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
10, 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 August 10, 2015 BioTime, Inc. issued a press release announcing its financial results for the three and six months ended June 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 August 10, 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: |
August 10, 2015 |
By: |
/s/ Robert W. Peabody |
|
|
Senior Vice President and |
|||
Chief Financial Officer |
Exhibit Number |
Description |
99.1 |
Press release dated August 10, 2015 |
2
Exhibit 99.1
BioTime, Inc. Reports Second Quarter 2015 Results and Recent Developments
ALAMEDA, Calif.--(BUSINESS WIRE)--August 10, 2015--BioTime, Inc. (NYSE MKT:BTX) today reported financial results for the second quarter ended June 30, 2015 and provided a corporate update.
“BioTime’s management team has sharpened its focus on our high priority programs,” said Dr. Michael D. West, BioTime’s Chief Executive Officer. “Our strategy for achieving the leadership role in regenerative medicine includes: continuing to advance the ongoing clinical trials of our products that are expected to address large unmet patient needs, collaborating with high-quality corporate partners and leading academic medical institutions, financial de-risking by leveraging various sources of non-dilutive financing, adding experienced biopharma executives to our teams at both BioTime and our subsidiaries, and progressively unlocking shareholder value in our subsidiaries. We continue to make progress with our several clinical programs in cell therapies, cell delivery matrices, and cancer diagnostics.”
2015 Highlights
Through the second quarter, BioTime and its subsidiaries have reported the following progress on key products and programs.
Cell Therapies
Cell Cure Neurosciences Ltd.
Asterias Biotherapeutics, Inc. (NYSE MKT: AST)
Cell Delivery Matrices
Cancer Diagnostics Platform
OncoCyte Corporation
Additional Updates
LifeMap Solutions, Inc.
Patents
Financial Results
Revenue
BioTime’s operating revenues are currently generated from research grants, licensing fees and royalties from the sale of Hextend®, and advertising from the marketing of the LifeMap Sciences, Inc.’s (LifeMap Sciences) online database products, and from the sale of hydrogels and stem cell products for research.
Total consolidated revenues for the six months ended June 30, 2015, on a consolidated basis, total revenues were $3.3 million, up $1.1 million or 50% from $2.2 million for the same period one year ago. The increase in revenues is primarily attributable to a $0.9 million increase in grant income primarily from Israel’s Office of the Chief Scientist and CIRM.
Expenses
Consolidated operating expenses for the second quarter were $15.2 million, compared to $13.9 million for the same period in 2014. General and administrative (G&A) expenses for the second quarter were $6.2 million, compared to $4.8 million in the second quarter a year ago. The $1.4 million increase is in part a result of increased staffing at Asterias and at LifeMap Solutions.
Operating expenses for the six months ended June 30, 2015 were $29.7 million, compared to expenses of $26.0 million for the same period of 2014. Excluding Asterias’ operating expense of $10.8 million, BioTime’s expenses alone total $18.9 million. The increase in operating expenses is primarily attributable to increase in staffing and increased expenditures in the Asterias, OncoCyte, and LifeMap Solutions product development programs offset in part by a reduction in development expenses in 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 June 30, 2015 was $9.7 million, including deferred income tax benefits of $1.3 million. For the same period in 2014, net loss was $9.5 million, including deferred income tax benefits of $1.5 million. On a per share basis, net loss for the second quarter in 2015 was $0.12 per share, compared to a net loss of $0.16 per share for the same period in 2014.
Net loss attributable to BioTime common shareholders for the six months ended June 30, 2015 was $19.9 million or $0.25 per share, compared to a net loss of $17.6 million or $0.29 per share per share for the same period in 2014. The increase in net loss is primarily attributed to increased expenditures in the Asterias, OncoCyte, and LifeMap Solutions product development programs offset in part by a reduction in development expenses in BioTime’s HyStem® hydrogel and the OrthoCyte and ReCyte Therapeutics product development programs. This increase is to some extent offset by the $2.4 million income tax benefit recorded as of June 30, 2015 and $2.9 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 and Subsequent Financing Events
Cash and cash equivalents totaled $31.5 million as of June 30, 2015, compared to $29.5 million as of December 31, 2014. The cash on hand as of June 30, 2015 includes $21.2 million held by Asterias and other subsidiaries.
During the six months ended June 30, 2015, BioTime and certain of its subsidiaries raised approximately $24.0 million of additional equity capital and $5.2 million in non-dilutive funding as follows:
Asterias
BioTime
Cell Cure Neurosciences
OncoCyte
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 PanC-Dx™ cancer diagnostics, nearing the completion of initial clinical studies for the detection of bladder, breast, and lung cancers. AST-VAC2, a cancer vaccine, is in the preclinical 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 PanC-Dx™ cancer diagnostics; LifeMap Sciences, Inc. (LifeMap Sciences), 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 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 BALANCE SHEETS | ||||||||||
(IN THOUSANDS) | ||||||||||
June 30, 2015 |
December 31, |
|||||||||
(Unaudited) |
2014 |
|||||||||
ASSETS | ||||||||||
CURRENT ASSETS | ||||||||||
Cash and cash equivalents | $ | 31,465 | $ | 29,487 | ||||||
Trade accounts and grants receivable, net | 979 | 1,042 | ||||||||
Inventory | 297 | 266 | ||||||||
Landlord receivable | 2,771 | 378 | ||||||||
Prepaid expenses and other current assets | 1,492 | 1,232 | ||||||||
Total current assets | 37,004 | 32,405 | ||||||||
Equipment, net and construction in progress | 5,652 | 2,858 | ||||||||
Deferred license fees | 282 | 337 | ||||||||
Deposits | 446 | 443 | ||||||||
Other long-term assets | 6 | 10 | ||||||||
Intangible assets, net | 36,220 | 38,848 | ||||||||
TOTAL ASSETS | $ | 79,610 | $ | 74,901 | ||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||
CURRENT LIABILITIES | ||||||||||
Accounts payable and accrued liabilities | $ | 6,604 | $ | 6,803 | ||||||
Capital lease liability, current portion | 58 | 58 | ||||||||
Related party convertible debt, net of discount | 238 | 60 | ||||||||
Deferred grant income | 1,932 |
- |
||||||||
Deferred license and subscription revenue, current portion | 360 | 208 | ||||||||
Total current liabilities | 9,192 | 7,129 | ||||||||
LONG-TERM LIABILITIES | ||||||||||
Deferred tax liabilities, net |
2,067 |
4,515 | ||||||||
Deferred rent liabilities, net of current portion | 36 | 97 | ||||||||
Lease liability | 3,331 | 378 | ||||||||
Capital lease liability, net of current portion | 3 | 31 | ||||||||
Other long-term liabilities | 30 | 28 | ||||||||
Total long-term liabilities |
5,467 |
5,049 | ||||||||
Commitments and contingencies | ||||||||||
SHAREHOLDERS' EQUITY | ||||||||||
Series A Convertible Preferred Stock, no par value, authorized 2,000 shares as of June 30, 2015 and December 31, 2014; 70 issued and outstanding as of June 30, 2015 and December 31, 2014 | 3,500 | 3,500 | ||||||||
Common shares, no par value, authorized 125,000 shares as of June 30, 2015 and December 31, 2014; 83,281 issued and 78,387 outstanding as of June 30, 2015 and 83,122 issued and 78,228 outstanding at December 31, 2014 | 235,555 | 234,850 | ||||||||
Accumulated other comprehensive income/(loss) | (131 | ) | 186 | |||||||
Accumulated deficit |
(202,055 |
) | (182,190 | ) | ||||||
Treasury stock at cost: 4,894 shares at June 30, 2015 and at December 31, 2014 | (19,890 | ) | (19,890 | ) | ||||||
BioTime, Inc. shareholders' equity |
16,979 |
36,456 | ||||||||
Non-controlling interest |
47,972 |
26,267 | ||||||||
Total shareholders' equity |
64,951 |
62,723 | ||||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 79,610 | $ | 74,901 | ||||||
BIOTIME, INC. | ||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) | ||||||||||||||||||||
(UNAUDITED) | ||||||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||||
REVENUES: | ||||||||||||||||||||
License fees | $ | 357 | $ | 300 | $ | 676 | $ | 594 | ||||||||||||
Royalties from product sales | 117 | 76 | 274 | 174 | ||||||||||||||||
Grant income | 1,437 | 640 | 2,130 | 1,216 | ||||||||||||||||
Sale of research products and services | 98 | 91 | 188 | 189 | ||||||||||||||||
Total revenues | 2,009 | 1,107 | 3,268 | 2,173 | ||||||||||||||||
Cost of sales | (260 | ) | (252 | ) | (525 | ) | (383 | ) | ||||||||||||
Gross Profit | 1,749 | 855 | 2,743 | 1,790 | ||||||||||||||||
OPERATING EXPENSES: |
||||||||||||||||||||
Research and development | (9,059 | ) | (9,081 | ) | (18,383 | ) | (17,470 | ) | ||||||||||||
General and administrative | (6,186 | ) | (4,836 | ) | (11,365 | ) | (8,503 | ) | ||||||||||||
Total operating expenses | (15,245 | ) | (13,917 | ) | (29,748 | ) | (25,973 | ) | ||||||||||||
Loss from operations | (13,496 | ) | (13,062 | ) | (27,005 | ) | (24,183 | ) | ||||||||||||
OTHER INCOME/(EXPENSE): |
||||||||||||||||||||
Interest income/(expenses), net |
4 | (10 | ) | (79 | ) | (18 | ) | |||||||||||||
Other income, net | 225 | 165 | 35 | 234 | ||||||||||||||||
Total other income/(expenses), net | 229 | 155 | (44 | ) | 216 | |||||||||||||||
LOSS BEFORE INCOME TAX BENEFIT | (13,267 | ) | (12,907 | ) | (27,049 | ) | (23,967 | ) | ||||||||||||
Deferred income tax benefit | 1,271 | 1,513 | 2,448 |
2,862 |
||||||||||||||||
NET LOSS | (11,996 | ) | (11,394 | ) | (24,601 | ) | (21,105 | ) | ||||||||||||
Net loss attributable to noncontrolling interest | 2,305 | 1,874 | 4,736 | 3,496 | ||||||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | (9,691 | ) | (9,520 | ) | (19,865 | ) | (17,609 | ) | ||||||||||||
Dividends on preferred shares | (52 | ) | (34 | ) | (52 | ) | (34 | ) | ||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS (1) | $ | (9,743 | ) | $ | (9,554 | ) | $ | (19,917 | ) | $ | (17,643 | ) | ||||||||
BASIC AND DILUTED NET LOSS PER COMMON SHARE (1) |
$ | (0.12 | ) | $ | (0.16 | ) | $ | (0.25 | ) | $ | (0.29 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED |
78,362 | 61,498 | 78,312 | 59,887 | ||||||||||||||||
(1) Basic and diluted loss per common share is calculated using "Net loss attributable to BioTime, Inc. common shareholders." | ||||||||||||||||||||
BIOTIME, INC. | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||||||
(IN THOUSANDS) | ||||||||||||||||
(UNAUDITED) | ||||||||||||||||
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
NET LOSS | $ | (11,996 | ) | $ | (11,394 | ) | $ | (24,601 | ) | $ | (21,105 | ) | ||||
Other comprehensive loss, net of tax: | ||||||||||||||||
Change in foreign currency translation and other comprehensive income/(loss) from equity investments: | ||||||||||||||||
Foreign currency translation loss | (317 | ) | (41 | ) | (318 | ) | (148 | ) | ||||||||
Unrealized gain/(loss) on available-for-sale securities, net of taxes | - | 1 | 1 | (1 | ) | |||||||||||
COMPREHENSIVE LOSS | (12,313 | ) | (11,434 | ) | (24,918 | ) | (21,254 | ) | ||||||||
Less: Comprehensive loss attributable to noncontrolling interest | (2,305 | ) | (1,874 | ) | (4,736 | ) | (3,496 | ) | ||||||||
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS BEFORE PREFERRED STOCK DIVIDEND | (10,008 | ) | (9,560 | ) | (20,182 | ) | (17,758 | ) | ||||||||
Preferred stock dividend | (52 | ) | (34 | ) | (52 | ) | (34 | ) | ||||||||
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS(1) | $ | (10,060 | ) | $ | (9,594 | ) | $ | (20,234 | ) | $ | (17,792 | ) |
(1) Comprehensive loss includes foreign currency translation loss of $317,000 and $318,000 for the three and six months ended June 30, 2015, respectively and translation loss of $41,000 and $148,000 for the same periods in the prior year, respectively which arise entirely from the translation of foreign subsidiary financial information for consolidation purposes and therefore not used in the calculation of basic and diluted loss per common share. Comprehensive loss does not include dividends on preferred shares.
CONTACT:
BioTime, Inc.
Dan L. Lawrence, 510-521-3390 ext. 349
dlawrence@biotimemail.com
or
Investor
Contact:
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com