Press ReleaseBioTime, Inc. Reports Second Quarter Results and Recent Corporate Accomplishments |
-
Therapeutic Candidates Continue Clinical Progress
-
Deconsolidation Simplifies Financials
-
Successful Public Equity Offering Strengthens Balance Sheet
ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 9, 2016--
BioTime, Inc. (NYSE MKT:BTX), a clinical-stage regenerative medicine
company with a focus on pluripotent stem cell technology, today reported
financial results for the second quarter ended June 30, 2016 and
provided a corporate update.
“During the second quarter, we continued to sharpen our focus on
clinical progress and simplifying our corporate structure,” said Adi
Mohanty, Co-Chief Executive Officer. “Our key therapeutic programs, Renevia®
in medical aesthetics and OpRegen® in dry AMD,
continue to advance in the clinic, and we expect additional meaningful
milestones from these programs in the second half of 2016. Meanwhile,
our public subsidiaries continue to demonstrate their ability to make
solid clinical progress. We strengthened our balance sheet by completing
a successful public equity offering with gross proceeds of approximately
$20.1 million from new and existing investors. Additionally, as we
previously announced in May, we have deconsolidated Asterias
Biotherapeutics, Inc. from our financial statements as result of its
recent financing. We continue to see Asterias playing an important role
in furthering therapies based on pluripotent stem cell technology.
Asterias will continue to file its own financial statements with the
SEC, allowing our shareholders to continue to follow its financial
progress.”
Second Quarter and Recent Highlights
Clinical Progress
Renevia® (adipose cells + cell delivery
matrix)
-
The Renevia® pivotal clinical trial for
HIV-related facial lipoatrophy continues to enroll new patients and is
on track to complete patient enrollment by the second half of 2016.
The objective of the trial is to assess the efficacy of Renevia®
in restoring normal skin contours in patients whose subcutaneous fat
has been lost due to antiviral drug treatment for HIV. The Company
expects top-line efficacy data in the first half of 2017, and plans to
submit an application for CE Mark approval in Europe in the first half
of 2017 if the data are positive. Positive data from the pivotal trial
could provide support for future studies of Renevia® in
certain broader applications of fat tissue deficits in various medical
aesthetics applications, such as age-related and trauma-related facial
fat loss.
OpRegen® (retinal pigment epithelial cells)
-
In June, the Data Safety Monitoring Board (DSMB) for the OpRegen®
Phase I/IIa clinical trial for the treatment of the advanced form of
dry age-related macular degeneration (AMD) completed its review of the
initial safety data from the first cohort and recommended dose
escalation to the second cohort. Enrollment has begun for the second
patient cohort, which is receiving a higher, more clinically
significant, dose of OpRegen® cells. The
Company expects completion of enrollment for the second cohort in 2016
and, if the data are positive, anticipates DSMB approval to proceed to
the third cohort by the end of 2016. OpRegen® has
received Fast Track designation from the U.S. Food and Drug
Administration for the treatment of dry AMD, which occurs in
approximately 90% of those afflicted with AMD.
AST-OPC1 (oligodendrocyte progenitor cells)
-
In July, enrollment and dosing of the first efficacy cohort was
completed in the AST-OPC1 SCiSTAR Phase 1/2a clinical trial in
complete cervical spinal cord injury. This is the second of three
cohorts in the study and it represents the first cohort in which
patients have been administered a dose high enough to fall within the
potentially efficacious range predicted by preclinical studies
conducted by Asterias. Top-line six-month efficacy and safety results
from this patient cohort are expected in January 2017. As of May 13,
2016, BioTime owned approximately 49% of the common shares outstanding
of Asterias Biotherapeutics (NYSE MKT:AST).
Cancer Diagnostics
-
OncoCyte Corporation (NYSE MKT:OCX), the cancer diagnostics subsidiary
of BioTime and developer of novel, non-invasive blood and urine based
tests for the early detection of cancer, presented positive data from
a clinical study for the non-invasive detection of bladder cancer at
the 2016 American Society of Clinical Oncology Annual Meeting. Interim
data from the clinical study, which was first reported at the American
Association for Cancer Research 2015 Annual Meeting, demonstrated a
high level of sensitivity and specificity in the detection of
urothelial carcinoma, the most common type of bladder cancer.
Corporate Developments
-
In June, BioTime closed a public offering of shares of its common
stock. In July, the underwriters exercised in full their
over-allotment option. Gross proceeds of the offering and full
exercise of the over-allotment option totaled approximately $20.1
million, before deducting underwriting discounts and commissions and
other offering expenses payable by BioTime.
-
On May 13, 2016, BioTime deconsolidated its former majority-owned
subsidiary, Asterias Biotherapeutics, Inc. As result, Asterias’
financial statements for periods after May 12, 2016 are no longer
included in BioTime’s consolidated financial statements, and BioTime
is now accounting for its investment in Asterias at fair value based
on the closing stock price of Asterias common stock on the NYSE MKT
and the number of shares held by BioTime. Changes in the fair value of
Asterias common stock are reflected as unrealized gains or losses in
BioTime’s consolidated statements of operations, as a non-operating
item. See Second Quarter Financial results below.
Second Quarter Financial Results
Note on deconsolidation of Asterias and comparability of results:
BioTime’s consolidated balance sheet at December 31, 2015, as reported,
included Asterias’ assets and liabilities. However, Asterias’ assets and
liabilities are not included in BioTime’s consolidated balance sheet at
June 30, 2016 due to the deconsolidation of Asterias on May 13, 2016.
Furthermore, BioTime’s consolidated statements of operations for the
three and six months ended June 30, 2016 include Asterias’ results for
the period through May 12, 2016, the day immediately preceding the
deconsolidation. For the three and six months ended June 30, 2015,
BioTime’s consolidated results include Asterias’ results for the full
periods presented.
All discussions about the results of operations, or balance sheet
amounts that follow, as appropriate and indicated, include both the
actual results and amounts pertaining to Asterias.
Cash Position and investments: Cash and cash equivalents totaled
$27.7 million as of June 30, 2016, compared to $42.2 million as of
December 31, 2015, which included Asterias’ cash and cash equivalents of
$11.2 million. The cash on hand as of June 30, 2016 includes $7.0
million held by subsidiaries and excludes Asterias due to the
deconsolidation. As of June 30, 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 approximately $104
million as of that date. On June 21, 2016, BioTime closed a $17.5
million public offering of shares of its common stock. On July 5, 2016,
BioTime announced the exercise in full of the underwriters’
over-allotment option to purchase an additional 1,098,326 shares of
BioTime common stock. The gross proceeds of the offering, including the
over-allotment option were approximately $20.1 million before deducting
underwriting discounts and commissions and other offering expenses
payable by BioTime.
Revenues: BioTime’s operating revenues are currently primarily
generated from research grants, licensing fees and advertising from the
marketing of online database products. Total consolidated revenues were
$1.3 million for the second quarter, compared to $2.0 million in the
second quarter of 2015. Asterias’ total revenues included in the second
quarter of 2016 and 2015 were $0.8 million in each respective period as
shown in the table below (in thousands).
|
|
|
|
|
|
|
|
Three months ended June 30, 2016
|
|
|
Three months ended June 30, 2015
|
|
|
Consolidated Results of Operations
|
|
Less: Asterias (42 days)
|
|
Consolidated Results less Asterias
|
|
Consolidated Results of Operations
|
|
Less: Asterias (3 months)
|
|
Consolidated Results less Asterias
|
Total revenues
|
|
$
|
1,266
|
|
$
|
760
|
|
$
|
506
|
|
$
|
2,009
|
|
$
|
772
|
|
$
|
1,237
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in BioTime’s total revenues was mainly due to less grant
revenue recorded in 2016 due to expiration of a National Institutes of
Health (NIH) grant in August 2015.
Operating Expenses (in thousands)
|
|
|
|
|
|
|
Three months ended June 30, 2016
|
|
Three months ended June 30, 2015
|
|
|
Consolidated Results of Operations
|
|
Less: Asterias (42 days)
|
|
Consolidated Results less Asterias
|
|
Consolidated Results of Operations
|
|
Less: Asterias (3 months)
|
|
Consolidated Results less Asterias
|
Research and development
|
|
$
|
8,938
|
|
$
|
2,343
|
|
$
|
6,595
|
|
$
|
9,059
|
|
$
|
3,696
|
|
$
|
5,363
|
General and administrative
|
|
|
6,636
|
|
|
1,357
|
|
|
5,279
|
|
|
6,186
|
|
|
1,845
|
|
|
4,341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D Expenses: Research and development expenses were $8.9
million for the second quarter, compared to $9.1 million for the
comparable period in 2015, including $2.3 million and $3.7 million
attributable to Asterias' research and development for the respective
periods.
The increase in R&D of approximately $1.2 million is in part a result of
increased expenses primarily related to regulatory and clinical trials
of BioTime’s Renevia® program and OncoCyte’s
cancer diagnostics, offset by a decrease of approximately $1.3 million
principally due to the deconsolidation of Asterias.
G&A Expenses: General and administrative expenses were $6.6
million for the second quarter, compared to $6.2 million for the second
quarter of 2015, including $1.4 million and $1.8 million attributable to
Asterias for the same periods, respectively. The $0.9 million increase
is in part a result of increased staffing needed to advance programs
under development at BioTime, including non-cash stock-based
compensation from BioTime and OncoCyte, offset by a $0.5 million
decrease due to the deconsolidation of Asterias.
Net Income attributable to BioTime: Net income attributable to
BioTime was $24.5 million for the three months ended June 30, 2016, or
$0.26 per share primarily due to the $49.0 million noncash gain on
deconsolidation of Asterias, offset by unrealized losses of $13.5
million from the decline in the fair value of the Asterias shares owned
by BioTime that occurred during the period May 13 through June 30, 2016.
There was no deferred income tax provision or benefit recorded in the
three months ended June 30, 2016. For the second quarter of 2015, net
loss attributable to BioTime was $9.7 million, or ($0.12) per share. Net
income (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, August 9,
2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the second
quarter results and recent corporate accomplishments.
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 13641621.
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 in the field of
regenerative medicine. The foundation of its core therapeutic technology
platform is pluripotent cells that are capable of becoming any of the
cell types in the human body. BioTime, Inc.’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, Inc.’s common stock is traded on the NYSE MKT 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, 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, Inc. 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
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(IN THOUSANDS, EXCEPT PER SHARE DATA)
|
(UNAUDITED)
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
REVENUES:
|
|
|
|
|
|
|
|
|
Subscription and advertisement revenues
|
|
$
|
288
|
|
|
$
|
357
|
|
|
$
|
631
|
|
|
$
|
676
|
|
Royalties from product sales
|
|
|
86
|
|
|
|
117
|
|
|
|
286
|
|
|
|
274
|
|
Grant income
|
|
|
760
|
|
|
|
1,437
|
|
|
|
2,247
|
|
|
|
2,130
|
|
Sale of research products and services
|
|
|
132
|
|
|
|
98
|
|
|
|
176
|
|
|
|
188
|
|
Total revenues
|
|
|
1,266
|
|
|
|
2,009
|
|
|
|
3,340
|
|
|
|
3,268
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
(95
|
)
|
|
|
(260
|
)
|
|
|
(320
|
)
|
|
|
(525
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
1,171
|
|
|
|
1,749
|
|
|
|
3,020
|
|
|
|
2,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(8,938
|
)
|
|
|
(9,059
|
)
|
|
|
(22,671
|
)
|
|
|
(18,383
|
)
|
General and administrative
|
|
|
(6,636
|
)
|
|
|
(6,186
|
)
|
|
|
(18,509
|
)
|
|
|
(11,365
|
)
|
Total operating expenses
|
|
|
(15,574
|
)
|
|
|
(15,245
|
)
|
|
|
(41,180
|
)
|
|
|
(29,748
|
)
|
Loss from operations
|
|
|
(14,403
|
)
|
|
|
(13,496
|
)
|
|
|
(38,160
|
)
|
|
|
(27,005
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
(76
|
)
|
|
|
4
|
|
|
|
(88
|
)
|
|
|
(79
|
)
|
BioTime’s share of losses in equity method investment in Ascendance
|
|
|
(98
|
)
|
|
|
-
|
|
|
|
(333
|
)
|
|
|
-
|
|
Gain on deconsolidation of Asterias
|
|
|
49,048
|
|
|
|
-
|
|
|
|
49,048
|
|
|
|
-
|
|
Loss on equity method investment in Asterias at fair value
|
|
|
(13,483
|
)
|
|
|
-
|
|
|
|
(13,483
|
)
|
|
|
-
|
|
Other income/(expense), net
|
|
|
237
|
|
|
|
225
|
|
|
|
363
|
|
|
|
35
|
|
Total other income/(expense), net
|
|
|
35,628
|
|
|
|
229
|
|
|
|
35,507
|
|
|
|
(44
|
)
|
INCOME (LOSS) BEFORE INCOME TAX BENEFIT
|
|
|
21,225
|
|
|
|
(13,267
|
)
|
|
|
(2,653
|
)
|
|
|
(27,049
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit
|
|
|
-
|
|
|
|
1,271
|
|
|
|
-
|
|
|
|
2,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS)
|
|
|
21,225
|
|
|
|
(11,996
|
)
|
|
|
(2,653
|
)
|
|
|
(24,601
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to non-controlling interest
|
|
|
3,324
|
|
|
|
2,305
|
|
|
|
10,091
|
|
|
|
4,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.
|
|
|
24,549
|
|
|
|
(9,691
|
)
|
|
|
7,438
|
|
|
|
(19,865
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on preferred shares
|
|
|
-
|
|
|
|
(52
|
)
|
|
|
-
|
|
|
|
(52
|
)
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON
SHAREHOLDERS
|
|
$
|
24,549
|
|
|
$
|
(9,743
|
)
|
|
$
|
7,438
|
|
|
$
|
(19,917
|
)
|
NET INCOME (LOSS) PER COMMON SHARE:
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
|
|
$
|
0.26
|
|
|
$
|
(0.12
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.25
|
)
|
DILUTED
|
|
$
|
0.26
|
|
|
$
|
(0.12
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.25
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
|
|
|
93,240
|
|
|
|
78,362
|
|
|
|
91,831
|
|
|
|
78,312
|
|
DILUTED
|
|
|
95,801
|
|
|
|
78,362
|
|
|
|
95,360
|
|
|
|
78,312
|
|
|
BIOTIME, INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED BALANCE SHEET
|
(IN THOUSANDS)
|
|
|
|
|
|
|
|
June 30, 2016 (Unaudited)
|
|
December 31, 2015
|
ASSETS
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
27,702
|
|
|
$
|
42,229
|
|
Available for sale securities
|
|
|
619
|
|
|
|
753
|
|
Trade accounts and grants receivable, net
|
|
|
783
|
|
|
|
1,078
|
|
Landlord receivable
|
|
|
156
|
|
|
|
567
|
|
Prepaid expenses and other current assets
|
|
|
1,787
|
|
|
|
2,610
|
|
Total current assets
|
|
|
31,047
|
|
|
|
47,237
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net and construction in progress
|
|
|
4,062
|
|
|
|
7,539
|
|
Deferred license fees
|
|
|
173
|
|
|
|
322
|
|
Deposits and other long-term assets
|
|
|
1,022
|
|
|
|
1,299
|
|
Equity method investment in Asterias, at fair value
|
|
|
52,194
|
|
|
|
-
|
|
Equity method investment in Ascendance
|
|
|
4,338
|
|
|
|
4,671
|
|
Intangible assets, net
|
|
|
11,491
|
|
|
|
33,592
|
|
TOTAL ASSETS
|
|
$
|
104,327
|
|
|
$
|
94,660
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
6,508
|
|
|
$
|
9,377
|
|
Capital lease liability, current portion
|
|
|
173
|
|
|
|
38
|
|
Promissory notes, current portion
|
|
|
95
|
|
|
|
95
|
|
Deferred grant income
|
|
|
-
|
|
|
|
2,513
|
|
Deferred license and subscription revenue, current portion
|
|
|
627
|
|
|
|
439
|
|
Total current liabilities
|
|
|
7,403
|
|
|
|
12,462
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
Deferred revenues, net of current portion
|
|
|
462
|
|
|
|
615
|
|
Deferred rent liabilities, net of current portion
|
|
|
28
|
|
|
|
158
|
|
Lease liability
|
|
|
1,386
|
|
|
|
4,400
|
|
Related party convertible debt, net of discount
|
|
|
701
|
|
|
|
324
|
|
Promissory notes, net of current portion
|
|
|
173
|
|
|
|
220
|
|
Capital lease, net of current and other liabilities
|
|
|
122
|
|
|
|
34
|
|
TOTAL LIABILITIES
|
|
|
10,275
|
|
|
|
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, 150,000 shares authorized; 102,288
shares issued and 101,668 shares outstanding at June 30, 2016;
94,894 issued and 90,421 outstanding at December 31, 2015
|
|
|
310,881
|
|
|
|
274,342
|
|
Accumulated other comprehensive income (loss)
|
|
|
(504
|
)
|
|
|
(237
|
)
|
Accumulated deficit
|
|
|
(221,743
|
)
|
|
|
(229,181
|
)
|
Treasury stock at cost: 620 shares at June 30, 2016 and 4,473 shares
at December 31, 2015
|
|
|
(2,891
|
)
|
|
|
(18,033
|
)
|
BioTime, Inc. shareholders' equity
|
|
|
85,743
|
|
|
|
26,891
|
|
Non-controlling interest
|
|
|
8,309
|
|
|
|
49,556
|
|
Total shareholders' equity
|
|
|
94,052
|
|
|
|
76,447
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
$
|
104,327
|
|
|
$
|
94,660
|
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20160809006429/en/
Source: BioTime, Inc.
BioTime, Inc. Dan L. Lawrence, 510-775-0510 dlawrence@biotimeinc.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
|
|