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Quotes & Info
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| ELGX > SEC Filings for ELGX > Form 10-Q on 8-May-2009 | All Recent SEC Filings |
8-May-2009
Quarterly Report
We continue to conduct clinical trials for other products related to the
Powerlink System. All the required 63 patients have been enrolled in a clinical
trial for a 34mm infrarenal bifurcated device designed to treat patients with
large aortic necks.
Results of Operations
Comparison of the Three Months Ended March 31, 2009 and 2008
Product Revenue. Product revenue increased 42% to $11.8 million in the three
months ended March 31, 2009 from $8.3 million in the three months ended
March 31, 2008. Domestic sales increased 49% to $10.2 million in the three
months ended March 31, 2009 from $6.8 million in the three months ended
March 31, 2008. The increase in domestic sales was primarily due to increased
productivity of our sales representatives, as well as the introduction of two
new products in 2008. In addition, we began marketing our new system to deliver
and deploy the Powerlink system in the first quarter of 2009. The new delivery
system, called IntuiTrak, was designed to further simplify the implant
procedure, and contributed to the increase in domestic revenue.
International sales increased 13% to $1.7 million in the three months ended
March 31, 2009 from $1.5 million for the comparable period in the prior year.
This increase was driven primarily by higher sales to Cosmotec in Japan due to
greater market acceptance.
We expect that product revenue will continue to grow, both sequentially and
compared to prior year periods. We anticipate that product revenue will be
between $47.0 to $50.0 million for the year ended December 31, 2009.
Cost of Product Revenue. The cost of product revenue increased 15% to
$2.9 million in the three months ended March 31, 2009 from $2.5 million in the
three months ended March 31, 2008, due to an increase in the volume of Powerlink
System sales. As a percentage of product revenue, cost of product revenue
decreased to 25% in the first quarter of 2009 as compared to 30% in the same
period of 2008. The percentage decline in the cost of product revenue was due to
the full substitution of in-house produced ePTFE graft material for higher-cost
purchased graft material, in the products sold during the 2009 period.
We believe that gross profit will increase in 2009 due to the expected higher
commercial sales of the Powerlink System both in and outside of the United
States. We also expect gross margin as a percentage of product revenues to
increase modestly due to expected higher average selling prices for the
IntuiTrak delivery system and due to efficiencies from higher manufacturing
volumes required to support sales growth.
Research, Development and Clinical. Research, development and clinical
expense was relatively unchanged at $1.4 million in the three months ended
March 31, 2009 as compared to $1.5 million for the three months ended March 31,
2008.
We expect that research, development, and clinical expense will increase
sequentially over the remaining quarters of 2009 as we pursue opportunities to
develop additional new products for the treatment of aortic disorders.
Marketing and Sales. Marketing and sales expense increased 14% to
$6.6 million in the three months ended March 31, 2009 from $5.8 million in the
three months ended March 31, 2008. The increase in the first quarter of 2009
resulted primarily from:
• marketing costs related to the launch of the IntuiTrak delivery system,
• expenses related to more intensive training of sales representatives, and
• higher commission expense on the 49% increase in domestic sales between those periods.
We anticipate that marketing and sales expense will increase for the remaining quarters of the year due to the addition of four to six additional sales territories, the higher compensation associated with the anticipated sales growth, the addition of executive staff in the second quarter, and the increase in marketing related costs for the broader launch of the IntuiTrak Express delivery system for Powerlink XL in the third quarter of the 2009 fiscal year.
General and Administrative. General and administrative expense decreased 9%
to $2.1 million in the three months ended March 31, 2009 from $2.2 million in
the three months ended March 31, 2008. The decrease is primarily due to the
resolution of certain legal matters ongoing during the first quarter of 2008,
offset by higher compensation expense paid in 2009.
We expect general and administrative expenses to be in the $1.9 million to
$2.1 million range per quarter through the balance of 2009.
Other Income(Expense). Other income decreased 176% to ($61,000) in the three
months ended March 31, 2009 from $80,000 in the same period of 2008. The
decrease in other income was primarily the result of interest expense in 2009
due to drawing down on the term loan and revolving line of credit with Silicon
Valley Bank in September 2008, the non-recurrence of income related to a credit
card rebate program and the loss in the value of our investment in Cianna
Medical.
Liquidity and Capital Resources
For the three months ended March 31, 2009, we incurred net losses of
$1.2 million. As of March 31, 2009, we had an accumulated deficit of
approximately $144.9 million. Historically, we have relied on the sale and
issuance of equity securities to provide a significant portion of funding for
our operations.
In February 2007, we entered into a revolving credit facility with Silicon
Valley Bank whereby we may borrow up to $5.0 million under a revolving line of
credit. All outstanding amounts under the revolving line of credit bear interest
at a variable rate equal to the lender's prime rate plus 0.5%, which is payable
on a monthly basis. The unused portion is subject to an unused revolving line
facility fee, payable quarterly, in arrears, on a calendar year basis, in an
amount equal to one quarter of one percent per annum of the average unused
portion of the revolving line of credit, as determined by the bank. The credit
facility also contains customary covenants regarding operations of our business
and financial covenants relating to ratios of current assets to current
liabilities and tangible net worth during any calendar quarter and is
collateralized by all of our assets with the exception of our intellectual
property. All amounts owing under the revolving line of credit become due and
payable in July 2010. In September 2008, we drew down $2.0 million. As of
March 31, 2009, we had $2.0 million in outstanding borrowings under the
revolving line of credit.
In July 2008, we entered into an amendment to the credit facility which added
a term loan whereby we may borrow up to $3.0 million. In September 2008, we drew
down the $3.0 million term loan, all of which was outstanding at March 31, 2009.
The term loan requires interest only payments at a variable rate equal to the
lender's prime rate plus 1.0%, which is payable on a monthly basis through
March 31, 2009. The term loan principal is due in 36 monthly installments
beginning in April 2009.
Our existing credit facility with Silicon Valley Bank contains negative
covenants on the operation of our business and financial covenants, including
requiring us to maintain a tangible net worth of $13.0 million. As of March 31,
2009, our tangible net worth was $13.6 million. If we are not able to maintain
compliance with our financial covenants, certain terms of the revolving line of
credit and term loan will change including an increase in the interest rate and
a limitation on the amounts available for borrowing under the credit facility
based on eligible accounts receivable. Further, if we do not maintain a tangible
net worth of at least $12.0 million from the first date on which we are not in
complete compliance with our financial covenants through June 29, 2009, and
$12.5 million thereafter, we will be in default under the credit facility which
could allow the lender to accelerate the repayment of the indebtedness under the
credit facility. As of March 31, 2009, we were in complete compliance with all
of our covenants under the credit facility.
At March 31, 2009, we had cash and cash equivalents of $6.8 million. We
expect that our continued growth, strong gross margins and expense controls will
enable us to achieve positive cash flow from operations in the second quarter of
2009, consequently, we believe that our current cash balance, in combination
with cash receipts generated from sales of the Powerlink System and borrowings
available under our credit facility, will be sufficient to meet anticipated cash
needs for operating and capital expenditures through at least the next twelve
months. If we do not realize expected revenue and gross profit margin levels, or
if we are unable to manage our operating expenses in line with our revenues, or
if we cannot maintain our days sales outstanding accounts receivable level, we
may not achieve positive cash flow from operations in the second quarter of
2009, nor be able to fund our operations through at least the next twelve
months.
We believe that the future growth of our business will depend upon our
ability to successfully develop new technologies and bring these technologies to
market, as well as increased market acceptance of the Powerlink System. If we
pursue additional research and development opportunities or fail to increase our
penetration of the AAA market, or if we fail to reduce certain discretionary
expenditures, as necessary, we may need to seek additional sources of financing.
In the event that we require additional funding to continue our operations, we
will attempt to raise the required capital through either debt or equity
arrangements.
The timing and amount of our future capital requirements will depend on many
factors, including:
• the rate of market acceptance of the Powerlink System;
• our requirements for additional manufacturing capacity;
• our requirements for additional IT infrastructure and systems;
• our requirements for additional facility space; and
• the need for additional capital to fund future development programs.
If we are required to obtain additional financing, we may not be able to do so on acceptable terms, if at all. Even if we are able to obtain such financing it may cause substantial dilution for our stockholders, in the case of an equity financing, or may contain burdensome restrictions on the operations of our business, in the case of debt financing.
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