Cytori Reports Third Quarter Results; Provides Update on Clinical Trials and Product Launch
Posted on: Monday, 12 November 2007, 09:01 CST
Cytori Therapeutics (NASDAQ:CYTX) reports financial results for the quarter ended September 30, 2007 and provides an update on recent developments and plans for commercialization.
"Marketing of the Celution™ System has begun," said Christopher J. Calhoun, chief executive officer. "Cytori and Green Hospital Supply have initiated commercialization efforts and intend to install the first Celution™-based StemSource™ Cell Bank in early 2008. In addition, we started commercial activities in Europe for the Celution™ market introduction in the first quarter of next year for reconstructive surgery. These efforts will be supported through two breast reconstruction post-marketing studies, RESTORE II and VENUS, which will begin in 2008. In parallel, we continue to move our product development pipeline forward, as approval was received to begin our APOLLO heart attack study and enrollment continues for the PRECISE chronic heart disease trial."
Upcoming milestones that may impact the Company's value include the following:
Sale of the first Celution™ System-based StemSource™ Cell Banks in Japan
Market introduction of the Celution™ System for plastic and reconstructive surgery in Europe
Report of results next month of an investigator-initiated breast reconstruction safety and feasibility study in Japan
Initiation of two post-marketing breast reconstruction studies in Europe in patients following partial mastectomy
Complete enrollment of our two heart disease clinical trials, a major part of our development pipeline
StemSource™ Product Launch
In the third quarter of 2007, Cytori entered into a partnership to commercialize Cytori's StemSource™ Cell Bank, which includes Cytori's Celution™ System, to hospitals throughout Japan. Cytori recently received regulatory approval in Japan on the Celution™ System for use in medical laboratories for stem cell collection and preservation procedures. Green Hospital Supply has begun training its sales team and developed and is introducing its marketing campaign for the sale of StemSource™ Cell Banks starting in early 2008.
Reconstructive Surgery Market Introduction
Recent approval in Europe (CE Mark) on the Celution™ System enables Cytori to begin targeted commercial introduction and sales to select reconstructive surgeons in Europe. This marketing effort will include an experienced network of healthcare distributors who have established relationships with physicians and hospitals in their respective regions. Cytori expects the first Celution™ System sales to begin in early 2008.
Enrollment was completed this year for an investigator-initiated study in Japan for breast reconstruction following partial mastectomy. Based on preliminary results, Cytori plans to initiate the RESTORE II and VENUS post-marketing trials to support future reimbursement and marketing efforts. These studies will evaluate the use of adipose-derived stem and regenerative cells processed with the Celution™ System for breast reconstruction following partial mastectomy. RESTORE II will be an approximately 70-patient, multi-center, study. VENUS will be a 20 patient single center study in patients with more severe radiation damage and contour defects.
Product Development Pipeline
"Cytori continues to rapidly move its product development pipeline forward along many fronts," said Marc H. Hedrick, M.D. president, Cytori Therapeutics.
Two randomized, placebo controlled, dose-escalation heart disease clinical trials are underway in Europe. The APOLLO heart attack study received final approval and enrollment is now ongoing. Cytori's PRECISE chronic myocardial ischemia trial started in January and enrollment is active.
An investigator initiated study for breast augmentation started in Japan in November 2007, the first of many expected investigator-initiated studies across a number of medical applications. These studies could accelerate and broaden the clinical uses for the Celution™ System. Data collected from these studies could play an important role in supporting future marketing efforts for the Celution™ System.
Preclinical spinal disc repair data was reported this fall showing that at six-months, adipose derived stem and regenerative cells could be used at the time of surgery to repair herniated discs or prevent spinal disc disease from spreading to adjacent levels. 12-month follow up data will be reported next year.
2008 Outlook
"For 2008, we will recognize Celution™ System revenues for the first time," said Mark E. Saad, chief financial officer. "We expect our total product revenues will be between $10 million and $12 million, which will consist mostly of StemSource™ Cell Bank installations."
Financials
Development revenues for the quarter and nine months ended September 30, 2007 were $3.4 million and $5.2 million, respectively, compared to $351,000 and $1.2 million, respectively, for the same periods in 2006.
General and administrative expenses for the quarter and nine months ended September 30, 2007 were $3.2 million and $9.8 million, respectively, compared to $3.2 million and $10.0 million, respectively, for the same periods in 2006. Research and development expenses for the quarter and nine months ended September 30, 2007 were $5.2 million and $14.6 million, respectively, compared to $5.6 million and $16.7 million, respectively, in the same periods in 2006. The decline in research and development for the third quarter and nine months ended September 30, 2007 is attributable to lower costs associated with preclinical studies, which were partially offset by clinical trial-related expenses.
Net loss for the quarter and nine months ended September 30, 2007 was $5.3 million, or $(0.22) per common share, and $18.0 million, or $(0.80) per common share, respectively, compared to a net loss of $8.8 million, or $(0.53) per common share, and $23.6 million or $(1.48) per common share, respectively, for the same periods in 2006.
Cash, cash equivalents and short term investments were $18.9 million as of September 30, 2007.
Management Discussion
The company will host a conference call today at 10 a.m. Eastern Daylight Time to discuss the financial results, provide an update on clinical trial progress, and review business related developments. The webcast may be accessed at www.cytoritx.com. The webcast will be available live and by replay two hours after the call on the company's website and archived for 90 days. A telephone replay will be available for one week. To access the replay, please call +1 (303) 590-3000 (PIN: 11099286#).
Cytori Therapeutics
Cytori Therapeutics is a global leader in the development of regenerative medicine products. The company is developing therapeutic applications for its Celution™ System to enable real-time regenerative cell therapy in conjunction with breast reconstruction surgery, cardiovascular disease, and other large unmet medical needs. The Company's StemSource™ Cell Bank, which is based on Cytori's innovative Celution™ System, will be commercialized in Japan starting in 2008 to hospitals and clinics to enable regenerative cell banking. www.cytoritx.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business, which may affect our future operating results and financial position. Such statements 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, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. 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
September 30, 2007
As of
December 31, 2006
Assets
Current assets:
Cash and cash equivalents
$
17,939,000
$
8,902,000
Short-term investments, available-for-sale
994,000
3,976,000
Accounts receivable, net of allowance for doubtful accounts of $1,000 and $2,000 in 2007 and 2006, respectively
31,000
225,000
Inventories, net
--
164,000
Other current assets
788,000
711,000
Total current assets
19,752,000
13,978,000
Property and equipment held for sale, net
--
457,000
Property and equipment, net
3,639,000
4,242,000
Investment in joint venture
77,000
76,000
Other assets
425,000
428,000
Intangibles, net
1,134,000
1,300,000
Goodwill
3,922,000
4,387,000
Total assets
$
28,949,000
$
24,868,000
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses
$
4,901,000
$
5,587,000
Current portion of long-term obligations
692,000
999,000
Total current liabilities
5,593,000
6,586,000
Deferred revenues, related party
18,748,000
23,906,000
Deferred revenues
2,379,000
2,389,000
Option liability
1,000,000
900,000
Long-term deferred rent
547,000
741,000
Long-term obligations, less current portion
444,000
1,159,000
Total liabilities
28,711,000
35,681,000
Commitments and contingencies
--
--
Stockholders' equity (deficit):
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding in 2007 and 2006
--
--
Common stock, $0.001 par value; 95,000,000 shares authorized; 25,801,091 and 21,612,243 shares issued and 23,928,257 and 18,739,409 shares outstanding in 2007 and 2006, respectively
26,000
22,000
Additional paid-in capital
128,458,000
103,053,000
Accumulated deficit
(121,452,000
)
(103,460,000
)
Treasury stock, at cost
(6,794,000
)
(10,414,000
)
Accumulated other comprehensive income
--
1,000
Amount due from exercises of stock options
--
(15,000
)
Total stockholders' equity (deficit)
238,000
(10,813,000
)
Total liabilities and stockholders' equity (deficit)
$
28,949,000
$
24,868,000
Consolidated Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
For the Three Months
Ended September 30,
For the Nine Months
Ended September 30,
2007
2006
2007
2006
Product revenues
$
--
$
133,000
$
792,000
$
1,087,000
Cost of product revenues
--
383,000
422,000
1,341,000
Gross profit (loss)
--
(250,000
)
370,000
(254,000
)
Development revenues:
Development, related party
3,362,000
--
5,158,000
683,000
Development
--
1,000
10,000
149,000
Research grant and other
11,000
350,000
65,000
413,000
3,373,000
351,000
5,233,000
1,245,000
Operating expenses:
Research and development
5,193,000
5,552,000
14,583,000
16,749,000
Sales and marketing
613,000
610,000
1,678,000
1,584,000
General and administrative
3,177,000
3,181,000
9,777,000
10,005,000
Change in fair value of option liabilities
--
(374,000
)
100,000
(3,514,000
)
Total operating expenses
8,983,000
8,969,000
26,138,000
24,824,000
Operating loss
(5,610,000
)
(8,868,000
)
(20,535,000
)
(23,833,000
)
Other income (expense):
Gain on sale of assets
--
--
1,858,000
--
Interest income
302,000
158,000
849,000
537,000
Interest expense
(33,000
)
(47,000
)
(128,000
)
(158,000
)
Other expense, net
18,000
(7,000
)
(37,000
)
(13,000
)
Equity gain (loss) from investment in joint venture
(5,000
)
(3,000
)
1,000
(68,000
)
Total other income
282,000
101,000
2,543,000
298,000
Net loss
(5,328,000
)
(8,767,000
)
(17,992,000
)
(23,535,000
)
Other comprehensive gain (loss) -- unrealized holding gain (loss)
--
6,000
(1,000
)
(18,000
)
Comprehensive loss
$
(5,328,000
)
$
(8,761,000
)
$
(17,993,000
)
$
(23,553,000
)
Basic and diluted net loss per common share
$
(0.22
)
$
(0.53
)
$
(0.80
)
$
(1.48
)
Basic and diluted weighted average common shares
23,903,082
16,641,423
22,502,133
15,891,674
Source: Business Wire
Related Articles
- Dia Bras Reports Highlights of Its 2007 Exploration And Development Program And Presents Its 2008 Objectives
- Cytori's Celution System Under Evaluation for Breast Augmentation
- 2007 U.S. Power System Wall Map Release Shows Where U.S. Power Grid Is Expanding
- Helix Biomedix to Present at the PCITX Product Development Conference 2006
- DataDirect Networks Showcases the Industry's Highest Performance Most Dense Storage System at SIGGRAPH 2006
- DOBI Medical International to Exhibit ComfortScan(R) System at the 2006 European Congress of Radiology
- MooBella Launches Revolutionary Ice Cream System at DEMO 2006
- Green Hills Software and I-Logix Redefine ``Integrated Development Environment'' With First Single Source Solution Addressing All Phases of Embedded Systems Development
- An Exploratory Assessment of the Pedagogical Effectiveness of a Systems Development Environment
- Strong Global Interest in Microsoft Office System Developer Conference Reflects Increased Commitment to Building Office-Based Solutions
 |
 |
User Comments (0)
RSS Feeds