Cytori Reports Fourth Quarter and Full Year 2015 Business and Financial Results
Thursday, March 03, 2016 4:25:00 PM ET Cytori Therapeutics (CYTX ) (Cytori or the "Company") today
announced its fourth quarter and year-end 2015 financial results and
provided updates on its corporate activity and clinical development.
Fourth quarter 2015 net loss allocable to common stockholders was $2.8
million, or a net loss of $5.4 million and $0.03 per share when
excluding a non-cash charge of $2.7 million related to the change in
fair value of warrant liabilities. Cytori continued to reduce its
operating cash burn, spending approximately $4.5 million in the fourth
quarter 2015. Cytori ended 2015 with $14.3 million of cash and cash
equivalents.
Full year 2015 net loss allocable to common stockholders was $19.4
million, or a net loss of $26.4 million and $0.19 per share when
excluding two non-cash charges - a $7.7 million gain related to the
change in fair value of warrant liabilities and a $0.7 million charge
related to the beneficial conversion feature for convertible preferred
stock. Full year 2015 operating cash burn was $20.5 million, compared to
$30.3 million in 2014.
"In 2015, the corporate repositioning that began in 2014 is largely
completed and we are now enrolling two Phase III studies in scleroderma
in the US and Europe, implementing a European patient access program for
scleroderma, supporting an approval trial in Japan for SUI, and
completing patient follow up for a mid-stage US OA trial," said Dr. Marc
H. Hedrick, President and CEO of Cytori Therapeutics. "The challenge for
us in 2016 is to continue to build upon the operational and financial
performance achieved over this past year and successfully meet or exceed
our key milestones this year."
Select Recent Highlights:
--
Presentation of 24 month follow-up data showing sustained benefit of
results in investigator-initiated pilot/phase I/II trial for
scleroderma hand dysfunction
--
Updated on enrollment status of U.S. pivotal/phase III trial for
scleroderma (STAR trial), which is on track to complete around mid-2016
--
Completed and reported interim top-line 6 month data on knee
osteoarthritis trial
--
Initiation of enrollment in a phase II investigator initiated trial
for fistula from Crohn’s disease
--
Publication of investigator-initiated phase I erectile dysfunction
trial data in Journal EBioMedicine
Q4 and Year End 2015 Financial Performance
--
Q4 and full-year 2015 operating cash burn of $4.5 million and $20.5
million, compared to $4.9 million and $30.3 million for the same
periods in 2014, respectively.
--
Cash and debt principal balances at December 31, 2015 of approximately
$14.3 million and $17.7 million, respectively.
--
Q4 and full-year 2015 total revenues of $3.4 million and $11.7
million, compared to $3.8 million and $7.6 million for the same
periods in 2014, respectively.
--
Q4 and full-year contribution (profit/loss) from our sales and
marketing organization, excluding share based compensation, of a
profit of $0.2 million and a loss of $0.8 million, compared to a
profit of $0.1 million and a loss of $3.8 million for the same periods
in 2014, respectively.
--
Q4 net loss, when excluding non-cash charges related to the change in
fair value of warrant liabilities and beneficial conversion feature
for convertible preferred stock, was $5.4 million or $0.03 per share,
compared to $6 million or $0.07 per share for the same period in 2014,
respectively.
--
Full-year net loss, when excluding non-cash charges related to the
change in fair value of warrant liabilities and beneficial conversion
feature for convertible preferred stock, was $26.4 million or $0.19
per share, compared to $37.7 million and $0.47 per share for the same
period in 2014, respectively.
"We succeeded in meeting our internal key financial and operating
metrics in 2015. This includes a reduction in our overall cash burn by
over 30% while expanding our investment in research and development
activities," said Tiago Girao, VP of Finance and CFO of Cytori
Therapeutics. "In 2016, we plan to continue to narrow our losses,
balancing ongoing capital requirements through a number of targeted
activities that include further ’across-the-board’ operational
efficiency measures, tighter working capital management, increased
revenue, and an intense focus on only those activities that we believe
will maximize stockholder value creation."
Upcoming Near Term Catalysts:
--
Report of 48-week US pilot/phase IIb ACT-OA trial (94 patients) with
data analysis in Q3 2016
--
Complete enrollment of US STAR phase III trial (anticipated mid 2016)
for scleroderma hand dysfunction
--
Complete enrollment of investigator-initiated EU phase III
SCLERADEC-II trial (anticipated in 2016) for scleroderma hand
dysfunction
--
File IDE and obtain approval for burn wound therapy trial related to
contract with BARDA (anticipated in 2016)
2016 Financial Guidance
--
Operating cash burn within a range of $18 million to $20 million
--
Total revenues (product and contract) within a range of $12 million to
$14 million
Management Conference Call Webcast
Cytori will host a management conference call at 5:30 p.m. Eastern Time
today to further discuss the Company’s 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: 32453785.
About Cytori
Cytori Therapeutics is a late stage cell therapy company developing
autologous cell therapies from adipose tissue to treat a variety of
medical conditions. Data from preclinical studies and clinical trials
suggest that Cytori Cell Therapy(TM) acts principally by improving blood
flow, modulating the immune system, and facilitating wound repair. As a
result, Cytori Cell Therapy(TM) 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. 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 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 the ACT-OA, STAR, SCLERADEC-I, SCLERADEC-II, ADRESU
trial and possible BARDA wound trial (including risks in the collection
and results of clinical data and final clinical outcomes), as well as
achievement of financial goals (including 2016 operating cash burn and
2016 total revenues), dependence on third party performance (including
performance of investigator-initiated trials), performance and
acceptance of our products in the marketplace, unexpected costs and
expenses that could adversely impact liquidity, our reliance on key
personnel, the right of the Federal Government to cut or terminate
further support of the thermal burn injury program (including any
decision not to proceed with a wound trial in 2016), our abilities to
capitalize on our internal restructuring and achieve profitability, and
other risks and uncertainties described under the "Risk Factors" in
Cytori’s Securities and Exchange Commission Filings, included in our
annual and quarterly reports.
There may be events in the future that we are unable to predict, or over
which we have no control, and our business, financial condition, results
of operations and prospects may change in the future. We assume no
responsibility to update or revise any forward-looking statements to
reflect events, trends or circumstances after the date they are made
unless we have an obligation under U.S. Federal securities laws to do so.
CYTORI THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
As of December 31,
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2015 2014
--------------------------------------------------------- ---------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 14,338,000 $ 14,622,000
Accounts receivable, net of reserves of $797,000 and of $1,523,000 1,052,000 1,243,000
in 2015 and 2014, respectively
Inventories, net 4,298,000 4,829,000
Other current assets 1,555,000 992,000
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total current assets 21,243,000 21,686,000
Property and equipment, net 1,631,000 1,583,000
Restricted cash and cash equivalents 350,000 350,000
Other assets 1,521,000 1,763,000
Intangibles, net 9,031,000 9,415,000
Goodwill 3,922,000 3,922,000
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total assets $ 37,698,000 $ 38,719,000
==================== ============== ==================== ==================== ============== ====================
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses $ 6,687,000 $ 5,546,000
Current portion of long-term obligations, net of discount -- 7,363,000
Joint Venture purchase obligation 1,750,000 3,008,000
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total current liabilities 8,437,000 15,917,000
Warrant liability -- 9,793,000
Deferred revenues 105,000 112,000
Long-term deferred rent 269,000 558,000
Long-term obligations, net of discount, less current portion 16,681,000 18,041,000
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total liabilities 25,492,000 44,421,000
Commitments and contingencies
Stockholders’ equity:
Series A 3.6% convertible preferred stock, $0.001 par value; -- --
5,000,000 shares authorized; 13,500 shares issued and no shares
outstanding in 2015; 13,500 shares issued and 5,311 outstanding in
2014
Common stock, $0.001 par value; 290,000,000 shares authorized; 195,000 99,000
195,058,395 and 99,348,377 shares issued and outstanding in 2015 and
2014, respectively
Additional paid-in capital 368,032,000 331,772,000
Accumulated other comprehensive income 996,000 700,000
Accumulated deficit (357,017,000 ) (338,273,000 )
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total stockholders’ equity (deficit) 12,206,000 (5,702,000 )
-------------------- -------------- -------------------- -------------------- -------------- --------------------
Total liabilities and stockholders’ equity (deficit) $ 37,698,000 $ 38,719,000
==================== ============== ==================== ==================== ============== ====================
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(UNAUDITED)
For the Three Months For the Twelve Months
Ended December 31, Ended December 31,
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------
2015 2014 2015 2014
--------------------------------------------------------------- --------------------------------------------------------------- --------------------------------- ------------------------------------
Product revenues $ 1,556,000 $ 2,469,000 4,838,000 4,953,000
Cost of product revenues 791,000 1,416,000 3,186,000 2,940,000
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Gross profit 765,000 1,053,000 1,652,000 2,013,000
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Development revenues:
Government contracts and other 1,820,000 1,301,000 6,821,000 2,645,000
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
1,820,000 1,301,000 6,821,000 2,645,000
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Operating expenses:
Research and development 4,629,000 2,999,000 19,000,000 15,105,000
Sales and marketing 603,000 1,074,000 2,662,000 6,406,000
General and administrative 2,104,000 2,831,000 9,765,000 15,953,000
Change in fair value of warrant liabilities (2,680,000 ) (235,000 ) (7,668,000 ) (369,000 )
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Total operating expenses 4,656,000 6,669,000 23,759,000 37,095,000
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Operating loss (2,071,000 ) (4,315,000 ) (15,286,000 ) (32,437,000 )
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Other income (expense):
Income (loss) on asset disposal (3,000 ) 57,000 3,000 42,000
Loss on debt extinguishment -- -- (260,000 ) --
Interest income 3,000 2,000 9,000 6,000
Interest expense (702,000 ) (1,086,000 ) (3,379,000 ) (4,371,000 )
Other income (expense), net 17,000 (413,000 ) 169,000 (608,000 )
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Total other expense (685,000 ) (1,440,000 ) (3,458,000 ) (4,931,000 )
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Net loss $ (2,756,000 ) $ (5,755,000 ) (18,744,000 ) (37,368,000 )
-- (1,169,000 ) (661,000 ) (1,169,000 )
Beneficial conversion feature for convertible preferred stock
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Net loss allocable to common stockholders $ (2,756,000 ) $ (6,924,000 ) (19,405,000 ) (38,537,000 )
==================== ==================== ==================== ==================== ==================== ==================== =========== ==================== ============== ====================
Basic and diluted net loss per share allocable to common stockholders $ (0.02 ) $ (0.08 ) (0.14 ) (0.48 )
==================== ==================== ==================== ==================== ==================== ==================== =========== ==================== ============== ====================
Basic and diluted weighted average shares used in calculating net 140,797,316 80,830,698
loss per share allocable to common stockholders 163,418,283 91,925,991
==================== ==================== ==================== ==================== ==================== ==================== =========== ==================== ============== ====================
Comprehensive loss:
Net loss (2,756,000 ) (5,755,000 ) (18,744,000 ) (37,368,000 )
Other comprehensive income (loss) - foreign currency translation (65,000 ) 243,000 296,000 444,000
adjustments
-------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------- -------------------- -------------- --------------------
Comprehensive loss (2,821,000 ) (5,512,000 ) (18,448,000 ) (36,924,000 )
==================== ==================== ==================== ==================== ==================== ==================== =========== ==================== ============== ====================
CYTORI THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Years Ended December 31,
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2015 2014 2013
--------------------------------------------------------- --------------------------------------------------------- ---------------------------------------------------------
Cash flows from operating activities:
Net loss $ (18,744,000 ) $ (37,368,000 ) $ (26,177,000 )
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 1,093,000 779,000 1,630,000
Amortization of deferred financing costs and debt discount 979,000 1,220,000 893,000
Joint venture acquisition obligation accretion 365,000 579,000 204,000
Provision for doubtful accounts (105,000 ) 1,084,000 1,141,000
Provision for expired enzymes -- 313,000 --
Change in fair value of warrants (7,668,000 ) (369,000 ) (418,000 )
Change in fair value of option liability -- -- (2,250,000 )
Stock-based compensation 2,041,000 3,101,000 3,608,000
Equity loss from investment in joint venture -- -- 48,000
Gain (loss) on asset disposal 8,000 (33,000 ) 257,000
Gain on previously held equity interest in Joint Venture -- -- (4,892,000 )
Gain on sale of assets -- -- (4,453,000 )
Loss on debt extinguishment 260,000 -- 708,000
Increases (decreases) in cash caused by changes in operating assets
and liabilities:
Accounts receivable 328,000 2,057,000 (1,209,000 )
Inventories 490,000 (815,000 ) (459,000 )
Other current assets (637,000 ) 510,000 (24,000 )
Other assets 363,000 11,000 (854,000 )
Accounts payable and accrued expenses 1,045,000 (1,147,000 ) (409,000 )
Deferred revenues, related party -- -- (638,000 )
Deferred revenues 3,000 (100,000 ) (1,223,000 )
Long-term deferred rent (289,000 ) (152,000 ) (46,000 )
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Net cash used in operating activities (20,468,000 ) (30,330,000 ) (34,563,000 )
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Cash flows from investing activities:
Purchases of property and equipment (611,000 ) (764,000 ) (519,000 )
Expenditures for intellectual property (13,000 ) (255,000 ) --
Proceeds from sale of assets 11,000 76,000 5,000,000
License agreement termination fee -- (400,000 ) (800,000 )
Cash acquired in purchase of joint venture -- -- 5,000
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Net cash (used in) provided by investing activities (613,000 ) (1,343,000 ) 3,686,000
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Cash flows from financing activities:
Principal payments on long-term debt obligations (25,032,000 ) (1,962,000 ) (22,304,000 )
Proceeds from long-term obligations 17,700,000 -- 27,000,000
Debt issuance costs and loan fees (1,854,000 ) -- (1,744,000 )
Joint venture purchase payments (1,623,000 ) (2,262,000 ) (221,000 )
Proceeds from exercise of employee stock options and warrants and 4,997,000 4,151,000 225,000
stock purchase plan
Proceeds from issuance of common stock 29,054,000 19,001,000 18,000,000
Proceeds from issuance of preferred stock -- 13,500,000 --
Costs from sale of common stock (2,370,000 ) (425,000 ) (184,000 )
Costs from sale of preferred stock -- (1,129,000 ) --
Dividends paid on preferred stock (75,000 ) -- --
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Net cash provided by financing activities 20,797,000 30,874,000 20,772,000
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Effect of exchange rate changes on cash and cash equivalents -- (85,000 ) (106,000 )
Net decrease in cash and cash equivalents (284,000 ) (884,000 ) (10,211,000 )
Cash and cash equivalents at beginning of year 14,622,000 15,506,000 25,717,000
-------------------- -------------- -------------------- -------------------- -------------- -------------------- -------------------- -------------- --------------------
Cash and cash equivalents at end of year $ 14,338,000 $ 14,622,000 $ 15,506,000
==================== ============== ==================== ==================== ============== ==================== ==================== ============== ====================
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SOURCE: Cytori Therapeutics
Cytori Therapeutics
Tiago Girao
+1.858.458.0900
ir@cytori.com
