Cytori Reports Fourth Quarter and Full Year 2016 Business and Financial Results
March 23 2017 - 4:25PM
Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today
announced its fourth quarter and year-end 2016 financial results
and provided updates on its corporate activity and clinical
development.
Fourth quarter and full year 2016 net loss
allocable to common stockholders was $4.9 million, or $0.24 per
share, and $22.0 million, or $1.28 per share, respectively.
Operating cash burn for the fourth quarter and full year 2016 was
approximately $4.2 million and $19.5 million, respectively. Cytori
ended the year with approximately $12.6 million of cash and cash
equivalents.
Selected Key Recent
Highlights:
- Completed enrollment of U.S. STAR pivotal/phase III trial for
scleroderma hand dysfunction.
- Completed acquisition of Azaya Therapeutics assets, and
initiated nanomedicine development programs.
- Reported 24 month publication of SCLERADEC-I reporting
sustained benefit at 24 months across multiple endpoints in
patients with scleroderma hand dysfunction.
- Received U.S. FDA orphan drug designation for cryopreserved or
centrally processed HabeoTM for treatment of hand manifestations of
systemic scleroderma.
- Received U.S. Small Business Designation and related fee
reductions.
Q4 and year-end 2016 Financial
Performance
- Q4 2016 and year-end operating cash burn was $4.2 million and
$19.5 million, compared to $4.5 million and $20.5 million for the
same periods in 2015, respectively.
- Q4 2016 and year-end total revenues were $3.0 million and $11.4
million, compared to $3.4 million and $11.7 million for the same
periods in 2015, respectively.
- Cash and debt principal balances at December 31, 2016 were
approximately $12.6 million and $17.7 million, respectively.
- Q4 2016 net loss allocable to common stockholders was $4.9
million or $0.24 per share, compared to a net loss of $2.8 million
or $0.25 per share (or a net loss of $5.4 million and $0.50 per
share when excluding a non-cash credit charge of $2.7 million
related to the change in fair value of warrant liabilities) for the
same period in 2015.
- 2016 net loss allocable to common stockholders was $22.0
million or $1.28 per share, compared to $19.4 million or $2.07 per
share (or a net loss of $26.4 million or $2.81 per share, which
excludes a non-cash charge of $7.7 million related to the change in
fair value of warrant liabilities and a beneficial conversion
feature charge for convertible preferred stock of $0.7 million) for
the same period in 2015.
“Our corporate priority and fundamental driver of stockholder
value remains the focused and expeditious development of our late
stage clinical pipeline and related commercial preparatory
activities. In 2016, we continued our focus on operational
efficiency and maintaining momentum in our clinical development
programs, nonetheless we reduced our net losses by 20%” said Tiago
Girao, VP of Finance and CFO of Cytori. “In 2017, we will continue
to make appropriate preparations for commercial launch of HabeoTM
in anticipation of receipt of STAR trial data, and we also intend
to complete the manufacturing activities necessary to submit a
marketing authorisation application (MAA) for our recently acquired
nanoparticle doxorubicin, ATI-0918, to the European Medicines
Agency (EMA). We will address ongoing capital requirements through
targeted activities, including, but not limited to, further
operational efficiency measures, tighter working capital
management, increased revenue, accessing the capital markets as
appropriate, and an intense focus on only those activities that we
believe will maximize stockholder value creation, such as business
development opportunities.”
Selected Key Anticipated
Milestones:
- Receive feedback from U.S. FDA regarding thermal burn IDE trial
application (Q2)
- Complete contracting discussions with BARDA regarding their
potential funding of our thermal burn trial (Q2)
- Report of 48-week US pivotal/phase III trial data for
scleroderma hand dysfunction and preparation for US PMA filing
(Q3)
- Complete manufacturing activities required for submission of an
MAA to the EMA for our recently acquired nanoparticle doxorubicin
(Q4)
2017 Financial Guidance
The Company expects full year 2017 operating cash burn to be
higher than 2016, primarily due to the development of assets
acquired from Azaya Therapeutics, as well as costs to be incurred
in preparation of anticipated HabeoTM launch and the Company’s
expansion of its development program for secondary Raynaud’s
Phenomenon.
- Operating cash burn forecasted to be within a range of $26
million to $29 million
Management Conference Call
Webcast
Cytori will host a management conference call at
5:30 p.m. Eastern Time today to further discuss its progress. The
webcast will be available live and by replay two hours after the
call and may be accessed under "Webcasts" in the Investor Relations
section of Cytori's website. If you are unable to access the
webcast, you may dial in to the call at +1.877.402.3914, Conference
ID: 9218454.
About Cytori
Cytori is a therapeutics company developing
regenerative and oncologic therapies from its proprietary cell
therapy and nanoparticle platforms for a variety of medical
conditions. Data from preclinical studies and clinical trials
suggest that Cytori Cell Therapy™ acts principally by improving
blood flow, modulating the immune system, and facilitating wound
repair. As a result, Cytori Cell Therapy™ may provide benefits
across multiple disease states and can be made available to the
physician and patient at the point-of-care through Cytori’s
proprietary technologies and products. Cytori Nanomedicine™ is
developing encapsulated therapies for regenerative medicine and
oncologic indications using technology that allows Cytori to use
the benefits of its encapsulation platform to develop novel
therapeutic strategies and reformulate other drugs to optimize
their clinical properties. For more information, visit
www.cytori.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes forward-looking
statements that involve known and unknown risks and uncertainties.
All statements, other than historical facts are forward looking
statements. Such statements, including, without limitation,
statements regarding anticipated commercial launch of our Habeo™
therapy; completion of manufacturing activities necessary to submit
an MAA to the EMA for our ATI-0918 drug candidate; our strategy for
addressing our capital requirements through various activities,
including operational efficiencies, revenue growth and accessing
the capital markets; receipt of feedback from the FDA on our
thermal burn IDE, and related discussions with BARDA regarding our
future contractual relationship with BARDA (and proposed BARDA
funding of our thermal burn pilot trial); and our expected 2017
cash burn and reasons for the anticipated cash burn; are subject to
risks and uncertainties that could cause our actual results and
financial position to differ materially. Some of these risks
include clinical, pre-clinical and regulatory uncertainties, such
as those associated with conduct and completion of the
Company-sponsored STAR trial and the proposed thermal burn trial,
as well as the Company-supported, investigator-initiated ADRESU
trial. Specifically, the Company faces risks in the collection and
results of the STAR and ADRESU trials, including the risks
that clinical data from one or more of these clinical trials will
fail to demonstrate safety or efficacy of our cellular
therapeutics, and risks that insufficiently positive clinical data
will adversely affect government funding, regulatory approval
pathways and commercial prospects for Habeo, ECCI-50, DCCT-10 and
the Company’s other potential cell therapy products. We also face
risks that investigator-initiated trials using our Cytori Cell
Therapy fail to fully enroll or otherwise are conducted in a manner
that ultimately is injurious to our business. We also face
the risk that we will be unable to time successfully manufacture
our ATI-0918 drug candidate in time to meet our projected timeline
for submission of an MAA to the EMA, or at all. We also face
risks regarding execution of our managed access program (MAP)
strategy in Europe, the Middle East and Africa (EMEA), including
risks relating to oiurj efforts to ethically direct prospective
scleroderma patients into our MAP program Some of these
risks also include risks relating to regulatory challenges the
Company faces (including the U.S,, EU, China, Japan and its other
key geographies) due to a number of factors including novelty of
the Company’s technology and product offerings, changes in and /or
evolution of regulatory approaches to cellular therapeutics like
the Company’s in its key geographies, and similar matters. The
Company also faces risks relating to achievement of the Company’s
financial goals (including balancing capital requirements and
meeting projected 2017 operating cash burn guidance). It is
possible that the Company could face unexpected revenue shortfalls,
expense increases or other occurrences that adversely affect our
cash burn and cash management strategies. Further the Company
face risks pertaining to dependence on third party performance and
approvals (including performance of investigator-initiated trials,
outcome of FDA review of the Company’s proposed burn wound trial
pursuant to its contract with BARDA, and outcome of the EMA’s
review of our ATI-0918 MAA); performance and acceptance of the
Company’s products in clinical studies/trials and in the
marketplace (including commercial acceptance of the Company’s
products in Japan and other markets where are products are
commercially available, and similar risks); material changes in the
marketplace that could adversely impact revenue projections
(including changes in market perceptions of the Company’s products,
and introduction of competitive products); unexpected costs and
expenses that could adversely impact liquidity and shorten the
Company’s current liquidity projections (which could in turn
require the Company to seek additional debt or equity capital
sooner than currently anticipated); the Company’s reliance on key
personnel; the Company’s ability to identify and develop new
programs or assets to expand the Company’s clinical pipeline; the
right of the U.S. government (BARDA) to cut or terminate further
support of the thermal burn injury program (including any decision
by BARDA not to proceed with our proposed thermal burn trial,
assuming FDA approval of the Company’s IDE submission); the
Company’s abilities to capitalize on its internal restructuring and
achieve break-even or profitability (or to continue to reduce our
operating losses); and other risks and uncertainties described
under the "Risk Factors" in Cytori's Securities and Exchange
Commission Filings, included in the Company’s annual and quarterly
reports.
There may be events in the future that the Company is unable to
predict, or over which it has no control, and its business,
financial condition, results of operations and prospects may change
in the future. The Company assumes no responsibility to update or
revise any forward-looking statements to reflect events, trends or
circumstances after the date they are made unless the Company has
an obligation under U.S. Federal securities laws to do so.
|
|
CYTORI THERAPEUTICS, INC. |
|
CONSOLIDATED CONDENSED BALANCE
SHEETS |
|
(UNAUDITED) |
|
(in thousands, except share and par value
data) |
|
|
|
|
|
As of December 31, |
|
|
|
2016 |
|
|
2015 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
12,560 |
|
|
$ |
14,338 |
|
Accounts
receivable, net of reserves of $167 and $797 in 2016 and
2015, respectively |
|
|
1,242 |
|
|
|
1,052 |
|
Restricted cash |
|
|
350 |
|
|
|
— |
|
Inventories, net |
|
|
3,725 |
|
|
|
4,298 |
|
Other
current assets |
|
|
870 |
|
|
|
1,555 |
|
Total
current assets |
|
|
18,747 |
|
|
|
21,243 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,157 |
|
|
|
1,631 |
|
Restricted cash |
|
|
— |
|
|
|
350 |
|
Other assets |
|
|
2,336 |
|
|
|
1,521 |
|
Intangibles, net |
|
|
8,447 |
|
|
|
9,031 |
|
Goodwill |
|
|
3,922 |
|
|
|
3,922 |
|
Total
assets |
|
$ |
34,609 |
|
|
$ |
37,698 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
5,872 |
|
|
$ |
6,687 |
|
Current
portion of long-term obligations, net of discount |
|
|
6,629 |
|
|
|
— |
|
Joint
venture purchase obligation |
|
|
— |
|
|
|
1,750 |
|
Total
current liabilities |
|
|
12,501 |
|
|
|
8,437 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues |
|
|
97 |
|
|
|
105 |
|
Long-term deferred rent
and other |
|
|
17 |
|
|
|
269 |
|
Long-term obligations,
net of discount, less current portion |
|
|
11,008 |
|
|
|
16,681 |
|
Total
liabilities |
|
|
23,623 |
|
|
|
25,492 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; 13,500
shares issued; no shares outstanding in 2016 and 2015 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value; 75,000,000 shares authorized; 21,707,890
and 13,003,893 shares issued and outstanding in 2016 and
2015, respectively |
|
|
22 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
388,769 |
|
|
|
368,214 |
|
Accumulated other comprehensive income |
|
|
1,258 |
|
|
|
996 |
|
Accumulated deficit |
|
|
(379,063 |
) |
|
|
(357,017 |
) |
Total
stockholders’ equity |
|
|
10,986 |
|
|
|
12,206 |
|
Total
liabilities and stockholders’ equity |
|
$ |
34,609 |
|
|
$ |
37,698 |
|
|
|
|
|
|
|
|
|
|
CYTORI THERAPEUTICS, INC. |
|
CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE (LOSS) INCOME |
|
(UNAUDITED) |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
|
For the Three MonthsEnded December
31, |
|
|
|
For the Twelve MonthsEnded December
31, |
|
|
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
$ |
1,466 |
|
|
|
$ |
1,556 |
|
|
|
$ |
4,656 |
|
|
$ |
4,838 |
|
Cost of product
revenues |
|
|
|
945 |
|
|
|
|
791 |
|
|
|
|
2,715 |
|
|
|
3,186 |
|
Gross
profit |
|
|
|
521 |
|
|
|
|
765 |
|
|
|
|
1,941 |
|
|
|
1,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government contracts and other |
|
|
|
1,561 |
|
|
|
|
1,820 |
|
|
|
|
6,724 |
|
|
|
6,821 |
|
|
|
|
|
1,561 |
|
|
|
|
1,820 |
|
|
|
|
6,724 |
|
|
|
6,821 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
2,862 |
|
|
|
|
4,629 |
|
|
|
|
16,197 |
|
|
|
19,000 |
|
Sales and
marketing |
|
|
|
869 |
|
|
|
|
603 |
|
|
|
|
3,611 |
|
|
|
2,662 |
|
General
and administrative |
|
|
|
1,939 |
|
|
|
|
2,104 |
|
|
|
|
8,563 |
|
|
|
9,765 |
|
Change in
fair value of warrant liabilities |
|
|
|
— |
|
|
|
|
(2,680 |
) |
|
|
|
— |
|
|
|
(7,668 |
) |
Total
operating expenses |
|
|
|
5,670 |
|
|
|
|
4,656 |
|
|
|
|
28,371 |
|
|
|
23,759 |
|
Operating
loss |
|
|
|
(3,588 |
) |
|
|
|
(2,071 |
) |
|
|
|
(19,706 |
) |
|
|
(15,286 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on
debt extinguishment |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
(260 |
) |
Interest
income |
|
|
|
13 |
|
|
|
|
3 |
|
|
|
|
19 |
|
|
|
9 |
|
Interest
expense |
|
|
|
(644 |
) |
|
|
|
(702 |
) |
|
|
|
(2,592 |
) |
|
|
(3,379 |
) |
Other
income (loss), net |
|
|
|
(699 |
) |
|
|
|
14 |
|
|
|
|
233 |
|
|
|
172 |
|
Total
other expense |
|
|
|
(1,330 |
) |
|
|
|
(685 |
) |
|
|
|
(2,340 |
) |
|
|
(3,458 |
) |
Net
loss |
|
|
$ |
(4,918 |
) |
|
|
$ |
(2,756 |
) |
|
|
$ |
(22,046 |
) |
|
$ |
(18,744 |
) |
Beneficial conversion feature for |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
convertible preferred stock |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
(661 |
) |
Net loss
allocable to common stockholders |
|
|
$ |
(4,918 |
) |
|
|
$ |
(2,756 |
) |
|
|
$ |
(22,046 |
) |
|
$ |
(19,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share allocable to common stockholders |
|
|
$ |
(0.24 |
) |
|
|
$ |
(0.25 |
) |
|
|
$ |
(1.28 |
) |
|
$ |
(2.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted weighted average shares used in calculating net loss per
share allocable to common stockholders |
|
|
|
20,685,307 |
|
|
|
|
10,894,552 |
|
|
|
|
17,290,933 |
|
|
|
9,386,488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
(4,918 |
) |
|
|
|
(2,756 |
) |
|
|
|
(22,046 |
) |
|
|
(18,744 |
) |
Other comprehensive
income (loss) – foreign currency translation adjustments |
|
|
|
583 |
|
|
|
|
(65 |
) |
|
|
|
262 |
|
|
|
296 |
|
Comprehensive loss |
|
|
$ |
(4,335 |
) |
|
|
$ |
(2,821 |
) |
|
|
$ |
(21,784 |
) |
|
$ |
(18,448 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYTORI THERAPEUTICS, INC. |
|
CONSOLIDATED CONDENSED STATEMENTS OF CASH
FLOWS |
|
(UNAUDITED) |
|
(in thousands) |
|
|
|
|
|
For the Years EndedDecember
31, |
|
|
|
2016 |
|
|
2015 |
|
Cash flows from
operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(22,046 |
) |
|
$ |
(18,744 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,182 |
|
|
|
1,093 |
|
Amortization of deferred financing costs and debt discount |
|
|
954 |
|
|
|
979 |
|
Joint
Venture acquisition obligation accretion |
|
|
24 |
|
|
|
365 |
|
Provision
for doubtful accounts |
|
|
— |
|
|
|
(105 |
) |
Provision
for expired inventory |
|
|
172 |
|
|
|
— |
|
Change in
fair value of warrants |
|
|
— |
|
|
|
(7,668 |
) |
Share-based compensation expense |
|
|
1,080 |
|
|
|
2,041 |
|
(Gain)
loss on asset disposal |
|
|
(127 |
) |
|
|
8 |
|
Loss on
debt extinguishment |
|
|
— |
|
|
|
260 |
|
Increases
(decreases) in cash caused by changes in operating assets and
liabilities: |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
|
(179 |
) |
|
|
328 |
|
Inventories |
|
|
471 |
|
|
|
490 |
|
Other
current assets |
|
|
633 |
|
|
|
(637 |
) |
Other
assets |
|
|
(764 |
) |
|
|
363 |
|
Accounts
payable and accrued expenses |
|
|
(673 |
) |
|
|
1,045 |
|
Deferred
revenues |
|
|
(8 |
) |
|
|
3 |
|
Long-term
deferred rent |
|
|
(252 |
) |
|
|
(289 |
) |
Net cash
used in operating activities |
|
|
(19,533 |
) |
|
|
(20,468 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
Purchases of property
and equipment |
|
|
(67 |
) |
|
|
(611 |
) |
Expenditures for
intellectual property |
|
|
— |
|
|
|
(13 |
) |
Proceeds from sale of
assets |
|
131 |
|
|
|
11 |
|
Net cash
provided by (used in) investing activities |
|
|
64 |
|
|
|
(613 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Principal payments on
long-term obligations |
|
|
— |
|
|
|
(25,032 |
) |
Proceeds from long-term
obligations |
|
|
— |
|
|
|
17,700 |
|
Debt issuance costs and
loan fees |
|
|
— |
|
|
|
(1,854 |
) |
Joint Venture purchase
payments |
|
|
(1,774 |
) |
|
|
(1,623 |
) |
Proceeds from exercise
of employee stock options and warrants |
|
|
— |
|
|
|
4,997 |
|
Proceeds from sale of
common stock |
|
|
21,467 |
|
|
|
29,054 |
|
Costs from sale of
common stock |
|
|
(2,084 |
) |
|
|
(2,370 |
) |
Dividends paid on
preferred stock |
|
|
— |
|
|
|
(75 |
) |
Net cash
provided by financing activities |
|
|
17,609 |
|
|
|
20,797 |
|
Effect of
exchange rate changes on cash and cash equivalents |
|
|
82 |
|
|
|
— |
|
Net
decrease in cash and cash equivalents |
|
|
(1,778 |
) |
|
|
(284 |
) |
Cash and cash
equivalents at beginning of period |
|
|
14,338 |
|
|
|
14,622 |
|
Cash and cash
equivalents at end of period |
|
$ |
12,560 |
|
|
$ |
14,338 |
|
|
|
|
|
|
|
|
|
|
CYTORI THERAPEUTICS CONTACT
Tiago Girao
+1.858.458.0900
ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
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Cytori Therapeutics (NASDAQ:CYTX)
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From Sep 2023 to Sep 2024