Conference Call and Webcast Today at 4:30 p.m.
Eastern Time
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)
- Positive early Renevia data presented
at the International Federation for Adipose Therapeutics and
Science meeting (IFATS) meeting in November. The data related to
the treatment of the initial 9 run-in patients for BioTime’s
ongoing pivotal clinical trial in Europe assessing the efficacy of
Renevia for the treatment of HIV-associated lipoatrophy. In
December, achieved the recruitment milestone of 50 patients
enrolled in the trial. Data from the run-in portion of the study
(N=9) indicated that adipose progenitor cells (fat cells), obtained
from a liposuction aspirate, remained viable and were observed to
proliferate when combined with Renevia hydrogel. Analysis suggests
that the grafts retain volume over the assessment period, and the
treating physician observed incremental volume was retained in
patients who had progressed to the one-year follow-up evaluation.
In addition, there were encouraging signs of new tissue
regeneration observed. No serious adverse events were noted during
the run-in portion of the study.
- Additional positive data from the
pivotal trial would allow the Company to launch a commercial
product in about a year and provide support for future studies
of Renevia in certain broader indications of fat tissue
deficits in various medical aesthetics applications, such as
age-related and trauma-related facial fat loss.
- Top-line clinical trial results are
expected to be read out mid-2017. If the data are positive, the
Company plans to submit an application for CE Mark approval
in Europe at the end of 2017.
OpRegen® (retinal pigment epithelial cells)
- Presented positive early OpRegen data
at the International Symposium on Ocular Pharmacology and
Therapeutics (ISOPT) in December. The data from the first cohort in
the Phase I/IIa clinical trial of OpRegen in the advanced form of
dry age-related macular degeneration (dry-AMD). The data suggest
that OpRegen is safe and well tolerated. Imaging data from a
patient who completed one-year of post-treatment clinical
assessment suggests that the graft can survive for at least 12
months.
- Enrollment in the second cohort, in
which patients are receiving a higher and more clinically
meaningful 200,000 cell dose started in 2016. The Company intends
to approach the DSMB in the second quarter of this year for
approval to begin administering the next higher 500,000 cell dose
to the third cohort, and if approved, also begin the fourth cohort
before year end.
- An abstract with data from the first
and second cohorts in the ongoing trial has been accepted for
poster presentation at the annual meeting for the Association for
Research in Vision and Ophthalmology (ARVO), which will take place
in Baltimore, MD, May 7- 11.
- The Company is expanding the trial to
U.S. sites and recently announced that two of the top retinal
surgeons will be enrolling patients at their centers of
excellence.
AST-OPC1 (oligodendrocyte progenitor cells)
- In November, BioTime’s affiliate,
Asterias (NYSE MKT: AST) reported the successful administration of
the highest dose of 20 million cells of AST-OPC1 to a patient with
complete cervical spinal cord injury (SCI) as part of the SCiStar
Phase I/IIa clinical trial. In January 2017, they announced
positive efficacy results that showed additional motor function
improvement at 6-months and 9-months following administration of 10
million AST-OPC1 cells in 6 AIS-A patients with complete cervical
SCIAsterias plans to initiate discussions with the FDA in mid-2017
to determine the most appropriate clinical and regulatory path
forward for AST-OPC1.
Liquid Biopsy (lung cancer confirmatory test)
- In early March, BioTime’s affiliate,
OncoCyte (NYSE MKT: OCX) reported successful completion of a
critical step in the development of its lung cancer diagnostic test
by locking the prediction algorithm. The cancer diagnostic, has
been selected for presentation in a poster discussion session at
the 2017 American Thoracic Society (ATS) International Conference
that will take place May 19-24 in Washington, D.C.
- The lung cancer diagnostic test targets
a multi-billion dollar market opportunity. On March 6, 2017,
OncoCyte announced the successful completion of the study and that
it has locked the prediction algorithm of the test. Based on the
study results, OncoCyte announced that it will begin ramping-up its
commercial capabilities in anticipation of the potential commercial
launch of the test. OncoCyte will initiate a clinical validation
phase for the diagnostic. During this phase, OncoCyte will also
continue to carry out analytical validation studies to refine its
operational stage laboratory processes, and will apply for
certification of its CLIA diagnostic testing lab. Upon CLIA
certification, OncoCyte will conduct a small CLIA lab validation
study to demonstrate that the full assay system utilized in the
CLIA lab provides the same results on clinical samples as those
obtained in the R&D lab. OncoCyte will then begin a clinical
validation study on a new set of at least 300 blinded prospectively
collected blood samples to confirm whether the sensitivity and
specificity of the test remain within commercial parameters in a
CLIA operational setting. Assuming successful completion of these
steps, OncoCyte anticipates launching the test commercially in the
second half of 2017.
Simplification and Unlocking
Value
Subsidiary Deconsolidation
- In February, OncoCyte financials were
deconsolidated from BioTime’s consolidated financial statements.
This will be reflected in BioTime’s future quarterly and annual
consolidated financial statements, beginning February 18,
2017.
Business Development
- In February, BioTime announced that it
expanded its ophthalmology portfolio with the acquisition of a
world-wide license to ophthalmology-related intellectual (IP)
property assets from University of Pittsburgh. The technology was
developed in part in collaboration with BioTime scientists. The IP
includes composition and methodologies to develop 3-D retinal
tissue constructs from pluripotent cells for their implantation in
patients with advanced stages of retinal degeneration.
- BioTime continues to leverage and
develop its delivery technology platforms. The Company’s Hystem®
technology is being used to deliver Renevia. ReGylde™ is in
preclinical development as a device for viscosupplementation and a
combination product for drug delivery in osteoarthritis. Delivery
is a third area of focus for the Company, in addition to aesthetics
and ophthalmology.
Management
- BioTime expanded its senior management
team with the appointments of Jim Knight as Senior Vice President
of Corporate Development, in October, and Stephana Patton, Ph.D.,
J.D., as General Counsel, in February. These industry veterans
further strengthen the BioTime management team, complementing other
management team additions, such as Oscar Cuzzani, M.D., Ph.D., Vice
President of Clinical Development. Dr. Cuzzani joined in February
2016.
Operations
- In January, the Company announced the
opening of a new, state-of-the art, cGMP manufacturing facility in
Jerusalem Bio Park on the campus of Hadassah University Hospital in
Jerusalem. This facility has the capabilities to produce multiple
cell therapy products.
Financial
- In February, the Company successfully
completed a public equity offering raising net proceeds of
approximately $18.7 million. The raise was completed on attractive
terms involving modest discounts and no warrants. It followed a
similarly successful raise in June of 2016.
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$000's
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$000's
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$000's
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$000's
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
SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS(IN
THOUSANDS, EXCEPT PER SHARE DATA)
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
SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(IN
THOUSANDS)
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170316006292/en/
for BioTime, Inc.Investor Contact:Brian Moore,
310-770-0389bmoore@evcgroup.comorMedia
Contact:Gotham Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
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