30, 2014 includes $5.0 million held by Asterias.
During the nine months ended September 30, 2014, BioTime and certain of its subsidiaries raised approximately $31.8 million of equity capital through the sale of BioTime common shares. Of that amount, approximately $15.8 million was raised through sales in “at the market transactions,” including $6.4 million from long-term BioTime investors. In addition, 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. The remaining $12.5 million was raised by BioTime’s subsidiary Asterias in June 2014 through the sale of 5,000,000 BioTime common shares, with warrants to purchase 5,000,000 shares of Asterias common stock, to two private investors who are long-term BioTime shareholders. Asterias raised an additional $0.5 million from the sale of 200,000 shares of Asterias common stock to its newly appointed President and Chief Executive Officer.
In addition to the above capital raise, during early October 2014, BioTime and certain of its subsidiaries raised $31 million of cash through the sale of BioTime common shares in transactions priced “at the market.” As a result, BioTime and its subsidiaries had approximately $35 million in cash and cash equivalents as of October 31, 2014.
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. Renevia™ (a HyStem® product), is now in a pivotal trial in Europe as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in the treatment of HIV-related lipoatrophy. 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:
BioTime stock is traded on the NYSE MKT, ticker BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
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 | |||||||
September 30, 2014 | December 31, | ||||||
(Unaudited) | 2013 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 7,416,235 | $ | 5,495,478 | |||
Inventory | 253,567 | 178,694 | |||||
Trade accounts and grants receivable, net | 1,014,183 | 998,393 | |||||
Prepaid expenses and other current assets | 1,255,479 | 1,277,405 | |||||
Total current assets | 9,939,464 | 7,949,970 | |||||
Equipment, net | 2,758,456 | 2,997,733 | |||||
Deferred license and consulting fees | 364,208 | 444,833 | |||||
Deposits | 435,317 | 129,129 | |||||
Other long-term assets | 53,127 | - | |||||
Intangible assets, net | 42,104,092 | 46,208,085 | |||||
TOTAL ASSETS | $ | 55,654,664 | $ | 57,729,750 | |||
LIABILITIES AND EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 5,550,698 | $ | 6,722,624 | |||
Capital lease liability, current portion | 57,500 | - | |||||
Related party convertible debt, net of discount | 3,088 | - | |||||
Deferred license and subscription revenue, current portion | 177,574 | 235,276 | |||||
Total current liabilities | 5,788,860 | 6,957,900 | |||||
LONG-TERM LIABILITIES | |||||||
Capital lease, net of current portion | 44,963 | - | |||||
Deferred tax liability, net | 10,787,141 | 8,277,548 | |||||
Other long-term liabilities | 79,108 | 231,981 | |||||
Total long-term liabilities | 10,911,212 | 8,509,529 | |||||
Commitments and contingencies | |||||||
STOCKHOLDERS' EQUITY | |||||||
Preferred shares, no par value, authorized 2,000,000 shares as of September 30, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of September 30, 2014 and December 31, 2013, respectively | 3,500,000 | - | |||||
Common shares, no par value, authorized 125,000,000 shares as of September 30, 2014 and December 31, 2013; 73,690,302 issued and 68,291,760 outstanding as of September 30, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013 | 201,298,235 | 203,456,401 | |||||
Contributed capital | 59,934 | 93,972 | |||||
Accumulated other comprehensive (loss)/income | (150,691) | 62,899 | |||||
Accumulated deficit | (171,606,642) | (145,778,547) | |||||
Treasury stock at cost: 5,398,542 and 10,697,715 shares at September 30, 2014 and at December 31, 2013, respectively | (22,119,467) | (43,033,957) | |||||
BioTime stockholders' equity | 10,981,369 | 14,800,768 | |||||
Non-controlling interest | 27,973,223 | 27,461,553 | |||||
Total stockholders' equity | 38,954,592 | 42,262,321 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 55,654,664 | $ | 57,729,750 | |||
BIOTIME, INC. AND SUBSIDIARIES |
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||
(UNAUDITED) | |||||||||||||||
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||
REVENUES: | |||||||||||||||
License fees | $ | 285,157 | $ | 382,767 | $ | 880,740 | $ | 1,094,843 | |||||||
Royalties from product sales | 147,811 | 80,592 | 321,806 | 291,505 | |||||||||||
Grant income | 647,580 | 160,431 | 1,863,310 | 941,226 | |||||||||||
Sale of research products and services | 110,555 | 90,272 | 299,615 | 214,277 | |||||||||||
Total revenues | 1,191,103 | 714,062 | 3,365,471 | 2,541,851 | |||||||||||
Cost of sales | (230,901) | (206,678) | (614,080) | (570,237) | |||||||||||
Gross Profit | 960,202 | 507,384 | 2,751,391 | 1,971,614 | |||||||||||
EXPENSES: | |||||||||||||||
Research and development | (8,836,341) | (6,441,462) | (26,267,792) | (17,389,409) | |||||||||||
General and administrative | (4,261,450) | (4,267,875) | (12,764,324) | (11,273,948) | |||||||||||
Total operating expenses | (13,097,791) | (10,709,337) | (39,032,116) | (28,663,357) | |||||||||||
Loss from operations | (12,137,589) | (10,201,953) | (36,280,725) | (26,691,743) | |||||||||||
OTHER INCOME/(EXPENSES): | |||||||||||||||
Interest (expense)/income, net | (7,632) | 509 | (29,786) | 2,033 | |||||||||||
(Loss)/gain on sale or write off of fixed assets | (133) | 5,830 | (8,709) | 5,120 | |||||||||||
Other (expense)/income, net | (118,796) | (60,704) | 165,135 | (169,512) | |||||||||||
Total other (expenses)/income, net | (126,561) | (54,365) | 126,640 | (162,359) | |||||||||||
LOSS BEFORE INCOME TAX BENEFIT | (12,264,150) | (10,256,318) | (36,154,085) | (26,854,102) | |||||||||||
Deferred income tax benefit |
|
2,312,693 |
- | 5,174,977 | - | ||||||||||
NET LOSS | (9,951,457) | (10,256,318) | (30,979,108) | (26,854,102) | |||||||||||
Net loss attributable to non-controlling interest | 1,683,532 | 1,253,150 | 5,151,013 | 2,583,581 | |||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | (8,267,925) | (9,003,168) | (25,828,095) | (24,270,521) | |||||||||||
Dividends on preferred shares | (34,038) | - | (34,038) | - | |||||||||||
Net loss attributable to common shareholders | (8,301,963) | (9,003,168) | (25,862,133) | (24,270,521) | |||||||||||
Unrealized loss on available-for-sale assets | (1,210) | - | (2,740) | - | |||||||||||
Foreign currency translation (loss)/gain | (66,768) | 7,016 | (216,330) | 184,310 | |||||||||||
TOTAL COMPREHENSIVE LOSS | $ | (8,335,903) | $ | (8,996,152) | $ | (26,047,165) | $ | (24,086,211) | |||||||
BASIC AND DILUTED NET LOSS PER COMMON SHARE | $ | (0.12) | $ | (0.16) | $ | (0.41) | $ | (0.45) | |||||||
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED | 67,920,853 | 55,621,564 | 62,594,212 | 53,545,834 |
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com
or
Investor
Contact:
EVC Group, Inc.
Brian Moore, 310-579-6199
bmoore@evcgroup.com
Gregory
Gin, 862-236-0673
ggin@evcgroup.com
Doug Sherk, 415-652-9100
dsherk@evcgroup.com