Press Releases
BioTime Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
- Completed Acquisition of
Asterias Biotherapeutics, Inc. - Completed Distribution of AgeX Therapeutics Shares to
BioTime Shareholders - Entered Into Exclusive Collaboration with
Orbit Biomedical Ltd.
“BioTime has been moving rapidly towards building a pioneering cell therapy company through strategic transactions on the corporate development, clinical, and operational fronts,” stated
Recent Highlights
- Completed acquisition of
Asterias Therapeutics, Inc. BioTime acquired all of the remaining outstanding common stock of Asterias not previously owned byBioTime , and the operations ofBioTime and Asterias were combined.BioTime is now advancing three clinical stage product candidates for the potential treatment of degenerative retinal diseases and neurological conditions associated with demyelination, and to potentially aid the body in detecting and combating cancer. - Announced exclusive agreement with
Orbit Biomedical Ltd. (Orbit) under whichBioTime and Orbit will collaborate on the use of Orbit’s proprietary injection technology to deliver OpRegen for the treatment of dry age-related macular degeneration (dry-AMD) in BioTime’s ongoing Phase I/IIa clinical study. - Completed the distribution of approximately 12.7 million shares of AgeX common stock owned by
BioTime on a pro rata basis to eligibleBioTime shareholders.BioTime retained an equity position in AgeX of 1.7 million shares, or approximately 5% of AgeX’s common stock. As ofMarch 13, 2019 , the value of BioTime’s AgeX share position was approximately$7.2 million . - Presented encouraging data on BioTime’s proprietary pluripotent stem cell technology as a platform to address the retinal degeneration disease continuum presented at the 14th Annual Scientific Meeting of the Association For Ocular Pharmacology and Therapeutics (AOPT 2019).
BioTime affiliateOncoCyte Corporation (NYSE American: OCX) recently reported positive results from an R&D validation study of DetermaVu™, its non-invasive liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. Following a recently completed$40.25 million public offering byOncoCyte ,BioTime owns approximately 28% of OncoCyte’s common stock, or 14.7 million shares. As ofMarch 13, 2019 , the value of BioTime’sOncoCyte share position was approximately$55.9 million .
Plans for 2019
- Present updated results from the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD and the Vision Restoration Program at the 2019
Association for Research in Vision and Ophthalmology Annual Meeting onMay 2, 2019 andApril 30, 2019 , respectively. - Pursuant to an exclusive collaboration with
Orbit Biomedical Ltd. for the use of Orbit’s proprietary injection technology, initiate dosing of the first patient with the Orbit device and a new thaw and inject formulation in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD, anticipated in Q2 2019. - Advance the OPC1 program and meet with the
FDA to discuss plans for next steps in the clinical development of the program, anticipated in 2019. - Strengthen and expand existing partnerships with the
California Institute for Regenerative M edicine andCancer Research UK , for the ongoing support of the development of the OPC1 and VAC2 programs. - Complete patient enrollment in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD, anticipated by year end 2019.
- Evaluate the development of OPC1 as a candidate for the potential treatment of multiple sclerosis (MS) and ischemic stroke through ongoing research collaborations with major universities.
- Announce decision on BioTime’s CE Mark application for Renevia, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures, expected in the second half of 2019.
Balance Sheet Highlights
Cash, cash equivalents and marketable securities totaled
BioTime’s investment in
BioTime’s promissory note from Juvenescence was valued at
Fourth Quarter Operating Results
Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenues for the three months ended
Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A) expenses. Total operating expenses for the three months ended
The reconciliation between GAAP and non-GAAP operating expenses, by entity, is provided in the financial tables included with this earnings release.
R&D Expenses: Beginning on
R&D expenses for the three months ended
G&A Expenses: Beginning on
G&A expenses for the three months ended
Other Income/(Expenses), Net: Other expenses, net for the three months ended
Net loss attributable to BioTime: The net loss attributable to
Year-to-Date Operating Results
Revenues: Total revenues for the year ended
Operating Expenses: Total operating expenses for the year ended
R&D Expenses: R&D expenses for the year ended
- a decrease of
$1.5 million in AgeX related programs, including LifeMap Sciences, due to the AgeX deconsolidation; - a decrease of
$0.8 million from the absence ofOncoCyte research and development expenses incurred in 2017 as a result of theOncoCyte deconsolidation inFebruary 2017 ; - a decrease of
$0.5 million in LifeMap Solutions expenses resulting from the cessation of its mobile health software development application business inJuly 2017 ; and - a decrease of
$0.3 million inBioTime related program expenses, primarily related to completing the Renevia clinical trial in early 2018.
The decreases were partially offset by an
G&A Expenses: G&A expenses for the year ended
- an increase of
$2.3 million related to management transition and other compensation related costs, including hiring costs for a new chief executive officer duringSeptember 2018 ; - an increase of
$2.1 million for legal, audit and compliance costs related to distributing 12.7 million shares of AgeX common stock toBioTime shareholders inNovember 2018 ; and - an increase of
$1.5 million in noncash stock-based compensation expense due to increases in equity award grants.
These increases were partially offset by decreases of
Other Income/(Expenses), Net: Other income/(expenses), net for the year ended
Net loss attributable to BioTime: The net loss attributable to
Conference Call and Webcast
About
Forward-Looking Statements
Tables to follow
BIOTIME, INC. AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(IN THOUSANDS) | ||||||||
December 31, | December 31, | |||||||
2018 | 2017 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 23,587 | $ | 36,838 | ||||
Marketable equity securities | 7,154 | 1,337 | ||||||
Trade accounts and grants receivable, net | 767 | 780 | ||||||
Landlord receivable | 840 | - | ||||||
Receivables from affiliates, net | 2,112 | 2,266 | ||||||
Prepaid expenses and other current assets | 1,898 | 1,402 | ||||||
Total current assets | 36,358 | 42,623 | ||||||
NONCURRENT ASSETS | ||||||||
Property and equipment, net | 5,835 | 5,533 | ||||||
Deposits and other long term assets | 505 | 1,018 | ||||||
Promissory note from Juvenescence | 22,104 | - | ||||||
Equity method investment in OncoCyte, at fair value | 20,250 | 68,235 | ||||||
Equity method investment in Asterias, at fair value | 13,483 | 48,932 | ||||||
Intangible assets, net | 3,125 | 6,900 | ||||||
TOTAL ASSETS | $ | 101,660 | $ | 173,241 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable and accrued liabilities | $ | 6,463 | $ | 5,718 | ||||
Capital lease and lease liability, current portion | 237 | 212 | ||||||
Promissory notes, current portion | 70 | 152 | ||||||
Deferred license and subscription revenues | - | 488 | ||||||
Deferred grant revenue | 42 | 309 | ||||||
Total current liabilities | 6,812 | 6,879 | ||||||
LONG-TERM LIABILITIES | ||||||||
Deferred rent liabilities, net of current portion | 244 | 105 | ||||||
Lease liability, net of current portion | 1,854 | 1,019 | ||||||
Capital lease, net of current portion | 104 | 132 | ||||||
Promissory notes, net of current portion | - | 18 | ||||||
Liability classified warrants and other long-term liabilities | 400 | 825 | ||||||
TOTAL LIABILITIES | 9,414 | 8,978 | ||||||
Commitments and contingencies | ||||||||
SHAREHOLDERS’ EQUITY | ||||||||
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of December 31, 2018 and 2017, respectively | - | - | ||||||
Common shares, no par value, 250,000 shares authorized; 127,136 and 126,866 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 354,270 | 378,487 | ||||||
Accumulated other comprehensive income | 1,426 | 451 | ||||||
Accumulated deficit | (261,856) | (216,297) | ||||||
BioTime, Inc. shareholders’ equity | 93,840 | 162,641 | ||||||
Noncontrolling interest (deficit) | (1,594) | 1,622 | ||||||
Total shareholders’ equity | 92,246 | 164,263 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 101,660 | $ | 173,241 | ||||
BIOTIME, INC. AND SUBSIDIARIES | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) | ||||||||||||||||
(UNAUDITED) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
REVENUES: | ||||||||||||||||
Grant revenue | $ | 587 | $ | 430 | $ | 3,572 | $ | 1,666 | ||||||||
Royalties from product sales and license fees | 80 | 112 | 392 | 389 | ||||||||||||
Subscription and advertisement revenues | - | 455 | 691 | 1,395 | ||||||||||||
Sale of research products and services | 91 | 2 | 333 | 8 | ||||||||||||
Total revenues | 758 | 999 | 4,988 | 3,458 | ||||||||||||
Cost of sales | (52) | (54) | (302) | (168) | ||||||||||||
Gross profit | 706 | 945 | 4,686 | 3,290 | ||||||||||||
OPERATING EXPENSES: | ||||||||||||||||
Research and development | (3,780) | (4,697) | (20,955) | (24,024) | ||||||||||||
Acquired in-process research and development | - |
- |
(800) | - | ||||||||||||
General and administrative | (7,033) | (5,811) | (24,726) | (19,922) | ||||||||||||
Total operating expenses | (10,813) | (10,508) | (46,481) | (43,946) | ||||||||||||
Gain on sale of assets | - | - | - | 1,754 | ||||||||||||
Loss from operations | (10,107) | (9,563) | (41,795) | (38,902) | ||||||||||||
OTHER INCOME/(EXPENSES): | ||||||||||||||||
Interest income (expense), net | 433 | 37 | 711 | (692) | ||||||||||||
Gain on sale of equity method investment in Ascendance | - | - | 3,215 |
- |
||||||||||||
Gain on sale of AgeX shares and deconsolidation of AgeX | - | - | 78,511 | - | ||||||||||||
Gain on deconsolidation of OncoCyte | - | - | - | 71,697 | ||||||||||||
Loss on equity method investment in OncoCyte at fair value | (16,435) | (42,555) | (47,985) | (2,935) | ||||||||||||
Loss on equity method investment in Asterias at fair value | (14,789) | (25,010) | (35,449) | (51,107) | ||||||||||||
Loss on equity method investment in AgeX at fair value | (4,181) | - | (4,181) | - | ||||||||||||
Unrealized gain on marketable equity securities | 523 | - | 1,158 | - | ||||||||||||
Loss on extinguishment of related party convertible debt | - | - | - | (2,799) | ||||||||||||
Other income/(expense), net | (774) | 247 | (1,315) | 1,449 | ||||||||||||
Total other income (expenses), net | (35,223) | (67,281) | (5,335) | 15,613 | ||||||||||||
LOSS BEFORE INCOME TAXES | (45,330) | (76,844) | (47,130) | (23,289) | ||||||||||||
Income tax benefit | 346 | 4,772 | 346 | - | ||||||||||||
NET LOSS | (44,984) | (72,072) | (46,784) | (23,289) | ||||||||||||
Net loss attributable to noncontrolling interest | 32 | 138 | 794 | 3,313 | ||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. | $ | (44,952) | $ | (71,934) | $ | (45,990) | $ | (19,976) | ||||||||
NET LOSS PER COMMON SHARE: | ||||||||||||||||
BASIC AND DILUTED | $ | (0.35) | $ | (0.58) | $ | (0.36) | $ | (0.17) | ||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: | ||||||||||||||||
BASIC AND DILUTED | 126,990 | 124,822 | 126,903 | 114,476 | ||||||||||||
BIOTIME, INC. AND SUBSIDIARIES | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(IN THOUSANDS) | ||||||||
Year Ended | ||||||||
December 31, | ||||||||
2018 | 2017 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss attributable to BioTime, Inc. | $ | (45,990) | $ | (19,976) | ||||
Net loss allocable to noncontrolling interest | (794) | (3,313) | ||||||
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities: | ||||||||
Gain on sale of AgeX shares and deconsolidation of AgeX | (78,511) | - | ||||||
Gain on deconsolidation of OncoCyte | - | (71,697) | ||||||
Gain on sale of equity method investment in Ascendance | (3,215) | - | ||||||
Acquired in-process research and development | 800 | - | ||||||
Unrealized loss on equity method investment in OncoCyte at fair value | 47,985 | 2,935 | ||||||
Unrealized loss on equity method investment in Asterias at fair value | 35,449 | 51,107 | ||||||
Unrealized loss on equity method investment in AgeX at fair value | 4,181 | - | ||||||
Unrealized gain on marketable equity securities | (1,158) | - | ||||||
Income tax benefit | (346) | - | ||||||
Depreciation expense, including amortization of leasehold improvements | 1,081 | 947 | ||||||
Amortization of intangible assets | 2,192 | 2,349 | ||||||
Stock-based compensation | 5,402 | 3,932 | ||||||
Liability classified warrants | (384) | 797 | ||||||
Amortization of discount on related party convertible debt | - | 640 | ||||||
Foreign currency remeasurement and other (gain) loss | 1,788 | (1,761) | ||||||
Gain on sale of assets | - | (1,754) | ||||||
Loss on extinguishment of related party debt | - | 2,799 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts and grants receivable, net | 46 | (172) | ||||||
Due from affiliates | 559 | 1,157 | ||||||
Prepaid expenses and other current assets | (437) | 145 | ||||||
Other long-term assets and liabilities | (487) | (22) | ||||||
Accounts payable and accrued liabilities | 1,100 | 1,299 | ||||||
Deferred revenues and grant income | (287) | 243 | ||||||
Deferred grant expense | - | (227) | ||||||
Deferred rent liabilities | 144 | 55 | ||||||
Net cash used in operating activities | (30,882) | (30,517) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Deconsolidation of cash and cash equivalents of AgeX | (9,704) | - | ||||||
Deconsolidation of cash and cash equivalents of OncoCyte | - | (8,898) | ||||||
Proceeds from the sale of AgeX common stock to Juvenescence | 21,600 | - | ||||||
Proceeds from the sale of equity method investment in Ascendance | 3,215 | - | ||||||
Purchase of in-process research and development by AgeX | (1,872) | - | ||||||
Purchase of property and equipment | (556) | (1,326) | ||||||
Payments on construction in progress | (859) | - | ||||||
Purchase of foreign available-for-sale securities | - | (189) | ||||||
Proceeds from sale of assets | - | 200 | ||||||
Security deposit paid and other | (8) | (12) | ||||||
Cash used provided by (used in) investing activities | 11,816 | (10,225) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from issuance of common shares | - | 48,875 | ||||||
Fees paid on sale of common shares | - | (3,798) | ||||||
Proceeds from exercise of stock options | - | 25 | ||||||
Common shares received and retired for employee taxes paid | (203) | (45) | ||||||
Proceeds from exercise of subsidiary stock options and warrants | - | 4 | ||||||
Proceeds from sale of subsidiary common shares and warrants | 6,000 | 9,968 | ||||||
Proceeds from sale of common shares at-the-market, net of fees | - | 835 | ||||||
Purchase and retirement of common shares from a related party | - | (843) | ||||||
Repayment of lease liability and capital lease obligation | (248) | (204) | ||||||
Reimbursement from landlord on construction in progress | 364 | 198 | ||||||
Proceeds from issuance of related party convertible debt | - | 425 | ||||||
Repayment of promissory notes | (101) | (49) | ||||||
Payment to repurchase subsidiary shares | (38) | - | ||||||
Net cash provided by financing activities | 5,774 | 55,391 | ||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 6 | 101 | ||||||
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (13,286) | 14,750 | ||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: | ||||||||
At beginning of year | 37,685 | 22,935 | ||||||
At end of year | $ | 24,399 | $ | 37,685 | ||||
Non-GAAP Financial Measures
This press release includes operating expenses prepared in accordance with accounting principles generally accepted in
Furthermore, management uses these non-GAAP financial measures in the aggregate and on an entity basis to establish budgets and operational goals, to manage BioTime’s business and to evaluate its performance and its programs in clinical development.
BIOTIME, INC. AND SUBSIDIARIES | ||||||||
RECONCILIATION OF NON-GAAP FINANCIAL MEASURE |
||||||||
ADJUSTED OPERATING EXPENSES |
||||||||
|
Amounts In Thousands | |||||||
For the Three Months | ||||||||
Ended December 31, | For the Year Ended | |||||||
2018 | December 31, 2018 | |||||||
(unaudited) | (unaudited) | |||||||
GAAP Operating Expenses - as reported(1) | $ | 10,813 | $ | 46,481 | ||||
Stock-based and other noncash compensation expense(2) | (2,003) | (5,395) | ||||||
Depreciation and amortization expense(2) | (734) | (3,273) | ||||||
Acquired AgeX in-process research and development expense(3) | - | (800) | ||||||
Non-GAAP Operating Expenses, as adjusted | $ | 8,076 | $ | 37,013 | ||||
GAAP Operating Expenses - by entity(1) | ||||||||
BioTime and subsidiaries other than AgeX Therapeutics, Inc.(4) | $ | 10,813 | $ | 38,754 | ||||
AgeX Therapeutics Inc. and subsidiaries(5) | - | 7,727 | ||||||
GAAP Operating Expenses - by entity | $ | 10,813 | $ | 46,481 | ||||
Non-GAAP Operating Expenses - as adjusted, by entity | ||||||||
BioTime and subsidiaries other than AgeX Therapeutics, Inc.(4) | $ | 8,076 | $ | 31,020 | ||||
AgeX Therapeutics Inc. and subsidiaries(5) | - | 5,993 | ||||||
Non-GAAP Operating Expenses - as adjusted, by entity | $ | 8,076 | $ | 37,013 |
(1) | Beginning on August 30, 2018, BioTime deconsolidated AgeX’s results and therefore BioTime’s results will not include AgeX’s results for periods after August 30, 2018. | ||
(2) | Noncash charges. | ||
(3) | AgeX acquired certain in-process research and development in March 2018, considered to be a nonrecurring item. See note (1). | ||
(4) | BioTime, Inc. includes Cell Cure Neurosciences Ltd., ES Cell International Pte. Ltd. and OrthoCyte Corporation. For the three and twelve months ended December 31, 2018, the GAAP and non-GAAP operating expenses do not include grant revenues of $0.6 million and $3.6 million, respectively, as grants are revenues for BioTime. | ||
(5) | AgeX Therapeutics, Inc. includes LifeMap Sciences Inc., LifeMap Sciences Ltd., and ReCyte Therapeutics, Inc. The information shown above is through August 29, 2018, the date before the deconsolidation of AgeX. See Note (1). |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190314005823/en/
Source:
BioTime Inc. IR
Ioana C. Hone
ir@biotimeinc.com
(510) 871-4188
Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949