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): March 3,
2009
CYTORI THERAPEUTICS,
INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-32501
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33-0827593
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(State
or Other Jurisdiction of Incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer Identification Number)
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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)
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| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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| 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 March
3, 2009, Cytori Therapeutics, Inc. issued a press release announcing its
preliminary finanical results for the fiscal year ended December 31, 2008, and
describing the Company’s 2009 sales forecast and strategic goals. 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 March 3, 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: March 3, 2009 | By: /s/ Christopher J. Calhoun |
| Christopher J. Calhoun | |
| Chief Executive Officer |
3
Exhibit
99.1
March
3, 2009
Cytori
Therapeutics Reports Preliminary 2008 Revenues and 2009 Revenue
Guidance;
Receives
First Celution® Order from GE Healthcare Partnership
San Diego, CA -- Cytori
Therapeutics (NASDAQ: CYTX) today reports 2008 preliminary and unaudited total
revenues of $6.9 million. Celution® System and StemSource® product sales
accounted for $4.5 million of the total. The Company forecasts 2009 product
revenues of at least $10 million. Product revenue in 2009 is expected to be
driven primarily by European and Asia-Pacific Celution® System sales to the
cosmetic and reconstructive surgery and translational medicine markets. The
translational medicine market consists of clinical investigators who purchase
systems and consumables for access to clinical grade cells for their own
sponsored studies.
Key
factors contributing to the 2009 sales forecast include: Celution System orders
received in the first two months of 2009, the recent installation of a
StemSource Cell Bank in Japan, 2009 sales expectations from Cytori’s marketing
and distribution partners and emerging customer consumable reorder trends.
Revenues may also include contributions from anticipated StemSource Cell Bank
orders and sales from complementary cosmetic and reconstructive surgery products
to be introduced later this year.
Cytori’s
marketing and distribution partnership with GE Healthcare is active and
contributing to 2009 sales. This quarter, Cytori received its opening order for
Celution System devices and consumables from GE Healthcare, trained their
European sales force, and both companies are broadly collaborating to grow 2009
sales in key European markets.
Cytori’s
preliminary and unaudited cash and cash equivalents at the end of 2008 was $12.6
million, compared to $11.5 million in cash and cash equivalents at the end of
2007. Full year preliminary and unaudited operating expenses were reduced in
2008 to $34.8 million compared to $37.0 million in 2007. Cost reductions in 2008
are mostly attributable to third and fourth quarter reductions in general and
administrative and, to a lesser degree, research and development expenses.
Cytori expects continued significant reduction in total operating expenses in
2009
2009
milestones and goals for Cytori include the following:
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·
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Exceed
global Celution® System and StemSource sales
targets
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Expand
global distribution network and related sales
impact
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Expand
Celution® System product claims and reimbursement in
Europe
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Complete
enrollment and report preliminary results from the RESTORE II breast
reconstruction study
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U.S.
product launch of key complementary cosmetic and reconstructive surgery
products
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Finalize
U.S. regulatory and clinical development and regulatory
strategy
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Complete
enrollment in cardiovascular studies (PRECISE &
APOLLO)
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The 2008
financial numbers are disclosed in this release as preliminary while Cytori’s
management completes its review of year end results.
About
Cytori
Cytori
Therapeutics, Inc. is commercializing cutting edge medical technologies, which
enable physicians to practice regenerative medicine. The Company’s main product
is the Celution® System, a device for processing a patient’s own stem and
regenerative cells at the bedside. Cytori is currently selling its Celution®
System into the cosmetic and reconstructive surgery market in Europe and Asia.
In addition, the Company is offering the Celution® System to hospitals in Europe
and Asia to perform cell-based translational research, and selling stem and
regenerative cell banking equipment globally to allow hospitals and tissue banks
to cryopreserve patients own cells for future use.
Because
regenerative medicine touches nearly every medical discipline, Cytori’s product
pipeline spans cardiovascular disease, renal failure, orthopedic damage,
gastrointestinal disorders, and pelvic health conditions, among others. 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, our product revenue drivers, our sales expectations
from our marketing and distribution partners, customer consumable reorder
trends, anticipated StemSource Cell Bank orders, and our ability to introduce
complementary cosmetic and reconstructive surgery products in 2009, are subject
to risks and uncertainties that could cause our actual results and financial
position to differ materially. Some of these risks and uncertainties include our
history of operating losses, the need for further financing, regulatory
uncertainties regarding the collection and results of, clinical data, dependence
on third party performance, and 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.
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