|
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): March
16, 2017
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))
Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime’s periodic reports filed with the SEC under the heading “Risk Factors” and other filings that BioTime may make with the Securities and Exchange Commission. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, BioTime disclaims any intent or obligation to update these forward-looking statements.
References in this Report to “BioTime,” “we” or “us” refer to BioTime, Inc.
This Report and the accompanying Exhibit 99.1 shall be deemed “furnished” and not “filed” under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by BioTime under the Securities Act of 1933, as amended, or the Exchange Act except as may be expressly set forth by specific reference in such filing.
Section 2 - Financial Information
Item 2.02 - Results of Operations and Financial Condition
On March 16, 2017, BioTime, Inc. issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 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 March 16, 2017 |
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: |
March 16, 2017 |
By: |
|
/s/ Russell Skibsted |
|
Chief Financial Officer |
Exhibit 99.1
BioTime, Inc. Reports Fourth Quarter and Fiscal Year 2016 Financial Results and Recent Corporate Accomplishments
Conference Call and Webcast Today at 4:30 p.m. Eastern Time
ALAMEDA, Calif.--(BUSINESS WIRE)--March 16, 2017--BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported financial results for the fourth quarter and year ended December 31, 2016.
“I’m happy with the tremendous progress we made last year in all three of our strategic objectives, clinical development, simplification and unlocking value of non-core programs,” said Adi Mohanty, Co-Chief Executive Officer. “We still have more to do, and are well on our way to transforming the company in 2017.”
“This year is shaping up to be the year of data with top line data from our registrational trial for Renevia® in Europe planned for mid-year, data from OpRegen® in Dry AMD to be reported in early May at ARVO and then again in the second half of the year, final validation data from our affiliate OncoCyte on its lung cancer diagnostic leading to a commercial launch in the second half of the year and additional data on OPC-1 for spinal cord injury from our affiliate Asterias and several other data reports from our other pipeline products. These data events and our planned actions to simplify the company while unlocking value will lead to continued positive transformation of BioTime,” concluded Mr. Mohanty.
Highlights
Clinical Progress
Renevia® (adipose cells + cell delivery matrix)
OpRegen® (retinal pigment epithelial cells)
AST-OPC1 (oligodendrocyte progenitor cells)
Liquid Biopsy (lung cancer confirmatory test)
Simplification and Unlocking Value
Subsidiary Deconsolidation
Business Development
Management
Operations
Financial
Cash Position and Marketable Securities:
Cash and cash equivalents totaled $22.1 million as of December 31, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. Based on the March 15, 2017 closing prices of Asterias and OncoCyte common stock owned by BioTime, the combined market value of these securities was $152 million on that date.
Revenues: Total revenues were $1.1 million for the fourth quarter, compared to $1.5 million in the fourth quarter of 2015. Asterias’ total revenues included in the fourth quarter of 2015 were $0.6 million as compared to none in 2016 due to the deconsolidation in May 2016. Total revenues for 2016 were $5.9 million compared to $7.0 million in 2015, which included revenues of Asterias of $2.4 million and $3.6 million, respectively. BioTime’s operating revenues are currently generated primarily from research grants, advertising from the marketing of online database products, sales of research products and royalties and licensing fees.
R&D Expenses: Research and development expenses were $7.0 million for the fourth quarter, compared to $12.8 million for the comparable period in 2015. For 2016, research and development expenses were $36.1 million compared to $42.6 million in 2015. The year over year decrease in research and development expenses of $6.5 million was primarily attributable to the deconsolidation of Asterias which contributed to $8.6 million of the decrease as shown below. This decrease was offset by an increase of $1.2 million in BioTime research and development programs and $0.9 million in OncoCyte expenses related to cancer diagnostics.
The tables below show BioTime’s research and development expenses, by program and by company, for the three months ended December 31, 2016 and 2015, and for the years then ended.
Three Months Ended December 31 |
|||||||||
Company | Program | 2016 | 2015 | ||||||
BioTime and ESI | PureStem® progenitor and pluripotent cell lines, and related research products | $ | 1,427 | $ | 1,609 | ||||
BioTime |
Hydrogel products, Renevia® and other HyStem ® products and research |
1,011 | 1,273 | ||||||
BioTime | Hextend® | 12 | 18 | ||||||
Cell Cure | OpRegen® | 1,653 | 1,357 | ||||||
OrthoCyte | Orthopedic therapy | 144 | 122 | ||||||
ReCyte Therapeutics | Cardiovascular therapy | 262 | 231 | ||||||
Subtotal therapeutic projects | 4,509 | 4,610 | |||||||
Asterias | Pluripotent cell therapy programs | - | 5,483 | ||||||
LifeMap Sciences | Databases and mobile health products | 1,099 | 1,459 | ||||||
OncoCyte | Cancer diagnostics | 1,405 | 1,236 | ||||||
Subtotal non-therapeutic projects | 2,504 | 2,695 | |||||||
Total research and development expenses | $ | 7,013 | $ | 12,788 |
Year Ended December 31 |
|||||||||
Company | Program | 2016 | 2015 | ||||||
BioTime and ESI | PureStem® progenitor and pluripotent cell lines, and related research products | $ | 6,060 | $ | 5,196 | ||||
BioTime | Renevia® and other HyStem ® products and research | 3,856 | 4,047 | ||||||
BioTime | Hextend® | 54 | 59 | ||||||
Cell Cure | OpRegen® | 4,803 | 4,086 | ||||||
OrthoCyte | Orthopedic therapy | 606 | 590 | ||||||
ReCyte Therapeutics | Cardiovascular therapy | 949 | 1,142 | ||||||
Subtotal therapeutic projects | 16,328 | 15,120 | |||||||
Asterias | Pluripotent cell therapy programs | 8,684 | 17,322 | ||||||
LifeMap Sciences | Databases and mobile health products | 5,348 | 5,251 | ||||||
OncoCyte | Cancer diagnostics | 5,746 | 4,911 | ||||||
Subtotal non-therapeutic projects | 11,094 | 10,162 | |||||||
Total research and development expenses | $ | 36,106 | $ | 42,604 | |||||
G&A Expenses: The tables below show BioTime’s general and administrative expenses, by program and by company, for the three months ended December 31, 2016 and 2015, and for the years then ended. General and administrative expenses were $5.3 million for the fourth quarter, compared to $10.2 million for the fourth quarter of 2015. The decrease was primarily due to the May 2016 deconsolidation of Asterias financial results which contributed by $2.9 million of G&A recorded in the fourth quarter of 2015. The remaining decrease of approximately $2.0 million in the fourth quarter of 2016 was principally due to lower stock-based compensation. Year over year G&A was relatively unchanged at $28.4 million and $29.1 million, respectively.
Three Months Ended December 31 |
|||||||||
Company | 2016 | 2015 | |||||||
BioTime | $ | 2,331 | $ | 3,573 | |||||
Cell Cure | 266 | 211 | |||||||
OrthoCyte | 322 | 422 | |||||||
ReCyte Therapeutics | 106 | 413 | |||||||
Subtotal therapeutic entities | 3,025 | 4,619 | |||||||
Asterias | - | 2,942 | |||||||
LifeMap Sciences | 665 | 1,094 | |||||||
OncoCyte | 1,653 | 1,568 | |||||||
Subtotal non-therapeutic entities | 2,318 | 2,662 | |||||||
Total general and administrative expenses | $ | 5,343 | $ | 10,223 | |||||
Year Ended December 31 |
|||||||||
Company | 2016 | 2015 | |||||||
BioTime | $ | 8,958 | $ | 9,761 | |||||
Cell Cure | 1,185 | 655 | |||||||
OrthoCyte | 570 | 583 | |||||||
ReCyte Therapeutics | 581 | 760 | |||||||
ESI | 276 | 245 | |||||||
Subtotal therapeutic entities | 11,570 |
12,003 |
|||||||
Asterias | 7,561 | 7,711 | |||||||
LifeMap Sciences | 3,385 | 5,142 | |||||||
OncoCyte | 5,910 |
4,278 |
|||||||
Subtotal non-therapeutic entities | 9,295 |
9,420 |
|||||||
Total general and administrative expenses | $ | 28,426 | $ | 29,134 | |||||
Net Income (loss) attributable to BioTime: Net loss attributable to BioTime was $5.1 million, or ($0.05) per basic and diluted common share for the three months ended December 31, 2016, compared to $13.4 million, or ($0.15) per basic and diluted common share due primarily to the deconsolidation of Asterias in May 2016. For 2016, net income attributable to BioTime was $33.6 million, or $0.35 per basic and $0.34 per diluted common share, compared to net loss attributable to BioTime of $47.4 million, or ($0.59) per basic and diluted common share. The 2016 net income attributable to BioTime was primarily due to the $49.0 million gain on deconsolidation of Asterias and the $34.4 million gain recognized from the increase in the market value of the Asterias shares owned by BioTime from May 13, 2016, the date of the deconsolidation, through the end of the year.
Conference Call and Webcast Details
BioTime is hosting a conference call and webcast today, Thursday, March 16, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the results and recent corporate developments.
The conference call dial-in number in the U.S./Canada is 1-877-407-0784. For international participants outside the U.S./Canada, the dial-in number is 1-201-689-8560. 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: 1-844-512-2921; international callers dial 1-412-317-6671. Use the Conference ID 13656362. 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 is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. Our clinical programs are based on two platform technologies: pluripotent stem cells and cell/drug delivery platform technologies. 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. The foundation of our cell delivery platform is its HyStem® cell and drug delivery matrix technology. The Company’s current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell/drug delivery. We also have significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (“Asterias”) and OncoCyte Corporation (“OncoCyte”), which we founded and which, until recently, were our majority-owned consolidated subsidiaries.
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
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries and affiliates, 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, Inc. and its subsidiaries and affiliates, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
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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Three Months Ended | Years Ended | ||||||||||||||||||
December 31, |
December 31, | ||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||
REVENUES: | |||||||||||||||||||
Grant income | $ | 325 | $ | 906 | $ | 3,671 | $ | 4,502 | |||||||||||
Royalties from product sales and license fees | 81 | 88 | 544 | 719 | |||||||||||||||
Subscription and advertisement revenues | 272 | 337 | 972 | 1,357 | |||||||||||||||
Sale of research products and services | 405 | 130 | 736 | 458 | |||||||||||||||
Total revenues | 1,083 | 1,461 | 5,923 | 7,036 | |||||||||||||||
Cost of sales | 20 | (155 | ) | (358 | ) | (1,107 | ) | ||||||||||||
Gross profit | 1,103 | 1,306 | 5,565 | 5,929 | |||||||||||||||
OPERATING EXPENSES: | |||||||||||||||||||
Research and development | (7,013 | ) | (12,788 | ) | (36,106 | ) | (42,604 | ) | |||||||||||
General and administrative | (5,343 | ) | (10,223 | ) | (28,426 | ) | (29,134 | ) | |||||||||||
Total operating expenses | (12,356 | ) | (23,011 | ) | (64,532 | ) | (71,738 | ) | |||||||||||
Loss from operations | (11,253 | ) | (21,705 | ) | (58,967 | ) | (65,809 | ) | |||||||||||
OTHER INCOME/(EXPENSES): | |||||||||||||||||||
Interest expense, net | (234 | ) | (133 | ) | (747 | ) | (340 | ) | |||||||||||
BioTime’s share of losses and impairment in equity method investment in Ascendance | (3,482 | ) | (35 | ) | (4,671 | ) | (35 | ) | |||||||||||
Gain on deconsolidation of Asterias | - | - | 49,048 | - | |||||||||||||||
Gain on equity method investment in Asterias at fair value | 7,829 | - | 34,361 | - | |||||||||||||||
Gain on investment | - | 3,694 | - | 3,694 | |||||||||||||||
Other income/(expense), net | (601 | ) | 245 | (403 | ) | (160 | ) | ||||||||||||
Total other income/(expense), net | 3,512 | 3,771 | 77,588 | 3,159 | |||||||||||||||
INCOME (LOSS) BEFORE INCOME TAX BENEFIT | (7,741 | ) | (17,934 | ) | 18,621 | (62,650 | ) | ||||||||||||
Deferred income tax benefit | - | 1,120 | - | 4,516 | |||||||||||||||
NET INCOME (LOSS) | (7,741 | ) | (16,814 | ) | 18,621 | (58,134 | ) | ||||||||||||
Net loss attributable to non-controlling interest | 2,665 | 3,382 | 14,951 | 11,143 | |||||||||||||||
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. | (5,076 | ) | (13,432 | ) | 33,572 | (46,991 | ) | ||||||||||||
Dividends on preferred shares | - | - | - | (415 | ) | ||||||||||||||
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS | (5,076 | ) | (13,432 | ) | 33,572 | (47,406 | ) | ||||||||||||
NET INCOME (LOSS) PER COMMON SHARE: | |||||||||||||||||||
BASIC | $ | (0.05 | ) | $ | (0.15 | ) | $ |
0.35 |
$ | (0.59 | ) | ||||||||
DILUTED | $ | (0.05 | ) | $ | (0.15 | ) | $ | 0.34 | $ | (0.59 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING: | |||||||||||||||||||
BASIC | 102,775 | 89,414 | 97,316 | 79,711 | |||||||||||||||
DILUTED | 102,775 | 89,414 | 99,553 | 79,711 |
BIOTIME, INC. AND SUBSIDIARIES |
|||||||
December 31, | December 31, | ||||||
2016 | 2015 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 22,088 | $ | 42,229 | |||
Available for sale securities | 627 | 753 | |||||
Trade accounts and grants receivable, net | 446 | 1,078 | |||||
Landlord receivable | 200 | 567 | |||||
Receivable from affiliates |
511 |
- |
|||||
Prepaid expenses and other current assets | 1,777 | 2,610 | |||||
Total current assets | 25,649 | 47,237 | |||||
Property, plant and equipment, net and construction in progress | 5,529 | 7,539 | |||||
Deferred license fees | 118 | 322 | |||||
Deposits and other long-term assets | 1,031 | 1,299 | |||||
Equity method investment in Asterias, at fair value | 100,039 |
- |
|||||
Equity method investment in Ascendance |
- |
4,671 |
|||||
Intangible assets, net | 10,206 | 33,592 | |||||
TOTAL ASSETS | $ | 142,572 | $ | 94,660 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued liabilities | $ | 7,144 | $ | 9,377 | |||
Capital lease liability, current portion | 202 | 38 | |||||
Promissory notes, current portion | 99 | 95 | |||||
Related party convertible debt, net of discount, current portion |
833 |
- | |||||
Deferred grant income | - | 2,513 | |||||
Deferred license and subscription revenue, current portion | 572 | 439 | |||||
Total current liabilities | 8,850 | 12,462 | |||||
LONG-TERM LIABILITIES | |||||||
Deferred revenues, net of current portion | 308 | 615 | |||||
Deferred rent liabilities, net of current portion | 50 | 158 | |||||
Lease liability | 1,386 | 4,400 | |||||
Capital lease liability, net of current portion |
310 | 26 | |||||
Related party convertible debt, net of discount | 1,032 | 324 | |||||
Promissory notes, net of current portion | 120 | 220 | |||||
Other long term liabilities | 8 | 8 | |||||
TOTAL LIABILITIES | 12,064 | 18,213 | |||||
Commitments and contingencies | |||||||
SHAREHOLDERS' EQUITY | |||||||
Series A Convertible preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of December 31, 2016 and 2015, respectively |
- | - | |||||
Common stock, no par value, authorized 150,000 shares; issued and outstanding shares; 103,396 shares issued and 102,776 outstanding as of December 31, 2016 and 94,894 issued and 90,421 outstanding as of December 31, 2015 |
317,878 |
273,979 |
|||||
Accumulated other comprehensive loss | (738) | (237) | |||||
Accumulated deficit |
(196,321) |
(229,893) |
|||||
Treasury stock at cost: 620 and 4,473 shares at December 31, 2016 and 2015, respectively | (2,891) | (18,033) | |||||
BioTime, Inc. shareholders' equity |
117,928 |
25,816 |
|||||
Noncontrolling interest |
12,580 |
50,631 |
|||||
Total shareholders' equity | 130,508 | 76,447 | |||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 142,572 | $ | 94,660 |
CONTACT:
for BioTime, Inc.
Investor Contact:
Brian Moore,
310-770-0389
bmoore@evcgroup.com
or
Media Contact:
Gotham
Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com