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): August
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 August 12, 2014 BioTime, Inc. issued a press release announcing its financial results for the three and six months ended June 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 August 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: |
August 12, 2014 |
By |
/s/ Robert W. Peabody |
|
|
Senior Vice President,
|
Exhibit Number |
Description |
99.1 | Press release dated August 12, 2014 |
Exhibit 99.1
BioTime Announces Second Quarter 2014 Results and Recent Developments
ALAMEDA, Calif.--(BUSINESS WIRE)--August 12, 2014--BioTime, Inc. (NYSE MKT: BTX) today reported financial results for the first quarter ended June 30, 2014 and highlighted recent corporate accomplishments.
“We are pleased with our success to date in building toward our goal of developing both near-term commercial applications of our technologies and maintaining our focus on the power of pluripotent stem cells to create innovative human therapeutics,” said Dr. Michael D. West, BioTime’s Chief Executive Officer. “Near-term product development underway includes our subsidiary OncoCyte Corporation’s three cancer diagnostic products undergoing clinical studies, mobile health product development in our subsidiary LifeMap Solutions, Inc., our Renevia™ pivotal clinical trial in Europe, steps to prepare for the marketing of our recently FDA-cleared wound healing product Premvia™, and growing research product sales by our ESI BIO division.”
“BioTime’s longer-term major therapeutic product opportunities are based on the broad range of cell-based regenerative therapies planned for development from its pluripotent stem cell technology platform. This platform is protected by over 600 patents and patent applications worldwide within the BioTime family of companies. Our subsidiary Asterias Biotherapeutics, Inc. has submitted an amended IND to the FDA for a Phase 1/2a clinical trial of AST-OPC1 for the treatment of cervical spinal cord injury and is currently awaiting clearance from the FDA for that trial. Asterias is also currently undertaking process development of AST-VAC2, a cancer immunotherapy targeting the important antigen called telomerase, for a potential clinical trial in lung cancer. This progress, along with the appointment of Pedro Lichtinger as Asterias’ CEO and the award of a $14 million grant from the California Institute for Regenerative Medicine, should fuel the development of these first-in-class therapeutic products. Recently, Asterias’ shares began to trade publicly under the symbol ASTYV, the first of our subsidiaries to have its shares trade publicly. Lastly, we expect that BioTime’s subsidiary Cell Cure Neurosciences Ltd. will soon file its IND to begin a clinical trial of OpRegen® for the treatment of age-related macular degeneration. Additional important cell-based product development is underway in our disease-focused subsidiaries OrthoCyte Corporation and ReCyte Therapeutics.”
“As we saw in the first quarter of this year, our expenses have risen compared to recent quarters, but our progress during the second quarter in streamlining our workforce through shared core resources among our subsidiaries should reduce our cash burn rate in the third quarter. We would like to thank those who share our goal of better health in the coming era of regenerative medicine. Their continued support and the diligent efforts of our collaborators at leading academic medical institutions is critical in advancing our products from the lab bench to the clinic, where they are desperately needed.”
Second Quarter and Recent Highlighted Corporate Accomplishments
Financial Results
Revenue
For the six months ended June 30, 2014, on a consolidated basis, total revenue was $2.2 million, up $0.3 million or 19% from $1.8 million for the same period one year ago. The increase in revenue is primarily attributable to a $0.4 million increase in grant income primarily from a grant awarded to BioTime’s subsidiary Cell Cure Neurosciences Ltd. (“Cell Cure Neurosciences”) from Israel’s Office of the Chief Scientist, offset in part by the decline in license fees of $0.1M primarily due to full recognition of the unamortized balance of the Summit license fees received in advance during the fourth quarter of 2013 as a result of the termination of our license agreements with Summit in 2013.
Expenses
Operating expenses for the six months ended June 30, 2014 were $26.0 million, compared to expenses of $18.0 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, including additional expenses in the Renevia™ clinical safety trial program, the development of OpRegen® by BioTime’s subsidiary Cell Cure Neurosciences for the treatment of dry age related macular degeneration, and the increased staffing and operations of Asterias in connection with the Geron stem cell asset acquisition and by LifeMap Solutions. In addition, during the first six months in 2014, operating expenses included $1.5 million of 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 common shareholders for the six months ended June 30, 2014 was $17.6 million or $0.29 per share, compared to a net loss of $15.3 million or $0.29 per share for the same period in 2013. The increase in net loss is primarily attributed to increased research and development related activity primarily in Asterias, LifeMap Solutions, and Cell Cure Neurosciences. This increase is to some extent offset by the $2.9 million income tax benefit recorded as of June 30, 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 $15.7 million as of June 30, 2014, compared with $5.5 million as of December 31, 2013. The cash on hand at June 30, 2014 includes $12.9 million held by Asterias. Subsequent to June 30, 2014, Asterias paid $5 million in cash to BioTime as a reimbursement of Asterias’ operating expenses paid or incurred by BioTime for Asterias’ account.
During the six months ended June 30, 2014, BioTime and certain of its subsidiaries raised approximately $15.8 million of additional equity capital through the sale of BioTime common shares in “at-the-market” transactions, including approximately $6.4 million in equity financing 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.
In addition, BioTime’s subsidiary Asterias received $12.5 million in June 2014 through the sale of 5,000,000 BioTime common shares, with warrants to purchase 5,000,000 shares of Asterias Series B 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 Series B common stock to its newly appointed President and Chief Executive Officer.
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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, and is planning to initiate a pivotal clinical trial around Renevia™, in 2014. 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 Market exchange, 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 | ||||||||||||||
|
June 30, 2014 |
|
December 31, |
|||||||||||
|
(Unaudited) |
|
2013 |
|||||||||||
ASSETS | ||||||||||||||
CURRENT ASSETS | ||||||||||||||
Cash and cash equivalents |
|
$ |
15,721,508 |
|
$ |
5,495,478 |
||||||||
Inventory | 257,929 | 178,694 | ||||||||||||
Trade accounts and grants receivable, net | 1,190,723 | 998,393 | ||||||||||||
Prepaid expenses and other current assets | 1,476,104 | 1,277,405 | ||||||||||||
Total current assets | 18,646,264 | 7,949,970 | ||||||||||||
Equipment, net | 2,982,973 | 2,997,733 | ||||||||||||
Deferred license and consulting fees | 391,584 | 444,833 | ||||||||||||
Deposits | 435,482 | 129,129 | ||||||||||||
Other long-term assets | 57,048 | - | ||||||||||||
Intangible assets, net | 43,472,089 | 46,208,085 | ||||||||||||
TOTAL ASSETS |
|
$ |
65,985,440 |
|
$ |
57,729,750 |
||||||||
LIABILITIES AND EQUITY | ||||||||||||||
CURRENT LIABILITIES | ||||||||||||||
Accounts payable and accrued liabilities |
|
$ |
4,741,617 |
|
$ |
6,722,624 |
||||||||
Capital lease liability, current portion | 57,500 | - | ||||||||||||
Deferred license and subscription revenue, current portion | 270,348 |
|
235,276 | |||||||||||
Total current liabilities | 5,069,465 | 6,957,900 | ||||||||||||
LONG-TERM LIABILITIES | ||||||||||||||
Deferred rent, net of current portion | 20,112 | 35,997 | ||||||||||||
Capital lease, net of current portion | 57,500 | - | ||||||||||||
Deferred tax liability, net | 14,244,078 | 8,277,548 | ||||||||||||
Other long-term liabilities | 9,860 | 195,984 | ||||||||||||
Total long-term liabilities | 14,331,550 | 8,509,529 | ||||||||||||
Commitments and contingencies | ||||||||||||||
STOCKHOLDERS' EQUITY | ||||||||||||||
Preferred shares, no par value, authorized 2,000,000 shares as of June 30, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of June 30, 2014 and December 31, 2013, respectively | 3,500,000 | - | ||||||||||||
Common shares, no par value, authorized 125,000,000 shares as of June 30, 2014 and December 31, 2013; 72,268,526 issued and 66,869,984 outstanding as of June 30, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013 | 199,944,402 | 203,456,401 | ||||||||||||
Contributed capital | 59,934 | 93,972 | ||||||||||||
Accumulated other comprehensive (loss)/income | (85,134 | ) | 62,899 | |||||||||||
Accumulated deficit | (163,387,382 | ) | (145,778,547 | ) | ||||||||||
Treasury stock at cost: 5,398,542 and 10,697,715 shares at June 30, 2014 and at December 31, 2013, respectively | (22,119,467 | ) | (43,033,957 | ) | ||||||||||
BioTime stockholders' equity | 17,912,353 | 14,800,768 | ||||||||||||
Noncontrolling interest | 28,672,072 | 27,461,553 | ||||||||||||
Total stockholders' equity | 46,584,425 | 42,262,321 | ||||||||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
65,985,440 |
|
$ |
57,729,750 |
||||||||
BIOTIME, INC. AND SUBSIDIARIES | ||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||||||||
(UNAUDITED) | ||||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||||||||
REVENUES: | ||||||||||||||||||||||
License fees | $ | 300,079 | $ | 362,249 | $ | 594,582 | $ | 712,078 | ||||||||||||||
Royalties from product sales | 76,109 | 103,315 | 173,996 | 210,914 | ||||||||||||||||||
Grant income | 640,034 | 693,480 | 1,215,614 | 777,293 | ||||||||||||||||||
Sale of research products | 90,478 | 57,281 | 189,068 | 124,005 | ||||||||||||||||||
Total revenues | 1,106,700 | 1,216,325 | 2,173,260 | 1,824,290 | ||||||||||||||||||
Cost of sales | (251,265 | ) | (180,811 | ) | (383,179 | ) | (363,560 | ) | ||||||||||||||
Gross Profit | 855,435 | 1,035,514 | 1,790,081 | 1,460,730 | ||||||||||||||||||
EXPENSES: | ||||||||||||||||||||||
Research and development | (9,081,137 | ) | (5,530,395 | ) | (17,469,570 | ) | (10,975,825 | ) | ||||||||||||||
General and administrative | (4,835,972 | ) | (3,621,570 | ) | (8,503,259 | ) | (7,005,091 | ) | ||||||||||||||
Total operating expenses | (13,917,109 | ) | (9,151,965 | ) | (25,972,829 | ) | (17,980,916 | ) | ||||||||||||||
Loss from operations | (13,061,674 | ) | (8,116,451 | ) | (24,182,748 | ) | (16,520,186 | ) | ||||||||||||||
OTHER INCOME/(EXPENSES): | ||||||||||||||||||||||
Interest (expense)/income, net | (10,024 | ) | 579 | (18,398 | ) | 1,522 | ||||||||||||||||
Gain/(loss) on sale or write off of fixed assets | - | 800 | (8,576 | ) | (710 | ) | ||||||||||||||||
Other income/(expense), net | 164,732 | (80,541 | ) | 242,868 | (109,520 | ) | ||||||||||||||||
Total other expenses, net | 154,708 | (79,162 | ) | 215,894 | (108,708 | ) | ||||||||||||||||
LOSS BEFORE INCOME TAX BENEFIT | (12,906,966 | ) | (8,195,613 | ) | (23,966,854 | ) | (16,628,894 | ) | ||||||||||||||
Deferred income tax benefit | 1,513,258 | - | 2,862,284 | - | ||||||||||||||||||
NET LOSS | (11,393,708 | ) | (8,195,613 | ) | (21,104,570 | ) | (16,628,894 | ) | ||||||||||||||
Net loss attributable to noncontrolling interest | 1,873,518 | 645,848 | 3,495,735 | 1,346,503 | ||||||||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | (9,520,190 | ) | (7,549,765 | ) | (17,608,835 | ) | (15,282,391 | ) | ||||||||||||||
Dividends on preferred shares | (34,038 | ) | (34,038 | ) | ||||||||||||||||||
Net loss attributable to common shareholders | (9,554,228 | ) | (7,549,765 | ) | (17,642,873 | ) | (15,282,391 | ) | ||||||||||||||
Unrealized gain/(loss) on available-for-sale assets | 1,120 | - | (1,530 | ) | - | |||||||||||||||||
Foreign currency translation (loss)/gain | (74,831 | ) | 28,857 | (182,071 | ) | 177,294 | ||||||||||||||||
TOTAL COMPREHENSIVE NET LOSS | $ | (9,593,901 | ) | $ | (7,520,908 | ) | $ | (17,792,436 | ) | $ | (15,105,097 | ) | ||||||||||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.16 | ) | $ | (0.14 | ) | $ | (0.29 | ) | $ | (0.29 | ) | ||||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED | 61,498,164 | 53,791,434 | 59,886,748 | 52,490,767 | ||||||||||||||||||
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com