Published: May 17, 2010
Cambridge Heart Reports Results for First Quarter 2010
TEWKSBURY, Mass. - (BUSINESS WIRE) - Cambridge Heart, Inc. (OTCBB: CAMH), today reported results for its
first quarter ended March 31, 2010. Full financial statements and
corresponding commentary can be found in the Company's Form 10-Q, which
is expected to be filed with the Securities and Exchange Commission on
May 17, 2010. The following financial and strategic milestones highlight
the first quarter and subsequent weeks:
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Revenue - Revenue for the first quarter was $658,000, compared to
$805,000 in the fourth quarter of 2009. The Company believes the
decrease in revenue is due to ongoing weakness in the sales of medical
equipment in general, limited scope of distribution, and the continued
uncertainty around certain global reductions in reimbursement,
resulting in delayed physician purchasing decisions. A total of eight
Heartwave II systems were sold or placed domestically in the first
quarter.
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MTWA Module Distribution Update - In April 2010, the Company received
clearance from the U.S. Food and Drug Administration (FDA) to begin
marketing its Microvolt T-Wave Alternans (MTWA) OEM module. This FDA
510(k) clearance allows the Company to begin marketing the MTWA OEM
module integrated with the Q-Stress line of stress systems
manufactured by Cardiac Science Corporation, Inc. The Company has
begun to work with Cardiac Science on sales training and marketing
materials and expects to launch the product in the third quarter of
this year.
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Financing - The Company has notified the investors in the December
2009 Series D Convertible Preferred Stock financing that it is
exercising its right to call all previously unexercised five-year
warrants to purchase shares of the Company's common stock issued to
the investors in connection with the Series D financing (the
"Long-Term Warrants" ). Assuming the Series D investors exercise all of
the Long-Term Warrants, the Company would receive $962,000 of
additional capital, $208,000 of which has previously been received by
the Company in connection with the exercise of certain Long- Term
Warrants. The Long-Term Warrants give the Series D investors the right
to purchase an aggregate of 6,775,611 of shares of common stock, at an
exercise price of $0.142 per share. The shares of common stock to be
issued by the Company upon exercise of the Long-Term Warrants are
subject to customary restrictions on the transfer of securities issued
in a private placement under the federal securities laws.
In addition, the Company has received proceeds of $261,000 from the
exercise of Short-Term Warrants by two Series D investors who, as noted
above, also have exercised their Long-Term Warrants.
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Cash Expense Reductions - In order to reduce cash expenditures, in
March 2010, the Company made effective the following cuts:
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Replaced 10 percent of senior management's salaries and 100
percent of senior management's 2009 earned cash bonuses with
options to purchase shares of common stock of the Company;
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Reduced the annual retainer paid to non-employee directors and
eliminated per meeting fees, which is expected to reduce
board-related cash compensation by 50 percent. In recognition of
this reduction in fees, each non-employee director was issued
options to purchase shares of common stock of the Company.
Commenting on the results of the quarter and recent events, Cambridge
Heart CEO Ali Haghighi-Mood said, "The FDA clearance of our MTWA OEM
module highlighted the first quarter and brings us one step closer to
launching that device, which we believe will positively impact our
financial results once it is on the market later this year." Mr.
Haghighi-Mood added, "In the meantime, we are hopeful that legislation
will be enacted in the near term to resolve some of the uncertainty
surrounding reimbursement that has negatively impacted the sales of our
MTWA systems."
Financial Results for the first quarter ended March 31, 2010
Total revenue for the first quarter ended March 31, 2010 was $658,000, a
decrease of 21% from total revenue of $836,000 reported during the same
period of 2009. The revenue compared to the 2009 period was adversely
impacted by ongoing weakness in the sales of medical equipment in
general, our limited scope of distribution, and the continued
uncertainty around certain reductions in reimbursement.
Cost of sales for the first quarter of 2010 was $510,000 (which includes
a $102,000 charge to reserve for potentially excess inventory) compared
to $493,000 in the same period in 2009. The reserve is based on the
uncertainty that the Company will realize the full value of the existing
inventory over the next 12 months. The inventory was built up in order
to satisfy our contractual obligations under the former co-marketing
agreement with St. Jude Medical.
Selling, general and administrative expenses for the first quarter of
2010 were $1,451,000, a decrease of $982,000, or 40%, compared to
$2,433,000 in the first quarter of 2009. The decrease in SG&A expense is
primarily driven by the reduction in headcount in March 2009, lower
consultative and advisory expenses, and lower variable selling expenses
as a result of lower sales of commissionable products in the U.S.
The operating loss for the first quarter of 2010 was $1,450,000,
compared to an operating loss of $2,165,000 for the same period last
year. Included in the operating loss for the first quarter of 2010 was
$394,000 of non-cash stock-based compensation expense, and a $102,000
reserve for potentially excess inventory. The net loss for the quarter
was $1,451,000 or $0.02 per share, compared to a net loss of $2,155,000,
or $0.03 per share, in the comparable 2009 period.
The Company ended the first quarter with cash and cash equivalents of
$2,228,000. The cash used by operations was $1,049,000 for the quarter
ended March 31, 2010. The Company believes that the existing resources
and currently projected financial results, which include sales of the
MTWA Module and Micro-V Alternans Sensors to Cardiac Science and the
exercise of the Long-Term Warrants, are sufficient to fund operations
through December 31, 2010. The projections do not include the potential
additional proceeds of up to $947,000 from the exercise of the
previously unexercised Short-Term Warrants that were issued in
connection with the Series D Private Placement.
The Company currently has a total of 92.6 million shares of common stock
and common stock equivalents issued and outstanding, including the
effect of converting the Series C-1 preferred stock and the Series D
preferred stock into shares of common stock. In addition, there are
options and warrants outstanding to purchase 27 million shares of common
stock, bringing the fully diluted share count to 119.7 million shares of
common stock.
Questions can be directed to the Company's management or its investor
relations firm at the contact numbers noted above.
About Cambridge Heart, Inc.
Cambridge Heart develops and commercializes non-invasive diagnostic
tests for cardiac disease, with a focus on identifying those at risk for
sudden cardiac arrest (SCA). The Company's products incorporate
proprietary Microvolt T-Wave Alternans measurement technologies,
including the patented Analytic Spectral Method and
ultrasensitive disposable electrode sensors. The Company's MTWA test,
originally based on research conducted at the Massachusetts Institute of
Technology, is reimbursed by Medicare under its National Coverage Policy.
Cambridge Heart, founded in 1990, is based in Tewksbury, MA. It is
traded on the Over-The-Counter Bulletin Board (OTCBB) under the symbol
CAMH.OB. http://www.cambridgeheart.com.
Statements contained in this press release that are not purely
historical are forward-looking statements for purposes of the safe
harbor provisions under The Private Securities Litigation Reform Act of
1995. In some cases, we use words such as "believes" , "expects" ,
"anticipates" , "plans" , "estimates" , "could" , and similar expressions
that convey uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements include
statements about the Company's expected launch of the MTWA Module, the
Company's expected reductions in operating expenses, and the Company's
belief that existing resources and currently projected financial results
are sufficient to fund operations through December 31, 2010. Actual
results may differ materially from those indicated by these
forward-looking statements. Material deviations from our current
operating plan, including a delay in gaining FDA clearance for the MTWA
Module, a delay in launching the MTWA Module with Cardiac Science, lower
than expected sales to Cardiac Science, lower than expected sales of our
Heartwave II System, may cause or contribute to such differences. Other
factors that may cause or contribute to such differences include failure
to achieve broad market acceptance of the Company's MTWA technology,
failure of our sales and marketing organization to market our products
effectively, inability to hire and retain qualified clinical
applications specialists in the Company's target markets, failure to
obtain or maintain adequate levels of first-party reimbursement for use
of the Company's MTWA test, customer delays in making final buying
decisions, decreased demand for the Company's products, failure to
obtain funding necessary to fund operations and to develop or enhance
our technology, adverse results in future clinical studies of our
technology, failure to obtain or maintain patent protection for our
technology and other factors identified in our most recent Annual Report
on Form 10-K under "Risk Factors" , which is on file with the SEC and
available at www.EDGAR.com.
In addition, any forward-looking statements represent our estimates
only as of today and should not be relied upon as representing our
estimates as of any subsequent date. While we may elect to update
forward-looking statements at some point in the future, we specifically
disclaim any obligation to do so except as may be legally necessary,
even if our estimates should change.
-Financial information follows-
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Cambridge Heart, Inc.
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Financial Highlights
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Statement of Operations
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Three months ended March 31,
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2009
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2010
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(unaudited)
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(unaudited)
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Revenue
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$
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835,522
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$
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658,312
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Cost of goods sold
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492,810
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509,625
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Gross profit
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$
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342,712
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$
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148,687
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Costs and expenses
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Research and development
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74,448
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148,395
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Selling, general and administrative
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2,432,955
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1,450,630
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Total operating expenses
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$
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2,507,403
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$
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1,599,025
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Loss from operations
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$
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(2,164,691
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$
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(1,450,338
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Interest income
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11,689
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58
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Interest expense
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(2,064
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(1,193
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Net loss
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$
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(2,155,066
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$
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(1,451,473
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Net loss per common share - basic and diluted
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$
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(0.03
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$
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(0.02
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Weighted average shares outstanding - basic
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and diluted
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64,543,021
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65,295,640
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Balance Sheet
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December 31,
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March 31,
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2009
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2010
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(unaudited)
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(unaudited)
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Assets
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Cash and cash equivalents
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$
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3,159,468
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$
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2,227,509
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Restricted cash, current portion
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100,000
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100,000
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Accounts receivable, net
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458,887
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444,895
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Inventory, net
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1,152,620
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990,530
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Other prepaid assets
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118,312
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147,284
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Total current assets
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4,989,287
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3,910,218
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Fixed assets, net
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239,970
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238,206
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Restricted cash, net current portion
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400,000
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300,000
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Other assets
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42,655
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53,996
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Total assets
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$
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5,671,912
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$
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4,502,420
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Liabilities and stockholders'
deficit
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Accounts payable and accrued expenses
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$
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1,500,431
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$
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1,261,427
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Current portion of capital lease obligation
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13,571
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4,032
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Total current liabilities
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1,514,002
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1,265,459
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Capital lease obligation, net of current portion
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13,551
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32,592
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Total liabilities
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$
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1,527,553
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$
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1,298,051
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Convertible preferred stock
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$
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12,870,613
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$
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12,870,613
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Stockholders' deficit
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Common stock
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64,905
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65,872
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Additional paid-in-capital
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87,201,360
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87,711,876
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Accumulated deficit
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(95,992,519
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(97,443,992
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Total stockholders' deficit
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(8,726,254
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(9,666,244
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Total liabilities and stockholders' deficit
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$
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5,671,912
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$
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4,502,420
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At Cambridge Heart: Vincenzo LiCausi, 978-654-7600 x 6645 Chief
Financial Officer vincenzol@cambridgeheart.com or Media: KOGS
Communication Edna Kaplan, 781-639-1910 kaplan@kogspr.com or Investor
Relations: Allen & Caron Matt H. Clawson, 949-474-4300 matt@allencaron.com
Copyright © 2012, Business Wire, Inc., All rights reserved. Copyright © 2012, NewsBlaze, Daily News
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