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): May
10, 2016
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 |
1010 Atlantic Avenue
Suite 102
Alameda, California 94501
(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 May 10, 2016, BioTime, Inc. issued a press release announcing its financial results for the three months ended March 31, 2016. 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 May 10, 2016
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: |
May 10, 2016 |
By: |
/s/ Michael D. West |
|
Co-Chief Executive Officer |
||||
|
|
Exhibit Number Description
99.1
Press release dated May 10, 2016
2
Exhibit 99.1
BioTime, Inc. Reports First Quarter Results and Recent Corporate Accomplishments
- First Cohort in OpRegen® Trial Completed
- Management to Host Investor Conference Call on May 17, 2016 at 4:30 p.m. ET
ALAMEDA, Calif.--(BUSINESS WIRE)--May 10, 2016--BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, today reported financial results for the first quarter ended March 31, 2016 and provided a corporate update. The Company also announced that management will host a conference call with investors to discuss the recent operating progress and corporate developments on Tuesday, May 17, 2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific. Details on how to access the call are provided later in this news release.
“We are off to a strong start in 2016 as we continue to make progress with BioTime’s key clinical therapeutic programs, Renevia® in medical aesthetics and OpRegen® in dry AMD,” said Adi Mohanty, Co-Chief Executive Officer. “We are also pleased with the significant operating progress achieved by our non-core assets as these companies mature towards standalone businesses. In particular, we are excited to see our digital health subsidiary, LifeMap Solutions, gaining more traction with clients and partners, including best-in-class institutions. Meanwhile, we in the BioTime organization continue to sharpen our focus on clinical progress and simplifying our corporate structure and seeking ways to unlock the value of our more mature revenue-generating subsidiaries for BioTime shareholders.”
First Quarter and Recent Highlights
Clinical Progress
OpRegen® (retinal pigment epithelial cells)
Renevia® (adipose cells + cell delivery matrix)
AST-VAC1 (antigen-presenting autologous dendritic cells)
AST-OPC1 (oligodendrocyte progenitor cells)
Cancer Diagnostics
Non-core Assets
Corporate Developments
First Quarter Financial Results
Cash (and available-for-sale securities) Position: Cash and cash equivalents totaled $27.1 million as of March 31, 2016, compared to $42.2 million as of December 31, 2015. The cash on hand as of March 31, 2016 includes $16.4 million held by subsidiaries. As of March 31, 2016, BioTime held $829,000 in available-for-sale securities. As of March 31, 2016, BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of $170 million as of that date.
Revenues: BioTime’s operating revenues are currently generated from research grants, licensing fees and advertising from the marketing of online database products. Total consolidated revenues were $2.1 million for the first quarter, compared to $1.3 million in the first quarter of 2015. The increase was primarily due to increases in grant revenue and subscription and advertising revenues.
R&D Expenses: Research and development expenses were $13.7 million for the first quarter, compared to $9.3 million for the comparable period in 2015. The increase is in part a result of increased expenses primarily related to regulatory and clinical trials of Asterias’ AST-OPC1 program, and OncoCyte’s cancer diagnostics.
G&A Expenses: General and administrative expenses were $11.9 million for the first quarter, compared to $5.2 million for the first quarter of 2015. The increase is in part a result of $3.1 million in non-cash expense for the estimated fair value of the distribution of 3,331,229 warrants to purchase Asterias common stock to Asterias shareholders other than BioTime declared by the Asterias board of directors on March 30, 2016, increased staffing needed to advance programs under development at BioTime, including non-cash stock-based compensation from BioTime, Asterias, and OncoCyte.
Net Loss attributable to BioTime: Net loss attributable to BioTime was $17.1 million for the three months ended March 31, 2016, or $0.19 per share. There was no deferred income tax benefit recorded in the three months ended March 31, 2016. For the first quarter of 2015, net loss attributable to BioTime was $10.2 million, or $0.13 per share including deferred income tax benefits of $1.2 million. Net loss attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.
Conference Call and Webcast Details
BioTime will host a conference call and webcast on Tuesday, May 17, 2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the first quarter results and recent corporate developments.
The conference call dial-in number in the U.S./Canada is (877) 407-0784. For international participants outside the U.S./Canada, the dial-in number is (201) 689-8560. For all callers, please refer to the “BioTime, Inc. Conference Call.” The live webcast can be accessed on the “Events & Presentations” page of the “Investors & Media” section on the company’s website at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./Canada: (877) 870-5176; international callers dial (858) 384-5517. Use the Conference ID 13636578. Additionally, the archived webcast will be available on the “Events & Presentations” page of the “Investors & Media” section on the company’s website at http://www.biotimeinc.com/.
About BioTime
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what we believe to be the world’s premier collection of pluripotent cell assets. The foundation of our core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
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 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||
(UNAUDITED) |
||||||||
Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2016 | 2015 | |||||||
REVENUES: | ||||||||
Subscription and advertisement revenues | $ | 420 | $ | 319 | ||||
Royalties from product sales | 123 | 156 | ||||||
Grant income | 1,487 | 699 | ||||||
Sale of research products and services | 43 | 90 | ||||||
Total revenues | 2,073 | 1,264 | ||||||
Cost of sales | (225 | ) | (264 | ) | ||||
Gross Profit | 1,848 | 1,000 | ||||||
OPERATING EXPENSES: | ||||||||
Research and development | 13,734 | 9,323 | ||||||
General and administrative | 11,872 | 5,179 | ||||||
Total operating expenses | 25,606 | 14,502 | ||||||
Loss from operations | (23,758 | ) | (13,502 | ) | ||||
OTHER INCOME/(EXPENSES): | ||||||||
Interest income/(expense), net | (132 | ) | (25 | ) | ||||
BioTime’s share of losses in equity method investment in Ascendance | (235 | ) | - | |||||
Other income/(expense), net | 128 | (240 | ) | |||||
Total other income/(expense), net | (239 | ) | (265 | ) | ||||
LOSS BEFORE INCOME TAX BENEFIT | (23,997 | ) | (13,767 | ) | ||||
Deferred income tax benefit | - | 1,177 | ||||||
NET LOSS | (23,997 | ) | (12,590 | ) | ||||
Net loss attributable to non-controlling interest | 6,885 | 2,423 | ||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | $ | (17,112 | ) | $ | (10,167 | ) | ||
BASIC AND DILUTED NET LOSS PER COMMON SHARE | $ | (0.19 | ) | $ | (0.13 | ) | ||
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: |
90,421 | 78,262 |
BIOTIME, INC. AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(IN THOUSANDS) | ||||||||
March 31, |
|
|||||||
2016 |
December 31, |
|||||||
(Unaudited) |
2015 |
|||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 27,132 | $ | 42,229 | ||||
Available for sale securities | 829 | 753 | ||||||
Trade accounts and grants receivable, net | 1,125 | 1,078 | ||||||
Landlord receivable | 943 | 567 | ||||||
Prepaid expenses and other current assets | 2,878 | 2,610 | ||||||
Total current assets | 32,907 | 47,237 | ||||||
Property, plant and equipment, net and construction in progress | 8,932 | 7,539 | ||||||
Deferred license fees | 293 | 322 | ||||||
Deposits and other long-term assets | 1,268 | 1,299 | ||||||
Equity method investment | 4,436 | 4,671 | ||||||
Intangible assets, net | 32,278 | 33,592 | ||||||
TOTAL ASSETS | $ | 80,114 | $ | 94,660 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable and accrued liabilities | $ | 10,674 | $ | 9,377 | ||||
Capital lease liability, current portion | 22 | 38 | ||||||
Promissory notes, current portion | 95 | 95 | ||||||
Deferred grant income | 2,269 | 2,513 | ||||||
Deferred license and subscription revenue, current portion | 609 | 439 | ||||||
Total current liabilities | 13,669 | 12,462 | ||||||
LONG-TERM LIABILITIES | ||||||||
Deferred revenues, net of current portion | 538 | 615 | ||||||
Deferred rent liabilities, net of current portion | 261 | 158 | ||||||
Lease liability | 5,408 | 4,400 | ||||||
Related party convertible debt, net of discount | 394 | 324 | ||||||
Promissory notes, net of current portion | 220 | 220 | ||||||
Capital lease, net of current and other liabilities | 32 | 34 | ||||||
TOTAL LIABILITIES | 20,522 | 18,213 | ||||||
Commitments and contingencies | ||||||||
SHAREHOLDERS' EQUITY | ||||||||
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding | - | - | ||||||
Common shares, no par value, 125,000 shares authorized; 94,894 issued and 90,421 outstanding as of March 31, 2016 and December 31, 2015 | 275,238 | 274,342 | ||||||
Accumulated other comprehensive loss | (60 | ) | (237 | ) | ||||
Accumulated deficit | (246,293 | ) | (229,181 | ) | ||||
Treasury stock at cost: 4,473 shares as of March 31, 2016 and December 31, 2015 | (18,033 | ) | (18,033 | ) | ||||
BioTime, Inc. shareholders' equity | 10,852 | 26,891 | ||||||
Non-controlling interest | 48,740 | 49,556 | ||||||
Total shareholders' equity | 59,592 | 76,447 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 80,114 | $ | 94,660 |
CONTACT:
BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimemail.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