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
9, 2015
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 the accompanying exhibit 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 9, 2015 BioTime, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2015. 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 9, 2015 |
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 9, 2015 |
By: |
/s/ Robert W. Peabody |
|
|
Senior Vice President and |
|||
Chief Financial Officer |
Exhibit Number |
Description |
99.1 |
Press release dated November 9, 2015 |
2
Exhibit 99.1
BioTime, Inc. Reports Third Quarter 2015 Results and Recent Corporate Accomplishments
ALAMEDA, Calif.--(BUSINESS WIRE)--November 9, 2015--BioTime, Inc. (NYSE MKT and TASE:BTX) today reported financial results for the third quarter ended September 30, 2015 and provided an update on its recent accomplishments.
“During the third quarter, BioTime and its family of companies achieved significant progress on multiple fronts,” said Adi Mohanty, BioTime’s co-Chief Executive Officer. “We are delivering on our commitment to reduce the complexity of our operations while progressively unlocking the value of our subsidiaries for BioTime shareholders. An important step forward in this effort was the announcement that OncoCyte Corporation, our cancer diagnostics subsidiary, had filed a Form 10 Registration Statement with the Securities and Exchange Commission for our planned distribution of OncoCyte common stock to our shareholders. On the financial front, we strengthened our capital position through the sale of $34.0 million of BioTime common shares to institutional investors in September and early October. At the same time, we continued to advance the clinical development of our products that are aimed at addressing large unmet patient needs. We also announced several collaborations with leading medical and academic institutions, as well as a major corporate partnership to develop bone grafting products. All the while, we’ve continued to evolve the management of the company toward an organization that is structured to support later-stage clinical trials and commercial products.”
“BioTime continues to strengthen its leadership position in regenerative medicine on many fronts,” said Dr. Michael D. West, BioTime’s co-Chief Executive Officer. “During the third quarter, BioTime’s ESI-BIO division launched its new technology platform that provides a more complete and accurate model to study the effects of drugs and therapeutic compounds on vascular network formation. The recently announced formation of Ascendance Biotechnology, Inc. by combining ESI-BIO with Hepregen Corporation has the potential to offer an enhanced, broad portfolio of products and services to the rapidly growing and largest segment of the research product market. Our proprietary PureStem® technology for the production of industrial-scale pure stem cells is the basis for the collaboration between our subsidiary OrthoCyte Corporation and Heraeus Medical GmbH for the development of bone grafting therapies. This collaboration represents validation for our human embryonic progenitor cell technology as we continue to develop other products based on PureStem®.”
Third Quarter and Recent Highlights
Corporate Developments
Cell Therapies
Cell Delivery Technology
Cancer Diagnostics Platform
Other Products
Financial Results
Revenue
BioTime’s operating revenues are currently generated from the following sources: research grants, licensing fees, and royalties from the sale of Hextend®; advertising from the marketing of the LifeMap Sciences online database products; and from the sale of hydrogels and stem cell products for research.
Total consolidated revenues for the third quarter were $2.3 million, up $1.1 million from $1.2 million for the same period one year ago. Total consolidated revenues for the nine months ended September 30, 2015 were $5.6 million, up $2.2 million from $3.4 million for the same period one year ago. The increase in revenues is primarily attributable to increases in grant income primarily from Israel’s Office of the Chief Scientist and the California Institute for Regenerative Medicine, and from sales of research products and services.
Expenses
Consolidated operating expenses for the third quarter were $19.0 million, compared to $13.1 million for the same period in 2014. Research and development expenses for the third quarter were $11.4 million, compared to $8.8 million in the third quarter a year ago. The increase is in part a result of increased expense primarily related to regulatory and clinical trials of Asterias’ AST-OPC1, and OncoCyte’s cancer diagnostic tests. General and administrative expenses for the third quarter were $7.5 million, compared to $4.3 million in the third quarter a year ago. The increase is in part a result of increased staffing at BioTime, OncoCyte, and LifeMap Sciences’ subsidiary LifeMap Solutions.
Operating expenses for the nine months ended September 30, 2015 were $48.7 million, compared to expenses of $39.0 million for the same period of 2014. Excluding Asterias’ operating expense of $17.0 million, the expenses of BioTime and its other subsidiaries, including OncoCyte and the ESI-BIO operations that are now part of Ascendance, totaled $31.7 million. The increase in operating expenses is primarily attributable to increases in staffing and increased expenditures for the Asterias, OncoCyte, and LifeMap Solutions product development programs, offset in part by a reduction in development expenses for BioTime’s HyStem® hydrogel and the OrthoCyte and ReCyte Therapeutics product development programs.
Net Loss
Net loss attributable to BioTime for the three months ended September 30, 2015 was $13.6 million, including deferred income tax benefits of $948,000. For the same period in 2014, net loss was $8.3 million, including deferred income tax benefits of $2.3 million. On a per share basis, net loss for the third quarter in 2015 was $0.18 per share, compared to a net loss of $0.12 per share for the same period in 2014.
Net loss attributable to BioTime common shareholders for the nine months ended September 30, 2015 was $33.6 million or $0.43 per share, compared to a net loss of $25.8 million or $0.41 per share for the same period in 2014. The increase in net loss is primarily attributed to increased expenditures for the Asterias, OncoCyte, and LifeMap Solutions product development programs, offset in part by a reduction in development expenses for BioTime’s HyStem® hydrogel and the OrthoCyte and ReCyte Therapeutics product development programs. This increase in net loss is also to some extent offset by the $3.4 million income tax benefit recorded as of September 30, 2015 and $5.2 million in the same period in 2014.
Net losses attributable to BioTime include losses from BioTime majority-owned subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.
Balance Sheet
Cash and cash equivalents totaled $29.4 million as of September 30, 2015, compared to $29.5 million as of December 31, 2014. The cash on hand as of September 30, 2015 includes $24.8 million held by Asterias, OncoCyte, and other subsidiaries.
During October 2015, BioTime raised an additional $25.5 million and BioTime’s subsidiary OncoCyte raised an additional $771,000 of equity capital through the sale of 8.4 million BioTime common shares, combined, to certain investors. As a result, BioTime had approximately $52.0 million in cash and cash equivalents as of October 31, 2015.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include OpRegen®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing the completion of initial clinical studies for the detection of lung, bladder, and breast cancers. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include the publicly traded Asterias Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen®; OncoCyte Corporation, developing cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated online database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP-compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI-BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases, and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol 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 STATEMENTS OF OPERATIONS |
||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||||||||||
(UNAUDITED) |
||||||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2015 |
2014 | 2015 | 2014 | |||||||||||||
REVENUES: | ||||||||||||||||
Subscription and advertisement revenues | $ | 343 | $ | 285 | $ | 1,020 | $ | 880 | ||||||||
Royalties from product sales | 357 | 148 | 631 | 322 | ||||||||||||
Grant income | 1,466 | 648 | 3,596 | 1,863 | ||||||||||||
Sale of research products and services | 140 | 110 | 328 | 300 | ||||||||||||
Total revenues | 2,306 | 1,191 | 5,575 | 3,365 | ||||||||||||
Cost of sales | (432 | ) | (231 | ) | (957 | ) | (614 | ) | ||||||||
Gross profit | 1,874 | 960 | 4,618 | 2,751 | ||||||||||||
OPERATING EXPENSES: | ||||||||||||||||
Research and development | (11,433 | ) | (8,836 | ) | (29,816 | ) | (26,268 | ) | ||||||||
General and administrative |
(7,545 | ) | (4,262 | ) | (18,911 | ) | (12,764 | ) | ||||||||
Total operating expenses | (18,978 | ) | (13,098 | ) | (48,727 | ) | (39,032 | ) | ||||||||
Loss from operations | (17,104 | ) | (12,138 | ) | (44,109 | ) | (36,281 | ) | ||||||||
OTHER INCOME/(EXPENSE): |
||||||||||||||||
Interest expense, net | (12 | ) | (7 | ) | (207 | ) | (30 | ) | ||||||||
Other income/(expense), net | (573 | ) | (119 | ) | (408 | ) | 157 | |||||||||
Total other income/(expense), net | (585 | ) | (126 | ) | (615 | ) | 127 | |||||||||
LOSS BEFORE INCOME TAX BENEFIT |
(17,689 | ) | (12,264 | ) | (44,724 | ) | (36,154 | ) | ||||||||
Deferred income tax benefit | 948 | 2,313 | 3,395 | 5,175 | ||||||||||||
NET LOSS | (16,741 | ) | (9,951 | ) | (41,329 | ) | (30,979 | ) | ||||||||
Net loss attributable to non-controlling interest | 3,115 | 1,683 | 7,762 | 5,151 | ||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. |
(13,626 | ) | (8,268 | ) | (33,567`) | (25,828 | ) | |||||||||
Dividends on preferred shares | (363 | ) | (34 | ) | (415 | ) | (34 | ) | ||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS |
$ | (13,989 | ) | $ | (8,302 | ) | $ | (33,982 | ) | $ | (25,862 | ) | ||||
BASIC AND DILUTED NET LOSS PER COMMON SHARE |
$ | (0.18 | ) | $ | (0.12 | ) | $ | (0.43 | ) | $ | (0.41 | ) | ||||
WEIGHTED AVERAGE NUMBER OF COMMON STOCK | ||||||||||||||||
OUTSTANDING: BASIC AND DILUTED |
79,224 | 67,921 | 78,619 | 62,594 | ||||||||||||
BIOTIME, INC. AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(IN THOUSANDS) | ||||||||
September 30, | December 31, | |||||||
2015 |
2014 |
|||||||
(Unaudited) |
|
|||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 29,378 | $ | 29,487 | ||||
Trade accounts and grants receivable, net | 944 | 1,042 | ||||||
Inventory | 260 | 266 | ||||||
Landlord receivable | 1,525 | 378 | ||||||
Loan receivable | 506 | - | ||||||
Prepaid expenses and other current assets | 1,752 | 1,232 | ||||||
Total current assets | 34,365 | 32,405 | ||||||
Equipment, net and construction in progress | 6,781 | 2,858 | ||||||
Deferred license fees | 352 | 337 | ||||||
Deposits and other long-term assets | 455 | 453 | ||||||
Intangible assets, net | 34,906 | 38,848 | ||||||
TOTAL ASSETS | $ | 76,859 | $ | 74,901 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable and accrued liabilities | $ | 7,793 | $ | 6,803 | ||||
Capital lease liability, current portion | 46 | 58 | ||||||
Promissory notes, current portion | 95 |
- |
||||||
Related party convertible debt, net of discount | 255 | 60 | ||||||
Deferred grant income | 1,869 | - | ||||||
Deferred license and subscription revenue, current portion | 278 | 208 | ||||||
Total current liabilities | 10,336 | 7,129 | ||||||
LONG-TERM LIABILITIES | ||||||||
Deferred tax liabilities, net | 1,119 | 4,515 | ||||||
Deferred rent liabilities, net of current portion | 95 | 97 | ||||||
Lease liability | 4,089 | 378 | ||||||
Capital lease liability, net of current portion | - | 31 | ||||||
Promissory notes, net of current portion | 268 |
- |
||||||
Other long-term liabilities | 18 | 28 | ||||||
Total long-term liabilities | 5,589 | 5,049 | ||||||
Commitments and contingencies | ||||||||
SHAREHOLDERS' EQUITY | ||||||||
Series A Convertible Preferred Stock, no par value, authorized 2,000 shares as of September 30, 2015 and December 31, 2014; none and 70 issued and outstanding as of September 30, 2015 and December 31, 2014, respectively |
- |
3,500 | ||||||
Common stock, no par value, authorized 125,000 shares as of September 30, 2015 and December 31, 2014; 86,764 issued and 82,045 outstanding as of September 30, 2015 and 83,122 issued and 78,228 outstanding at December 31, 2014 |
248,069 |
234,850 | ||||||
Accumulated other comprehensive income/(loss) | (87 | ) | 186 | |||||
Accumulated deficit | (215,757 | ) | (182,190 | ) | ||||
Treasury stock at cost: 4,719 and 4,894 shares at September 30, 2015 and at December 31, 2014, respectively |
(19,182 |
) |
(19,890 | ) | ||||
BioTime, Inc. shareholders' equity | 13,043 | 36,456 | ||||||
Non-controlling interest | 47,891 | 26,267 | ||||||
Total shareholders' equity | 60,934 | 62,723 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 76,859 | $ | 74,901 | ||||
CONTACT:
BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimeinc.com
or
Investor
Contact:
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Media
Contact:
Gotham Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com
or
Israel
Contact:
Gelbart-Kahana Investor Relations
Zeev Gelbart,
+972-3-6074717
zeevg@gk-biz.com