Press Releases
BioTime Reports Third Quarter 2018 Financial Results and Provides Business Update
- Industry Veteran Brian M. Culley Appointed as CEO
- Signed Agreement to
Acquire Asterias Biotherapeutics, Inc. - Received
$43.2 Million from AgeX Sale Transaction withJuvenescence Ltd. - Positive OpRegen® Data Presented at 2018
American Academy of Ophthalmology Annual Meeting - Date Set for Distribution of AgeX Therapeutics Shares to
BioTime Stockholders
“I am excited to have joined
Recent Highlights
- Biotech executive
Brian M. Culley appointed as Chief Executive Officer. Mr. Culley brings more than 25 years of experience, spanning diverse operational areas including strategy, finance, licensing, and clinical development. Ms. Culley holds a B.S. in biology fromBoston College , a masters in biochemistry from theUniversity of California, Santa Barbara and an M.B.A. fromThe Johnson School of Business atCornell University . He has worked as a bench scientist, technology transfer professional, head of business development and most recently served consecutively as the CEO of two publicly-traded biotech companies. - Announced today entry into a merger agreement to acquire
Asterias Therapeutics, Inc. (NYSE American:AST) in an all stock transaction. Upon consummation of the transaction and as a result of the merger,BioTime will acquire two clinical-stage cell therapy product candidates addressing significant unmet medical needs in spinal cord injury and immuno-oncology. - Received
$43.2 million for approximately one-half of BioTime’s interest inAgeX Therapeutics Inc. (“AgeX”) toJuvenescence Ltd. , which will help support development of BioTime’s core programs.BioTime received$21.6 million in cash. The remaining$21.6 million was received in the form of a two year promissory note, which is convertible into Juvenescence common stock, upon its IPO, if completed prior to maturity.BioTime and AgeX will continue to collaborate towards the success of both companies in order to maximize the potential of the AgeX programs and provide for enhanced equity value, milestone payments, and royalties owed toBioTime under this agreement. - Encouraging OpRegen® Data Presented at 2018
American Academy of Ophthalmology Annual Meeting. Treatment with OpRegen® continues to be well tolerated and shows signs of structural improvement in the retina and decreases in drusen density in some patients. Notably, early data from Cohort 4 patients with earlier-stage dry-AMD are promising and indicate structural improvement within the retina, evidence of the continued presence of the transplanted OpRegen® cells, and improvements in visual acuity. - Announced
November 16, 2018 Record Date andNovember 28, 2018 Distribution Date for the distribution of the majority of shares of AgeX common stock owned byBioTime on a pro rata basis to eligibleBioTime shareholders as of the Record Date.BioTime shareholders will receive one share of AgeX common stock for every 10 Shares ofBioTime common stock held as of the Record Date.BioTime shareholders will not have to surrender or exchangeBioTime common shares in order to receive AgeX shares.
Third Quarter Financial Results
Value of Holdings in Public Affiliates: At
If the planned AgeX distribution is completed on or about
If the Juvenescence note is converted to Juvenescence common stock prior to its maturity date, the Juvenescence common stock may be a marketable security that
Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenue was
Total revenue was
Operating Expenses: Total operating expenses for the third quarter of 2018 were
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: Third quarter research and development expenses were
Beginning on
G&A Expenses: Third quarter general and administrative expenses were
General and administrative expenses for the nine months ended
Beginning on
Net Income or loss attributable to BioTime: Third quarter net income attributable to
Conference Call and Webcast
About
BioTime is a clinical-stage biotechnology company focused on the development and commercialization of novel therapies for the treatment of degenerative diseases. BioTime’s pipeline is based on two platform technologies which encompass cell replacement and cell/drug delivery. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy in Phase 2 development for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world. BioTime’s lead cell delivery clinical program is Renevia®, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures. BioTime also has significant equity holdings in two publicly traded companies,
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn,
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. 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 forward-looking statements. Investors are cautioned that statements in this press release regarding: (a) any value to BioTime shareholders of the AgeX common stock; (b) BioTime's plans or expectations for the distribution of shares of AgeX common stock; (c) potential listing of AgeX common stock on NYSE American, constitute forward-looking statements; (d) the consummation of BioTime’s pending acquisition of Asterias; (e) BioTime’s continued collaboration with its partners, including AgeX following its spin-off and Juvenescence; and (f) the initiation, timing, progress and reporting of results of BioTime’s clinical programs and its research and development programs. Forward-looking statements involve risks and uncertainties. These risks and uncertainties, include, without limitation: (i) the possibility that BioTime shareholders may realize little or no value from the AgeX common stock; (ii) the potential inability of BioTime to complete distribution in a timely manner or at all, including as a result of the failure of BioTime and/or AgeX to obtain or maintain required federal and state registrations and qualifications necessary to enable the distribution, and related transactions; (iii) the possibility of litigation that could arise as a result of or in connection with the distribution and related transactions; and (iv) that there is no existing public market for AgeX common stock, nor may a public market for such securities ever develop. 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
Additional Information and Where to Find It
This communication is being made in respect of the proposed business combination involving
No Offer or Solicitation
This document does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
| BIOTIME, INC. AND SUBSIDIARIES | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (IN THOUSANDS) | ||||||||||
| September 30, |
December 31, |
|||||||||
| 2018 |
2017 |
|||||||||
| (Unaudited) |
|
|||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS | ||||||||||
| Cash and cash equivalents | $ | 19,467 | $ | 36,838 | ||||||
| Marketable equity securities | 1,972 | 1,337 | ||||||||
| Trade accounts and other receivables, net | 721 | 780 | ||||||||
| Receivable from affiliates, net | 2,185 | 2,266 | ||||||||
| Receivable from Juvenescence | 10,800 | - | ||||||||
| Prepaid expenses and other current assets | 1,761 | 1,402 | ||||||||
| Total current assets | 36,906 | 42,623 | ||||||||
| NONCURRENT ASSETS | ||||||||||
| Property, plant and equipment, net | 5,117 | 5,533 | ||||||||
| Deposits and other long-term assets | 518 | 1,018 | ||||||||
| Promissory note from Juvenescence | 21,730 | - | ||||||||
| Equity method investment in AgeX, at fair value | 43,248 | - | ||||||||
| Equity method investment in OncoCyte, at fair value | 36,686 | 68,235 | ||||||||
| Equity method investment in Asterias, at fair value | 28,272 | 48,932 | ||||||||
| Intangible assets, net | 3,600 | 6,900 | ||||||||
| TOTAL ASSETS | $ | 176,077 | $ | 173,241 | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
| CURRENT LIABILITIES | ||||||||||
| Accounts payable and accrued liabilities | $ | 4,082 | $ | 5,718 | ||||||
| Capital lease and lease liabilities, current portion | 231 | 212 | ||||||||
| Promissory notes, current portion | 70 | 152 | ||||||||
| Deferred license and subscription revenues | 77 | 488 | ||||||||
| Deferred grant revenue | 43 | 309 | ||||||||
| Total current liabilities | 4,503 | 6,879 | ||||||||
| LONG-TERM LIABILITIES | ||||||||||
| Deferred rent liabilities, net of current portion | 238 | 105 | ||||||||
| Lease liability, net of current portion | 1,221 | 1,019 | ||||||||
| Capital lease, net of current portion | 110 | 132 | ||||||||
| Promissory notes, net of current portion | - | 18 | ||||||||
| Liability classified warrants and other long-term liabilities | 447 | 825 | ||||||||
| TOTAL LIABILITIES | 6,519 | 8,978 | ||||||||
|
Commitments and contingencies |
||||||||||
| SHAREHOLDERS’ EQUITY | ||||||||||
|
Preferred shares, no par value, authorized 2,000 shares; |
- | - | ||||||||
|
Common shares, no par value, 250,000 shares authorized; |
386,858 | 378,487 | ||||||||
| Accumulated other comprehensive income | 1,174 | 451 | ||||||||
| Accumulated deficit | (216,905) | (216,297) | ||||||||
| BioTime, Inc. shareholders’ equity | 171,127 | 162,641 | ||||||||
| Noncontrolling interest (deficit) | (1,569) | 1,622 | ||||||||
| Total shareholders’ equity | 169,558 | 164,263 | ||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 176,077 | $ | 173,241 | ||||||
| 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, | |||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||
| REVENUES: | ||||||||||||||||||||
| Grant revenue | $ | 718 | $ | 1,225 | $ | 2,985 | $ | 1,236 | ||||||||||||
| Royalties from product sales and license fees | 85 | 86 | 312 | 277 | ||||||||||||||||
| Subscription and advertisement revenues | 119 | 376 | 691 | 940 | ||||||||||||||||
| Sale of research products and services | 60 | 1 | 242 | 6 | ||||||||||||||||
| Total revenues | 982 | 1,688 | 4,230 | 2,459 | ||||||||||||||||
| Cost of sales | (35) | (52) | (250) | (114) | ||||||||||||||||
| Gross Profit | 947 | 1,636 | 3,980 | 2,345 | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||||||
| Research and development | (4,882) | (6,562) | (17,175) | (19,327) | ||||||||||||||||
| Acquired in-process research and development | - | - | (800) | - | ||||||||||||||||
| General and administrative | (6,422) | (4,587) | (17,585) | (14,111) | ||||||||||||||||
| Total operating expenses | (11,304) | (11,149) | (35,560) | (33,438) | ||||||||||||||||
| Gain on sale of assets | - | - | - | 1,754 | ||||||||||||||||
| Loss from operations | (10,357) | (9,513) | (31,580) | (29,339) | ||||||||||||||||
| OTHER INCOME/(EXPENSES): | ||||||||||||||||||||
| Interest income (expense), net | 174 | (10) | 278 | (729) | ||||||||||||||||
|
Gain on sale of equity method |
- | - | 3,215 | - | ||||||||||||||||
|
Gain on sale of AgeX shares |
78,511 | - | 78,511 | - | ||||||||||||||||
|
Gain on deconsolidation of OncoCyte |
- | - | - | 71,697 | ||||||||||||||||
|
Gain (loss) on equity method |
(734) | 34,485 | (31,550) | 39,620 | ||||||||||||||||
|
Loss on equity method investment |
(1,087) | (3,262) | (20,660) | (26,097) | ||||||||||||||||
|
Unrealized gain on marketable |
23 | - | 635 | - | ||||||||||||||||
|
Loss on extinguishment of related |
- | (2,799) | - | (2,799) | ||||||||||||||||
| Other income (expenses), net | 14 | (143) | (649) | 1,202 | ||||||||||||||||
| Total other income, net | 76,901 | 28,271 | 29,780 | 82,894 | ||||||||||||||||
| INCOME (LOSS) BEFORE INCOME TAXES | 66,544 | 18,758 | (1,800) | 53,555 | ||||||||||||||||
| Deferred income tax expense | - | (4,772) | - | (4,772) | ||||||||||||||||
| NET INCOME (LOSS) | 66,544 | 13,986 | (1,800) | 48,783 | ||||||||||||||||
|
Net loss attributable to |
181 | 335 | 762 | 3,175 | ||||||||||||||||
|
NET INCOME (LOSS) |
$ | 66,725 | $ | 14,321 | $ | (1,038) | $ | 51,958 | ||||||||||||
|
NET INCOME (LOSS) PER COMMON SHARE: |
||||||||||||||||||||
| BASIC | $ | 0.53 | $ | 0.12 | $ | (0.01) | $ | 0.47 | ||||||||||||
| DILUTED | $ | 0.53 | $ | 0.12 | $ | (0.01) | $ | 0.47 | ||||||||||||
|
WEIGHTED AVERAGE NUMBER OF |
||||||||||||||||||||
| BASIC | 126,878 | 115,288 | 126,872 | 110,989 | ||||||||||||||||
| DILUTED | 126,973 | 115,298 | 126,872 | 111,124 | ||||||||||||||||
| BIOTIME, INC. AND SUBSIDIARIES | ||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||||
| (IN THOUSANDS) | ||||||||||
| (UNAUDITED) | ||||||||||
| Nine Months Ended | ||||||||||
| September 30, | ||||||||||
| 2018 | 2017 | |||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||
| Net income (loss) attributable to BioTime, Inc. | $ | (1,038) | $ | 51,958 | ||||||
| Net loss allocable to noncontrolling interest | (762) | (3,175) | ||||||||
|
Adjustments to reconcile net income (loss) attributable to BioTime, Inc. |
||||||||||
| 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 (gain) loss in equity investment in OncoCyte at fair value |
31,550 | (39,620) | ||||||||
| Unrealized loss on equity method investment in Asterias at fair value | 20,660 | 26,097 | ||||||||
| Deferred income tax expense | - | 4,772 | ||||||||
| Unrealized gain on marketable equity securities | (635) | - | ||||||||
| Depreciation expense, including amortization of leasehold improvements | 814 | 670 | ||||||||
| Amortization of intangible assets | 1,715 | 1,766 | ||||||||
| Amortization of deferred license fees | - | (166) | ||||||||
| Stock-based compensation | 3,397 | 2,903 | ||||||||
| Amortization of discount on related party convertible debt | - | 640 | ||||||||
| Foreign currency remeasurement and other (gain) loss | 788 | (980) | ||||||||
| Gain on sale of assets | - | (1,754) | ||||||||
| Loss on extinguishment of related party convertible debt | - | 2,799 | ||||||||
| Changes in operating assets and liabilities: | ||||||||||
| Accounts and grants receivable, net | 107 | (905) | ||||||||
| Receivables from affiliates, net of payables | 486 | 760 | ||||||||
| Prepaid expenses and other current assets | (708) | 93 | ||||||||
| Accounts payable and accrued liabilities | (314) | 1,276 | ||||||||
| Deferred revenue and other liabilities | (204) | (279) | ||||||||
| Net cash used in operating activities | (25,070) | (24,842) | ||||||||
| 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 | 10,800 | - | ||||||||
| Proceeds from the sale of equity method investment in Ascendance | 3,215 | - | ||||||||
| Purchase of in-process research and development | (1,872) | - | ||||||||
| Purchase of equipment and other assets | (399) | (930) | ||||||||
| Proceeds from sale of assets and other | (8) | 186 | ||||||||
| Net cash provided by (used in) investing activities | 2,032 | (9,642) | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||
| Proceeds from issuance of common shares | - | 20,125 | ||||||||
| Fees paid on sale of common shares | - | (1,623) | ||||||||
| Proceeds from exercises of stock options | - | 29 | ||||||||
| Common shares received and retired for employee taxes paid | (26) | (38) | ||||||||
| Proceeds from sale of common shares of subsidiary | 5,000 | 9,968 | ||||||||
| Proceeds from sale of subsidiary warrants | 1,000 | - | ||||||||
| Repayment of lease liability and capital lease obligation | (155) | (31) | ||||||||
| Reimbursement from landlord on construction in progress | - | 198 | ||||||||
| Proceeds from issuance of related party convertible debt | - | 384 | ||||||||
| Repayment of principal portion of promissory note | (101) | - | ||||||||
| Payment to repurchase subsidiary shares | (38) | - | ||||||||
| Net cash provided by financing activities | 5,680 | 29,012 | ||||||||
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | (40) | 46 | ||||||||
| NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (17,398) | (5,426) | ||||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH: | ||||||||||
| At beginning of the period | 37,685 | 22,935 | ||||||||
| At end of the period | $ | 20,287 | $ | 17,509 | ||||||
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 |
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|
RECONCILIATION OF NON-GAAP FINANCIAL MEASURE |
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|
ADJUSTED OPERATING EXPENSES |
||||||||||
|
Amounts In Thousands |
||||||||||
|
For the Three Months |
For the Nine Months |
|||||||||
| GAAP Operating Expenses - as reported(1) | $ | 11,304 | $ | 35,560 | ||||||
| Stock-based and other noncash compensation expense(2) | (1,651) | (4,238) | ||||||||
| Depreciation and amortization expense(2) | (805) | (2,539) | ||||||||
| Acquired in-process research and development expense(3) | - | (800) | ||||||||
| Non-GAAP Operating Expenses, as adjusted | $ | 8,848 | $ | 27,983 | ||||||
| GAAP Operating Expenses - by entity(1) | ||||||||||
| BioTime and subsidiaries other than AgeX Therapeutics, Inc.(4) | $ | 9,712 | $ | 27,833 | ||||||
| AgeX Therapeutics Inc. and subsidiaries(5) | 1,592 | 7,727 | ||||||||
| GAAP Operating Expenses - by entity | $ | 11,304 | $ | 35,560 | ||||||
| Non-GAAP Operating Expenses - as adjusted, by entity | ||||||||||
| BioTime and subsidiaries other than AgeX Therapeutics, Inc.(4) | $ | 7,472 | $ | 21,990 | ||||||
| AgeX Therapeutics Inc. and subsidiaries(5) | 1,376 | 5,993 | ||||||||
| Non-GAAP Operating Expenses - as adjusted, by entity | $ | 8,848 | $ | 27,983 | ||||||
(1) Beginning on
(2) Noncash charges.
(3) AgeX acquired certain in-process research and development in
(4)
(5)
View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005311/en/
Source:
BioTime Inc. IR
Ioana C. Hone
ir@biotimeinc.com
(510) 871-4188
or
Solebury Trout IR
Gitanjali Jain Ogawa
Gogawa@troutgroup.com
(646) 378-2949
