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BioTime Reports Second Quarter Results and Recent Corporate Accomplishments
August 02, 2017

Conference Call and Live Webcast 4.30pm Eastern Time Today

ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 2, 2017-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported financial results for the second quarter ended June 30, 2017.

“The second quarter of 2017 was very productive for BioTime, with numerous significant clinical, financial and operational accomplishments. BioTime and its subsidiaries and affiliates now have six products in clinical trials. The data from those trials continue to be positive and encouraging,” said Adi Mohanty, Co-Chief Executive Officer. “On the strength of the positive results from our pivotal study of Renevia, we are preparing to file for a CE mark for commercial approval in Europe. Our goal is to commercialize Renevia in its first indication in 2018. For OpRegen, our therapeutic product candidate for the treatment of dry AMD, we were pleased to receive DSMB approval to advance the ongoing Phase I/IIa trial to the third cohort, which will include clinical sites in the U.S.”

“We continue to make progress on simplifying our corporate structure to allow us to execute our objectives more efficiently, as well as to make it easier for investors and other external stakeholders to better understand BioTime,” continued Mr. Mohanty. “We achieved an important milestone toward accomplishing these goals with the launch of AgeX Therapeutics, a subsidiary formed to consolidate our early-stage research and development programs related to the biology of aging and age-related disease. AgeX recently commenced operations following a $10 million equity financing.”

Highlights

Clinical Progress

Renevia® (adipose cells + cell delivery matrix)

  • Renevia® successfully met its primary endpoint in a pivotal trial in patients with HIV-associated lipoatrophy (facial fat loss) conducted in Europe. Treated patients retained approximately 100% of transplanted volume at 6 months compared to no incremental hemifacial volume in the untreated patients (p<0.001). All Renevia transplants were shown to be safe and well tolerated and there were no serious adverse events during the trial.
  • BioTime is on track to file for CE Mark for commercial approval for Renevia in Europe by the end of 2017.
  • Additional trials in the U.S. are planned that target a broader $7 billion aesthetics market opportunity, which is consistent with the previously stated goal of indication and geographic expansion for Renevia.

OpRegen® (retinal pigment epithelial cells)

  • In April, new positive clinical data on OpRegen were presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The data, from the first and second cohorts of the ongoing Phase I/IIa clinical trial in the advanced form of dry-AMD, showed that OpRegen cells engraft and that there was evidence of a biological response.
  • The Data Safety Monitoring Board (DSMB) monitoring the Phase I/IIa OpRegen trial has authorized BioTime to move forward with enrollment for cohort 3 which will include two US sites with leading ophthalmologists.
  • An abstract related to the Phase I/IIa OpRegen trial has been accepted for presentation at the American Academy of Ophthalmology (AAO) annual meeting being held in New Orleans, November 11-14, 2017.
  • BioTime expanded its ophthalmology program with the signing of a revised and expanded licensing agreement with Hadassah Medical Organization of Jerusalem, Israel. The revised and expand license agreement increases BioTime’s field-of-use for RPE cells to all eye disorders, and also adds photoreceptor cells for all eye disorders.

AST-OPC1 (oligodendrocyte progenitor cells)

  • In June, BioTime’s affiliate, Asterias Bio-Therapeutics (NYSE MKT: AST) announced new 9-month follow-up data from the company's ongoing SCiStar Phase I/IIa clinical trial. The results showed that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced 9 months following dosing.
  • The FDA has accepted Asterias' amendment to the clinical research protocol for the SCiStar trial to include patients with a C-4 spinal cord injury, the second most common form of cervical spinal cord injury.

Liquid Biopsy (lung cancer confirmatory blood test)

  • In May, BioTime’s affiliate, OncoCyte (NYSE MKT: OCX) presented positive results from its 300-patient multi-site R&D validation study for its lung cancer diagnostic test at the American Thoracic Society 2017 International Conference (ATS) in Washington, D.C. Results from this study of the optimized final predictive algorithm confirmed the data from a previous study completed in 2016 and further validate the test’s commercial potential.
  • OncoCyte is on track to launch its lung cancer confirmatory liquid biopsy diagnostic test in 2017. The test could eventually replace a high percentage of invasive, risky, and expensive lung biopsies with simple blood tests, improving outcomes for patients while also capturing significant cost savings for the U.S. healthcare system. The test targets a market opportunity believed to exceed $4 billion annually.

Simplification and Unlocking Value

New Subsidiary AgeX Therapeutics, Inc.

  • In April, BioTime announced the formation of AgeX Therapeutics, Inc. a new subsidiary that will focus on applying technology relating to cell immortality and regenerative biology, to aging and age-related diseases. AgeX has three initial areas of product development: pluripotent stem cell-derived brown adipocytes (AGEX-BAT1); vascular progenitors (AGEX-VASC1); and induced Tissue Regeneration (iTR). Initial planned indications for these products are Type II diabetes, cardiac ischemia, and cancer, respectively.
  • In August, AgeX closed an equity financing to raise $10 million. The transaction values AgeX at approximately $68 million. BioTime retains approximately 87% ownership of AgeX.

Value of Holdings in Public Affiliates

At June 30, 2017, BioTime held common stock in publicly-traded affiliates valued at $153.5 million. This amount was the market value of BioTime’s 21.7 million shares in Asterias Bio-Therapeutics (NYSE MKT: AST) and 14.7 million shares in OncoCyte (NYSE MKT: OCX).

Second Quarter Financial Results

Cash Position and Marketable Securities: Cash, cash equivalents, restricted cash in escrow, and available for sale securities totaled $20.9 million as of June 30, 2017, compared to $24.7 million as of March 31, 2017.

Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenue was $381,000 for the second quarter of 2017, compared to $1.3 million in the second quarter of 2016.

Operating Expenses: Operating expenses for the second quarter of 2017 were $10.7 million. On an adjusted basis, operating expenses were $8.8 million, of which $7.5 million was mainly attributable to our clinical programs, $0.8 million in expenses is expected to be funded by AgeX investors going forward and $0.5 million was incurred by our subsidiary LifeMap Solutions, expenses, which are not expected to recur.

Our operating expenses for the six months ended June 30, 2017 were $22.3 million. Adjusted operating expenses were $18.2 million for this period, including $14.4 million spent on our clinical and early stage programs. The remaining $3.8 million in expenses were contributed by OncoCyte during the period in 2017 in which it was consolidated or were in areas to be funded by AgeX going forward; these expenses are not expected to recur.

Cash expenditures in the first half of 2017 were higher than normal due to annual bonuses, AgeX formation costs and some project-based, non-recurring legal expenses. Cash expenditures were further impacted in the second quarter of 2017 due to timing of the payments of certain expenses, including executive bonuses and an extra payroll period.

The reconciliation between GAAP and non-GAAP operating expenses by entity, is provided in the financial tables included with this press release.

R&D Expenses: Research and development expenses were $6.3 million for the second quarter of 2017, compared to $8.9 million for the comparable period in 2016, a decrease of $2.6 million. This decrease was primarily attributable to the deconsolidation of Asterias in May 2016 and OncoCyte in February 2017.

G&A Expenses: General and administrative expenses were $4.4 million for the second quarter of 2017 compared to $6.6 million for the comparable period in 2016. The $2.2 million decrease was primarily due to the deconsolidation of Asterias and OncoCyte.

Net Income or loss attributable to BioTime: Net loss attributable to BioTime was $11.7 million, or ($0.11) per basic and diluted common share for the three months ended June 30, 2017, compared to net income of $24.5 million, or $0.26 per basic and diluted common share for the three months ended June 30, 2016. For the six months ended June 30, 2017, net income attributable to BioTime was $37.6 million, or $0.34 per diluted common share, compared to $7.4 million, or $0.08 per share for the six months ended June 30, 2016. Results in each period were primarily driven by noncash deconsolidation gains and noncash gains and losses in the changes in share prices of our public affiliate investments in Asterias and OncoCyte common stock.

Conference Call and Webcast Details

BioTime is hosting a conference call and webcast today, Wednesday, August 2, 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 13665025. 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. Its clinical programs are based on two platform technologies: pluripotent cells and cell/drug delivery. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. The foundation of the Company’s 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. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (“Asterias”) and OncoCyte Corporation (“OncoCyte”).

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+.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com.

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, 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, 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.

             

BIOTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS)

             
    June 30,

2017

(Unaudited)

    December

31,

2016

 
ASSETS            
CURRENT ASSETS            
Cash and cash equivalents   $ 14,550     $ 22,088  
Restricted cash equivalents in escrow     5,100       -  
Available for sale securities     1,220       627  
Trade accounts and other receivables     360       646  
Receivable from affiliates, net     2,706       511  
Prepaid expenses and other current assets     1,589       1,777  
Total current assets     25,525       25,649  
                 
Property, plant and equipment, net     5,240       5,529  
Deposits and other long term assets     1,014       1,149  
Equity method investment in OncoCyte, at fair value     76,306       -  
Equity method investment in Asterias, at fair value     77,204       100,039  
Intangible assets, net     8,064       10,206  
TOTAL ASSETS   $ 193,353     $ 142,572  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY                
CURRENT LIABILITIES                
Accounts payable and accrued liabilities   $ 5,130     $ 7,144  
Escrow liability     5,100       -  
Capital lease liability, current portion     -       202  
Promissory notes, current portion     124       99  
Related party convertible debt, net of discount     2,555       833  
Deferred revenues, current portion     621       572  
Total current liabilities     13,530       8,850  
                 
LONG-TERM LIABILITIES                
Deferred revenues, net of current portion     154       308  
Deferred rent liabilities, net of current portion     79       50  
Lease liability     1,301       1,386  
Capital lease liability, net of current and other liabilities     -       310  
Related party convertible debt, net of discount     -       1,032  
Promissory notes, net of current portion     95       120  
Other long term liabilities     9       8  
TOTAL LIABILITIES     15,168       12,064  
                 
Commitments and contingencies                
                 
SHAREHOLDERS’ EQUITY                
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of June 30, 2017 and December 31, 2016     -       -  
Common shares, no par value, 150,000 shares authorized; 110,876 shares issued and outstanding and 103,396 shares issued and 102,776 shares outstanding as of June 30, 2017 and December 31, 2016, respectively     334,538       317,878  
Accumulated other comprehensive income (loss)     271       (738 )
Accumulated deficit     (158,684 )     (196,321 )
Treasury stock at cost: no shares as of June 30, 2017; 620 shares as of December 31, 2016     -       (2,891 )
BioTime, Inc. shareholders’ equity     176,125       117,928  
Non-controlling interest     2,060       12,580  
Total shareholders’ equity     178,185       130,508  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 193,353     $ 142,572  
                 
             

BIOTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(UNAUDITED)

             
    Three Months Ended

June 30,

    Six Months Ended

June 30,

 
    2017     2016     2017     2016  
REVENUES:                        
Grant income   $ -     $ 760     $ 11     $ 2,247  
Royalties from product sales and license fees     81       86       191       286  
Subscription and advertisement revenues     300       288       564       631  
Sale of research products     -       132       5       176  
Total revenues     381       1,266       771       3,340  
                                 
Cost of sales     (5 )     (95 )     (62 )     (320 )
                                 
Gross Profit     376       1,171       709       3,020  
                                 
OPERATING EXPENSES:                                
Research and development     (6,271 )     (8,938 )     (12,765 )     (22,671 )
General and administrative     (4,423 )     (6,636 )     (9,524 )     (18,509 )
Total operating expenses     (10,694 )     (15,574 )     (22,289 )     (41,180 )
Loss from operations     (10,318 )     (14,403 )     (21,580 )     (38,160 )
OTHER INCOME/(EXPENSES):                                
Interest expense, net     (413 )     (76 )     (719 )     (88 )
BioTime’s share of losses in equity method investment in Ascendance Biotechnology, Inc.     -       (98 )     -       (333 )
Gain on deconsolidation of Asterias     -       49,048       -       49,048  
Gain on deconsolidation of OncoCyte     -       -       71,697       -  
Gain (loss) on equity method investment in Asterias at fair value     3,262       (13,483 )     (22,835 )     (13,483 )
Gain (loss) on equity method investment in OncoCyte at fair value     (11,006 )     -       5,136       -  
Other income, net     2,371       237       3,098       363  
Total other income/(expense), net     (5,786 )     35,628       56,377       35,507  
INCOME (LOSS) BEFORE INCOME TAX BENEFIT     (16,104 )     21,225       34,797       (2,653 )
                                 
Deferred income tax benefit     3,877       -       -       -  
                                 
NET INCOME (LOSS)     (12,227 )     21,225       34,797       (2,653 )
                                 
Net loss attributable to noncontrolling interests     576       3,324       2,840       10,091  
                                 
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.   $ (11,651 )   $ 24,549     $ 37,637     $ 7,438  
                                 
NET INCOME (LOSS) PER COMMON SHARE:                                
BASIC   $ (0.11 )   $ 0.26     $ 0.35     $ 0.08  
DILUTED   $ (0.11 )   $ 0.26     $ 0.34     $ 0.08  
                                 
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:                                
BASIC     110,874       93,240       108,804       91,831  
DILUTED     110,874       95,801       109,296       95,360  
                                 
       

BIOTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(UNAUDITED)

       
    Six Months Ended

June 30,

 
    2017     2016  
CASH FLOWS FROM OPERATING ACTIVITIES:            
Net income attributable to BioTime, Inc.   $ 37,637     $ 7,438  
Net loss allocable to noncontrolling interests     (2,840 )     (10,091 )
Adjustments to reconcile net income attributable to BioTime, Inc. to net cash used in operating activities:                
Gain on deconsolidation of Asterias     -       (49,048 )
Gain on deconsolidation of OncoCyte     (71,697 )        
Unrealized loss on equity method investment in Asterias at fair value     22,835       13,483  
Unrealized gain on equity method investment in OncoCyte at fair value     (5,136 )     -  
Depreciation expense, including amortization of leasehold improvements     421       748  
Amortization of intangible assets     1,184       2,292  
Stock-based compensation     1,930       5,593  
Subsidiary shareholder expense for subsidiary warrants     -       3,125  
Amortization of discount on related party convertible debt     640       245  
Foreign currency remeasurement (gain) or loss and other     (1,814 )     883  
Gain on sale of assets     (1,754 )     -  
Changes in operating assets and liabilities:                
Accounts and grants receivable, net     299       (54 )
Deferred revenue     -       1,496  
Receivables from affiliates, net of payables     332       -  
Prepaid expenses and other current assets     105       (396 )
Accounts payable and accrued liabilities     841       (211 )
Other     (144 )     (62 )
Net cash used in operating activities     (17,161 )     (24,559 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
Deconsolidation of cash and cash equivalents of OncoCyte     (8,898 )     -  
Deconsolidation of cash and cash equivalents of Asterias     -       (8,376 )
Purchase of equipment and other assets     (474 )     (1,384 )
Restricted cash equivalents in escrow     (5,100 )     -  
Payments on construction in progress     -       (278 )
Other     (12 )     22  
Cash used in investing activities     (14,484 )     (10,016 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Proceeds from issuance of common shares     20,125       17,500  
Fees paid on sale of common shares     (1,669 )     (1,311 )
Proceeds deposited in escrow account     5,100       -  
Proceeds from exercises of stock options     29       2,015  
Reimbursement from landlord on construction in progress     198       411  
Shares retired to pay for employees’ taxes     (31 )     -  
Repayment of capital lease obligation     (31 )     (74 )
Net proceeds from sale of common shares of subsidiary     -       171  
Proceeds from issuance of related party convertible debt     299       1,019  
Net cash provided by financing activities     24,020       19,731  
                 
Effect of exchange rate changes on cash and cash equivalents     87       317  
                 
NET DECREASE IN CASH AND CASH EQUIVALENTS     (7,538 )     (14,527 )
CASH AND CASH EQUIVALENTS:                
At beginning of the period     22,088       42,229  
At end of the period   $ 14,550     $ 27,702  
                 

Non-GAAP Financial Measures

This press release includes operating expenses prepared in accordance with accounting principles generally accepted in the United States (GAAP) and, includes operating expenses, by entity, prepared in accordance with GAAP. This press release also includes certain historical non-GAAP operating expenses and non-GAAP operating expenses, by entity. In particular, BioTime has provided both (a) non-GAAP total operating expenses, adjusted to exclude noncash stock-based and other compensation and depreciation and amortization expense, and (b) non-GAAP operating expenses, by entity, to exclude those same noncash charges by the respective entities for consistency. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable financial measures prepared in accordance with GAAP. However, BioTime believes the presentation of non-GAAP total operating expenses and non-GAAP operating expenses, by entity, when viewed in conjunction with our GAAP total operating expenses, and GAAP operating expenses by entity, respectively, is helpful in understanding BioTime’s ongoing operating expenses and its programs within various entities, including BioTime’s programs in clinical development.

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
June 30, 2017
(unaudited)

 

For the Six Months
Ended June 30,
2017 (unaudited)

GAAP Operating Expenses - as reported   $ 10,694     $ 22,289  
Stock-based and other noncash compensation expense (1)     (1,111 )     (2,468 )
Depreciation and amortization expense (1)     (787 )     (1,605 )
Non-GAAP Operating Expenses, as adjusted   $ 8,796     $ 18,216  
         
GAAP Operating Expenses - by entity        
BioTime and subsidiaries   $ 9,145     $ 17,711  
OncoCyte results for the period from January 1 through February 16, 2017     -       1,388  
LifeMap Solutions     610       1,325  
LIfeMap Sciences and ReCyte     939       1,865  
GAAP Operating Expenses - by entity   $ 10,694     $ 22,289  
         
Non-GAAP Operating Expenses - as adjusted, by entity        
BioTime and subsidiaries   $ 7,539     $ 14,384  
OncoCyte results for the period from January 1 through February 16, 2017 (2)     -       1,185  
LifeMap Solutions (3)     506       1,116  
LifeMap Sciences and ReCyte (4)     751       1,531  
Non-GAAP Operating Expenses - as adjusted, by entity   $ 8,796     $ 18,216  
                 

(1)

 

Noncash charges,

     

(2)

 

OncoCyte’s results for the period from January 1 through February 16, 2017, the date immediately before the OncoCyte Deconsolidation included in BioTime’s consolidated results, which are not going to recur,

     

(3)

 

Entities whose operating expenses will not recur in the future,

     

(4)

 

Certain entities whose operating expenses are going to be funded by AgeX.

 

Source: BioTime, Inc.

Investor Contact:
BioTime, Inc.
David Nakasone, 510-871-4188
dnakasone@biotimeinc.com
or
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com
or
Media Contact:
JQA Partners, Inc.
Jules Abraham, 917-885-7378
jabraham@jqapartners.com