SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C.
20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of
Report (Date of
earliest event reported): May 11,
2009
CYTORI THERAPEUTICS,
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
000-32501
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33-0827593
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File
Number)
|
(I.R.S.
Employer Identification Number)
|
3020 Callan Road, San Diego,
California 92121
(Address
of principal executive offices, with zip code)
(858) 458-0900
(Registrant's
telephone number, including area code)
n/a
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General
Instruction A.2. below):
| o |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
| o |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
2.02 Results
of Operations and Financial Condition
On May
11, 2009, Cytori Therapeutics, Inc. issued a press release announcing its
financial results for the first quarter ended March 31, 2009. A copy
of the press release is attached hereto as Exhibit 99.1 and is incorporated
herein by reference.
The
information disclosed under this Item 2.02 in this report, including Exhibit
99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be
incorporated by reference into any registration statement or other document
pursuant to the Securities Act of 1933, as amended, except as expressly set
forth in such filing.
Item
9.01 Financial
Statements and Exhibits
(d) Exhibits
Exhibit
No. Description
99.1 Cytori Therapeutics, Inc. Press
Release, dated May 11, 2009*
* Exhibit 99.1
hereto is being furnished and shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be
incorporated by reference into any registration statement or other document
pursuant to the Securities Act of 1933, as amended, except as expressly set
forth in such filing.
2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| CYTORI THERAPEUTICS, INC. | |
| Date: May 11, 2009 | By: /s/ Christopher J. Calhoun |
| Christopher J. Calhoun | |
| Chief Executive Officer |
Exhibit
99.1
Cytori
Reports First Quarter 2009 Financial Results
May 11, 2009, San
Diego, CA -- Cytori Therapeutics (NASDAQ: CYTX) reports financial results
for the first quarter ended March 31, 2009. These results highlight the
Company’s progress and demonstrate commercial, clinical and strategic
achievements, which year-to-date include:
|
·
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Continued
growth in product revenues
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|
·
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EU
partnership with GE Healthcare to commercialize Celution® and StemSource®
products in the cosmetic and reconstructive surgery, research and stem
cell banking markets in select European
countries
|
|
·
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North
American partnership with GE Healthcare to commercialize StemSource®
products
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|
·
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Installed
first Japanese StemSource® Cell Bank at Kyoto Prefectural University of
Medicine
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|
·
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Completed
enrollment of the APOLLO heart attack
trial
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|
·
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Expanded
protection for Celution® and StemSource platforms through receipt of three
patents and one allowance relating to cell banking, automated cell
processing systems, and important methods for cell-enhanced
reconstruction
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Product
revenues increased to $1.9 million for the first quarter of 2009, compared to
$153,000 recognized in the first quarter of 2008, the first period for which
Cytori’s regenerative medicine products were commercially available. First
quarter 2009 product revenues consisted of $1.3 million in Celution® System
sales in Europe and Asia and the recognition of $0.6 million from the
installation of a StemSource® Cell Bank in Japan. Gross profit for the first
quarter was $825,000, compared to $93,000 in the first quarter of
2008.
“Cytori’s
first quarter sales reflect the progress the Company has made since it
introduced its regenerative medicine product line early last year,” said
Christopher J. Calhoun, chief executive officer for Cytori. “We achieved a
significant year over year increase in product revenues based on a diverse mix
of orders between the Celution® System and StemSource® Cell Bank sales in Europe
and Asia and we believe we are on track to meet our $10 million revenue
projection for 2009. During the remainder of the year, we anticipate revenues to
be driven by increased interest in the Celution® system from cosmetic and
reconstructive surgeons in Europe and Asia, the achievement of periodic
international StemSource orders, and the introduction of the StemSource®
research products in the United States through GE Healthcare.”
During
the first quarter of 2009, Cytori reduced total operating expenses to $6.4
million, as compared to $9.2 million for the same period in 2008. This decrease
is due to a reduction in research and development and general and administrative
expenses and recognition of a gain from the change in fair value of warrant
liability, offset by a planned increase in sales and marketing expenses. This
trend is expected to continue due, in part, to further cost containment measures
enacted in March 2009 and which are expected to take full effect in the second
quarter of 2009. These measures include continued reduction in research and
development, as resources have been shifted to managing the sales and marketing
activities of our distribution partners.
Net loss
for the first quarter of 2009 decreased to $6.1 million, as compared to $8.3
million for the first quarter in 2008. Cytori ended the first quarter of 2009
with $15.5 million in cash and cash equivalents compared to $12.6 million in
cash and cash equivalents at December 31, 2008. Subsequent to the end of the
quarter, Cytori entered into agreements to raise $4.2 million in proceeds from a
private placement.
Conference
Call
Cytori
will host a conference call at 10:00 a.m. Eastern Time today to discuss these
results. The audio webcast of the conference call may be accessed under "Events
& Webcasts" in the Investor Relations section of the Cytori’s website (www.cytoritx.com).
The webcast will be available live and by replay two hours after the call and
archived for 90 days. A telephone replay will be available for one week,
accessible at +1 (303) 590-3030 (PIN: 4059504).
About
Cytori
Cytori
develops and globally commercializes regenerative medicine technologies, which
provide real-time, point-of-care access to clinical grade regenerative cells.
Our technology is incorporated into two product families. The Celution®-related
products are sold throughout Europe and Asia primarily into the cosmetic and
reconstructive surgery market and are under evaluation by the U.S. FDA. Our
StemSource® products are sold globally for cell banking and research
applications. We are also developing additional clinical uses of our technology
for the treatment of multiple medical conditions, including cardiovascular
disease, urinary tract disorders, and wound related conditions. To commercialize
our technology, Cytori has partnered with global and regional leaders in
healthcare such as Olympus Corp, GE Healthcare, and Green Hospital Supply. www.cytoritx.com
Cautionary
Statement Regarding Forward-Looking Statements
This
press release includes forward-looking statements regarding events, trends and
business prospects, which may affect our future operating results and financial
position. Such statements, including, but not limited to, those regarding our
forecasts for 2009 product revenues, anticipated continued reduction in
operating expenses for 2009 and the timing of that reduction, our sales
expectations from our marketing and distribution partners, customer consumable
reorder trends, anticipated StemSource® Cell Bank orders, our ability to
introduce complementary cosmetic and reconstructive surgery products in
2009, are all subject to risks and uncertainties that could cause our
actual results and financial position to differ materially. Some of these risks
and uncertainties include, but are not limited to, risks related to our history
of operating losses, the need for further financing and our ability to access
the necessary additional capital for our business, inherent risk and uncertainty
in the protection intellectual property rights, regulatory uncertainties
regarding the collection and results of, clinical data, dependence on third
party performance, as well as other risks and uncertainties described under the
"Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume
no responsibility to update or revise any forward-looking statements to reflect
events, trends or circumstances after the date they are made.
###
CONSOLIDATED
CONDENSED BALANCE SHEETS
(UNAUDITED)
|
As
of
March
31, 2009
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As
of
December
31, 2008
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|||||||
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Assets
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||||||||
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Current
assets:
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||||||||
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Cash
and cash equivalents
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$ | 15,472,000 | $ | 12,611,000 | ||||
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Accounts
receivable, net of allowance for doubtful accounts of $272,000 and
$122,000 in 2009 and 2008, respectively
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1,219,000 | 1,308,000 | ||||||
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Inventories,
net
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1,851,000 | 2,143,000 | ||||||
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Other
current assets
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1,158,000 | 1,163,000 | ||||||
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Total
current assets
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19,700,000 | 17,225,000 | ||||||
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Property
and equipment, net
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2,278,000 | 2,552,000 | ||||||
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Investment
in joint venture
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308,000 | 324,000 | ||||||
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Other
assets
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649,000 | 729,000 | ||||||
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Intangibles,
net
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801,000 | 857,000 | ||||||
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Goodwill
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3,922,000 | 3,922,000 | ||||||
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Total
assets
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$ | 27,658,000 | $ | 25,609,000 | ||||
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Liabilities
and Stockholders’ Deficit
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||||||||
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Current
liabilities:
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||||||||
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Accounts
payable and accrued expenses
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$ | 4,395,000 | $ | 5,088,000 | ||||
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Current
portion of long-term obligations
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2,497,000 | 2,047,000 | ||||||
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Total
current liabilities
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6,892,000 | 7,135,000 | ||||||
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Deferred
revenues, related party
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16,474,000 | 16,474,000 | ||||||
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Deferred
revenues
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2,464,000 | 2,445,000 | ||||||
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Warrant
liability
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677,000 | — | ||||||
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Option
liability
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2,270,000 | 2,060,000 | ||||||
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Long-term
deferred rent
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84,000 | 168,000 | ||||||
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Long-term
obligations, less current portion
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4,520,000 | 5,044,000 | ||||||
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Total
liabilities
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33,381,000 | 33,326,000 | ||||||
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Commitments
and contingencies
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||||||||
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Stockholders’
deficit:
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||||||||
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Preferred
stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued
and outstanding in 2009 and 2008
|
— | — | ||||||
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Common
stock, $0.001 par value; 95,000,000 shares authorized; 34,088,915 and
31,176,275 shares issued and 34,088,915 and 29,303,441 shares outstanding
in 2009 and 2008, respectively
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34,000 | 31,000 | ||||||
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Additional
paid-in capital
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159,629,000 | 161,214,000 | ||||||
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Accumulated
deficit
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(165,386,000 | ) | (162,168,000 | ) | ||||
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Treasury
stock, at cost
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— | (6,794,000 | ) | |||||
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Total
stockholders’ deficit
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(5,723,000 | ) | (7,717,000 | ) | ||||
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Total
liabilities and stockholders’ deficit
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$ | 27,658,000 | $ | 25,609,000 | ||||
CONSOLIDATED
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
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For
the Three Months Ended March 31,
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||||||||
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2009
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2008
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|||||||
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Product
revenues:
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||||||||
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Related
party
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$ | 564,000 | $ | — | ||||
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Third
party
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1,348,000 | 153,000 | ||||||
| 1,912,000 | 153,000 | |||||||
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Cost
of product revenues
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1,087,000 | 60,000 | ||||||
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Gross
profit
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825,000 | 93,000 | ||||||
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Development
revenues:
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||||||||
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Development,
related party
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— | 774,000 | ||||||
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Research
grants and other
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8,000 | 37,000 | ||||||
| 8,000 | 811,000 | |||||||
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Operating
expenses:
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||||||||
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Research
and development
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3,468,000 | 4,963,000 | ||||||
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Sales
and marketing
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1,286,000 | 958,000 | ||||||
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General
and administrative
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2,494,000 | 3,111,000 | ||||||
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Change
in fair value of warrants
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(1,021,000 | ) | — | |||||
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Change
in fair value of option liability
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210,000 | 200,000 | ||||||
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Total
operating expenses
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6,437,000 | 9,232,000 | ||||||
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Operating
loss
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(5,604,000 | ) | (8,328,000 | ) | ||||
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Other
income (expense):
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||||||||
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Interest
income
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14,000 | 76,000 | ||||||
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Interest
expense
|
(400,000 | ) | (23,000 | ) | ||||
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Other
income (expense), net
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(92,000 | ) | 11,000 | |||||
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Equity
loss from investment in joint venture
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(16,000 | ) | (9,000 | ) | ||||
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Total
other income (expense), net
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(494,000 | ) | 55,000 | |||||
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Net
loss
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$ | (6,098,000 | ) | $ | (8,273,000 | ) | ||
|
Basic
and diluted net loss per share
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$ | (0.20 | ) | $ | (0.34 | ) | ||
|
Basic
and diluted weighted average common shares
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30,266,169 | 24,442,655 | ||||||